Completed

NCT Number: NCT03299959

Agili-C™ Implant Performance Evaluation

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.

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Key information

Conditions

Cartilage or Osteochondral Defects in the Knee Up to Moderate Osteoarthritis

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Monica, Antwerp, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

21 -75 years
Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea
Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits
Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable)
Non-responsive to physical therapy for at least 3-4 weeks

Exclusion criteria

KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100)
Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy
Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above
Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray
Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure
Meniscal transplantation in the past 6 months
Any known tumor of the index knee
Any known history of intra-articular or osseous infection of the index knee
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)
Any known history of inflammatory arthropathy or crystal-deposition arthropathy
Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta
Body Mass Index (BMI) > 35
Chemotherapy in the past 12 months
Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months
Any previous ligamentous repair or malalignment correction in the index knee within the last 6 months
History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
Patient who is pregnant or intends to become pregnant during the study
History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies
Known substance or alcohol abuse
Participation in other clinical trials within 60 days prior to the study or concurrent with the study
Known insulin dependent diabetes mellitus
Unable to undergo either MRI or X-ray
Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed
Previous intra-articular steroid injection within the last 1 month
Prisoners
Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy
Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy

Treatment and study plan

Agili-C implant

Device

Agili-C implant

SSOC

Procedure

microfracture and/or debridement

Primary outcomes

Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months

Time frame: 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 outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score Change From Baseline to 60 Months

Time frame: 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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Change From Baseline to 60 Months

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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).
Single Lesion: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months

Time frame: 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).
Multiple Lesions: Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 36 Months, 48 Months, and 60 Months

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee

Important dates

Study start: 2017
Primary completion: 2024
Study completion: 2024
First posted: Oct 3, 2017
Registry last updated: Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed