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.
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)
All inflammatory and synovial pathologies
Diffuse or mirror lesions
An unfavorable biomechanical environment
Obesity grade II or higher, with a BMI>35 kg/m2
Parallel
MACT
Procedure/Surgery* A biopsy of healthy cartilage is taken from a non-weight bearing area of the knee joint during an arthroscopic procedure. * The biopsy is processed in the GMP accredited laboratory to isolate and amplify chondrocytes. * The cells are seeded and cultured on a collagen matrix (Chondro-Gide®, Geistlich Pharma) * The membrane is implanted and sutured onto the injured site.
AMT
Procedure/SurgeryThis treatment combines the microfracture procedure with the application of a bilayer matrix of porcine type I/III collagen (Chondro-Gide, Geistlich Pharma) and the supplementation of autologous bone.
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
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
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).
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).
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)
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Centre Hospitalier Universitaire Vaudois
Lead sponsor
Virginie PHILIPPE
Collaborator
Lee Ann LAURENT APPLEGATE
Collaborator
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