TerminatedNot Applicable

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

Stopped: The study was terminated early due to a change in business strategy at the sponsor, unrelated to any safety concerns with the medical device.

China75 participantsStarted 2023-03-10

Plain-language 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

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patients aged 18-55 years (including 18 years and 55 years);
✓. Localized cartilage defects on knee joint, the size of the defect after debridement is 2.0 squared cm - 8.0 squared cm (including 2.0 squared cm and 8.0 squared cm), which was classified by the International Cartilage Repair Society (ICRS) as grade Ⅲ or grade IV;
✓. The subjects voluntarily consent to participate in this trial and sign the informed consent form (ICF).

Exclusion criteria

✕. Body mass index (BMI) ≥ 30 kg/meter squared (BMI = weight divided by height squared);
✕. Unilateral knee cartilage defect with the ICRS classification of grade III or grade IV, and with three or more defects;
✕. Patients with abnormal lower limb mechanical axis requiring correction, except those that could be corrected during the treatment of cartilage injury;
✕. Varus or valgus of lower limb axis \> 5°, requiring osteotomy for correction;
✕. Patients with multiple ligament injury or total meniscectomy;
✕. Those who are known to be allergic to porcine-derived materials or collagen, or refuse to use porcine-derived medical products;
✕. Those with severe arthroclisis or arthrofibrosis;
✕. Those who have received open knee surgery in the past 6 months;

What they're measuring

Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)

Timeframe: 24 months postoperative

Trial details

NCT IDNCT05785949

SponsorGeistlich Pharma AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-04

View on ClinicalTrials.gov More Cartilage Defects trials