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NCT05651997
Study Comparing Two Methods for the Treatment of Large Chondral and Osteochondral Defects of the Knee
Conditions: Articular Cartilage Defect, Chondral Defect, Osteochondritis
Sex: All
Ages: 15 Years – 50 Years
Phase: NA
Enrollment: 80
Sponsor: Centre Hospitalier Universitaire Vaudois
Location: Switzerland
Summary
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.
Eligibility Criteria
Inclusion Criteria:Patients aged between 15-50 yearsSymptomatic chondral and osteochondral defect, grade III and IV according to the ICRS classification, and size between 2.5 and 15 cm2Failure of a conservative treatmentPatient 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-upConsent to participate in the studyExclusion Criteria:All inflammatory and synovial pathologiesDiffuse or mirror lesionsAn unfavorable biomechanical environmentObesity grade II or higher, with a BMI>35 kg/m2Active smoking/ active drug dependency (hard drugs)Poor complianceThe patient is already part of another clinical trial that may compromise the present studyVulnerable 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.
Source: ClinicalTrials.gov (NCT05651997). StuddyBuddy aggregates publicly available trial information.