Trial Outcomes & Findings for Study of Suture Repair of Torn Meniscus in the Knee (NCT NCT02237001)
NCT ID: NCT02237001
Last Updated: 2020-12-04
Results Overview
Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.
COMPLETED
NA
30 participants
6 months, 1 year, and 2 years
2020-12-04
Participant Flow
Subjects enrolled at clinics from 19NOV2014 until 08NOV2017; last subject visit was 18NOV2019
The planned sample size of 30 subjects was accrued for the Safety Population (SAF); however, a total of 4 subjects were excluded to comprise the Analysis Population (AS) due to late screen failure (eligibility criteria) or withdrawal by the subject.
Participant milestones
| Measure |
Treatment
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
6 Month Follow-up
|
27
|
|
Overall Study
12 Month Follow-up
|
21
|
|
Overall Study
24 Month Follow-up
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Treatment
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Eligibility criteria/Late Screen Failure
|
3
|
|
Overall Study
Re-operation
|
4
|
|
Overall Study
Incarceration
|
1
|
Baseline Characteristics
Study of Suture Repair of Torn Meniscus in the Knee
Baseline characteristics by cohort
| Measure |
Treatment
n=30 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
Height
|
69.25 inches
STANDARD_DEVIATION 3.897 • n=5 Participants
|
|
Weight
|
176.68 pounds (lb)
STANDARD_DEVIATION 33.356 • n=5 Participants
|
|
Body Mass Index
|
25.68 kg/m^2
STANDARD_DEVIATION 3.502 • n=5 Participants
|
|
Body Mass Index (BMI) Group
<30
|
26 Participants
n=5 Participants
|
|
Body Mass Index (BMI) Group
>=30
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months, 1 year, and 2 yearsPopulation: Overall number of participants analyzed indicates total number of participants enrolled in the Safety Population (SAF) at 6 months that provided data. Number analyzed for each time frame indicates all data available starting at 6 months.
Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.
Outcome measures
| Measure |
Treatment
n=27 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
Freedom from re-operation at 6 months · Participants Free From Re-operation
|
26 Participants
|
|
Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
Freedom from re-operation at 6 months · Participants Requiring Re-operation
|
1 Participants
|
|
Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
Freedom from re-operation at 1 year · Participants Free From Re-operation
|
23 Participants
|
|
Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
Freedom from re-operation at 1 year · Participants Requiring Re-operation
|
2 Participants
|
|
Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
Freedom from re-operation at 2 years · Participants Free From Re-operation
|
19 Participants
|
|
Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
Freedom from re-operation at 2 years · Participants Requiring Re-operation
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, and 2 yearsPopulation: 30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.
Change in knee pain and function will be measured by completion of The International Knee Documentation Committee (IKDC) Subjective score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and knee function prior to knee injury (1 item, not included in the score). Responses vary for each item. The possible score ranges from 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms.
Outcome measures
| Measure |
Treatment
n=26 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years
IKDC Change from Baseline at 3 months
|
23.9 score on a scale
Standard Deviation 24.1
|
|
Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years
IKDC Change from Baseline at 6 months
|
32.3 score on a scale
Standard Deviation 25.1
|
|
Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years
IKDC Change from Baseline at 2 years
|
41.8 score on a scale
Standard Deviation 21.0
|
|
Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years
IKDC Baseline
|
36.7 score on a scale
Standard Deviation 16.2
|
|
Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years
IKDC Change from Baseline at 1 year
|
40.8 score on a scale
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 yearsPopulation: 30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Outcome measures
| Measure |
Treatment
n=26 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years
Pain Score Change from Baseline at 6 months
|
26.8 score on a scale
Standard Deviation 23.0
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years
Pain Score Change from Baseline at 2 years
|
31.4 score on a scale
Standard Deviation 22.1
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years
Pain Score Baseline
|
52.2 score on a scale
Standard Deviation 19.1
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years
Pain Score Change from Baseline at 3 months
|
26.9 score on a scale
Standard Deviation 26.2
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years
Pain Score Change from Baseline at 1 year
|
32.9 score on a scale
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 yearsPopulation: 30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Outcome measures
| Measure |
Treatment
n=26 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
ADL Score Baseline
|
58.4 score on a scale
Standard Deviation 21.7
|
|
Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
ADL Score Change from Baseline at 3 months
|
25.4 score on a scale
Standard Deviation 24.0
|
|
Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
ADL Score Change from Baseline at 6 months
|
26.1 score on a scale
Standard Deviation 20.0
|
|
Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
ADL Score Change from Baseline at 1 year
|
31.7 score on a scale
Standard Deviation 18.2
|
|
Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
ADL Score Change from Baseline at 2 years
|
28.9 score on a scale
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 yearsPopulation: 30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Outcome measures
| Measure |
Treatment
n=26 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Sport Score Baseline
|
29.6 score on a scale
Standard Deviation 21.9
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Sport Score Change from Baseline at 3 months
|
22.9 score on a scale
Standard Deviation 34.1
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Sport Score Change from Baseline at 6 months
|
33.0 score on a scale
Standard Deviation 36.3
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Sport Score Change from Baseline at 1 year
|
46.8 score on a scale
Standard Deviation 31.3
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years
Sport Score Change from Baseline at 2 years
|
48.7 score on a scale
Standard Deviation 31.2
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 yearsPopulation: 30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Outcome measures
| Measure |
Treatment
n=26 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years
Symptom Score Baseline
|
56.3 score on a scale
Standard Deviation 19.5
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years
Symptom Score Change from Baseline at 3 months
|
19.6 score on a scale
Standard Deviation 30.3
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years
Symptom Score Change from Baseline at 6 months
|
21.0 score on a scale
Standard Deviation 23.7
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years
Symptom Score Change from Baseline at 1 year
|
28.4 score on a scale
Standard Deviation 20.8
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years
Symptom Score Change from Baseline at 2 years
|
28.4 score on a scale
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 yearsPopulation: 30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.
Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Outcome measures
| Measure |
Treatment
n=26 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
QOL Score Baseline
|
28.1 score on a scale
Standard Deviation 18
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
QOL Score Change from Baseline at 3 months
|
27.6 score on a scale
Standard Deviation 29
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
QOL Score Change from Baseline at 1 year
|
42.0 score on a scale
Standard Deviation 26.5
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
QOL Score Change from Baseline at 2 years
|
43.8 score on a scale
Standard Deviation 27.2
|
|
Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
QOL Score Change from Baseline at 6 months
|
32.8 score on a scale
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, and 2 yearsPopulation: 30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.
Change in knee pain and function will be measured by completion of the Lysholm Knee Questionnaire. This tool measures the domains of symptoms and complaints and functioning of daily activities. The scale consists of 8 item and is scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning.
Outcome measures
| Measure |
Treatment
n=26 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years
Lysholm Score Baseline
|
50.2 score on a scale
Standard Deviation 17.6
|
|
Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years
Lysholm Score Change from Baseline at 3 months
|
21.3 score on a scale
Standard Deviation 27.8
|
|
Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years
Lysholm Score Change from Baseline at 6 months
|
25.4 score on a scale
Standard Deviation 23.9
|
|
Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years
Lysholm Score Change from Baseline at 1 year
|
30.9 score on a scale
Standard Deviation 24.3
|
|
Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years
Lysholm Score Change from Baseline at 2 years
|
32.5 score on a scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, and 2 yearsPopulation: 30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.
Change in knee pain and function will be measured by completion of the Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10. Each value indicates the ability to perform specific activities. An activity level of 10 corresponds to participation in competitive sports, including soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation in recreational sports; and an activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems. An activity level of 5 to 10 is recorded only if the patient participates in recreational or competitive sports.
Outcome measures
| Measure |
Treatment
n=26 Participants
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years
Tegner Score Baseline
|
3.3 score on a scale
Standard Deviation 2.4
|
|
Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years
Tegner Score Change from Baseline at 3 months
|
0.2 score on a scale
Standard Deviation 2.1
|
|
Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years
Tegner Score Change from Baseline at 6 months
|
1.3 score on a scale
Standard Deviation 3.3
|
|
Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years
Tegner Score Change from Baseline at 1 year
|
1.8 score on a scale
Standard Deviation 2.6
|
|
Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years
Tegner Score Change from Baseline at 2 years
|
1.7 score on a scale
Standard Deviation 2.5
|
Adverse Events
Treatment
Serious adverse events
| Measure |
Treatment
n=30 participants at risk
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
3.3%
1/30 • Number of events 1 • Enrollment through end of study (2 years)
Adverse events were collected \& reported as complications per the protocol. A complication was any untoward medical occurrence, unfavorable and unintended sign (including clinically significant abnormal laboratory finding), symptom, or condition experienced by the subject and temporally associated with the procedure whether or not considered related to the procedure. The Sponsor then reviewed all AEs and classified per ISO, using the higher level of classification, whether it be Site or Sponsor.
|
|
Musculoskeletal and connective tissue disorders
Further non-repairable tear meniscus
|
3.3%
1/30 • Number of events 1 • Enrollment through end of study (2 years)
Adverse events were collected \& reported as complications per the protocol. A complication was any untoward medical occurrence, unfavorable and unintended sign (including clinically significant abnormal laboratory finding), symptom, or condition experienced by the subject and temporally associated with the procedure whether or not considered related to the procedure. The Sponsor then reviewed all AEs and classified per ISO, using the higher level of classification, whether it be Site or Sponsor.
|
|
Musculoskeletal and connective tissue disorders
Swelling in knee
|
3.3%
1/30 • Number of events 1 • Enrollment through end of study (2 years)
Adverse events were collected \& reported as complications per the protocol. A complication was any untoward medical occurrence, unfavorable and unintended sign (including clinically significant abnormal laboratory finding), symptom, or condition experienced by the subject and temporally associated with the procedure whether or not considered related to the procedure. The Sponsor then reviewed all AEs and classified per ISO, using the higher level of classification, whether it be Site or Sponsor.
|
|
Musculoskeletal and connective tissue disorders
Knee repair did not heal
|
3.3%
1/30 • Number of events 1 • Enrollment through end of study (2 years)
Adverse events were collected \& reported as complications per the protocol. A complication was any untoward medical occurrence, unfavorable and unintended sign (including clinically significant abnormal laboratory finding), symptom, or condition experienced by the subject and temporally associated with the procedure whether or not considered related to the procedure. The Sponsor then reviewed all AEs and classified per ISO, using the higher level of classification, whether it be Site or Sponsor.
|
Other adverse events
| Measure |
Treatment
n=30 participants at risk
Suture-based meniscal repair
Suture-based meniscal repair: Suture-based meniscal repair
|
|---|---|
|
Nervous system disorders
Neuropathy
|
3.3%
1/30 • Number of events 1 • Enrollment through end of study (2 years)
Adverse events were collected \& reported as complications per the protocol. A complication was any untoward medical occurrence, unfavorable and unintended sign (including clinically significant abnormal laboratory finding), symptom, or condition experienced by the subject and temporally associated with the procedure whether or not considered related to the procedure. The Sponsor then reviewed all AEs and classified per ISO, using the higher level of classification, whether it be Site or Sponsor.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
13.3%
4/30 • Number of events 5 • Enrollment through end of study (2 years)
Adverse events were collected \& reported as complications per the protocol. A complication was any untoward medical occurrence, unfavorable and unintended sign (including clinically significant abnormal laboratory finding), symptom, or condition experienced by the subject and temporally associated with the procedure whether or not considered related to the procedure. The Sponsor then reviewed all AEs and classified per ISO, using the higher level of classification, whether it be Site or Sponsor.
|
|
Musculoskeletal and connective tissue disorders
Swelling of knee
|
13.3%
4/30 • Number of events 5 • Enrollment through end of study (2 years)
Adverse events were collected \& reported as complications per the protocol. A complication was any untoward medical occurrence, unfavorable and unintended sign (including clinically significant abnormal laboratory finding), symptom, or condition experienced by the subject and temporally associated with the procedure whether or not considered related to the procedure. The Sponsor then reviewed all AEs and classified per ISO, using the higher level of classification, whether it be Site or Sponsor.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60