A Prospective, Multicenter, Randomized, Parallel Controlled Study Evaluating the Safety and Efficacy of Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair
Overview
- Phase
- Not Applicable
- Intervention
- Microfracture
- Conditions
- Cartilage Defects
- Sponsor
- Geistlich Pharma AG
- Enrollment
- 75
- Locations
- 18
- Primary Endpoint
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
- Status
- Terminated
- Last Updated
- last month
Overview
Brief 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
Detailed Description
This is a prospective, multicenter, randomized, parallel controlled and superiority clinical trial. It is planned to be carried out in hospitals with qualifications as a national-level clinical trial institution. Subjects who have signed the ICF, meet all inclusion criteria and do not meet any exclusion criteria will be included in this study. Subjects included will be randomly assigned into the experimental group and the control group at a ratio of 1:1. Those in the control group will receive microfracture, and those in the experimental group will receive microfracture plus Chondro-Gide® bilayer collagen membrane. The primary efficacy evaluation indicator of this clinical study is the MOCART score at 24 months postoperative. The secondary efficacy evaluation indicators are IKDC score (before operation, 3, 6, 12 and 24 months postoperative), MOCART score (6 and 12 months postoperative), hyaline cartilage production (T2 mapping ratio) (12 and 24 months postoperative), Lysholm score (before operation, 3, 6, 12 and 24 months postoperative), and device performance evaluation of the investigational product. Safety evaluation indicators include adverse events (or serious adverse events), device-related adverse events (or serious adverse events), device deficiencies and laboratory examination.
Investigators
Eligibility Criteria
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;
- •Those who have received microfracture, mosaicplasty or autologous cartilage implantation in the past 3 months;
- •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;
Arms & Interventions
Microfracture + Chondro-Gide®
Microfracture + Chondro-Gide® bilayer collagen membrane
Intervention: Microfracture
Microfracture + Chondro-Gide®
Microfracture + Chondro-Gide® bilayer collagen membrane
Intervention: Chondro-Gide bilayer collagen membrane
Microfracture
Microfracture
Intervention: Microfracture
Outcomes
Primary Outcomes
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
Time Frame: 24 months postoperative
Cartilage repair is evaluated by MOCART score from nine aspects, such as degree of defect repair and filling of the defect, integration to border zone, surface of repair tissue, structure of the repair tissue, adhesions and subchondral lamina.
Secondary Outcomes
- International Knee Documentation Committee (IKDC) score(before operation and at 3, 6, 12 and 24 months postoperative)
- Safety indicators; adverse events and device deficiencies(through study completion, an average of 2 years)
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)(6 and 12 months postoperative)
- Hyaline cartilage production (T2 mapping ratio)(12 and 24 months postoperative)
- Device performance evaluation questionnaire(perioperative (after surgical intervention), on the day of surgery)
- Safety indicators; Laboratory examination(before operation, 7 days and 6 months postoperative)
- Lysholm score(before operation and at 3, 6, 12 and 24 months postoperative)