Trial Outcomes & Findings for Agili-C™ Implant Performance Evaluation (NCT NCT03299959)

NCT ID: NCT03299959

Last Updated: 2025-12-05

Results Overview

Change from Baseline to 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 251 participants
• Primary outcome timeframe: Baseline, 60 Months
• Results posted on: 2025-12-05

Participant Flow

Participant milestones

Measure	Agili-C™ Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach	Surgical Standard of Care (SSOC) Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).
Overall Study STARTED	167	84
Overall Study COMPLETED	130	57
Overall Study NOT COMPLETED	37	27

Reasons for withdrawal

Measure	Agili-C™ Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach	Surgical Standard of Care (SSOC) Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).
Overall Study Lost to Follow-up	7	9
Overall Study Death	1	0
Overall Study Withdrawal by Subject	13	9
Overall Study Changes in study team and government regulations	1	1
Overall Study Participant underwent surgical intervention in the index knee	15	8

Baseline Characteristics

Agili-C™ Implant Performance Evaluation

Baseline characteristics by cohort

Measure	Agili-C™ n=167 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach	Surgical Standard of Care (SSOC) n=84 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Total n=251 Participants Total of all reporting groups
Age, Customized Age Category · ≥50	40 Participants n=37 Participants	34 Participants n=37 Participants	74 Participants n=74 Participants
Age, Customized Age Category · <50	127 Participants n=37 Participants	50 Participants n=37 Participants	177 Participants n=74 Participants
Age, Customized Age Group · 21 to <45 (Young adulthood)	94 Participants n=37 Participants	41 Participants n=37 Participants	135 Participants n=74 Participants
Age, Customized Age Group · 45 to <65 (Middle adulthood)	68 Participants n=37 Participants	40 Participants n=37 Participants	108 Participants n=74 Participants
Age, Customized Age Group · ≥65 (Elderly)	5 Participants n=37 Participants	3 Participants n=37 Participants	8 Participants n=74 Participants
Sex: Female, Male Female	60 Participants n=37 Participants	33 Participants n=37 Participants	93 Participants n=74 Participants
Sex: Female, Male Male	107 Participants n=37 Participants	51 Participants n=37 Participants	158 Participants n=74 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=37 Participants	1 Participants n=37 Participants	3 Participants n=74 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	164 Participants n=37 Participants	82 Participants n=37 Participants	246 Participants n=74 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	1 Participants n=37 Participants	2 Participants n=74 Participants
Race/Ethnicity, Customized Race · White	159 Participants n=37 Participants	81 Participants n=37 Participants	240 Participants n=74 Participants
Race/Ethnicity, Customized Race · Black	6 Participants n=37 Participants	2 Participants n=37 Participants	8 Participants n=74 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants
Race/Ethnicity, Customized Race · Native	1 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	0 Participants n=37 Participants	1 Participants n=37 Participants	1 Participants n=74 Participants
Region of Enrollment United States	33 Participants n=37 Participants	18 Participants n=37 Participants	51 Participants n=74 Participants
Region of Enrollment Israel	24 Participants n=37 Participants	15 Participants n=37 Participants	39 Participants n=74 Participants
Region of Enrollment Belgium	6 Participants n=37 Participants	2 Participants n=37 Participants	8 Participants n=74 Participants
Region of Enrollment Poland	6 Participants n=37 Participants	3 Participants n=37 Participants	9 Participants n=74 Participants
Region of Enrollment Hungary	2 Participants n=37 Participants	1 Participants n=37 Participants	3 Participants n=74 Participants
Region of Enrollment Romania	21 Participants n=37 Participants	10 Participants n=37 Participants	31 Participants n=74 Participants
Region of Enrollment Italy	17 Participants n=37 Participants	9 Participants n=37 Participants	26 Participants n=74 Participants
Region of Enrollment Serbia	58 Participants n=37 Participants	26 Participants n=37 Participants	84 Participants n=74 Participants
Body Mass Index (BMI) ≥30 Yes	37 Participants n=37 Participants	27 Participants n=37 Participants	64 Participants n=74 Participants
Body Mass Index (BMI) ≥30 No	130 Participants n=37 Participants	57 Participants n=37 Participants	187 Participants n=74 Participants

PRIMARY outcome

Timeframe: Baseline, 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.

Change from Baseline to 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=71 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=146 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months	19.52 score on a scale Interval 14.4 to 24.72	38.75 score on a scale Interval 35.22 to 42.25

SECONDARY outcome

Timeframe: Baseline, 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score consists of 9 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.

The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=71 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=146 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months	18.68 score on a scale Interval 13.89 to 23.43	37.71 score on a scale Interval 34.47 to 40.93

SECONDARY outcome

Timeframe: Baseline, 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score consists of 4 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.

The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=71 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=146 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months	22.29 score on a scale Interval 15.53 to 29.15	45.22 score on a scale Interval 40.49 to 49.93

SECONDARY outcome

Timeframe: Baseline, 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score consists of 17 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.

The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=71 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=146 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months	16.45 score on a scale Interval 11.84 to 21.12	33.03 score on a scale Interval 29.84 to 36.18

SECONDARY outcome

Timeframe: Baseline, 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score consists of 7 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.

The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=71 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=146 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months	15.52 score on a scale Interval 10.38 to 20.72	30.52 score on a scale Interval 27.0 to 34.02

SECONDARY outcome

Timeframe: Baseline, 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score consists of 5 items. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Scores are transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome.

The change from baseline score is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=71 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=146 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months	25.11 score on a scale Interval 18.15 to 32.08	47.32 score on a scale Interval 42.46 to 52.18

SECONDARY outcome

Timeframe: Baseline, 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline for the specified time frame.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score consists of 5 subscales. A Likert scale is used with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Subscale scores are combined to produce the Overall Score that is transformed to a 0 to 100 scale, with 0 representing a worse outcome and 100 representing a better outcome. Responder rate was defined as the proportion of participants achieving ≥30-point improvement from baseline to 60 months in the KOOS Overall Score.

The change from baseline data is reported as the mean of posterior distribution with 95% credible interval using the Bayesian model.

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=71 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=146 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months	0.34 proportion of participants Interval 0.24 to 0.46	0.74 proportion of participants Interval 0.67 to 0.81

SECONDARY outcome

Timeframe: Baseline, 36 Months, and 48 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.

Change from Baseline to 36 Months and 48 months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=73 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=150 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months Change from Baseline to 36 Months	19.3 score on a scale Standard Deviation 19.2 • Interval -7.8 to 55.7	41.4 score on a scale Standard Deviation 21.3 • Interval -6.8 to 86.4
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months Change from Baseline to 48 months	17.3 score on a scale Standard Deviation 20.0 • Interval -29.6 to 59.5	41.9 score on a scale Standard Deviation 21.6 • Interval 0.0 to 86.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in the International Knee Documentation Committee (IKDC) Subjective Evaluation 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. The possible score ranges from 0 to 100, with a higher score indicating no limitation with daily or sporting activities and the absence of symptoms (i.e., a better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=73 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=150 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	18.8 score on a scale Standard Deviation 20.6 • Interval -11.5 to 71.3	41.1 score on a scale Standard Deviation 22.6 • Interval -20.7 to 82.8
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	17.9 score on a scale Standard Deviation 21.3 • Interval -16.1 to 69.0	41.6 score on a scale Standard Deviation 23.0 • Interval -13.8 to 82.8
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	18.4 score on a scale Standard Deviation 21.9 • Interval -13.8 to 70.1	41.0 score on a scale Standard Deviation 24.2 • Interval -8.1 to 82.8

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in 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, with a higher score indicating higher levels of activity (i.e., a better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=73 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=150 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	1.0 score on a scale Standard Deviation 1.5 • Interval -1.0 to 8.0	2.3 score on a scale Standard Deviation 1.9 • Interval -3.0 to 9.0
Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	0.9 score on a scale Standard Deviation 1.6 • Interval -2.0 to 8.0	2.2 score on a scale Standard Deviation 1.8 • Interval -1.0 to 8.0
Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	0.9 score on a scale Standard Deviation 1.7 • Interval -2.0 to 8.0	2.1 score on a scale Standard Deviation 1.8 • Interval -2.0 to 7.0

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Physical Component Score. The SF-12 Physical Component Score assesses health related quality of life. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=73 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=150 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	6.4 score on a scale Standard Deviation 10.9 • Interval -14.8 to 38.7	15.5 score on a scale Standard Deviation 10.6 • Interval -14.2 to 36.2
Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	6.1 score on a scale Standard Deviation 11.0 • Interval -16.3 to 42.2	15.2 score on a scale Standard Deviation 11.5 • Interval -20.9 to 39.0
Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	7.3 score on a scale Standard Deviation 10.9 • Interval -18.4 to 40.3	15.4 score on a scale Standard Deviation 9.8 • Interval -4.0 to 39.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates participants with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in SF-12 Mental Component Score. The SF-12 Mental Component Score assesses mental health and well-being. The score is on a scale ranging from 0 to 100, with a higher score indicating a better outcome.

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=73 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=150 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	1.7 score on a scale Standard Deviation 10.1 • Interval -19.4 to 34.5	5.2 score on a scale Standard Deviation 12.9 • Interval -23.5 to 38.1
Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	1.4 score on a scale Standard Deviation 9.4 • Interval -16.9 to 37.3	4.3 score on a scale Standard Deviation 13.7 • Interval -27.7 to 36.4
Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	1.7 score on a scale Standard Deviation 8.7 • Interval -16.6 to 37.3	5.4 score on a scale Standard Deviation 12.8 • Interval -23.2 to 36.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants that had chondral lesions with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Chondral Lesions measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=59 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=94 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	19.8 score on a scale Standard Deviation 19.4 • Interval -7.8 to 55.7	42.9 score on a scale Standard Deviation 21.3 • Interval -6.8 to 86.4
Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	19.0 score on a scale Standard Deviation 19.3 • Interval -1.5 to 59.5	42.1 score on a scale Standard Deviation 23.1 • Interval 0.0 to 86.4
Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	18.5 score on a scale Standard Deviation 20.1 • Interval -0.6 to 64.1	41.3 score on a scale Standard Deviation 23.7 • Interval -2.5 to 86.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants that had osteochondral lesions with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Osteochondral Lesions measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=14 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=56 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Osteochondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	17.0 score on a scale Standard Deviation 18.8 • Interval 0.0 to 54.9	39.0 score on a scale Standard Deviation 21.1 • Interval -5.0 to 79.0
Osteochondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	9.7 score on a scale Standard Deviation 21.7 • Interval -29.6 to 55.4	41.5 score on a scale Standard Deviation 19.0 • Interval 0.0 to 80.3
Osteochondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	10.0 score on a scale Standard Deviation 21.3 • Interval -26.9 to 54.9	36.6 score on a scale Standard Deviation 22.9 • Interval 0.0 to 80.5

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants that had a single lesion with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a Single Lesion measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=51 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=97 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	20.4 score on a scale Standard Deviation 19.5 • Interval -1.0 to 55.7	43.7 score on a scale Standard Deviation 19.6 • Interval 0.0 to 86.4
Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	18.5 score on a scale Standard Deviation 19.1 • Interval -1.5 to 56.1	43.8 score on a scale Standard Deviation 20.8 • Interval 0.0 to 86.4
Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	17.8 score on a scale Standard Deviation 19.5 • Interval 0.0 to 56.3	41.5 score on a scale Standard Deviation 22.5 • Interval -2.5 to 86.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants that had multiple lesions with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with Multiple Lesions measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=22 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=53 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	16.6 score on a scale Standard Deviation 18.7 • Interval -7.8 to 53.7	37.3 score on a scale Standard Deviation 23.6 • Interval -6.8 to 76.8
Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	14.7 score on a scale Standard Deviation 21.9 • Interval -29.6 to 59.5	38.4 score on a scale Standard Deviation 22.8 • Interval 0.0 to 78.0
Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	14.9 score on a scale Standard Deviation 22.6 • Interval -26.9 to 64.1	36.0 score on a scale Standard Deviation 24.9 • Interval 0.0 to 80.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with the specified level of osteoarthritis with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Participants were categorized as without osteoarthritis based on Kellgren-Lawrence (K/L) grade of 0 to 1. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), and Grade 3 (Moderate).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=25 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=83 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Level of Osteoarthritis (Kellgren-Lawrence Grade 0-1): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	20.4 score on a scale Standard Deviation 16.4 • Interval -1.0 to 53.5	42.5 score on a scale Standard Deviation 20.6 • Interval 0.0 to 86.4
Level of Osteoarthritis (Kellgren-Lawrence Grade 0-1): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	17.2 score on a scale Standard Deviation 15.7 • Interval -1.5 to 43.2	43.1 score on a scale Standard Deviation 21.7 • Interval 0.0 to 86.4
Level of Osteoarthritis (Kellgren-Lawrence Grade 0-1): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	14.3 score on a scale Standard Deviation 15.3 • Interval 0.0 to 48.1	39.4 score on a scale Standard Deviation 23.9 • Interval 0.0 to 86.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with the specified level of osteoarthritis with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants based on their level of osteoarthritis measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Participants categorized with osteoarthritis based on Kellgren-Lawrence (K/L) grade of 2 to 3. K/L grading included Grade 0 (No evidence of osteoarthritis), Grade 1 (Doubtful), Grade 2 (Minimal), or Grade 3 (Moderate).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=48 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=67 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Level of Osteoarthritis (Kellgren-Lawrence Grade 2-3): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	18.7 score on a scale Standard Deviation 20.7 • Interval -7.8 to 55.7	40.1 score on a scale Standard Deviation 22.2 • Interval -6.8 to 79.5
Level of Osteoarthritis (Kellgren-Lawrence Grade 2-3): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	17.3 score on a scale Standard Deviation 22.0 • Interval -29.6 to 59.5	40.5 score on a scale Standard Deviation 21.5 • Interval 0.0 to 79.5
Level of Osteoarthritis (Kellgren-Lawrence Grade 2-3): Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	18.2 score on a scale Standard Deviation 22.6 • Interval -26.9 to 64.1	39.8 score on a scale Standard Deviation 23.0 • Interval -2.5 to 80.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with the specified lesion area size with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area ≤3cm² measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=36 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=60 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Total Lesion Area ≤3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	21.5 score on a scale Standard Deviation 17.8 • Interval 0.0 to 55.7	38.3 score on a scale Standard Deviation 20.3 • Interval 0.0 to 86.4
Total Lesion Area ≤3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	20.7 score on a scale Standard Deviation 19.3 • Interval 0.0 to 56.1	38.4 score on a scale Standard Deviation 21.1 • Interval 0.0 to 86.4
Total Lesion Area ≤3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	18.9 score on a scale Standard Deviation 19.6 • Interval 0.0 to 56.3	36.2 score on a scale Standard Deviation 22.1 • Interval 0.0 to 86.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with the specified lesion area size with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with a lesion area >3cm² measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=37 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=90 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Total Lesion Area >3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	17.1 score on a scale Standard Deviation 20.5 • Interval -7.8 to 54.9	43.5 score on a scale Standard Deviation 21.8 • Interval -6.8 to 79.5
Total Lesion Area >3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	14.0 score on a scale Standard Deviation 20.3 • Interval -29.6 to 59.5	44.3 score on a scale Standard Deviation 21.7 • Interval 0.0 to 79.8
Total Lesion Area >3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	15.0 score on a scale Standard Deviation 21.3 • Interval -26.9 to 64.1	41.8 score on a scale Standard Deviation 24.2 • Interval -2.5 to 81.7

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants without previous ligament reconstruction with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants without previous ligament reconstruction was measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=35 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=52 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Without Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	18.1 score on a scale Standard Deviation 19.7 • Interval -7.8 to 54.9	37.0 score on a scale Standard Deviation 24.3 • Interval -6.8 to 79.0
Without Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	12.3 score on a scale Standard Deviation 19.1 • Interval -29.6 to 59.5	38.8 score on a scale Standard Deviation 24.7 • Interval 0.0 to 80.3
Without Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	11.8 score on a scale Standard Deviation 19.9 • Interval -26.9 to 64.1	35.5 score on a scale Standard Deviation 26.4 • Interval 0.0 to 81.7

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants with previous ligament reconstruction with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants with previous ligament reconstruction was measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=7 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=12 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
With Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	25.8 score on a scale Standard Deviation 23.1 • Interval 0.0 to 53.5	34.7 score on a scale Standard Deviation 19.9 • Interval 0.0 to 58.3
With Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	23.4 score on a scale Standard Deviation 23.3 • Interval 0.0 to 53.5	31.9 score on a scale Standard Deviation 21.5 • Interval 0.0 to 56.1
With Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	25.7 score on a scale Standard Deviation 24.6 • Interval 0.0 to 53.8	31.9 score on a scale Standard Deviation 21.9 • Interval 0.0 to 53.9

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants in the meniscus status specified with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of intact meniscus (i.e., without a concomitant meniscectomy) was measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=38 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=85 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
With Intact Meniscus: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	20.9 score on a scale Standard Deviation 18.1 • Interval -1.0 to 55.7	41.9 score on a scale Standard Deviation 19.5 • Interval 0.0 to 79.0
With Intact Meniscus: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	19.0 score on a scale Standard Deviation 19.4 • Interval -1.5 to 56.1	42.0 score on a scale Standard Deviation 20.1 • Interval 0.0 to 80.3
With Intact Meniscus: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	18.3 score on a scale Standard Deviation 19.1 • Interval 0.0 to 56.3	40.7 score on a scale Standard Deviation 21.4 • Interval -2.5 to 80.5

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants in the meniscus status specified with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of previous partial meniscectomy (i.e., with a prior meniscectomy) was measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=21 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=21 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
With Previous Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	14.5 score on a scale Standard Deviation 19.9 • Interval -7.8 to 53.7	38.4 score on a scale Standard Deviation 26.2 • Interval -6.8 to 75.8
With Previous Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	11.3 score on a scale Standard Deviation 20.1 • Interval -29.6 to 59.5	38.5 score on a scale Standard Deviation 25.5 • Interval 0.0 to 79.8
With Previous Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	11.7 score on a scale Standard Deviation 21.9 • Interval -26.9 to 64.1	38.3 score on a scale Standard Deviation 26.2 • Interval 0.0 to 81.7

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants in the meniscus status specified with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized by a meniscus status of concomitant partial meniscectomy (i.e., with a concomitant meniscectomy) was measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=14 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=44 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
With Concomitant Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	21.9 score on a scale Standard Deviation 211.3 • Interval -6.6 to 54.9	42.0 score on a scale Standard Deviation 22.3 • Interval 0.0 to 86.4
With Concomitant Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	22.2 score on a scale Standard Deviation 20.6 • Interval 0.0 to 53.5	43.4 score on a scale Standard Deviation 22.4 • Interval 0.0 to 86.4
With Concomitant Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	21.3 score on a scale Standard Deviation 21.4 • Interval -0.6 to 53.8	38.1 score on a scale Standard Deviation 26.1 • Interval 0.0 to 86.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants categorized as active pre-injury based on Tegner score with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as active prior to injury (based on Tegner score) was measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=52 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=118 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	20.2 score on a scale Standard Deviation 19.1 • Interval -6.6 to 54.9	39.6 score on a scale Standard Deviation 21.0 • Interval -6.8 to 86.4
Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	17.4 score on a scale Standard Deviation 20.2 • Interval -29.6 to 59.5	40.4 score on a scale Standard Deviation 21.1 • Interval 0.0 to 86.4
Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	17.5 score on a scale Standard Deviation 21.1 • Interval -26.9 to 64.1	38.0 score on a scale Standard Deviation 22.3 • Interval -2.5 to 86.4

SECONDARY outcome

Timeframe: Baseline, 36 Months, 48 Months, and 60 Months

Population: Full Analysis Set (FAS) consisted of all randomized participants with treatment in the Agili-C™ arm and in the SSOC arm with a valid KOOS overall score at baseline and at least one valid KOOS overall score post-baseline. Number analyzed in each row indicates only participants categorized as non-active pre-injury based on Tegner score with data collected for the time frame indicated.

Change from Baseline to 36 Months, 48 Months, and 60 Months in Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score for participants categorized as non-active prior to injury (based on Tegner score) was measured by the five subscales of 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 for all items with five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the subscale scores are combined to calculate the KOOS Overall Score. The Overall Score is transformed to 0 to 100 scale, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).

Outcome measures

Measure	Surgical Standard of Care (SSOC) n=21 Participants Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).	Agili-C™ n=32 Participants Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach
Non-Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 36 Months	17.1 score on a scale Standard Deviation 19.8 • Interval -7.8 to 55.7	48.4 score on a scale Standard Deviation 21.2 • Interval 0.0 to 79.5
Non-Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 48 Months	17.1 score on a scale Standard Deviation 19.8 • Interval 0.0 to 56.1	48.0 score on a scale Standard Deviation 22.9 • Interval 0.0 to 79.8
Non-Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months Change from Baseline to 60 Months	15.6 score on a scale Standard Deviation 19.0 • Interval 0.0 to 56.3	46.0 score on a scale Standard Deviation 27.2 • Interval 0.0 to 81.7

Adverse Events

Agili-C™

Serious events: 49 serious events

Other events: 120 other events

Deaths: 1 deaths

Surgical Standard of Care (SSOC)

Serious events: 25 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Measure	Agili-C™ n=167 participants at risk Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach	Surgical Standard of Care (SSOC) n=84 participants at risk Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).
Hepatobiliary disorders cholelithiasis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Immune system disorders allergy to metals	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations covid-19	2.4% 4/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations covid-19 pneumonia	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications ankle fracture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications cartilage injury	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications contusion	2.4% 4/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications hand fracture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications injury	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications limb injury	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications meniscus injury	1.8% 3/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications nerve injury	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications post procedural haematoma	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications road traffic accident	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications spinal compression fracture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Cardiac disorders coronary artery disease	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Cardiac disorders myocardial infarction	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Ear and labyrinth disorders conductive deafness	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders abdominal hernia	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders abdominal pain	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders haemorrhoids	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders inguinal hernia	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	2.4% 2/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
General disorders asthenia	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Hepatobiliary disorders cholecystitis chronic	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications tendon rupture	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications traumatic arthropathy	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders ankylosing spondylitis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders arthralgia	2.4% 4/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders cervical spinal stenosis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders intervertebral disc degeneration	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders osteoarthritis	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders osteochondrosis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders patellofemoral pain syndrome	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders rotator cuff syndrome	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders spinal synovial cyst	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) breast cancer	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) choroid neoplasm	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders sciatica	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Pregnancy, puerperium and perinatal conditions foetal hypokinesia	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Product Issues device breakage	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Renal and urinary disorders nephrolithiasis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Reproductive system and breast disorders menometrorrhagia	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Reproductive system and breast disorders vaginal haemorrhage	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Respiratory, thoracic and mediastinal disorders acute respiratory failure	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Respiratory, thoracic and mediastinal disorders pneumothorax	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Surgical and medical procedures ligament operation	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Vascular disorders thrombophlebitis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders Decreased range of motion compared to baseline	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Vascular disorders Deep Vein Thrombosis (DVT) and related complications	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders Increased transient or chronic pain in the operated joint, compared to baseline	3.6% 6/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	11.9% 10/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations Infection & related symptoms	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders Progression of osteoarthritis compared to baseline	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	2.4% 2/84 • Adverse events were collected from surgery through the end of study, approximately 60 months

Other adverse events

Measure	Agili-C™ n=167 participants at risk Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach	Surgical Standard of Care (SSOC) n=84 participants at risk Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).
Injury, poisoning and procedural complications cartilage injury	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations otitis media	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations pharyngitis streptococcal	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	2.4% 2/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations pneumonia	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations sinusitis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations stitch abscess	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations suspected covid-19	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations tooth abscess	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations tooth infection	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations upper respiratory tract infection	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations urinary tract infection	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations viral infection	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications animal bite	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Metabolism and nutrition disorders hyperlipidaemia	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Metabolism and nutrition disorders obesity	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Metabolism and nutrition disorders type 2 diabetes mellitus	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders arthralgia	11.4% 19/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	14.3% 12/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders back pain	1.8% 3/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	3.6% 3/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders bursitis	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders chondropathy	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders foot deformity	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders haemarthrosis	1.8% 3/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders intervertebral disc degeneration	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders intervertebral disc disorder	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders joint effusion	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders syncope	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders thoracic outlet syndrome	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Pregnancy, puerperium and perinatal conditions haemorrhage in pregnancy	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Psychiatric disorders anxiety	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Psychiatric disorders claustrophobia	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Psychiatric disorders depression	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Reproductive system and breast disorders dysmenorrhoea	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Reproductive system and breast disorders menometrorrhagia	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Reproductive system and breast disorders menopausal symptoms	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Reproductive system and breast disorders pelvic pain	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Reproductive system and breast disorders penile discharge	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Reproductive system and breast disorders prostatism	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Reproductive system and breast disorders vulvovaginal discomfort	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Respiratory, thoracic and mediastinal disorders acute respiratory failure	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Respiratory, thoracic and mediastinal disorders bronchiectasis	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Respiratory, thoracic and mediastinal disorders dyspnoea	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Respiratory, thoracic and mediastinal disorders pulmonary fibrosis	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Respiratory, thoracic and mediastinal disorders sleep apnoea syndrome	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Skin and subcutaneous tissue disorders dermal cyst	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Skin and subcutaneous tissue disorders dermatitis contact	2.4% 4/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Skin and subcutaneous tissue disorders psoriasis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Skin and subcutaneous tissue disorders rash	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Skin and subcutaneous tissue disorders skin discolouration	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Skin and subcutaneous tissue disorders urticaria	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Vascular disorders lymphoedema	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Vascular disorders phlebitis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Vascular disorders thrombosis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Vascular disorders varicose vein	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders Decreased range of motion compared to baseline	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders Increased swelling (or effusion) in the operated joint, compared to baseline	6.0% 10/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	3.6% 3/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations covid-19	2.4% 4/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	3.6% 3/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations coxsackie viral infection	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations diverticulitis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations ear infection fungal	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations folliculitis	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations gastroenteritis	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations influenza	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations molluscum contagiosum	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations nasopharyngitis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations oesophageal candidiasis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations onychomycosis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Infections and infestations orchitis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Eye disorders eye irritation	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Eye disorders eye pain	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Eye disorders eyelid ptosis	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Eye disorders retinal vein occlusion	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Eye disorders vision blurred	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders abdominal pain upper	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders anal fissure	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders anal fistula	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders colitis	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders colitis ulcerative	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders constipation	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders crohn's disease	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders diarrhoea	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders gastrooesophageal reflux disease	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders inguinal hernia	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Gastrointestinal disorders umbilical hernia	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
General disorders adverse drug reaction	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
General disorders chest pain	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
General disorders influenza like illness	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
General disorders thermal burn	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Hepatobiliary disorders cholelithiasis	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Immune system disorders drug hypersensitivity	1.8% 3/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Cardiac disorders atrioventricular block second degree	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Congenital, familial and genetic disorders arteriovenous malformation	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Ear and labyrinth disorders middle ear effusion	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Endocrine disorders hypothyroidism	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Endocrine disorders secondary hypogonadism	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Eye disorders blepharospasm	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Eye disorders cataract	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications chemical burns of eye	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications contusion	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	4.8% 4/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications epicondylitis	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	2.4% 2/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications facial bones fracture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications fall	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications hand fracture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications head injury	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications iatrogenic injury	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications iliotibial band syndrome	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications inadequate osteointegration	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications joint injury	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications ligament sprain	3.0% 5/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications limb fracture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications limb injury	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications muscle rupture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications muscle strain	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications neck injury	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications post-traumatic neck syndrome	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications procedural pain	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications repetitive strain injury	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications rib fracture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications road traffic accident	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	2.4% 2/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications sciatic nerve injury	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications skin laceration	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications tooth fracture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Injury, poisoning and procedural complications wrist fracture	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Metabolism and nutrition disorders abnormal weight gain	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Metabolism and nutrition disorders dehydration	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Metabolism and nutrition disorders gout	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders joint instability	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders joint swelling	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders muscle tightness	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders muscular weakness	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders musculoskeletal chest pain	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders musculoskeletal stiffness	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders neck pain	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders osteoarthritis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders osteochondrosis	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders pain in extremity	1.8% 3/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders patellofemoral pain syndrome	1.8% 3/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders plantar fasciitis	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders spinal osteoarthritis	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders spondylolisthesis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders synovial cyst	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders temporomandibular joint syndrome	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders tendon disorder	2.4% 4/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders tendonitis	1.8% 3/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	2.4% 2/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders tenosynovitis	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders trigger finger	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) colon adenoma	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) giant cell tumour of tendon sheath	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neuroma	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders burning sensation	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders carpal tunnel syndrome	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders cervical radiculopathy	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders migraine without aura	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders peroneal nerve palsy	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders post-traumatic headache	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Nervous system disorders sciatica	6.0% 10/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	6.0% 5/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders Increased transient or chronic pain in the operated joint, compared to baseline	18.6% 31/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	36.9% 31/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders Joint locking	0.60% 1/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders Muscle atrophy compared to baseline	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	0.00% 0/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Musculoskeletal and connective tissue disorders Progression of osteoarthritis compared to baseline	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	2.4% 2/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Vascular disorders Vascular damage	0.00% 0/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	1.2% 1/84 • Adverse events were collected from surgery through the end of study, approximately 60 months
Skin and subcutaneous tissue disorders Wound complications (wound dehiscence, hematoma, site drainage or superficial infection)	1.2% 2/167 • Adverse events were collected from surgery through the end of study, approximately 60 months	2.4% 2/84 • Adverse events were collected from surgery through the end of study, approximately 60 months

Additional Information

Senior Manager Clinical Compliance

Smith+Nephew, Inc

Phone: 07811407089

Email: datasharing.gcs@smith-nephew.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is the sponsor can review results communications before public release and can prohibit communications about trial results for less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor may request amendments or object to the publication. If requested, the PI will use best efforts to accept the incorporation into the publication any such amendments.
• Publication restrictions are in place

Restriction type: OTHER