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

NCT ID: NCT05785949

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2028-12-31

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.

Conditions

Cartilage Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Microfracture + Chondro-Gide®

Microfracture + Chondro-Gide® bilayer collagen membrane

Group Type: EXPERIMENTAL

Microfracture

Intervention Type: PROCEDURE

Use of standard tool kit to drill vertically from the periphery to the center with a hole spacing of 3\~4 mm with care to prevent penetrating adjacent holes. The hole depth should be 3\~5 mm and fat droplets or blood oozing is seen after loosening the tourniquet. However, no blood oozing is observed in some holes and in such case, the hole depth should be deepened to 5\~7 mm.

Chondro-Gide bilayer collagen membrane

Intervention Type: DEVICE

After the Microfracture, the porous layer of the bilayer collagen membrane faces the bone surface. The already trimmed, cut and wetted membrane is insert into the defect and fixed symmetrically with absorbable surgical suture with needle. Knots are put on the pinhole of collagen membrane to avoid tearing of surrounding cartilage or collagen membrane during knotting.

Microfracture

Microfracture

Group Type: ACTIVE_COMPARATOR

Microfracture

Intervention Type: PROCEDURE

Use of standard tool kit to drill vertically from the periphery to the center with a hole spacing of 3\~4 mm with care to prevent penetrating adjacent holes. The hole depth should be 3\~5 mm and fat droplets or blood oozing is seen after loosening the tourniquet. However, no blood oozing is observed in some holes and in such case, the hole depth should be deepened to 5\~7 mm.

Interventions

Microfracture

Use of standard tool kit to drill vertically from the periphery to the center with a hole spacing of 3\~4 mm with care to prevent penetrating adjacent holes. The hole depth should be 3\~5 mm and fat droplets or blood oozing is seen after loosening the tourniquet. However, no blood oozing is observed in some holes and in such case, the hole depth should be deepened to 5\~7 mm.

Intervention Type: PROCEDURE

Chondro-Gide bilayer collagen membrane

After the Microfracture, the porous layer of the bilayer collagen membrane faces the bone surface. The already trimmed, cut and wetted membrane is insert into the defect and fixed symmetrically with absorbable surgical suture with needle. Knots are put on the pinhole of collagen membrane to avoid tearing of surrounding cartilage or collagen membrane during knotting.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TigerMed

INDUSTRY

Sponsor Role: collaborator

Geistlich Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabiana Martinelli

Role: STUDY_DIRECTOR

Geistlich Pharma AG

Locations

Shen Zhen Secondary People hospital

Shenzhen, Guangdong, China

Peking University Shen Zhen hospital

Shenzhen, Guangdong, China

The Second People Hospital of Yi Bin

Yibin, Guangdong, China

The Second Hospital of Tang Shan

Tangshan, Hebei, China

Nan Chang First Hospital

Nanchang, Jiangxi, China

QiLu Hospital of Shan Dong University

Jinan, Shandong, China

The First People Hospital of Ka Shi

Kashgar, Xinjiang, China

Tai Zhou Hospital of Zhe Jiang Province

Taizhou, Zhejiang, China

Sino-Japanese Friendship Hospital

Beijing, , China

Peking University Third Hospital

Beijing, , China

The Second Hospital of Jilin University

Changchun, , China

The First Affiliated Hospital of Jinan University

Guangzhou, , China

The Third Affiliated Hospital of Southern Medical University

Guangzhou, , China

The second affiliated hospital of Zhejiang University School of Medicine

Hanzhou, , China

Inner Mongolia People's Hospital

Hohhot, , China

The First Affiliated Hospital of Kunming Medical University

Kunming, , China

The First Affiliated Hospital Of Nanchang University

Nanchang, , China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, , China

Countries

China

Other Identifiers

13575-238

Identifier Type: -

Identifier Source: org_study_id