Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee

Study Overview
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Brief Summary
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Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment of small chondral lesions treated with microfracture alone.

Detailed Description
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The study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.Eligible patients with a large lesion will be treated with microfracture plus the Chondro-Gide® ACC and compared to patients with small lesions that are treated with microfracture alone. Outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.

Official Title
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A ProSpective, MulticEnter, Concurrently Controlled Clinical Study of Chondro-Gide® ArticUlar Cartilage CoveR for the Treatment of Large Chondral Lesions in the KnEe (SECURE)

Conditions
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Knee Injuries, Cartilage Injury, Cartilage Disease, Knee Discomfort

Intervention / Treatment
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* Procedure: Microfracture
* Device: Microfracture plus placement of Chondro-Gide® ACC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy Between 18 and 55 years of age Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol Exclusion Criteria: BMI ≥ 30 kg/m2 Symptomatic contralateral knee Diagnosis of radiographic osteoarthritis with Kellgren-Lawrence grade 3 or more Prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment) Patella dysplasia Chronic inflammatory arthritis or infectious arthritis History of autoimmune disease or immunodeficiency History of connective tissue disease Intra-articular steroid use within the 3 months prior to enrollment Other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment The patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone Pregnancy or lack of adequate contraceptives if a female of child-bearing potential Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study Active infection of the index knee Previous diagnosis of osteoporosis as diagnosed by DEXA, bone densitometry or CT scan Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions History or current substance or alcohol abuse as defined by the DSM-V Any other medical condition that the investigator determines would interfere with the validity of the study Known allergy to porcine collagen Symptom duration greater than 36 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>Patients with small chondral lesions of the knee | Procedure: Microfracture<br>* Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.<br>|
| Experimental: Investigational Group<br>Patients with large chondral lesions of the knee | Device: Microfracture plus placement of Chondro-Gide® ACC<br>* Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells, followed by affixing Chondro-Gide® with fibrin glue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS | The CCS is defined as a patient meeting all of the three following criteria: Improvement in the Pain sub-scale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) between baseline to 24 months follow-up Improvement in function, defined as an improvement in the International Knee Documentation Committee (IKDC) score between baseline to 24 months follow-up Freedom from device- or procedure-related serious adverse events (SAEs) or secondary surgical intervention related to the device, procedure, or treated lesion | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. Calculate the mean score of the individual items of each subscale and divide by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 
| Magnetic Resonance Observation of Cartilage Score | Magnetic Resonance Image (MRI) will be obtain during the course of the study at 3 months and 24 months. MOCART 2.0 scoring will occur by independent assessment using the MOCART score. The score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score. | 3 months, 24 months | 
| Patient satisfaction | Were you satisfied with the procedure? (Satisfied, Somewhat satisfied, Neutral, Somewhat unsatisfied, Unsatisfied) Would you have this procedure again if needed on the other knee? (Definitely yes, Probably yes, Not Sure, Probably Not, Definitely Not) | 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 
| Tegner Activity Scale | The Tegner activity score is a one-item score that grades activity based on work and sports activities. Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. A scale of the highest level activity being 10 and the lowest being 0 | 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 
| Employment status | Employment status will be collected as: Employed full-time, Employed part-time, Not employed due to knee problems, Not employed due to reasons other than knee problems. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 
| EuroQol-5 Dimension (EQ-5D) | The EQ-5D measures as a descriptive system comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microfracture, Cartilage, Knee