Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair
NCT05785949 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2026-03-09
Summary
A prospective, multicenter, randomized, parallel controlled study evaluating the safety and efficacy of Chondro-Gide® bilayer collagen membrane in knee cartilage defect repair. The objective of this clinical trial is to evaluate the efficacy and safety of Chondro-Gide® bilayer collagen membrane in knee cartilage defect repair
Conditions
- Cartilage Defects
Interventions
- PROCEDURE
-
Microfracture
Use of standard tool kit to drill vertically from the periphery to the center with a hole spacing of 3\~4 mm with care to prevent penetrating adjacent holes. The hole depth should be 3\~5 mm and fat droplets or blood oozing is seen after loosening the tourniquet. However, no blood oozing is observed in some holes and in such case, the hole depth should be deepened to 5\~7 mm.
- DEVICE
-
Chondro-Gide bilayer collagen membrane
After the Microfracture, the porous layer of the bilayer collagen membrane faces the bone surface. The already trimmed, cut and wetted membrane is insert into the defect and fixed symmetrically with absorbable surgical suture with needle. Knots are put on the pinhole of collagen membrane to avoid tearing of surrounding cartilage or collagen membrane during knotting.
Sponsors & Collaborators
-
TigerMed
collaborator INDUSTRY -
Geistlich Pharma AG
lead INDUSTRY
Principal Investigators
-
Fabiana Martinelli · Geistlich Pharma AG
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-10
- Primary Completion
- 2025-12-04
- Completion
- 2026-01-31
Countries
- China
Study Locations
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