Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair

NCT05785949 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-09

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05785949 on ClinicalTrials.gov