Cartilage or Osteochondral Defects in the Knee, Up to Moderate Osteoarthritis
Conditions
Brief summary
The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.
Detailed description
This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™ vs. SSOC for the repair of joint surface lesions. Follow-up visits will be performed at 2 weeks and at 3, 6, 12, 18, 24, 36, 48 and 60 months post-procedure to evaluate the patient's knee condition and clinical health. The following questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation , SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18, 24, 36, 48 and 60 months. Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 24, 36, 48 and 60 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months.
Interventions
DEVICEAgili-C implant
Agili-C implant
PROCEDURESSOC
microfracture and/or debridement
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-Label, adaptive design with interim analyses
Intervention model description
Open-label Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 21 -75 years 2. Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea 3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation 4. Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits 5. Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable) 6. Non-responsive to physical therapy for at least 3-4 weeks
Exclusion criteria
1. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100) 2. Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy 3. Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above 4. Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading 5. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal) 6. Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray 7. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure 8. Meniscal transplantation in the past 6 months 9. Any known tumor of the index knee 10. Any known history of intra-articular or osseous infection of the index knee 11. Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other) 12. Any known history of inflammatory arthropathy or crystal-deposition arthropathy 13. Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta 14. Body Mass Index (BMI) \> 35 15. Chemotherapy in the past 12 months 16. Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months 17. Any previous ligamentous repair or malalignment correction in the index knee within the last 6 months 18. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate 19. Patient who is pregnant or intends to become pregnant during the study 20. History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies 21. Known substance or alcohol abuse 22. Participation in other clinical trials within 60 days prior to the study or concurrent with the study 23. Known insulin dependent diabetes mellitus 24. Unable to undergo either MRI or X-ray 25. Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed 26. Previous intra-articular steroid injection within the last 1 month 27. Prisoners 28. Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy 29. Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months | Baseline, 60 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months | Baseline, 60 Months | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months | Baseline, 60 Months | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months | Baseline, 60 Months | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months | Baseline, 60 Months | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months | Baseline, 60 Months | 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. |
| Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months | Baseline, 36 Months, and 48 Months | 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). |
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Short Form Survey (SF-12) Physical Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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. |
| Short Form Survey (SF-12) Mental Component Score Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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. |
| Chondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Osteochondral Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months | Baseline, 60 Months | 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. |
| Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| 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 | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| 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 | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Total Lesion Area ≤3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Total Lesion Area >3cm²: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Without Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| With Previous Ligament Reconstruction: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| With Intact Meniscus: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| With Previous Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| With Concomitant Partial Meniscectomy: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Non-Active Pre-injury: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
| Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months | Baseline, 36 Months, 48 Months, and 60 Months | 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). |
Countries
Belgium, Hungary, Israel, Italy, Poland, Romania, Serbia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Agili-C™ Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach | 167 |
| 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). | 84 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Changes in study team and government regulations | 1 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 9 |
| Overall Study | Participant underwent surgical intervention in the index knee | 15 | 8 |
| Overall Study | Withdrawal by Subject | 13 | 9 |
Baseline characteristics
| Characteristic | Agili-C™ | Surgical Standard of Care (SSOC) | Total |
|---|---|---|---|
| Age, Customized Age Category <50 | 127 Participants | 50 Participants | 177 Participants |
| Age, Customized Age Category ≥50 | 40 Participants | 34 Participants | 74 Participants |
| Age, Customized Age Group 21 to <45 (Young adulthood) | 94 Participants | 41 Participants | 135 Participants |
| Age, Customized Age Group 45 to <65 (Middle adulthood) | 68 Participants | 40 Participants | 108 Participants |
| Age, Customized Age Group ≥65 (Elderly) | 5 Participants | 3 Participants | 8 Participants |
| Body Mass Index (BMI) ≥30 No | 130 Participants | 57 Participants | 187 Participants |
| Body Mass Index (BMI) ≥30 Yes | 37 Participants | 27 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 164 Participants | 82 Participants | 246 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black | 6 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 159 Participants | 81 Participants | 240 Participants |
| Region of Enrollment Belgium | 6 Participants | 2 Participants | 8 Participants |
| Region of Enrollment Hungary | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment Israel | 24 Participants | 15 Participants | 39 Participants |
| Region of Enrollment Italy | 17 Participants | 9 Participants | 26 Participants |
| Region of Enrollment Poland | 6 Participants | 3 Participants | 9 Participants |
| Region of Enrollment Romania | 21 Participants | 10 Participants | 31 Participants |
| Region of Enrollment Serbia | 58 Participants | 26 Participants | 84 Participants |
| Region of Enrollment United States | 33 Participants | 18 Participants | 51 Participants |
| Sex: Female, Male Female | 60 Participants | 33 Participants | 93 Participants |
| Sex: Female, Male Male | 107 Participants | 51 Participants | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 167 | 0 / 84 |
| other Total, other adverse events | 120 / 167 | 68 / 84 |
| serious Total, serious adverse events | 49 / 167 | 25 / 84 |
Outcome results
Primary
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Agili-C™ | Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months | 38.75 score on a scale |
| Surgical Standard of Care (SSOC) | Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months | 19.52 score on a scale |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 39.6 score on a scale | Standard Deviation 21 |
| Agili-C™ | 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 | 40.4 score on a scale | Standard Deviation 21.1 |
| Agili-C™ | 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 | 38.0 score on a scale | Standard Deviation 22.3 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 42.9 score on a scale | Standard Deviation 21.3 |
| Agili-C™ | 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 | 42.1 score on a scale | Standard Deviation 23.1 |
| Agili-C™ | 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 | 41.3 score on a scale | Standard Deviation 23.7 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 41.1 score on a scale | Standard Deviation 22.6 |
| Agili-C™ | 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 | 41.6 score on a scale | Standard Deviation 23 |
| Agili-C™ | 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 | 41.0 score on a scale | Standard Deviation 24.2 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Agili-C™ | Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Score Change From Baseline to 60 Months | 33.03 score on a scale |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Agili-C™ | Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months | 0.74 proportion of participants |
| Surgical Standard of Care (SSOC) | Knee Injury and Osteoarthritis Outcome Score (KOOS) Overall Score Responder Rate Change From Baseline to 60 Months | 0.34 proportion of participants |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Agili-C™ | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months | 37.71 score on a scale |
| Surgical Standard of Care (SSOC) | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months | 18.68 score on a scale |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Agili-C™ | Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months | 45.22 score on a scale |
| Surgical Standard of Care (SSOC) | Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months | 22.29 score on a scale |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Agili-C™ | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months | 47.32 score on a scale |
| Surgical Standard of Care (SSOC) | Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports Score Change From Baseline to 60 Months | 25.11 score on a scale |
Secondary
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Agili-C™ | Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months | 30.52 score on a scale |
| Surgical Standard of Care (SSOC) | Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms Score Change From Baseline to 60 Months | 15.52 score on a scale |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 42.5 score on a scale | Standard Deviation 20.6 |
| Agili-C™ | 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 | 43.1 score on a scale | Standard Deviation 21.7 |
| Agili-C™ | 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 | 39.4 score on a scale | Standard Deviation 23.9 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 40.1 score on a scale | Standard Deviation 22.2 |
| Agili-C™ | 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 | 40.5 score on a scale | Standard Deviation 21.5 |
| Agili-C™ | 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 | 39.8 score on a scale | Standard Deviation 23 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 37.3 score on a scale | Standard Deviation 23.6 |
| Agili-C™ | 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 | 38.4 score on a scale | Standard Deviation 22.8 |
| Agili-C™ | 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 | 36.0 score on a scale | Standard Deviation 24.9 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 48.4 score on a scale | Standard Deviation 21.2 |
| Agili-C™ | 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 | 48.0 score on a scale | Standard Deviation 22.9 |
| Agili-C™ | 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 | 46.0 score on a scale | Standard Deviation 27.2 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 39.0 score on a scale | Standard Deviation 21.1 |
| Agili-C™ | 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 | 41.5 score on a scale | Standard Deviation 19 |
| Agili-C™ | 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 | 36.6 score on a scale | Standard Deviation 22.9 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months | Change from Baseline to 36 Months | 41.4 score on a scale | Standard Deviation 21.3 |
| Agili-C™ | Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months and 48 Months | Change from Baseline to 48 months | 41.9 score on a scale | Standard Deviation 21.6 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 5.4 score on a scale | Standard Deviation 12.8 |
| Agili-C™ | 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 | 5.2 score on a scale | Standard Deviation 12.9 |
| Agili-C™ | 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 | 4.3 score on a scale | Standard Deviation 13.7 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 15.4 score on a scale | Standard Deviation 9.8 |
| Agili-C™ | 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 | 15.5 score on a scale | Standard Deviation 10.6 |
| Agili-C™ | 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 | 15.2 score on a scale | Standard Deviation 11.5 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 43.7 score on a scale | Standard Deviation 19.6 |
| Agili-C™ | 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 | 43.8 score on a scale | Standard Deviation 20.8 |
| Agili-C™ | 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 | 41.5 score on a scale | Standard Deviation 22.5 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months | Change from Baseline to 36 Months | 2.3 score on a scale | Standard Deviation 1.9 |
| Agili-C™ | Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months | Change from Baseline to 48 Months | 2.2 score on a scale | Standard Deviation 1.8 |
| Agili-C™ | Tegner Activity Scale Change From Baseline to 36 Months, 48 Months, and 60 Months | Change from Baseline to 60 Months | 2.1 score on a scale | Standard Deviation 1.8 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 38.3 score on a scale | Standard Deviation 20.3 |
| Agili-C™ | 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 | 38.4 score on a scale | Standard Deviation 21.1 |
| Agili-C™ | 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 | 36.2 score on a scale | Standard Deviation 22.1 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 43.5 score on a scale | Standard Deviation 21.8 |
| Agili-C™ | 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 | 44.3 score on a scale | Standard Deviation 21.7 |
| Agili-C™ | 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 | 41.8 score on a scale | Standard Deviation 24.2 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 42.0 score on a scale | Standard Deviation 22.3 |
| Agili-C™ | 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 | 43.4 score on a scale | Standard Deviation 22.4 |
| Agili-C™ | 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 | 38.1 score on a scale | Standard Deviation 26.1 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 41.9 score on a scale | Standard Deviation 19.5 |
| Agili-C™ | 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 | 42.0 score on a scale | Standard Deviation 20.1 |
| Agili-C™ | 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 | 40.7 score on a scale | Standard Deviation 21.4 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 37.0 score on a scale | Standard Deviation 24.3 |
| Agili-C™ | 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 | 38.8 score on a scale | Standard Deviation 24.7 |
| Agili-C™ | 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 | 35.5 score on a scale | Standard Deviation 26.4 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 34.7 score on a scale | Standard Deviation 19.9 |
| Agili-C™ | 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 | 31.9 score on a scale | Standard Deviation 21.5 |
| Agili-C™ | 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 | 31.9 score on a scale | Standard Deviation 21.9 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
Secondary
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, 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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agili-C™ | 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 | 38.4 score on a scale | Standard Deviation 26.2 |
| Agili-C™ | 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 | 38.5 score on a scale | Standard Deviation 25.5 |
| Agili-C™ | 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 | 38.3 score on a scale | Standard Deviation 26.2 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |
| Surgical Standard of Care (SSOC) | 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 |