RecruitingOsteochondral Lesions of the Knee JointOsteochondritis Dissecans (OCD)Early Osteoarthritis

MaioRegen Prime Study for the Treatment of Deep Osteochondral Lesion of the Knee

Eligible age

18–60 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: Fin-Ceramica Faenza Spa

You may qualify if…

✓ 1. Informed consent prior to any study-related procedures;
✓ 2. Male or female patients aged between 18 and 60 years (inclusive);
✓ 3. Body Mass Index (BMI) ≤ 35;
✓ 4. 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);
✓ 5. 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;
✓ 6. 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);
✓ 7. IKDC Subjective score at baseline (pre-op evaluation) is less than 70;
✓ 8. Non-responsive to physical therapy for at least 6 weeks;

You may not qualify if…

✕ 1. IKDC subjective score at Baseline is more than or equal to 70;
✕ 2. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain = 0, pain free = 100);
✕ 3. Osteochondral tibial plateau and/or patella defects;
✕ 4. Patients affected by advanced osteoarthritis in the index knee (Kellgren and Lawrence classification 3 or 4);
✕ 5. Bony defect depth deeper than 5 mm, according to baseline MRI, measured from the original subchondral bone plate level;
✕ 6. Uncontained defects: lack of vital bone wall at least 2 mm thick, completely surrounding the lesion - based on MRI;
✕ 7. Patients with untreated patellofemoral malalignment or who have undergone realignment procedures within 6 months;
✕ 8. Patients with bone fracture or uncorrected malalignment more than 5 degrees varus or valgus according to standing X-ray.

Where it's recruiting

Ohio

Columbus

Source: ClinicalTrials.gov · NCT07332182 · last updated 2026-09-23