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);