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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Fin-Ceramica Faenza Spa
Study ID
NCT07332182
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • osteochondral scaffold implant — DEVICE
    three layered biomimetic osteochondral scaffold implant for osteochondral lesions of the knee
  • SSOC — PROCEDURE
    Debridement

Study Details

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.

Key Dates

First listed
Jan 12, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Apr 30, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MaioRegen Prime
    Medical Device: MaioRegen Prime implant
  • Active Comparator: Surgical Standard of Care (SSOC)
    Debridement

Primary Outcome Measure

Superiority of MaioRegen Prime vs Debridement [ Time Frame: baseline, 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State UniversityColumbusOhio43210-

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By research site
Ohio State University· Columbus, OH

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