MaioRegen Prime Study for the Treatment of Deep Osteochondral Lesion of the Knee (NCT07332182) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
MaioRegen Prime Study for the Treatment of Deep Osteochondral Lesion of the Knee
400 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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);
✓. Knee osteochondral lesion(s) (Grade IVa and IVb according to ICRS Classification) or not re-fixable knee Osteochondritis Dissecans lesions as determined by baseline MRI;
✓. Lesions with an overall treatable area 1-7 cm2 (as determined by baseline MRI). In case of multiple lesions (maximum 3 lesions) in the same knee compartment a minimum distance of 3 mm is required);
✓. IKDC Subjective score at baseline (pre-op evaluation) is less than 70;
✓. Non-responsive to physical therapy for at least 6 weeks;
Exclusion criteria
✕. 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);