MaioRegen Prime Study for the Treatment of Deep Osteochondral Lesion of the Knee
NCT07332182 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2026-01-12
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.
Conditions
- Osteochondral Lesions of the Knee Joint
- Osteochondritis Dissecans (OCD)
- Early Osteoarthritis
Interventions
- DEVICE
-
osteochondral scaffold implant
three layered biomimetic osteochondral scaffold implant for osteochondral lesions of the knee
- PROCEDURE
-
SSOC
Debridement
Sponsors & Collaborators
-
Fin-Ceramica Faenza Spa
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2031-04-30
- Completion
- 2031-04-30
- FDA Device
- Yes
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