Trial Outcomes & Findings for Treatment of Partial-Thickness Rotator Cuff Tears (NCT NCT03734536)

NCT ID: NCT03734536

Last Updated: 2024-11-19

Results Overview

American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 168 participants
• Primary outcome timeframe: Baseline and 3 months
• Results posted on: 2024-11-19

Participant Flow

First participant consented 05 December 2018; study premature termination 14 February 2023 with last participant termination on 11 September 2023.

There were 168 participants enrolled in the study with 50 participants excluded during surgery or prior to surgery that resulted in 118 participants being treated and allocated into treatment arms.

Participant milestones

Measure	REGENETEN™ Bioinductive Implant Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Overall Study STARTED	59	59
Overall Study COMPLETED	48	47
Overall Study NOT COMPLETED	11	12

Reasons for withdrawal

Measure	REGENETEN™ Bioinductive Implant Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Overall Study Withdrew Consent	1	5
Overall Study Lost to Follow-up	10	7

Baseline Characteristics

Treatment of Partial-Thickness Rotator Cuff Tears

Baseline characteristics by cohort

Measure	REGENETEN™ Bioinductive Implant n=59 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=59 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.	Total n=118 Participants Total of all reporting groups
Age, Continuous	52.51 years STANDARD_DEVIATION 10.57 • n=5 Participants	58.98 years STANDARD_DEVIATION 8.14 • n=7 Participants	55.75 years STANDARD_DEVIATION 9.94 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · White	55 Participants n=5 Participants	52 Participants n=7 Participants	107 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Black or African American	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · African/Caribbean	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants	59 participants n=7 Participants	118 participants n=5 Participants
Body Mass Index (BMI)	31.08 kg/m^2 STANDARD_DEVIATION 8.30 • n=5 Participants	29.41 kg/m^2 STANDARD_DEVIATION 4.81 • n=7 Participants	30.25 kg/m^2 STANDARD_DEVIATION 6.80 • n=5 Participants
Index shoulder Left	19 Participants n=5 Participants	28 Participants n=7 Participants	47 Participants n=5 Participants
Index shoulder Right	40 Participants n=5 Participants	31 Participants n=7 Participants	71 Participants n=5 Participants
Index shoulder Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prescription opioid or non-opioid pain medication use to manage pain other than index shoulder pain No	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prescription opioid or non-opioid pain medication use to manage pain other than index shoulder pain Yes	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Prescription opioid or non-opioid pain medication use to manage pain other than index shoulder pain Missing	53 Participants n=5 Participants	54 Participants n=7 Participants	107 Participants n=5 Participants
Surgery on Dominant Arm Yes	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Surgery on Dominant Arm No	12 Participants n=5 Participants	25 Participants n=7 Participants	37 Participants n=5 Participants
Surgery on Dominant Arm Missing	25 Participants n=5 Participants	10 Participants n=7 Participants	35 Participants n=5 Participants
Treatment to Manage Index Shoulder: Prescription Non-Opioid Pain Medication No	44 Participants n=5 Participants	40 Participants n=7 Participants	84 Participants n=5 Participants
Treatment to Manage Index Shoulder: Prescription Non-Opioid Pain Medication Yes	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Treatment to Manage Index Shoulder: Prescription Non-Opioid Pain Medication Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Treatment to Manage Index Shoulder: Prescription Opioid Pain Medication No	56 Participants n=5 Participants	51 Participants n=7 Participants	107 Participants n=5 Participants
Treatment to Manage Index Shoulder: Prescription Opioid Pain Medication Yes	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Treatment to Manage Index Shoulder: Prescription Opioid Pain Medication Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Treatment to Manage Index Shoulder: Steroid Injection(s) No	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Treatment to Manage Index Shoulder: Steroid Injection(s) Yes	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Treatment to Manage Index Shoulder: Steroid Injection(s) Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Treatment to Manage Index Shoulder: Shoulder Surgery No	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Treatment to Manage Index Shoulder: Shoulder Surgery Yes	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Treatment to Manage Index Shoulder: Shoulder Surgery Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants with available data for each treatment at the time frame indicated

American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=58 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=56 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
American Shoulder and Elbow Surgeons (ASES) Score Baseline	59.46 score on a scale Standard Deviation 17.07	52.10 score on a scale Standard Deviation 15.61
American Shoulder and Elbow Surgeons (ASES) Score 3 months	80.07 score on a scale Standard Deviation 13.30	74.61 score on a scale Standard Deviation 12.35

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2,Week 3,Week 4,Week 5,Week 6,Week 7,Week 8,Week 9,Week 10,Week 11, & Week 12

Population: Overall number of participants with available data for the treatment and time frame indicated.

American Shoulder and Elbow Surgeons (ASES) score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=58 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=56 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 6	66.25 score on a scale Standard Deviation 13.05	59.06 score on a scale Standard Deviation 11.77
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 7	66.72 score on a scale Standard Deviation 14.42	62.18 score on a scale Standard Deviation 12.66
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 8	70.74 score on a scale Standard Deviation 13.98	63.74 score on a scale Standard Deviation 11.98
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 9	73.70 score on a scale Standard Deviation 13.94	66.05 score on a scale Standard Deviation 12.54
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 10	76.81 score on a scale Standard Deviation 11.43	69.62 score on a scale Standard Deviation 11.69
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 11	78.14 score on a scale Standard Deviation 11.94	71.80 score on a scale Standard Deviation 13.43
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Baseline	59.46 score on a scale Standard Deviation 17.07	52.10 score on a scale Standard Deviation 15.61
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 1	49.00 score on a scale Standard Deviation 13.42	44.42 score on a scale Standard Deviation 11.22
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 2	54.77 score on a scale Standard Deviation 13.04	50.04 score on a scale Standard Deviation 12.92
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 12	80.07 score on a scale Standard Deviation 13.30	74.61 score on a scale Standard Deviation 12.35
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 3	57.67 score on a scale Standard Deviation 13.65	51.77 score on a scale Standard Deviation 12.62
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 4	60.22 score on a scale Standard Deviation 12.69	51.77 score on a scale Standard Deviation 11.19
American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery Week 5	63.90 score on a scale Standard Deviation 12.91	56.89 score on a scale Standard Deviation 9.84

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12

Population: Overall number of participants with available data for the treatment and time frame indicated.

Single Assessment Numeric Evaluation (SANE) score at baseline and weekly up to 12 weeks (3 months). SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question:

''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=59 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=59 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 1	28.22 score on a scale Standard Deviation 21.63	17.85 score on a scale Standard Deviation 17.23
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 2	35.37 score on a scale Standard Deviation 20.93	24.27 score on a scale Standard Deviation 17.86
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 4	45.73 score on a scale Standard Deviation 16.76	42.27 score on a scale Standard Deviation 17.18
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 5	49.00 score on a scale Standard Deviation 17.18	40.19 score on a scale Standard Deviation 18.56
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 6	54.60 score on a scale Standard Deviation 16.83	42.27 score on a scale Standard Deviation 17.18
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 11	69.86 score on a scale Standard Deviation 14.80	59.45 score on a scale Standard Deviation 18.04
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 12	73.31 score on a scale Standard Deviation 16.38	63.89 score on a scale Standard Deviation 16.11
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Baseline	47.42 score on a scale Standard Deviation 21.34	36.78 score on a scale Standard Deviation 17.90
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 3	39.89 score on a scale Standard Deviation 18.79	31.94 score on a scale Standard Deviation 16.35
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 7	56.35 score on a scale Standard Deviation 18.59	46.56 score on a scale Standard Deviation 16.48
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 8	59.91 score on a scale Standard Deviation 19.88	49.77 score on a scale Standard Deviation 15.81
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 9	61.82 score on a scale Standard Deviation 18.22	53.55 score on a scale Standard Deviation 15.17
Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery Week 10	67.66 score on a scale Standard Deviation 16.23	57.27 score on a scale Standard Deviation 15.15

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12

Population: Overall number of participants with available data for the treatment and time frame indicated.

Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline and every week up to 12 weeks (3 months) post-index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=58 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=56 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Baseline	4.35 score on a scale Standard Deviation 2.54	5.49 score on a scale Standard Deviation 2.49
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 1	3.53 score on a scale Standard Deviation 2.27	4.15 score on a scale Standard Deviation 2.23
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 4	2.42 score on a scale Standard Deviation 2.09	3.34 score on a scale Standard Deviation 1.98
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 5	2.32 score on a scale Standard Deviation 1.99	2.84 score on a scale Standard Deviation 1.64
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 6	2.15 score on a scale Standard Deviation 1.94	2.77 score on a scale Standard Deviation 1.90
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 7	2.20 score on a scale Standard Deviation 2.13	2.58 score on a scale Standard Deviation 1.90
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 8	1.79 score on a scale Standard Deviation 2.01	2.41 score on a scale Standard Deviation 1.66
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 9	1.57 score on a scale Standard Deviation 1.91	2.41 score on a scale Standard Deviation 1.73
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 2	3.03 score on a scale Standard Deviation 2.14	3.49 score on a scale Standard Deviation 2.02
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 3	2.65 score on a scale Standard Deviation 2.10	3.29 score on a scale Standard Deviation 2.25
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 10	1.32 score on a scale Standard Deviation 1.55	1.97 score on a scale Standard Deviation 1.58
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 11	1.27 score on a scale Standard Deviation 1.62	1.92 score on a scale Standard Deviation 2.00
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery Week 12	1.31 score on a scale Standard Deviation 1.83	1.79 score on a scale Standard Deviation 1.75

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, 18 months and 24 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

American Shoulder and Elbow Surgeons (ASES) score at baseline, 6, 12, 18 and 24 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=55 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=56 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 6 months	90.38 score on a scale Standard Deviation 11.73	87.42 score on a scale Standard Deviation 11.25
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 12 months	90.83 score on a scale Standard Deviation 16.55	91.98 score on a scale Standard Deviation 12.90
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 18 months	94.71 score on a scale Standard Deviation 13.07	92.87 score on a scale Standard Deviation 13.40
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 24 months	94.77 score on a scale Standard Deviation 13.76	94.17 score on a scale Standard Deviation 11.76
American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months Baseline	59.46 score on a scale Standard Deviation 17.07	52.10 score on a scale Standard Deviation 15.61

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, 18 months and 24 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

Single Assessment Numeric Evaluation (SANE) score at baseline, 6, 12, 18 and 24 months following index surgery. SANE scores range from 0 to 100, with 100 indicating a better outcome. SANE is a simple, patient-based shoulder function assessment tool measured by answering a single question:

''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=59 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=59 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months Baseline	47.42 score on a scale Standard Deviation 21.34	36.78 score on a scale Standard Deviation 17.90
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 24 months	90.67 score on a scale Standard Deviation 19.17	94.20 score on a scale Standard Deviation 8.07
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 6 months	86.18 score on a scale Standard Deviation 12.47	81.15 score on a scale Standard Deviation 14.12
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 12 months	87.27 score on a scale Standard Deviation 17.35	87.86 score on a scale Standard Deviation 14.64
Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 18 months	91.74 score on a scale Standard Deviation 12.52	90.03 score on a scale Standard Deviation 10.30

SECONDARY outcome

Timeframe: Baseline, 6 months, 12 months, 18 months and 24 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

Participant reported shoulder pain was measured using the American Shoulder and Elbow Surgeons Visual Analog Scale (AES-VAS) Pain score at baseline, 6, 12, 18 and 24 months following index surgery. ASES-VAS Pain scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (i.e., a lower score is a better outcome).

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=55 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=56 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months Baseline	4.35 score on a scale Standard Deviation 2.54	5.49 score on a scale Standard Deviation 2.49
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 6 months	0.79 score on a scale Standard Deviation 1.56	0.89 score on a scale Standard Deviation 1.38
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 12 months	1.09 score on a scale Standard Deviation 2.12	0.68 score on a scale Standard Deviation 1.62
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 18 months	0.50 score on a scale Standard Deviation 1.56	0.77 score on a scale Standard Deviation 1.75
American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months 24 months	0.48 score on a scale Standard Deviation 1.61	0.47 score on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months, and 24 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

Constant-Murley Score at baseline, 3, 6, 12, and 24 months following index surgery. The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The test is divided into four subscales: pain, activities of daily living, strength, and range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder). Constant-Murley Scores range from 0 to 100, with higher scores indicating better shoulder function & lower scores indicating worse shoulder function.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=48 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=50 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months Baseline	53.73 score on a scale Standard Deviation 15.81	45.40 score on a scale Standard Deviation 14.13
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months 3 months	60.73 score on a scale Standard Deviation 12.05	52.35 score on a scale Standard Deviation 12.08
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months 24 months	71.76 score on a scale Standard Deviation 8.65	71.18 score on a scale Standard Deviation 9.08
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months 6 months	66.10 score on a scale Standard Deviation 10.57	61.13 score on a scale Standard Deviation 11.62
Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months 12 months	69.33 score on a scale Standard Deviation 11.11	66.24 score on a scale Standard Deviation 12.45

SECONDARY outcome

Timeframe: Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12

Population: Overall number of participants with available data for the treatment and time frame indicated. One extreme outlier was excluded from the Arthroscopic repair treatment group due to a data irregularity. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.

Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=22 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=27 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Directly after surgery	7.82 defined daily dose Standard Deviation 22.93	3.10 defined daily dose Standard Deviation 7.53
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 1	18.28 defined daily dose Standard Deviation 42.90	4.22 defined daily dose Standard Deviation 10.93
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 2	4.38 defined daily dose Standard Deviation 6.12	1.73 defined daily dose Standard Deviation 2.05
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 3	3.85 defined daily dose Standard Deviation 3.21	3.35 defined daily dose Standard Deviation 5.12
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 4	2.81 defined daily dose Standard Deviation 1.64	2.58 defined daily dose Standard Deviation 2.20
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 5	1.17 defined daily dose Standard Deviation 0.85	1.97 defined daily dose Standard Deviation 2.01
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 6	0.97 defined daily dose Standard Deviation 0.99	1.98 defined daily dose Standard Deviation 2.04
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 7	—	1.56 defined daily dose Standard Deviation 2.44
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 8	—	0.66 defined daily dose Standard Deviation NA Standard Deviation could not be calculated due to insufficient participant data available
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 9	—	2.11 defined daily dose Standard Deviation 1.71
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 10	—	2.50 defined daily dose Standard Deviation NA Standard Deviation could not be calculated due to insufficient participant data available
Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 11	—	2.34 defined daily dose Standard Deviation 2.35

SECONDARY outcome

Timeframe: Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12

Population: Overall number of participants with available data for the treatment and time frame indicated. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.

Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery and weekly for up to 12 weeks (3 months) as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=7 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=11 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Directly after surgery	6.94 defined daily dose Standard Deviation 3.20	2.67 defined daily dose Standard Deviation 0.89
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 1	10.50 defined daily dose Standard Deviation 7.67	4.21 defined daily dose Standard Deviation 6.24
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 2	10.50 defined daily dose Standard Deviation 8.71	5.05 defined daily dose Standard Deviation 6.86
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 3	20.00 defined daily dose Standard Deviation 0	3.47 defined daily dose Standard Deviation 2.79
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 4	20.00 defined daily dose Standard Deviation 0	1.48 defined daily dose Standard Deviation 0.87
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 5	14.78 defined daily dose Standard Deviation 9.05	4.22 defined daily dose Standard Deviation 3.85
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 6	13.83 defined daily dose Standard Deviation 10.68	5.63 defined daily dose Standard Deviation 3.96
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 8	15.83 defined daily dose Standard Deviation 7.22	6.75 defined daily dose Standard Deviation 7.42
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 9	16.00 defined daily dose Standard Deviation 4.00	5.01 defined daily dose Standard Deviation 5.20
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 10	12.00 defined daily dose Standard Deviation 11.31	5.83 defined daily dose Standard Deviation 4.86
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 11	20.00 defined daily dose Standard Deviation NA Standard Deviation could not be calculated due to insufficient participant data available	5.17 defined daily dose Standard Deviation 5.42
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 12	27.00 defined daily dose Standard Deviation NA Standard Deviation could not be calculated due to insufficient participant data available	11.27 defined daily dose Standard Deviation 15.18
Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery Week 7	14.00 defined daily dose Standard Deviation 10.39	5.17 defined daily dose Standard Deviation 3.48

SECONDARY outcome

Timeframe: Directly after surgery, 6 months, and 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated. One extreme outlier was excluded from the Arthroscopic repair treatment group due to a data irregularity. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.

Opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=22 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=27 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months Directly after surgery	7.82 defined daily dose Standard Deviation 22.93	3.10 defined daily dose Standard Deviation 7.53
Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months 6 months	2.40 defined daily dose Standard Deviation NA Standard Deviation could not be calculated due to insufficient participant data available	—

SECONDARY outcome

Timeframe: Directly after surgery, 6 months, and 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated. Only medications with an assigned WHO-specified daily dose were included in the analysis, as the calculation of the total number of defined daily doses (DDD) depends on this value. Medications without a WHO-assigned daily dose value were excluded from the analysis.

Non-opioid prescription medication use to treat the index shoulder post-index surgery was measured directly after surgery, 6 months, and 12 months as the total number of defined daily doses (DDD). Participants recorded their use of non-opioid pain medication in a log within their diary. The total number of DDD was calculated by multiplying the total quantity of the drug (e.g., number of tablets) by the strength (e.g., milligrams per tablet) to obtain the total dosage (e.g., total number of milligrams), then dividing by the World Health Organization (WHO) specified defined daily dose.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=7 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=11 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months 12 months	—	2.00 defined daily dose Standard Deviation NA Standard Deviation could not be calculated due to insufficient participant data available
Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months Directly after surgery	6.94 defined daily dose Standard Deviation 3.20	2.67 defined daily dose Standard Deviation 0.89
Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months 6 months	3.20 defined daily dose Standard Deviation NA Standard Deviation could not be calculated due to insufficient participant data available	19.00 defined daily dose Standard Deviation NA Standard Deviation could not be calculated due to insufficient participant data available

SECONDARY outcome

Timeframe: Following index surgery, up to 7 weeks

Population: Overall number of participants with available data for the treatment and time frame indicated.

Duration of shoulder immobilization measured as days spent in a sling

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=53 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=50 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Duration of Shoulder Immobilization	18.40 days Standard Deviation 14.55	35.72 days Standard Deviation 12.55

SECONDARY outcome

Timeframe: Up to 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated. It was possible for participants to return to partial, modified, or part-time employment, and then return to fulltime employment within the 12 month period. Meaning, multiple responses were allowed.

Participants ability to return to previous type of work within 12 months post-index surgery was measured by the number of participants work status. Work status was identified as "Not currently employed", "Did not return to work", "Returned to partial, modified, or parttime employment", or "Returned to fulltime employment." The type of work for each work status (excluding "Not currently employed") was then categorized as:

• Very heavy work
• Heavy work
• Medium work
• Light work
• Sedentary work

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=48 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=49 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Not currently employed	16 Participants	20 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Did not return to work : Very heavy work	0 Participants	0 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Did not return to work : Heavy work	0 Participants	0 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Did not return to work : Medium work	0 Participants	1 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Did not return to work : Light work	0 Participants	0 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Did not return to work : Sedentary work	0 Participants	0 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to partial, modified, or parttime employment : Very heavy work	0 Participants	0 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to partial, modified, or parttime employment : Heavy work	5 Participants	2 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to partial, modified, or parttime employment : Medium work	6 Participants	4 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to partial, modified, or parttime employment : Light work	3 Participants	3 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to partial, modified, or parttime employment : Sedentary work	2 Participants	3 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to fulltime employment : Very heavy work	2 Participants	0 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to fulltime employment : Heavy work	4 Participants	5 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to fulltime employment : Medium work	8 Participants	7 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to fulltime employment : Light work	10 Participants	7 Participants
Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery Returned to fulltime employment : Sedentary work	8 Participants	11 Participants

SECONDARY outcome

Timeframe: Following index surgery, up to 139 days

Population: Overall number of participants with available data for the treatment and time frame indicated.

Time to return to driving post-index surgery measured in days.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=53 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=48 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Time to Return to Driving	18.3 days Standard Deviation 21.60	24.54 days Standard Deviation 19.85

SECONDARY outcome

Timeframe: Following index surgery, approximately 1 year

Population: Overall number of participants with available data for the treatment and time frame indicated.

Time to return to sports involving overhead throwing post-index surgery measured in days.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=8 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=2 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Time to Return to Sports	202 days Standard Deviation 87.18	93.50 days Standard Deviation 17.68

SECONDARY outcome

Timeframe: 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following:

• Tendinosis
• Low-grade Partial Thickness Tear
• High-grade Partial Thickness Tear
• Full-Thickness Tear
• Intact

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=49 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=48 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=Yes | Low-grade Partial Thickness Tear	6 Participants	5 Participants
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=Yes | High-grade Partial Thickness Tear	7 Participants	5 Participants
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=Yes | Full-Thickness Tear	1 Participants	2 Participants
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=Yes | Intact	2 Participants	1 Participants
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=No | Tendinosis	5 Participants	7 Participants
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=Yes | Tendinosis	7 Participants	8 Participants
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=No | Low-grade Partial Thickness Tear	12 Participants	6 Participants
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=No | High-grade Partial Thickness Tear	6 Participants	5 Participants
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=No | Full-Thickness Tear	0 Participants	0 Participants
Number of Participants With Progression to Full-Thickness Tear at 12 Months Bursal=No | Intact	3 Participants	9 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The number of participants with progression to full-thickness tear at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was classified as bursal (Yes/No), then categorized as one of the following:

• Tendinosis
• Low-grade Partial Thickness Tear
• High-grade Partial Thickness Tear
• Full-Thickness Tear
• Intact

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=47 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=21 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=Yes | Tendinosis	10 Participants	4 Participants
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=Yes | Low-grade Partial Thickness Tear	5 Participants	2 Participants
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=Yes | High-grade Partial Thickness Tear	3 Participants	2 Participants
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=Yes | Full-Thickness Tear	1 Participants	0 Participants
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=No | Intact	4 Participants	2 Participants
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=Yes | Intact	3 Participants	0 Participants
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=No | Tendinosis	5 Participants	4 Participants
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=No | Low-grade Partial Thickness Tear	13 Participants	6 Participants
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=No | High-grade Partial Thickness Tear	3 Participants	1 Participants
Number of Participants With Progression to Full-Thickness Tear at 24 Months Bursal=No | Full-Thickness Tear	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 12 months post-index surgery as bursal (Yes/No), then categorized as one of the following:

• 0% to < 25%
• 25% to < 50%
• 50% to < 75%
• 75% to <100%
• 100%

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=33 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=41 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=Yes | 0% to < 25%	1 Participants	3 Participants
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=Yes | 25% to < 50%	1 Participants	0 Participants
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=Yes | 50% to < 75%	2 Participants	1 Participants
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=Yes | 75% to < 100%	6 Participants	7 Participants
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=Yes | 100%	4 Participants	4 Participants
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=No | 0% to < 25%	1 Participants	4 Participants
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=No | 25% to < 50%	5 Participants	2 Participants
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=No | 50% to < 75%	2 Participants	3 Participants
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=No | 75% to < 100%	10 Participants	6 Participants
Number of Participants Percent Filling of Rotator Cuff at 12 Months Bursal=No | 100%	1 Participants	11 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The number of participants percent filling of the rotator cuff was identified by supraspinatus imagining of the tear location at 24 months post-index surgery as bursal (Yes/No), then categorized as one of the following:

• 0% to < 25%
• 25% to < 50%
• 50% to < 75%
• 75% to <100%
• 100%

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=33 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=20 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=Yes | 0% to < 25%	0 Participants	3 Participants
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=Yes | 25% to < 50%	0 Participants	0 Participants
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=Yes | 50% to < 75%	0 Participants	1 Participants
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=Yes | 75% to < 100%	6 Participants	3 Participants
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=Yes | 100%	7 Participants	1 Participants
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=No | 0% to < 25%	2 Participants	0 Participants
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=No | 25% to < 50%	3 Participants	1 Participants
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=No | 50% to < 75%	3 Participants	1 Participants
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=No | 75% to < 100%	10 Participants	5 Participants
Number of Participants Percent Filling of Rotator Cuff at 24 Months Bursal=No | 100%	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Overall number of participants with available data for the treatment and time frame indicated.

Rotator cuff tendon thickness in millimeters (mm) at 12 months post-index surgery categorized as:

• Total Thickness (where tendon thickness cannot be differentiated)
• Thickness of Native (where tendon thickness can be differentiated)
• Thickness of New Tissue (where tendon thickness can be differentiated)
• Total Thickness (where tendon thickness can be differentiated)

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=47 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=47 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Rotator Cuff Tendon Thickness at 12 Months Total Thickness (where tendon thickness cannot be differentiated)	4.45 millimeters (mm) Standard Deviation 1.86	4.57 millimeters (mm) Standard Deviation 1.75
Rotator Cuff Tendon Thickness at 12 Months Thickness of Native (where tendon thickness can be differentiated)	3.50 millimeters (mm) Standard Deviation 0.85	1.87 millimeters (mm) Standard Deviation 1.13
Rotator Cuff Tendon Thickness at 12 Months Thickness of New Tissue (where tendon thickness can be differentiated)	2.40 millimeters (mm) Standard Deviation 0.42	2.53 millimeters (mm) Standard Deviation 0.79
Rotator Cuff Tendon Thickness at 12 Months Total Thickness (where tendon thickness can be differentiated)	5.90 millimeters (mm) Standard Deviation 0.77	4.40 millimeters (mm) Standard Deviation 1.60

SECONDARY outcome

Timeframe: 24 Months

Population: Overall number of participants with available data for the treatment and time frame indicated.

Rotator cuff tendon thickness in millimeters (mm) at 24 months post-index surgery categorized as:

• Total Thickness (where tendon thickness cannot be differentiated)
• Thickness of Native (where tendon thickness can be differentiated)
• Thickness of New Tissue (where tendon thickness can be differentiated)
• Total Thickness (where tendon thickness can be differentiated)

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=46 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=21 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Rotator Cuff Tendon Thickness at 24 Months Total Thickness (where tendon thickness cannot be differentiated)	4.88 millimeters (mm) Standard Deviation 1.90	4.63 millimeters (mm) Standard Deviation 1.47
Rotator Cuff Tendon Thickness at 24 Months Thickness of Native (where tendon thickness can be differentiated)	4.00 millimeters (mm) Standard Deviation 0.91	2.80 millimeters (mm) Standard Deviation 1.13
Rotator Cuff Tendon Thickness at 24 Months Thickness of New Tissue (where tendon thickness can be differentiated)	2.38 millimeters (mm) Standard Deviation 0.41	2.90 millimeters (mm) Standard Deviation 0.85
Rotator Cuff Tendon Thickness at 24 Months Total Thickness (where tendon thickness can be differentiated)	6.38 millimeters (mm) Standard Deviation 0.90	5.70 millimeters (mm) Standard Deviation 0.28

SECONDARY outcome

Timeframe: 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following:

• Grade 1
• Grade 2
• Grade 3
• Grade 4
• Grade 0

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=49 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=48 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=Yes | Grade 1	15 Participants	13 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=Yes | Grade 2	1 Participants	2 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=Yes | Grade 3	0 Participants	0 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=Yes | Grade 4	0 Participants	0 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=Yes | Grade 0	7 Participants	6 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=No | Grade 1	12 Participants	16 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=No | Grade 3	0 Participants	0 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=No | Grade 0	11 Participants	7 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=No | Grade 4	0 Participants	0 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 12 Months Bursal=No | Grade 2	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The Goutallier classification was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. The number of participants Goutallier classification grade of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following:

• Grade 1
• Grade 2
• Grade 3
• Grade 4
• Grade 0

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=47 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=21 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=Yes | Grade 1	13 Participants	6 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=Yes | Grade 2	1 Participants	0 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=Yes | Grade 3	0 Participants	0 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=Yes | Grade 4	0 Participants	0 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=Yes | Grade 0	8 Participants	2 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=No | Grade 1	11 Participants	7 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=No | Grade 2	3 Participants	3 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=No | Grade 3	0 Participants	0 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=No | Grade 4	0 Participants	0 Participants
Number of Participants Goutallier Classification of Rotator Cuff at 24 Months Bursal=No | Grade 0	11 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 12 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following:

• Type I
• Type II
• Type III
• Type IV
• Type V

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=47 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=47 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=Yes | Type I	4 Participants	4 Participants
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=Yes | Type II	8 Participants	8 Participants
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=Yes | Type III	8 Participants	6 Participants
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=Yes | Type IV	1 Participants	2 Participants
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=Yes | Type V	0 Participants	0 Participants
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=No | Type I	6 Participants	11 Participants
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=No | Type II	12 Participants	10 Participants
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=No | Type III	8 Participants	6 Participants
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=No | Type IV	0 Participants	0 Participants
Number of Participants Sugaya Score of Rotator Cuff at 12 Months Bursal=No | Type V	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The Sugaya score was used to measure the rotator cuff integrity. The Sugaya score ranges from Type I to Type V. Type I indicates a repaired cuff that had sufficient thickness with homogeneously low intensity on the MRI image while Type V indicates the presence of a major discontinuity on the MRI images suggesting a medium or large tear. The number of participants Sugaya Score of the rotator cuff at 24 months post-index surgery were identified by supraspinatus imagining of the tear location. The rotator cuff tear was identified as bursal (Yes/No), then classified as one of the following:

• Type I
• Type II
• Type III
• Type IV
• Type V

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=45 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=21 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=Yes | Type I	5 Participants	1 Participants
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=Yes | Type II	10 Participants	5 Participants
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=Yes | Type III	4 Participants	2 Participants
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=Yes | Type IV	1 Participants	0 Participants
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=Yes | Type V	0 Participants	0 Participants
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=No | Type I	7 Participants	3 Participants
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=No | Type II	14 Participants	8 Participants
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=No | Type III	4 Participants	2 Participants
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=No | Type IV	0 Participants	0 Participants
Number of Participants Sugaya Score of Rotator Cuff at 24 Months Bursal=No | Type V	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Following index surgery, up to 24 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

Incidence of revision surgery measured by the number of participants with Revision Surgery (Yes/No) defined as any revision surgery involving the index shoulder for any cause within 24 months post-index surgery.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=59 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=59 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Participants With Revision Surgery Revision Surgery: Yes	1 Participants	4 Participants
Number of Participants With Revision Surgery Revision Surgery: No	58 Participants	55 Participants

SECONDARY outcome

Timeframe: Following index surgery, up to 12 months

Population: Appropriate data not collected to perform analysis as a result of study termination

Related health care utilization costs over 12 months post- surgery will be calculated based on health care utilization as reported in the participant diary and/or in the participant's medical records.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intra-operative

Population: Overall number of participants with available data for the treatment and time frame indicated.

Operating time for the index surgery, defined as the time from first incision to wound closure (measured in minutes) as recorded in the operative procedure notes.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=55 Participants Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=59 Participants Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Operating Room Time (Index Surgery)	46.89 minutes Standard Deviation 19.13	57.05 minutes Standard Deviation 19.16

SECONDARY outcome

Timeframe: Following index surgery, up to 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The number of steroid injections per participant administered to the index shoulder over 12 months post-index surgery as reported in the participant diary and/or in the participant's medical record.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=19 injections Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=16 injections Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Steroid Injections	1.58 injections Standard Deviation 1.00	1.60 injections Standard Deviation 1.00

SECONDARY outcome

Timeframe: Following index surgery, up to 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The number of unscheduled clinic visits per participant (defined as a return visit to a health care provider for examination/evaluation of the index shoulder) over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record.

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=214 unscheduled visits Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=232 unscheduled visits Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Unscheduled Clinic Visits	4.1 unscheduled visits Standard Deviation 1.94	5.16 unscheduled visits Standard Deviation 2.08

SECONDARY outcome

Timeframe: Following index surgery, up to 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The total number of for cause imaging procedures (e.g., MRI or ultrasound) per participant performed on the index shoulder over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=25 for-cause imaging procedures Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=15 for-cause imaging procedures Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of For-Cause Imaging Procedures	2.27 for-cause imaging procedures Standard Deviation 2.28	1.50 for-cause imaging procedures Standard Deviation 0.85

SECONDARY outcome

Timeframe: Following index surgery, up to 12 months

Population: Overall number of participants with available data for the treatment and time frame indicated.

The total number of physiotherapy sessions per participant over 12 months post-index surgery, as reported in the participant diary and/or in the participant's medical record

Outcome measures

Measure	REGENETEN™ Bioinductive Implant n=773 physiotherapy sessions Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=1253 physiotherapy sessions Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Number of Physiotherapy Sessions	18.40 physiotherapy sessions Standard Deviation 8.23	27.84 physiotherapy sessions Standard Deviation 13.41

Adverse Events

REGENETEN™ Bioinductive Implant

Serious events: 33 serious events

Other events: 51 other events

Deaths: 0 deaths

Arthroscopic Repair of the High-grade (>50%) Partial-thickness

Serious events: 17 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Measure	REGENETEN™ Bioinductive Implant n=59 participants at risk Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=59 participants at risk Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukemia in Relapse	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Renal and urinary disorders Acute Pyelonephritis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Respiratory, thoracic and mediastinal disorders acute respiratory failure and covid-19 pneumonia	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Respiratory, thoracic and mediastinal disorders acute respiratory failure, pneumonia, and left pleural effusion	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Adhesive capsulitis left shoulder	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Cardiac disorders atherosclerotic occlusive coronary artery disease	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Avascular Necrosis {left shoulder, hip, ankle with concomitant medial malleolar stress fracture}	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Candidal Skin Infection	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Cellulitis of Right Upper Extremity	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
General disorders Chemotherapy Induced Nausea	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations COVID-19 (Hospitalization)	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Respiratory, thoracic and mediastinal disorders Covid-19, Pneumonia	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Cytomegalovirus	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Vascular disorders Deep Vein Thrombosis and Superficial Venous Thrombosis of Left Upper Extremity	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Gastrointestinal disorders epigastric pain with vomiting; anal fistula	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Failure of Left total knee replacement, subsequent encounter	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Failure of RIGHT total knee replacement, subsequent encounter	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Immune system disorders Graft vs Host Disease	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations infection of left elbow	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Skin and subcutaneous tissue disorders Labial Lesion	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left Knee internal derangement of posterior horn medial meniscus	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left knee tibial plateau fracture	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations left lower extremity cellulitis status post coronary artery bypass	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders left shoulder arthrofibrosis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders left shoulder pain	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Left shoulder partial rotator cuff tear (non-study arm)	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Cardiac disorders Left Side Pulmonary Embolism	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple Pulmonary Nodules/Lesions	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Immune system disorders Neutropenic Fever	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Endocrine disorders Noninsulin Dependent Diabetes Mellitus with Hyperglycemia	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Cardiac disorders Non-ST Elevation Myocardial Infarction	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Blood and lymphatic system disorders Pancytopenia due to Chemotherapy	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Planned Hospital admission for FLU/CY/TBI Haplo AllSCT for AML	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Planned Hospital admit for Cycle 1 of HiDose APA-c	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Renal and urinary disorders Postprocedural Bulbous Urethral Stricture	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Vascular disorders Pulmonary Embolism	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Gastrointestinal disorders revision repair of ventral incisional hernia	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right Anterior supraspinatus recurrent supraspinatus tear status post prior repair	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right carpal tunnel syndrome and right trigger thumb	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders right deltoid muscle strain progressed to rotator cuff re-tear	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Gastrointestinal disorders Right inguinal hernia	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Blood and lymphatic system disorders Right Knee Anteromedial Osteoarthritis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders right rotator cuff repair revision with bicep repair	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right Rotator cuff tear	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Right Shoulder Pain Status post Fall	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Metabolism and nutrition disorders Severe iron deficiency anemia requiring blood transfusion	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Surgical and medical procedures Unknown dental issue requiring tooth extraction	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Vascular disorders unstable angina	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Renal and urinary disorders Ureteral Calculus	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Renal and urinary disorders Urinary Tract Infection	3.4% 2/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Gastrointestinal disorders ventral hernia	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years

Other adverse events

Measure	REGENETEN™ Bioinductive Implant n=59 participants at risk Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. REGENETEN™ Bioinductive Implant: The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.	Arthroscopic Repair of the High-grade (>50%) Partial-thickness n=59 participants at risk Surgical treatment of partial-thickness rotator cuff tears using standard techniques. Arthroscopic repair of the high-grade (\>50%) partial-thickness: Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Infections and infestations Abscess of Right Axilla	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Acute Costochondritis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Immune system disorders Allergic Reaction of unknown origin -Likely food related	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Skin and subcutaneous tissue disorders alopecia	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Ankle sprain	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Back muscle strain	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Bilateral biceps tendinitis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Nervous system disorders Bilateral Headaches	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Bilateral Shoulder Pain	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Eye disorders Blurry Vision	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Respiratory, thoracic and mediastinal disorders Bronchitis and sinus infection	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Nervous system disorders chronic regional pain syndrome	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications chronic right shoulder pain status post fall, possible adhesive capsulitis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Clostridioides Difficile Diarrhea	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Surgical and medical procedures Colonoscopy to determine cause of increased diarrhea and stomach pain	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications contact dermatitis from surgical tape	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
General disorders cough, diarrhea, muscle pain, weakness	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations COVID-19	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	6.8% 4/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders decrease range of motion right shoulder	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications dermatitis from surgical bandages	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Ear and labyrinth disorders Dizziness	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Due to dehydration, patient fell. She had mild soreness in index shoulder.	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Skin and subcutaneous tissue disorders Eczema	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Hepatobiliary disorders Elevated liver enzymes - fatty liver	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Gastrointestinal disorders Food poisoning/stomach infection/inflamed intestines	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Fractured Rib after Fall	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Gout Flare up to Left Ankle	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Renal and urinary disorders Gross Hematuria	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Renal and urinary disorders hematuria	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Herpes Simplex Virus Infection ( Right Upper Lip)	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Blood and lymphatic system disorders Hypokalemia	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Blood and lymphatic system disorders Hypophosphatemia	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Increased left bicep and shoulder pain after increased PT/"bursitis" type symptoms	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Increased left shoulder pain after fall into wall	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Increased left shoulder pain after overuse	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Increased left shoulder pain after slipping in shower and grabbing bar with left arm.	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Increased left shoulder pain, especially when lifting arm out to the side	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Increased left shoulder stiffness and pain	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders left AC Joint pain	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left Adhesive Capsulitis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left foot arthritis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left mild tendinopathy	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders left rotator cuff tendonitis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left shoulder biceps tendonitis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left shoulder bursitis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left shoulder impingement	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders left shoulder osteoarthritis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders left shoulder pain	3.4% 2/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	5.1% 3/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Left shoulder pain after napping without sling	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications left shoulder pain from fall	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	6.8% 4/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications left shoulder pain secondary to a partial thickness bursal sided rotator cuff retear	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left shoulder soreness/pain when raising arm to mid-chest level	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Left wrist pain with numbness in fingers. Carpal tunnel-like symptoms.	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders lumbar pain	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Lyme disease	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Mucositis due to Antineoplastic Therapy	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Muscle cramps in left shoulder	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Myofascial pain around left mid-scapular border	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications new onset pain and motion loss left shoulder due to over-exerting left shoulder	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Pain under right arm, in armpit area	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Patient Fall	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications Patient felt a pop and acute increased pain in right shoulder	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Nervous system disorders Peripheral Neuropathy	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Nervous system disorders primary headache syndrome	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Skin and subcutaneous tissue disorders Pruritis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Renal and urinary disorders Pseudomonas Urinary Tract Infection	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Skin and subcutaneous tissue disorders Rash in Adult located on Left Scapula area	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Respiratory Syncytial Virus	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders right acromioclavicular Joint arthritris	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right Adhesive Capsulitis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right biceps tendonitis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Renal and urinary disorders Right Flank Pain	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right great toe stress fracture	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right hand gamekeeper's thumb	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders right hip bursitis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders right knee osteoarthritis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right partial thickness rotator cuff tear	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders right shoulder AC Joint osteoarthritis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right Shoulder Adhesive Capsulitis	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right Shoulder Adhesive Capsulitis/ anterior shoulder pain (impingement)	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right shoulder impingement syndrome	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders right shoulder pain	6.8% 4/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	3.4% 2/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders right shoulder pain due to flare up of biceps tenotomy	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Injury, poisoning and procedural complications right shoulder pain from fall	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right shoulder pain from physical therapy	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders right shoulder stiffness	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right shoulder tendinosis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Musculoskeletal and connective tissue disorders Right thumb trigger finger	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Skin and subcutaneous tissue disorders Right Upper Extremity Hematoma	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Nervous system disorders Sciatica down right leg	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Sinus Infection	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Skin and subcutaneous tissue disorders Skin lesion on right foot 4th toe	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Tooth abscess	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Nervous system disorders Tremors of right upper extremity	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Reproductive system and breast disorders Unspecified Lump in the Left Breast	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Reproductive system and breast disorders Vaginitis	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Cardiac disorders Vasovagal episode/fall causing broken nose	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Ear and labyrinth disorders Vertigo	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years
Infections and infestations Yeast infection	0.00% 0/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years	1.7% 1/59 • Adverse events were collected upon implantation of device through study termination, up to 2 years

Additional Information

Samantha Andrews

Smith+Nephew

Phone: 9789718990

Email: samantha.andrews@smith-nephew.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor has the right to modify any proposed publication within 30 days after receipt if it discloses potentially patentable items, patent, trade secret, or other proprietary or confidential information of Sponsor. If patentable items are involved, proposed, disclosure to third party may be delayed up to 90 days. If not submitted within 18 months after the Study's conclusion, the Site/Investigator may publish results after Sponsor's review.
• Publication restrictions are in place

Restriction type: OTHER