Trial Outcomes & Findings for REGENETEN™ Bioinductive Implant System in Full-thickness Tears (NCT NCT04450342)
NCT ID: NCT04450342
Last Updated: 2025-05-23
Results Overview
Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
6 months
Results posted on
2025-05-23
Participant Flow
Overall, 119 participants were enrolled to the study at 15 sites.
Participant milestones
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
24
|
|
Overall Study
COMPLETED
|
10
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
37
|
34
|
12
|
Reasons for withdrawal
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Device not used
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject & Study Terminated by Sponsor
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
0
|
|
Overall Study
Reoperation
|
1
|
1
|
0
|
|
Overall Study
Screen Failures
|
0
|
0
|
2
|
|
Overall Study
Site Terminated by Sponsor
|
1
|
1
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
31
|
29
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
Baseline Characteristics
Number of participants analyzed indicated those in the safety analysis set (SAF) with data collected for measure specified.
Baseline characteristics by cohort
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=47 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 7.6 • n=47 Participants
|
62.2 years
STANDARD_DEVIATION 8.7 • n=48 Participants
|
58.3 years
STANDARD_DEVIATION 9.2 • n=24 Participants
|
61.5 years
STANDARD_DEVIATION 8.5 • n=119 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=47 Participants
|
21 Participants
n=48 Participants
|
5 Participants
n=24 Participants
|
42 Participants
n=119 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=47 Participants
|
27 Participants
n=48 Participants
|
19 Participants
n=24 Participants
|
77 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=47 Participants
|
2 Participants
n=48 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=47 Participants
|
41 Participants
n=48 Participants
|
21 Participants
n=24 Participants
|
102 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=47 Participants
|
5 Participants
n=48 Participants
|
3 Participants
n=24 Participants
|
11 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · White / Caucasian
|
43 Participants
n=47 Participants
|
37 Participants
n=48 Participants
|
22 Participants
n=24 Participants
|
102 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Black / African American
|
0 Participants
n=47 Participants
|
2 Participants
n=48 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Asian Indian
|
1 Participants
n=47 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Chinese
|
3 Participants
n=47 Participants
|
5 Participants
n=48 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Japanese
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Korean
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Vietnamese
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Other Asian
|
0 Participants
n=47 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Aboriginal and Torres Strait Islander
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=119 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=47 Participants
|
2 Participants
n=48 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=119 Participants
|
|
Body Mass Index (BMI)
|
29.7 kg/m^2
STANDARD_DEVIATION 6.0 • n=45 Participants • Number of participants analyzed indicated those in the safety analysis set (SAF) with data collected for measure specified.
|
29.5 kg/m^2
STANDARD_DEVIATION 5.8 • n=46 Participants • Number of participants analyzed indicated those in the safety analysis set (SAF) with data collected for measure specified.
|
28.3 kg/m^2
STANDARD_DEVIATION 5.4 • n=24 Participants • Number of participants analyzed indicated those in the safety analysis set (SAF) with data collected for measure specified.
|
29.3 kg/m^2
STANDARD_DEVIATION 5.8 • n=115 Participants • Number of participants analyzed indicated those in the safety analysis set (SAF) with data collected for measure specified.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=42 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=19 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Retear Rate at 6 Months
|
57.14 percentage of retears
Interval 40.96 to 72.28
|
50.00 percentage of retears
Interval 34.19 to 65.81
|
42.11 percentage of retears
Interval 20.25 to 66.5
|
SECONDARY outcome
Timeframe: 3 months, 12 months, and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=31 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=25 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=10 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Number of Retears at 3 Months, 12 Months, and 24 Months
3 months
|
12 Participants
|
10 Participants
|
6 Participants
|
|
Number of Retears at 3 Months, 12 Months, and 24 Months
12 months
|
7 Participants
|
6 Participants
|
—
|
|
Number of Retears at 3 Months, 12 Months, and 24 Months
24 months
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Seven participants had out of range scores (i.e., scores were greater than the highest score possible) and were not included for analysis. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=44 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=45 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=23 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Oxford Shoulder Score (OSS)
Baseline
|
33.1 score on a scale
Standard Deviation 7.7
|
34.0 score on a scale
Standard Deviation 7.5
|
29.5 score on a scale
Standard Deviation 7.8
|
|
Oxford Shoulder Score (OSS)
3 months
|
25.1 score on a scale
Standard Deviation 8.0
|
29.4 score on a scale
Standard Deviation 9.7
|
23.4 score on a scale
Standard Deviation 9.6
|
|
Oxford Shoulder Score (OSS)
6 months
|
18.9 score on a scale
Standard Deviation 6.6
|
19.9 score on a scale
Standard Deviation 7.9
|
18.9 score on a scale
Standard Deviation 7.6
|
|
Oxford Shoulder Score (OSS)
12 months
|
18.8 score on a scale
Standard Deviation 8.5
|
17.3 score on a scale
Standard Deviation 7.9
|
—
|
|
Oxford Shoulder Score (OSS)
24 months
|
19.0 score on a scale
Standard Deviation 7.1
|
15.0 score on a scale
Standard Deviation 4.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=46 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
Baseline
|
1271.3 score on a scale
Standard Deviation 366.6
|
1307.5 score on a scale
Standard Deviation 398.7
|
1194.0 score on a scale
Standard Deviation 427.6
|
|
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
3 months
|
860.7 score on a scale
Standard Deviation 350.1
|
936.7 score on a scale
Standard Deviation 472.4
|
703.9 score on a scale
Standard Deviation 365.1
|
|
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
6 months
|
533.6 score on a scale
Standard Deviation 429.5
|
540.1 score on a scale
Standard Deviation 475.1
|
548.8 score on a scale
Standard Deviation 493.4
|
|
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
12 months
|
432.8 score on a scale
Standard Deviation 453.7
|
405.6 score on a scale
Standard Deviation 596.5
|
—
|
|
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
24 months
|
281.5 score on a scale
Standard Deviation 252.4
|
62.5 score on a scale
Standard Deviation 81.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Six participants had out of range scores (i.e., scores were greater than the highest score possible) and were not included for analysis. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=45 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=45 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=23 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Constant-Murley Score
Baseline
|
56.5 score on a scale
Standard Deviation 13.5
|
54.9 score on a scale
Standard Deviation 13.7
|
55.6 score on a scale
Standard Deviation 16.8
|
|
Constant-Murley Score
3 months
|
—
|
55.0 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
43.4 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
|
Constant-Murley Score
6 months
|
57.0 score on a scale
Standard Deviation 13.0
|
53.7 score on a scale
Standard Deviation 12.3
|
53.4 score on a scale
Standard Deviation 9.4
|
|
Constant-Murley Score
12 months
|
59.1 score on a scale
Standard Deviation 13.8
|
57.2 score on a scale
Standard Deviation 10.7
|
—
|
|
Constant-Murley Score
24 months
|
58.5 score on a scale
Standard Deviation 3.5
|
51.0 score on a scale
Standard Deviation 11.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=46 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Subjective Shoulder Value (SSV)
Baseline
|
38.3 score on a scale
Standard Deviation 21.6
|
38.1 score on a scale
Standard Deviation 24.6
|
47.1 score on a scale
Standard Deviation 22.7
|
|
Subjective Shoulder Value (SSV)
3 months
|
60.1 score on a scale
Standard Deviation 21.0
|
57.1 score on a scale
Standard Deviation 20.8
|
72.5 score on a scale
Standard Deviation 16.8
|
|
Subjective Shoulder Value (SSV)
6 months
|
74.1 score on a scale
Standard Deviation 17.7
|
77.3 score on a scale
Standard Deviation 20.6
|
76.3 score on a scale
Standard Deviation 21.4
|
|
Subjective Shoulder Value (SSV)
12 months
|
80.0 score on a scale
Standard Deviation 14.9
|
88.9 score on a scale
Standard Deviation 10.2
|
—
|
|
Subjective Shoulder Value (SSV)
24 months
|
77.5 score on a scale
Standard Deviation 24.7
|
91.5 score on a scale
Standard Deviation 9.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the participant's health state and consists of five dimensions to create an index score for mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=46 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
Baseline
|
0.618 score on a scale
Standard Deviation 0.186
|
0.574 score on a scale
Standard Deviation 0.229
|
0.597 score on a scale
Standard Deviation 0.216
|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
3 months
|
0.720 score on a scale
Standard Deviation 0.194
|
0.649 score on a scale
Standard Deviation 0.206
|
0.776 score on a scale
Standard Deviation 0.173
|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
6 months
|
0.781 score on a scale
Standard Deviation 0.216
|
0.786 score on a scale
Standard Deviation 0.232
|
0.834 score on a scale
Standard Deviation 0.165
|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
12 months
|
0.719 score on a scale
Standard Deviation 0.227
|
0.805 score on a scale
Standard Deviation 0.256
|
—
|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
24 months
|
0.679 score on a scale
Standard Deviation 0.200
|
0.919 score on a scale
Standard Deviation 0.115
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=46 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
Baseline
|
73.4 score on a scale
Standard Deviation 15.4
|
69.8 score on a scale
Standard Deviation 17.5
|
65.3 score on a scale
Standard Deviation 23.1
|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
3 months
|
74.2 score on a scale
Standard Deviation 15.7
|
73.0 score on a scale
Standard Deviation 16.4
|
80.3 score on a scale
Standard Deviation 20.5
|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
6 months
|
82.5 score on a scale
Standard Deviation 15.4
|
79.3 score on a scale
Standard Deviation 19.0
|
73.5 score on a scale
Standard Deviation 21.8
|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
12 months
|
75.1 score on a scale
Standard Deviation 16.6
|
75.0 score on a scale
Standard Deviation 15.2
|
—
|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
24 months
|
30.0 score on a scale
Standard Deviation 28.3
|
87.5 score on a scale
Standard Deviation 3.5
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question "How satisfied are you with your medical care?". Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=46 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Patient Satisfaction Questionnaire: Medical Care
Baseline
|
88.6 score on a scale
Standard Deviation 19.8
|
94.3 score on a scale
Standard Deviation 8.3
|
89 score on a scale
Standard Deviation 19.2
|
|
Patient Satisfaction Questionnaire: Medical Care
3 months
|
88.8 score on a scale
Standard Deviation 13.7
|
93.1 score on a scale
Standard Deviation 13.3
|
89.2 score on a scale
Standard Deviation 27.3
|
|
Patient Satisfaction Questionnaire: Medical Care
6 months
|
89.7 score on a scale
Standard Deviation 19.9
|
93.6 score on a scale
Standard Deviation 16.6
|
90.8 score on a scale
Standard Deviation 23.4
|
|
Patient Satisfaction Questionnaire: Medical Care
12 months
|
91.5 score on a scale
Standard Deviation 11.3
|
94.4 score on a scale
Standard Deviation 9
|
—
|
|
Patient Satisfaction Questionnaire: Medical Care
24 months
|
90 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
90 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery relieve the pain?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=43 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=20 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
3 months · Excellent
|
7 Participants
|
9 Participants
|
5 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
3 months · Very Good
|
11 Participants
|
7 Participants
|
5 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
3 months · Good
|
11 Participants
|
4 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
3 months · Fair
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
3 months · Poor
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
6 months · Excellent
|
15 Participants
|
18 Participants
|
10 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
6 months · Very Good
|
17 Participants
|
13 Participants
|
6 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
6 months · Good
|
8 Participants
|
4 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
6 months · Fair
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
6 months · Poor
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
12 months · Excellent
|
5 Participants
|
6 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
12 months · Very Good
|
4 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
12 months · Good
|
1 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
12 months · Fair
|
0 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
12 months · Poor
|
2 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
24 months · Excellent
|
1 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
24 months · Very Good
|
0 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
24 months · Good
|
1 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
24 months · Fair
|
0 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
24 months · Poor
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery improve your ability to perform regular activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=43 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=20 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
3 months · Excellent
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
3 months · Very Good
|
6 Participants
|
7 Participants
|
8 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
3 months · Good
|
14 Participants
|
6 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
3 months · Fair
|
4 Participants
|
9 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
3 months · Poor
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
6 months · Excellent
|
13 Participants
|
8 Participants
|
8 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
6 months · Very Good
|
16 Participants
|
21 Participants
|
6 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
6 months · Good
|
9 Participants
|
7 Participants
|
3 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
6 months · Fair
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
6 months · Poor
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
12 months · Excellent
|
5 Participants
|
6 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
12 months · Very Good
|
3 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
12 months · Good
|
2 Participants
|
2 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
12 months · Fair
|
1 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
12 months · Poor
|
1 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
24 months · Excellent
|
1 Participants
|
2 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
24 months · Very Good
|
0 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
24 months · Good
|
1 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
24 months · Fair
|
0 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
24 months · Poor
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery allow you to perform heavy work or sport activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=41 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=43 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=20 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
3 months · Excellent
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
3 months · Very Good
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
3 months · Good
|
10 Participants
|
1 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
3 months · Fair
|
9 Participants
|
9 Participants
|
3 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
3 months · Poor
|
10 Participants
|
13 Participants
|
3 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
6 months · Excellent
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
6 months · Very Good
|
10 Participants
|
20 Participants
|
6 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
6 months · Good
|
14 Participants
|
6 Participants
|
4 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
6 months · Fair
|
7 Participants
|
9 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
6 months · Poor
|
3 Participants
|
7 Participants
|
5 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
12 months · Excellent
|
2 Participants
|
5 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
12 months · Very Good
|
6 Participants
|
2 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
12 months · Good
|
1 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
12 months · Fair
|
2 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
12 months · Poor
|
1 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
24 months · Excellent
|
0 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
24 months · Very Good
|
1 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
24 months · Good
|
1 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
24 months · Fair
|
0 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
24 months · Poor
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery meet your expectations?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=43 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=20 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
3 months · Excellent
|
11 Participants
|
8 Participants
|
8 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
3 months · Very Good
|
8 Participants
|
9 Participants
|
3 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
3 months · Good
|
9 Participants
|
7 Participants
|
0 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
3 months · Fair
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
3 months · Poor
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
6 months · Excellent
|
17 Participants
|
17 Participants
|
7 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
6 months · Very Good
|
11 Participants
|
13 Participants
|
5 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
6 months · Good
|
10 Participants
|
6 Participants
|
3 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
6 months · Fair
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
6 months · Poor
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
12 months · Excellent
|
5 Participants
|
6 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
12 months · Very Good
|
3 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
12 months · Good
|
1 Participants
|
2 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
12 months · Fair
|
2 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
12 months · Poor
|
1 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
24 months · Excellent
|
1 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
24 months · Very Good
|
0 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
24 months · Good
|
1 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
24 months · Fair
|
0 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
24 months · Poor
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "Would you repeat the operation again if needed on another joint?" with one of the following responses: * Definitely Yes * Probably Yes * Possibly Not * Definitely Not
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=43 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=20 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
3 months · Definitely Yes
|
20 Participants
|
18 Participants
|
11 Participants
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
3 months · Probably Yes
|
11 Participants
|
7 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
3 months · Possibly Not
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
3 months · Definitely Not
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
6 months · Definitely Yes
|
22 Participants
|
25 Participants
|
10 Participants
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
6 months · Probably Yes
|
14 Participants
|
12 Participants
|
7 Participants
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
6 months · Possibly Not
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
6 months · Definitely Not
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
12 months · Definitely Yes
|
6 Participants
|
6 Participants
|
—
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
12 months · Probably Yes
|
3 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
12 months · Possibly Not
|
2 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
12 months · Definitely Not
|
1 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
24 months · Definitely Yes
|
2 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
24 months · Probably Yes
|
0 Participants
|
1 Participants
|
—
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
24 months · Possibly Not
|
0 Participants
|
0 Participants
|
—
|
|
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
24 months · Definitely Not
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 weeks, 6 weeks, 3 months and 6 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Data not collected for ARCR+Regeneten subjects at 3 months.
Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=43 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=42 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Pain - Visual Analog Scale (VAS) Score
2 weeks
|
31.2 score on a scale
Standard Deviation 27.7
|
27.4 score on a scale
Standard Deviation 26.6
|
21.6 score on a scale
Standard Deviation 25.8
|
|
Pain - Visual Analog Scale (VAS) Score
6 weeks
|
21.5 score on a scale
Standard Deviation 24.3
|
24 score on a scale
Standard Deviation 26.5
|
19.3 score on a scale
Standard Deviation 23.8
|
|
Pain - Visual Analog Scale (VAS) Score
3 months
|
—
|
20 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
2 score on a scale
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
|
Pain - Visual Analog Scale (VAS) Score
6 months
|
10.4 score on a scale
Standard Deviation 18
|
8 score on a scale
Standard Deviation 17.9
|
9.2 score on a scale
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. Baseline score not collected as all participants had full-thickness tears. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=40 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=18 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
3 months · Type I
|
1 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
3 months · Type II
|
17 Participants
|
15 Participants
|
3 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
3 months · Type III
|
1 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
3 months · Type IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
3 months · Type V
|
12 Participants
|
10 Participants
|
6 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
3 months · Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
6 months · Type I
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
6 months · Type II
|
17 Participants
|
21 Participants
|
11 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
6 months · Type III
|
1 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
6 months · Type IV
|
3 Participants
|
1 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
6 months · Type V
|
21 Participants
|
18 Participants
|
7 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
6 months · Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
12 months · Type I
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
12 months · Type II
|
6 Participants
|
3 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
12 months · Type III
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
12 months · Type IV
|
2 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
12 months · Type V
|
5 Participants
|
5 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
12 months · Indeterminate
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
24 months · Type I
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
24 months · Type II
|
1 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
24 months · Type III
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
24 months · Type IV
|
1 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
24 months · Type V
|
0 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Sugaya Score
24 months · Indeterminate
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. Baseline score not collected as all participants had full-thickness tears. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=40 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=18 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
12 months · Type IV
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
3 months · Type I
|
1 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
3 months · Type II
|
23 Participants
|
20 Participants
|
5 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
3 months · Type III
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
3 months · Type IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
3 months · Type V
|
7 Participants
|
5 Participants
|
4 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
3 months · Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
6 months · Type I
|
1 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
6 months · Type II
|
27 Participants
|
31 Participants
|
14 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
6 months · Type III
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
6 months · Type IV
|
1 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
6 months · Type V
|
13 Participants
|
9 Participants
|
4 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
6 months · Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
12 months · Type I
|
1 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
12 months · Type II
|
8 Participants
|
6 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
12 months · Type III
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
12 months · Type V
|
4 Participants
|
3 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
12 months · Indeterminate
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
24 months · Type I
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
24 months · Type II
|
2 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
24 months · Type III
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
24 months · Type IV
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
24 months · Type V
|
0 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Sugaya Score
24 months · Indeterminate
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=41 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=39 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=18 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
3 months · Grade 0
|
6 Participants
|
3 Participants
|
1 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
3 months · Grade 1
|
22 Participants
|
16 Participants
|
8 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
3 months · Grade 2
|
2 Participants
|
4 Participants
|
1 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
3 months · Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
3 months · Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
3 months · Unable to assess
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
6 months · Grade 0
|
5 Participants
|
5 Participants
|
1 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
6 months · Grade 1
|
30 Participants
|
23 Participants
|
15 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
6 months · Grade 2
|
6 Participants
|
7 Participants
|
1 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
6 months · Grade 3
|
0 Participants
|
2 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
6 months · Grade 4
|
0 Participants
|
2 Participants
|
1 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
6 months · Unable to assess
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
12 months · Grade 0
|
1 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
12 months · Grade 1
|
10 Participants
|
4 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
12 months · Grade 2
|
2 Participants
|
2 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
12 months · Grade 3
|
0 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
12 months · Grade 4
|
0 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
12 months · Unable to assess
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
24 months · Grade 0
|
0 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
24 months · Grade 1
|
2 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
24 months · Grade 2
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
24 months · Grade 3
|
0 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
24 months · Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Supraspinatus Goutallier Classification
24 months · Unable to assess
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=40 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=40 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=18 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
3 months · Grade 0
|
3 Participants
|
6 Participants
|
1 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
3 months · Grade 1
|
16 Participants
|
13 Participants
|
3 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
3 months · Grade 2
|
8 Participants
|
3 Participants
|
5 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
3 months · Grade 3
|
2 Participants
|
2 Participants
|
1 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
3 months · Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
3 months · Unable to assess
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
6 months · Grade 0
|
3 Participants
|
9 Participants
|
1 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
6 months · Grade 1
|
19 Participants
|
19 Participants
|
10 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
6 months · Grade 2
|
13 Participants
|
7 Participants
|
6 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
6 months · Grade 3
|
4 Participants
|
3 Participants
|
1 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
6 months · Grade 4
|
1 Participants
|
2 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
6 months · Unable to assess
|
0 Participants
|
0 Participants
|
0 Participants
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
12 months · Grade 0
|
1 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
12 months · Grade 1
|
7 Participants
|
6 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
12 months · Grade 2
|
4 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
12 months · Grade 3
|
1 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
12 months · Grade 4
|
0 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
12 months · Unable to assess
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
24 months · Grade 0
|
0 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
24 months · Grade 1
|
1 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
24 months · Grade 2
|
1 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
24 months · Grade 3
|
0 Participants
|
0 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
24 months · Grade 4
|
0 Participants
|
1 Participants
|
—
|
|
MRI Tendon Findings: Infraspinatus Goutallier Classification
24 months · Unable to assess
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. No (0) ARCR alone subjects tendon thickness at 24 months could be reported as no data was collected because relevant images were missing, not available, or relevant anatomy not visible in field of view.
Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=20 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=19 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=8 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Total Tendon Thickness
3 months
|
5.6 millimeters (mm)
Standard Deviation 1.4
|
5.4 millimeters (mm)
Standard Deviation 1.1
|
6.2 millimeters (mm)
Standard Deviation 1.5
|
|
Total Tendon Thickness
6 months
|
5.9 millimeters (mm)
Standard Deviation 1.2
|
5.5 millimeters (mm)
Standard Deviation 1
|
5.7 millimeters (mm)
Standard Deviation 1.1
|
|
Total Tendon Thickness
12 months
|
4.9 millimeters (mm)
Standard Deviation 1
|
5.5 millimeters (mm)
Standard Deviation 0.6
|
—
|
|
Total Tendon Thickness
24 months
|
5 millimeters (mm)
Standard Deviation 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=29 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=27 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=11 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Total Tendon Length
3 months
|
36.4 millimeters (mm)
Standard Deviation 9.3
|
32.6 millimeters (mm)
Standard Deviation 11.3
|
40.2 millimeters (mm)
Standard Deviation 1.3
|
|
Total Tendon Length
6 months
|
34.7 millimeters (mm)
Standard Deviation 9.6
|
33.9 millimeters (mm)
Standard Deviation 10.4
|
38.2 millimeters (mm)
Standard Deviation 4
|
|
Total Tendon Length
12 months
|
33.6 millimeters (mm)
Standard Deviation 10.3
|
29.6 millimeters (mm)
Standard Deviation 13
|
—
|
|
Total Tendon Length
24 months
|
49.1 millimeters (mm)
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
19.9 millimeters (mm)
Standard Deviation 13.6
|
—
|
SECONDARY outcome
Timeframe: Day 0, 3 months and 6 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated.
Area of retear in millimeters squared (mm\^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=24 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=16 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=7 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])
Day 0
|
1041.7 millimeters squared (mm^2)
Standard Deviation 482.7
|
1004 millimeters squared (mm^2)
Standard Deviation 448.5
|
877.1 millimeters squared (mm^2)
Standard Deviation 218.3
|
|
Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])
3 months
|
1173.2 millimeters squared (mm^2)
Standard Deviation 698.5
|
1099.6 millimeters squared (mm^2)
Standard Deviation 554.1
|
1158.2 millimeters squared (mm^2)
Standard Deviation 790.8
|
|
Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])
6 months
|
1000.6 millimeters squared (mm^2)
Standard Deviation 699.2
|
1203.0 millimeters squared (mm^2)
Standard Deviation 624.3
|
1159.6 millimeters squared (mm^2)
Standard Deviation 1022.3
|
SECONDARY outcome
Timeframe: Day 0, 3 months and 6 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated.
Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=24 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=16 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=7 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Size of Retear: Anteroposterior (AP) Length
Day 0
|
32.1 millimeters (mm)
Standard Deviation 7.2
|
31.8 millimeters (mm)
Standard Deviation 7.4
|
30 millimeters (mm)
Standard Deviation 8.2
|
|
Size of Retear: Anteroposterior (AP) Length
3 months
|
29.9 millimeters (mm)
Standard Deviation 12.5
|
30.7 millimeters (mm)
Standard Deviation 9.8
|
28.1 millimeters (mm)
Standard Deviation 14.0
|
|
Size of Retear: Anteroposterior (AP) Length
6 months
|
27.4 millimeters (mm)
Standard Deviation 12.1
|
29.9 millimeters (mm)
Standard Deviation 10.9
|
26.8 millimeters (mm)
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Day 0, 3 months and 6 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated.
Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=24 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=16 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=7 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Size of Retear: Mediolateral (ML) Length
Day 0
|
31.7 millimeters (mm)
Standard Deviation 8.7
|
31.7 millimeters (mm)
Standard Deviation 11.4
|
29.4 millimeters (mm)
Standard Deviation 1.5
|
|
Size of Retear: Mediolateral (ML) Length
3 months
|
36.9 millimeters (mm)
Standard Deviation 8.9
|
33.6 millimeters (mm)
Standard Deviation 11.4
|
37.6 millimeters (mm)
Standard Deviation 11.1
|
|
Size of Retear: Mediolateral (ML) Length
6 months
|
32.1 millimeters (mm)
Standard Deviation 12.8
|
37.1 millimeters (mm)
Standard Deviation 13.2
|
38.1 millimeters (mm)
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Day 0Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated.
Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes: * Crescent * L Shape * Reverse L * U Shape * Massive/Contracted * Unable to Determine
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=26 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=24 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=13 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Shape of Retear: Operative Visit
Crescent
|
12 Participants
|
8 Participants
|
7 Participants
|
|
Shape of Retear: Operative Visit
L Shape
|
2 Participants
|
7 Participants
|
0 Participants
|
|
Shape of Retear: Operative Visit
Reverse L
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Shape of Retear: Operative Visit
U Shape
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Shape of Retear: Operative Visit
Massive/Contracted
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Shape of Retear: Operative Visit
Unable to Determine
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months and 24 monthsPopulation: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes: * Intact (i.e., no re-tear) * Crescent * Longitudinal * Massive * Unable to Determine
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=40 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=18 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
3 months · Intact (i.e., no re-tear)
|
18 Participants
|
14 Participants
|
3 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
3 months · Crescent
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
3 months · Longitudinal
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
3 months · Massive
|
8 Participants
|
8 Participants
|
4 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
3 months · Unable to Assess
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
6 months · Intact (i.e., no re-tear)
|
16 Participants
|
21 Participants
|
10 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
6 months · Crescent
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
6 months · Longitudinal
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
6 months · Massive
|
18 Participants
|
14 Participants
|
3 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
6 months · Unable to Assess
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
12 months · Intact (i.e., no re-tear)
|
5 Participants
|
3 Participants
|
—
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
12 months · Crescent
|
0 Participants
|
0 Participants
|
—
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
12 months · Longitudinal
|
3 Participants
|
2 Participants
|
—
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
12 months · Massive
|
4 Participants
|
4 Participants
|
—
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
12 months · Unable to Assess
|
1 Participants
|
0 Participants
|
—
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
24 months · Intact (i.e., no re-tear)
|
1 Participants
|
1 Participants
|
—
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
24 months · Crescent
|
1 Participants
|
0 Participants
|
—
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
24 months · Longitudinal
|
0 Participants
|
0 Participants
|
—
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
24 months · Massive
|
0 Participants
|
1 Participants
|
—
|
|
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
24 months · Unable to Assess
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 weeks, 6 weeks, 3 months and 6 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Each group with 0 participants analyzed for "Since last follow-up visit did you take additional time off..." question at 2 weeks, 6 weeks, 3 months, \& 6 months indicated no responses were provided (i.e., data not collected).
Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions: * Returned to work? * Have you been able to return to the job you did before your surgery? * Did you feel ready to go back to work physically? * Since returning to work, any time off due to shoulder pain or weakness? * Since last follow-up visit did you take additional time off due to shoulder pain/weakness?
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=25 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=25 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=11 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Return to Work Questionnaire
6 weeks: Returned to work? · Yes
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Return to Work Questionnaire
6 weeks: Returned to work? · No
|
15 Participants
|
16 Participants
|
5 Participants
|
|
Return to Work Questionnaire
3 months: Returned to work? · Yes
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Return to Work Questionnaire
3 months: Returned to work? · No
|
12 Participants
|
11 Participants
|
1 Participants
|
|
Return to Work Questionnaire
6 months: Returned to work? · Yes
|
4 Participants
|
14 Participants
|
3 Participants
|
|
Return to Work Questionnaire
6 months: Returned to work? · No
|
8 Participants
|
9 Participants
|
3 Participants
|
|
Return to Work Questionnaire
2 weeks: Have you been able to return to the job you did before your surgery? · Yes
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Return to Work Questionnaire
2 weeks: Have you been able to return to the job you did before your surgery? · No
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Return to Work Questionnaire
6 weeks: Have you been able to return to the job you did before your surgery? · Yes
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Return to Work Questionnaire
6 weeks: Have you been able to return to the job you did before your surgery? · No
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Return to Work Questionnaire
3 months: Have you been able to return to the job you did before your surgery? · Yes
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Return to Work Questionnaire
3 months: Have you been able to return to the job you did before your surgery? · No
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Return to Work Questionnaire
6 months: Have you been able to return to the job you did before your surgery? · Yes
|
4 Participants
|
10 Participants
|
3 Participants
|
|
Return to Work Questionnaire
6 months: Have you been able to return to the job you did before your surgery? · No
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Return to Work Questionnaire
2 weeks: Did you feel ready to go back to work physically? · Yes
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Return to Work Questionnaire
2 weeks: Did you feel ready to go back to work physically? · No
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Return to Work Questionnaire
6 weeks: Did you feel ready to go back to work physically? · Yes
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Return to Work Questionnaire
6 weeks: Did you feel ready to go back to work physically? · No
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire
3 months: Did you feel ready to go back to work physically? · Yes
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Return to Work Questionnaire
3 months: Did you feel ready to go back to work physically? · No
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Return to Work Questionnaire
6 months: Did you feel ready to go back to work physically? · Yes
|
4 Participants
|
12 Participants
|
2 Participants
|
|
Return to Work Questionnaire
6 months: Did you feel ready to go back to work physically? · No
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Return to Work Questionnaire
2 weeks: Since returning to work, any time off due to shoulder pain or weakness? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire
2 weeks: Since returning to work, any time off due to shoulder pain or weakness? · No
|
7 Participants
|
5 Participants
|
3 Participants
|
|
Return to Work Questionnaire
6 weeks: Since returning to work, any time off due to shoulder pain or weakness? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire
6 weeks: Since returning to work, any time off due to shoulder pain or weakness? · No
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Return to Work Questionnaire
3 months: Since returning to work, any time off due to shoulder pain or weakness? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire
3 months: Since returning to work, any time off due to shoulder pain or weakness? · No
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Return to Work Questionnaire
6 months: Since returning to work, any time off due to shoulder pain or weakness? · Yes
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Return to Work Questionnaire
6 months: Since returning to work, any time off due to shoulder pain or weakness? · No
|
4 Participants
|
13 Participants
|
2 Participants
|
|
Return to Work Questionnaire
6 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? · Yes
|
—
|
1 Participants
|
0 Participants
|
|
Return to Work Questionnaire
6 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? · No
|
—
|
2 Participants
|
1 Participants
|
|
Return to Work Questionnaire
2 weeks: Returned to work? · Yes
|
7 Participants
|
5 Participants
|
3 Participants
|
|
Return to Work Questionnaire
2 weeks: Returned to work? · No
|
18 Participants
|
20 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 weeks, 6 weeks, 3 months, 6 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Returned to work?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=18 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=20 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=8 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
6 months · Motivation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
6 months · Other
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
2 weeks · Physical capability
|
12 Participants
|
13 Participants
|
5 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
2 weeks · Safety
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
2 weeks · Motivation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
2 weeks · Other
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
6 weeks · Physical capability
|
11 Participants
|
12 Participants
|
4 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
6 weeks · Safety
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
6 weeks · Motivation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
6 weeks · Other
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
3 months · Physical capability
|
7 Participants
|
8 Participants
|
1 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
3 months · Safety
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
3 months · Motivation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
3 months · Other
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
6 months · Physical capability
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Return to Work Questionnaire: Reason for Not Getting Back to Work
6 months · Safety
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks, 6 weeks, 3 months, 6 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Have you been able to return to the job you did before your surgery?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=2 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=3 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=2 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
2 weeks · Physical capability
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
2 weeks · Safety
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
2 weeks · Motivation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
2 weeks · Other
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
6 weeks · Physical capability
|
—
|
1 Participants
|
1 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
6 weeks · Safety
|
—
|
1 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
6 weeks · Motivation
|
—
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
6 weeks · Other
|
—
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
3 months · Physical capability
|
—
|
1 Participants
|
1 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
3 months · Safety
|
—
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
3 months · Motivation
|
—
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
3 months · Other
|
—
|
0 Participants
|
0 Participants
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
6 months · Physical capability
|
—
|
2 Participants
|
—
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
6 months · Safety
|
—
|
0 Participants
|
—
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
6 months · Motivation
|
—
|
0 Participants
|
—
|
|
Return to Work Questionnaire: Reason Couldn't Return to Activities
6 months · Other
|
—
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 weeks, 6 weeks, 3 months, 6 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Since returning to work, any time off due to shoulder pain or weakness?" question were asked to provide how long they have taken off in days.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=1 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=1 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Return to Work Questionnaire: Time Off
6 months
|
—
|
8 days
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
2 days
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
SECONDARY outcome
Timeframe: 2 weeks, 6 weeks, 3 months, 6 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Data not collected for 2 subjects who responded yes at 6 months in ARCR alone group.
Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Returned to work?" question were asked to provide the number of days taken away from work
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=7 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=12 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=3 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Return to Work Questionnaire: Duration Away From Work (Days)
2 weeks
|
6.7 days
Standard Deviation 3
|
7.2 days
Standard Deviation 4.4
|
6.7 days
Standard Deviation 5.1
|
|
Return to Work Questionnaire: Duration Away From Work (Days)
6 weeks
|
19 days
Standard Deviation NA
Standard Deviation could not be calculated because only 1 participant had data collected for analysis
|
23 days
Standard Deviation 4.6
|
30.3 days
Standard Deviation 15.9
|
|
Return to Work Questionnaire: Duration Away From Work (Days)
3 months
|
68.3 days
Standard Deviation 20.8
|
64.5 days
Standard Deviation 16.3
|
52 days
Standard Deviation 11.3
|
|
Return to Work Questionnaire: Duration Away From Work (Days)
6 months
|
74.5 days
Standard Deviation 69.9
|
80.3 days
Standard Deviation 63.8
|
75 days
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: Following surgery, up to 14 daysPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=42 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=21 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Duration of Opioid Use
|
7.9 days
Standard Deviation 4.9
|
7.1 days
Standard Deviation 4.5
|
6.3 days
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Following surgery, up to 14 daysPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=42 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=42 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=21 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Opioid Use for More Than 5 Days Post-Surgery
No
|
17 Participants
|
18 Participants
|
10 Participants
|
|
Opioid Use for More Than 5 Days Post-Surgery
Yes
|
25 Participants
|
24 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: IntraoperativePopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
Total operative time in minutes.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=46 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Total Operative Time
|
176.2 minutes
Standard Deviation 60.9
|
138.8 minutes
Standard Deviation 42.7
|
172.8 minutes
Standard Deviation 47.7
|
SECONDARY outcome
Timeframe: up to 3 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following: * Standard Sling * Shoulder Immobilizer * Sling and Swathe * Abduction Sling * External Rotation Sling * Other * Missing
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=46 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Sling Type
External Rotation Sling
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Sling Type
Standard Sling
|
13 Participants
|
17 Participants
|
5 Participants
|
|
Sling Type
Shoulder Immobilizer
|
20 Participants
|
16 Participants
|
6 Participants
|
|
Sling Type
Sling and Swathe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Sling Type
Abduction Sling
|
8 Participants
|
4 Participants
|
4 Participants
|
|
Sling Type
Other
|
4 Participants
|
4 Participants
|
7 Participants
|
|
Sling Type
Missing
|
1 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 3 monthsPopulation: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
Mobilization time was the duration, measured in weeks, that participants spent in a sling.
Outcome measures
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=45 Participants
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=45 Participants
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=22 Participants
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Mobilization Time in Sling
|
5.5 weeks
Standard Deviation 1.1
|
5.4 weeks
Standard Deviation 1.3
|
5.6 weeks
Standard Deviation 1.1
|
Adverse Events
ARCR Augmented With REGENETEN™ Bioinductive Implant
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
ARCR Alone
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Revision Group
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=47 participants at risk
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 participants at risk
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 participants at risk
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Nervous system disorders
Stroke/CVA
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
General disorders
Low Blood Pressure/Hypotension
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Nervous system disorders
Syncope/Fainting
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Loss of Range of Motion
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Renal and urinary disorders
Urinary Retention
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle/Tendon Damage
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Cardiac disorders
Myocardial Infarction
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Unspecified Musculoskeletal Problem
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
General disorders
Pain
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
Other adverse events
| Measure |
ARCR Augmented With REGENETEN™ Bioinductive Implant
n=47 participants at risk
During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
|
ARCR Alone
n=48 participants at risk
The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
|
Revision Group
n=24 participants at risk
Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
|
|---|---|---|---|
|
General disorders
Pain
|
2.1%
1/47 • Number of events 2 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Eye disorders
Blurred Vision
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Injury, poisoning and procedural complications
Fall
|
10.6%
5/47 • Number of events 5 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Nervous system disorders
Peripheral Nervous Injury
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
General disorders
Inflammation
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
General disorders
Chest Pain
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Infections and infestations
Unspecified Infection
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
2/48 • Number of events 2 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Gastrointestinal disorders
Gastrointestinal Regurgitation
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
General disorders
Swelling/Edema
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Injury, poisoning and procedural complications
Post Operative Wound Infection
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Nervous system disorders
Sleep Dysfunction
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Investigations
Low Oxygen Saturation
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
General disorders
Insufficient Information
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
General disorders
Hernia
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Renal and urinary disorders
Dysuria
|
2.1%
1/47 • Number of events 2 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Renal and urinary disorders
Hematuria
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Injury, poisoning and procedural complications
Damage to Ligament(s)
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Skin Inflammation/Irritation
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Infections and infestations
Respiratory Tract Infection
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Vascular disorders
Hemorrhage/Bleeding
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Loss of Range of Motion
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Unspecified Musculoskeletal Problem
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Injury, poisoning and procedural complications
Foreign Body in Patient
|
0.00%
0/47 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.1%
1/47 • Number of events 1 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/48 • Adverse events were collected during surgery to early termination, up to 24 months.
|
0.00%
0/24 • Adverse events were collected during surgery to early termination, up to 24 months.
|
Additional Information
Senior Manager Clinical Compliance
Smith+Nephew, Inc
Phone: +44 7811 407089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Upon completion of the Trial the PI may prepare the data derived from the Trial for publication, and will submit to Sponsor for review and comment prior to publication. To ensure that Sponsor will be able to make comment and suggestions where pertinent, the material for public dissemination will be submitted for review at least 40 to 90 days\* prior to submission for publication, public dissemination or review by a publication committee. \*Country dependent, no timeframe is mandated for France.
- Publication restrictions are in place
Restriction type: OTHER