NCT07332182

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

Multicenter Prospective Randomized Study of MaioRegenTM Prime vs. Debridement (Surgical Standard of Care (SSOC)) for the Treatment of Osteochondral Lesion of the Knee Joint - OSTEOCONFIRM Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Fin-Ceramica Faenza Spa · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is multicenter, prospective, randomized clinical trial, subjects will be randomized (2:1) to MaioRegen Prime or debridement. All randomized patients will be followed with post-operative visits at 15 days, 6 weeks, 3, 6, 12, 18 and 24 months after surgery and annually post-24 months visit (until last patient reaches 24 months). During screening period and at follow-up visits commonly used specific scores will be evaluated: IKDC Subjective Knee Evaluation Form, IKDC Knee Examination Form, KOOS, Tegner Score, VAS pain, PROMIS-29, ICRS Cartilage Repair Assessment and MRI related scores.

Conditions

• Osteochondral Lesions of the Knee Joint
• Osteochondritis Dissecans (OCD)
• Early Osteoarthritis

Interventions

Type	Name	Description
DEVICE	osteochondral scaffold implant	three layered biomimetic osteochondral scaffold implant for osteochondral lesions of the knee
PROCEDURE	SSOC	Debridement

Timeline

• Start date: 2026-05-01
• Primary completion: 2031-04-30
• Completion: 2031-04-30
• First posted: 2026-01-12
• Last updated: 2026-01-12

Regulatory

• FDA-regulated device study