Articular Cartilage Defect Clinical Trial
Official title:
Randomized Study Comparing Two Methods for the Treatment of Large Chondral and Osteochondral Defects of the Knee: Augmented Microfracture Technique vs. 3rd Generation of ACI
The major objective of this study is to evaluate the efficacy of the MACT versus the AMT for the treatment of large cartilage defects in patellofemoral and femorotibial injuries.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | June 1, 2032 |
Est. primary completion date | June 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 50 Years |
Eligibility | Inclusion Criteria: - Patients aged between 15-50 years - Symptomatic chondral and osteochondral defect, grade III and IV according to the ICRS classification, and size between 2.5 and 15 cm2 - Failure of a conservative treatment - Patient in good general condition, documented by an ASA score = 2 (American Society of Anesthesiologists) - Patient considered compliant and able to participate in rehabilitation and pre- and post-operative follow-up - Consent to participate in the study Exclusion Criteria: - All inflammatory and synovial pathologies - Diffuse or mirror lesions - An unfavorable biomechanical environment - Obesity grade II or higher, with a BMI>35 kg/m2 - Active smoking/ active drug dependency (hard drugs) - Poor compliance - The patient is already part of another clinical trial that may compromise the present study - Vulnerable populations (except minors aged 15-18 years) - Presence of open growth plate (15-18 years) - Pregnancy or planned pregnancy during the study (MRI-related contra-indication) - Proven allergy to penicillin and gentamicin (for MACT group) and porcine collagen (for both groups) For final inclusion, an additional exclusion criteria will be assessed after randomization: - Positive to HIV, HBV, HCV, syphilis. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Hôpital Fribourgeois- HFR | Fribourg | |
Switzerland | Centre Hospitalier Universitaire Vaudois - CHUV | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois | Lee Ann LAURENT APPLEGATE, Virginie PHILIPPE |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Self-reported physical pain and function are assessed by International Knee Documentation Committee score (IKDC) | A score will be calculated, and it ranges from 0 (worst score) to 100 (best score). | Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the patellofemoral and femorotibial joints. | |
Other | Rate of implantation-associated complications: serious adverse events (SAEs) and serious adverse reactions (SARs) | Post-implantation data collection: Types, probability and severity of treatment (inflammation, infection,pain, joint effusion, delamination, transplant rejection, fibrocartilage, incomplete cartilage repair). | Up to 60 months. | |
Other | The cartilage repair is assesed by Magnetic Resonance Observation of Cartilage Repair | MOCART scoring system is based on MRI analysis. A score in points will be calculated, and it ranges from 0 points (no repair) to 100 points (excellent cartilage defect repair) | Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation. | |
Primary | Patellofemoral joint-related function and quality-of-life are assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS). | KOOS includes five subscales: symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score). Self-assessment by the patient | Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the patellofemoral joint. | |
Secondary | Femorotibial joint-related function and quality-of-life are assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS). | KOOS includes five subscales: symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score).Self-assessment by the patient | Change from baseline to 3, 6 12, 24, 36, 48 and 60 months post-implantation in the femorotibial joint. |
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