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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Agili-C | Experimental |
| |
| Surgical Standard of Care (SSOC) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Agili-C implant | Device | Agili-C implant |
| |
| SSOC |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 60 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizaveta Kon, MD | Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Clinical Research | San Diego | California | 91942 | United States | ||
| LSU Healthcare Network Orthopedic & Sports Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40080289 | Derived | Kon E, De Caro F, Dasa V, M Scopp J, Di Matteo B, Flanigan D, Shabshin N, Strickland S, Altschuler N. Female patients report comparable results to males after the implantation of an aragonite-based scaffold for the treatment of knee chondral and osteochondral defects: a gender-based analysis of a RCT at 4 years' follow-up. J Orthop Traumatol. 2025 Mar 13;26(1):17. doi: 10.1186/s10195-025-00829-y. | |
| 36779614 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Agili-C™ | Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach |
| FG001 | Surgical Standard of Care (SSOC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2022 | Aug 5, 2025 |
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Open-label Randomized Controlled Trial
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Open-Label, adaptive design with interim analyses
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| Procedure |
microfracture and/or debridement |
|
| Baseline, 60 Months |
| 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. | Baseline, 60 Months |
| 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. | Baseline, 60 Months |
| 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. | Baseline, 60 Months |
| 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. | Baseline, 60 Months |
| 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. | Baseline, 60 Months |
| 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). | Baseline, 36 Months, and 48 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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. | Baseline, 36 Months, 48 Months, and 60 Months |
| 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. | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| 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). | Baseline, 36 Months, 48 Months, and 60 Months |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Peninsula Orthopaedic Associates | Salisbury | Maryland | 21804 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02467 | United States |
| University of Missouri, Missouri Orthopaedic Institute | Columbia | Missouri | 65212 | United States |
| NYU Langone Orthopedic Hospital | New York | New York | 10003 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Ohio State University, Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Arlington Orthopedic Associates | Arlington | Texas | 76015 | United States |
| OrthoVirginia | Richmond | Virginia | 23294 | United States |
| AZ Monica | Antwerp | Belgium |
| Uzsoki Utcai Kórház | Budapest | 1114 | Hungary |
| Kastélypark Klinika | Tata | 2892 | Hungary |
| Assaf Harofeh Medical Center | Be’er Ya‘aqov | 60930 | Israel |
| "Carmel" Medical Center | Haifa | 3436212 | Israel |
| Hadassah Medical Center | Jerusalem | Israel |
| Hasharon Hospital, Petach Tikva | Petah Tikva | Israel |
| Souraski Medical Center | Tel Aviv | 6423906 | Israel |
| Humanitas Gavazzeni | Bergamo | Italy |
| Istituto Clinico Humanitas | Rozzano | Italy |
| Specialist Hospital. Louis Rydygier in Krakow | Krakow | Poland |
| County Hospital Timis Othopedy and Trauma Clinic | Timișoara | Romania |
| Atlas General hospital | Belgrade | Serbia |
| Clinic for Orthopedic Surgery "Banjica" | Belgrade | Serbia |
| Clinical Center of Vojvodina | Novi Sad | Serbia |
| Derived |
| Altschuler N, Zaslav KR, Di Matteo B, Sherman SL, Gomoll AH, Hacker SA, Verdonk P, Dulic O, Patrascu JM, Levy AS, Robinson D, Kon E. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023 Mar;51(4):957-967. doi: 10.1177/03635465231151252. Epub 2023 Feb 13. |
Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb).
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| NOT COMPLETED |
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The Safety Analysis Set included randomized participants that received treatment with Agili-C™ or Surgical Standard of Care (SSOC).
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| ID | Title | Description |
|---|---|---|
| BG000 | Agili-C™ | Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number of participants categorized by age in years as either ≥50 or <50 | Count of Participants | Participants |
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| Age, Customized | Number of participants were categorized by age group as one of the following:
| Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Number | Participants |
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| Body Mass Index (BMI) ≥30 | Participants with body mass index (BMI) greater than or equal to 30 kg/m²(Yes/No). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 60 Months |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 60 Months |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 60 Months |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 60 Months |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 60 Months |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline, 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, and 48 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 36 Months, 48 Months, and 60 Months |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 60 Months |
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Adverse events were collected from surgery through the end of study, approximately 60 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Agili-C™ | Participants randomized to the investigational arm that received the Agili-C™ implant following arthroscopy via a mini-arthrotomy or arthrotomy approach | 1 | 167 | 49 | 167 | 120 | 167 |
| EG001 | 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). | 0 | 84 | 25 | 84 | 68 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| coronary artery disease | Cardiac disorders | Systematic Assessment |
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| myocardial infarction | Cardiac disorders | Systematic Assessment |
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| conductive deafness | Ear and labyrinth disorders | Systematic Assessment |
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| abdominal hernia | Gastrointestinal disorders | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
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| inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
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| asthenia | General disorders | Systematic Assessment |
| ||
| cholecystitis chronic | Hepatobiliary disorders | Systematic Assessment |
| ||
| cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| allergy to metals | Immune system disorders | Systematic Assessment |
| ||
| covid-19 | Infections and infestations | Systematic Assessment |
| ||
| covid-19 pneumonia | Infections and infestations | Systematic Assessment |
| ||
| ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| cartilage injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| hand fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| meniscus injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| nerve injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| post procedural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| spinal compression fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| tendon rupture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| traumatic arthropathy | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| ankylosing spondylitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| cervical spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| osteochondrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| spinal synovial cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| choroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| sciatica | Nervous system disorders | Systematic Assessment |
| ||
| foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| device breakage | Product Issues | Systematic Assessment |
| ||
| nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| menometrorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ligament operation | Surgical and medical procedures | Systematic Assessment |
| ||
| thrombophlebitis | Vascular disorders | Systematic Assessment |
| ||
| Decreased range of motion compared to baseline | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis (DVT) and related complications | Vascular disorders | Systematic Assessment |
| ||
| Increased transient or chronic pain in the operated joint, compared to baseline | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Infection & related symptoms | Infections and infestations | Systematic Assessment | Infection (including septicemia or deep infections in the operated joint) and related symptoms, such as fever and/or pus |
| |
| Progression of osteoarthritis compared to baseline | Musculoskeletal and connective tissue disorders | Systematic Assessment | Progression of osteoarthritis (degeneration of surrounding bone and cartilage or delamination) compared to baseline |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
| ||
| arteriovenous malformation | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| middle ear effusion | Ear and labyrinth disorders | Systematic Assessment |
| ||
| hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| secondary hypogonadism | Endocrine disorders | Systematic Assessment |
| ||
| blepharospasm | Eye disorders | Systematic Assessment |
| ||
| cataract | Eye disorders | Systematic Assessment |
| ||
| eye irritation | Eye disorders | Systematic Assessment |
| ||
| eye pain | Eye disorders | Systematic Assessment |
| ||
| eyelid ptosis | Eye disorders | Systematic Assessment |
| ||
| retinal vein occlusion | Eye disorders | Systematic Assessment |
| ||
| vision blurred | Eye disorders | Systematic Assessment |
| ||
| abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| anal fissure | Gastrointestinal disorders | Systematic Assessment |
| ||
| anal fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| colitis ulcerative | Gastrointestinal disorders | Systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| crohn's disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| umbilical hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| adverse drug reaction | General disorders | Systematic Assessment |
| ||
| chest pain | General disorders | Systematic Assessment |
| ||
| influenza like illness | General disorders | Systematic Assessment |
| ||
| thermal burn | General disorders | Systematic Assessment |
| ||
| cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| drug hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| covid-19 | Infections and infestations | Systematic Assessment |
| ||
| coxsackie viral infection | Infections and infestations | Systematic Assessment |
| ||
| diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| ear infection fungal | Infections and infestations | Systematic Assessment |
| ||
| folliculitis | Infections and infestations | Systematic Assessment |
| ||
| gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| influenza | Infections and infestations | Systematic Assessment |
| ||
| molluscum contagiosum | Infections and infestations | Systematic Assessment |
| ||
| nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| oesophageal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| onychomycosis | Infections and infestations | Systematic Assessment |
| ||
| orchitis | Infections and infestations | Systematic Assessment |
| ||
| otitis media | Infections and infestations | Systematic Assessment |
| ||
| pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
| ||
| pneumonia | Infections and infestations | Systematic Assessment |
| ||
| sinusitis | Infections and infestations | Systematic Assessment |
| ||
| stitch abscess | Infections and infestations | Systematic Assessment |
| ||
| suspected covid-19 | Infections and infestations | Systematic Assessment |
| ||
| tooth abscess | Infections and infestations | Systematic Assessment |
| ||
| tooth infection | Infections and infestations | Systematic Assessment |
| ||
| upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| viral infection | Infections and infestations | Systematic Assessment |
| ||
| animal bite | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| cartilage injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| chemical burns of eye | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| epicondylitis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| facial bones fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| hand fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| head injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| iatrogenic injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| iliotibial band syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| inadequate osteointegration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| joint injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| limb fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| muscle rupture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| neck injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| post-traumatic neck syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| repetitive strain injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| sciatic nerve injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| skin laceration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| wrist fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| abnormal weight gain | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| obesity | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| chondropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| foot deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| haemarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| intervertebral disc disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| joint effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| joint instability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| muscle tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| osteochondrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| plantar fasciitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| spinal osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| spondylolisthesis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| synovial cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| tendon disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| tenosynovitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| trigger finger | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| giant cell tumour of tendon sheath | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| burning sensation | Nervous system disorders | Systematic Assessment |
| ||
| carpal tunnel syndrome | Nervous system disorders | Systematic Assessment |
| ||
| cervical radiculopathy | Nervous system disorders | Systematic Assessment |
| ||
| migraine without aura | Nervous system disorders | Systematic Assessment |
| ||
| peroneal nerve palsy | Nervous system disorders | Systematic Assessment |
| ||
| post-traumatic headache | Nervous system disorders | Systematic Assessment |
| ||
| sciatica | Nervous system disorders | Systematic Assessment |
| ||
| syncope | Nervous system disorders | Systematic Assessment |
| ||
| thoracic outlet syndrome | Nervous system disorders | Systematic Assessment |
| ||
| haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| claustrophobia | Psychiatric disorders | Systematic Assessment |
| ||
| depression | Psychiatric disorders | Systematic Assessment |
| ||
| dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| menometrorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| menopausal symptoms | Reproductive system and breast disorders | Systematic Assessment |
| ||
| pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| penile discharge | Reproductive system and breast disorders | Systematic Assessment |
| ||
| prostatism | Reproductive system and breast disorders | Systematic Assessment |
| ||
| vulvovaginal discomfort | Reproductive system and breast disorders | Systematic Assessment |
| ||
| acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| bronchiectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| dermal cyst | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| skin discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| lymphoedema | Vascular disorders | Systematic Assessment |
| ||
| phlebitis | Vascular disorders | Systematic Assessment |
| ||
| thrombosis | Vascular disorders | Systematic Assessment |
| ||
| varicose vein | Vascular disorders | Systematic Assessment |
| ||
| Decreased range of motion compared to baseline | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased swelling (or effusion) in the operated joint, compared to baseline | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased transient or chronic pain in the operated joint, compared to baseline | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint locking | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle atrophy compared to baseline | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Progression of osteoarthritis compared to baseline | Musculoskeletal and connective tissue disorders | Systematic Assessment | Progression of osteoarthritis (degeneration of surrounding bone and cartilage or delamination) compared to baseline |
| |
| Vascular damage | Vascular disorders | Systematic Assessment |
| ||
| Wound complications (wound dehiscence, hematoma, site drainage or superficial infection) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The only disclosure restriction on the PI is the sponsor can review results communications before public release and can prohibit communications about trial results for less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor may request amendments or object to the publication. If requested, the PI will use best efforts to accept the incorporation into the publication any such amendments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | 07811407089 | datasharing.gcs@smith-nephew.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2020 | Dec 2, 2025 | SAP_002.pdf |
Not provided
| 45 to <65 (Middle adulthood) |
|
| ≥65 (Elderly) |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Asian |
|
| Native |
|
| Unknown or Not Reported |
|
| Israel |
|
| Belgium |
|
| Poland |
|
| Hungary |
|
| Romania |
|
| Italy |
|
| Serbia |
|
| No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb). |
|
|
Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb). |
|
|
Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb). |
|
|
Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb). |
|
|
| OG001 | 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). |
|
|
| OG001 | 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). |
|
|
Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb). |
|
|
Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb). |
|
|
| 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). |
|
|
Participants randomized to the control arm received surgical standard of care (SSOC) that included two procedures, microfracture (MFX) and debridement (Deb). |
|
|
| 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). |
|
|
| 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). |
|
|
| OG001 |
| 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). |
|
|
| 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). |
|
|
| 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). |
|
|
|
|