The present study aims to compare the efficacy and the safety of MaioRegen Prime to Debridement (SSOC) in patients with deep osteochondral lesions of the knee joint. The foreseen population involves patients with osteochondral lesions with different etiology, dimension, shape, and location.
The evaluation will be performed through clinical, subjective and objective assessments.
Informed consent prior to any study-related procedures;
Male or female patients aged between 18 and 60 years (inclusive);
Body Mass Index (BMI) ≤ 35;
Up to 3 treatable osteochondral lesions localized in femoral condyles and/or trochlea (the patient might have other lesion in other parts of the joint, but they should not be more severe than ICRS Grade II lesions as determined by baseline MRI);
IKDC subjective score at Baseline is more than or equal to 70;
KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain = 0, pain free = 100);
Osteochondral tibial plateau and/or patella defects;
Patients affected by advanced osteoarthritis in the index knee (Kellgren and Lawrence classification 3 or 4);
Parallel
osteochondral scaffold implant
Devicethree layered biomimetic osteochondral scaffold implant for osteochondral lesions of the knee
SSOC
Procedure/SurgeryDebridement
Superiority of MaioRegen Prime vs Debridement
The primary endpoint is the success rate defined as a composite binary endpoint, where a patient is a success if they meet all of the following criteria: * At least a 15 points IKDC increase at 24 months * Lack of SAE related to MaioRegen treatment or debridement during the 24-month follow-up * Lack of related re-intervention after MaioRegen treatment or debridement during the 24-month follow-up
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 24 months of MaioRegen Prime compared to debridement
Subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100. Higher scores indicate higher levels of function and lower levels of symptoms, (i.e., a better outcome).
Rate of responder in IKDC Subjective Knee Evaluation at 24 months of MaioRegen Prime compared to debridement as defined as improvement in IKDC Subjective Knee Evaluation of ≥15 points
The new IKDC Subjective Knee Evaluation Form, published in 2000, is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100. Higher scores indicate higher levels of function and lower levels of symptoms, (i.e., a better outcome).
Proportion of patients without SAEs related to MaioRegen treatment or debridement treatment during the 24-month follow-up period
Proportion of patients without related re-intervention after MaioRegen treatment or debridement treatment at 24 month follow-up period
Safety Outcome
Adverse Events rate per type, severity, seriousness, and relatedness to the treatment, including Serious Adverse Events and Serious Adverse Device Effect, Adverse Device Effect, Unanticipated Adverse Device Effect, Re-operations, Complaint and Treatment Failures up to 24 months will be evaluated and adjudicated by CEC members.
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