Repairing knee cartilage defects using Chondro-Gide® collagen membrane

A Prospective, Multicenter, Randomized, Parallel Controlled Study Evaluating the Safety and Efficacy of Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair

This study is testing if using a special collagen membrane along with a common knee surgery can help repair cartilage defects better than the surgery alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Geistlich Pharma AG (Industry-sponsored)
• Locations: 10 sites (Changchun and 9 other locations)
• Trial ID: NCT05785949 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the Chondro-Gide® bilayer collagen membrane in repairing knee cartilage defects. It is a multicenter, randomized, parallel controlled trial where participants will be assigned to either receive microfracture alone or microfracture combined with the Chondro-Gide® membrane. The study will assess outcomes using various scoring systems at multiple postoperative intervals, focusing on cartilage repair and safety indicators. Participants must meet specific inclusion criteria and will be monitored for adverse events throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18-55 with localized grade III or IV knee cartilage defects sized between 2.0 and 8.0 square cm.

Not a fit: Patients with a BMI of 30 or higher, multiple cartilage defects, or significant lower limb mechanical axis abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the healing and functionality of knee cartilage defects for patients.

How similar studies have performed: Other studies have shown promising results with similar collagen membrane approaches in cartilage repair, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients aged 18-55 years (including 18 years and 55 years);
2. 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;
3. The subjects voluntarily consent to participate in this trial and sign the informed consent form (ICF).

Exclusion Criteria:

1. Body mass index (BMI) ≥ 30 kg/meter squared (BMI = weight divided by height squared);
2. Unilateral knee cartilage defect with the ICRS classification of grade III or grade IV, and with three or more defects;
3. Patients with abnormal lower limb mechanical axis requiring correction, except those that could be corrected during the treatment of cartilage injury;
4. Varus or valgus of lower limb axis \> 5°, requiring osteotomy for correction;
5. Patients with multiple ligament injury or total meniscectomy;
6. Those who are known to be allergic to porcine-derived materials or collagen, or refuse to use porcine-derived medical products;
7. Those with severe arthroclisis or arthrofibrosis;
8. Those who have received open knee surgery in the past 6 months;
9. Those who have received microfracture, mosaicplasty or autologous cartilage implantation in the past 3 months;
10. Those who have serious primary cardiovascular diseases, lung diseases, endocrine and metabolic diseases (severe diabetes, severe osteoporosis) or serious diseases affecting their survival, and are considered unsuitable for inclusion by the investigators;
11. Pregnant and lactating women, or those who plan to conceive during the trial, and those who have positive blood/urine pregnancy test results before the trial;
12. Patients with knee infection；
13. Those with connective tissue diseases;
14. Those with nervous system diseases or muscle degeneration;
15. Patients who participated in drug clinical trials within 3 months prior to the enrollment or patients who participated in any other device clinical trials within 1 months prior to the enrollment;
16. Other circumstances which are considered by the investigator not suitable for enrollment in this study.

Where this trial is running

Changchun and 9 other locations

• The Second Hospital of Jilin University — Changchun, China (Recruiting)
• The First Affiliated Hospital of Jinan University — Guangzhou, China (Recruiting)
• The Third Affiliated Hospital of Southern Medical University — Guangzhou, China (Recruiting)
• The second affiliated hospital of Zhejiang University School of Medicine — Hanzhou, China (Recruiting)
• Inner Mongolia People's Hospital — Hohhot, China (Recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, China (Recruiting)
• The First Affiliated Hospital Of Nanchang University — Nanchang, China (Recruiting)
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, China (Recruiting)
• Sino-Japanese Friendship Hospital — Peking, China (Recruiting)
• Peking University Third Hospital — Peking, China (Recruiting)

Study contacts

• Study coordinator: Despoina Natsiou Schmiady, Dr.

Conditions Cartilage Defects; Chondro-Gide®