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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
. 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;