Clinical trial NCT05785949: Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair
Official title: A Prospective, Multicenter, Randomized, Parallel Controlled Study Evaluating the Safety and Efficacy of Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cartilage Defects
Keywords: Chondro-Gide®
Lead sponsor: Geistlich Pharma AG
Sponsor class: INDUSTRY
Collaborators: name: TigerMed
First posted: 2023-03-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, parallel-controlled design is adopted. The experimental group and the control group will complete the study under the same study conditions at basically synchronous study time.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
timeFrame: 24 months postoperative
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC) score
timeFrame: before operation and at 3, 6, 12 and 24 months postoperative
measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
timeFrame: 6 and 12 months postoperative
measure: Hyaline cartilage production (T2 mapping ratio)
timeFrame: 12 and 24 months postoperative
measure: Lysholm score
timeFrame: before operation and at 3, 6, 12 and 24 months postoperative
measure: Device performance evaluation questionnaire
timeFrame: perioperative (after surgical intervention), on the day of surgery
measure: Safety indicators; adverse events and device deficiencies
timeFrame: through study completion, an average of 2 years
measure: Safety indicators; Laboratory examination
timeFrame: before operation, 7 days and 6 months postoperative
Other outcomes:
Locations:
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Southern Medical University
city: Hanzhou
country: China
facility: The second affiliated hospital of Zhejiang University School of Medicine
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital Of Nanchang University
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
city: Peking
country: China
facility: Sino-Japanese Friendship Hospital
city: Peking
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Geistlich Pharma AG
name: Despoina Natsiou Schmiady, Dr.
role: STUDY_DIRECTOR
References: