Study 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.
Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair
A Prospective, Multicenter, Randomized, Parallel Controlled Study Evaluating the Safety and Efficacy of Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair
1 other identifier
interventional
75
1 country
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Typical duration for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2023
CompletedStudy Start
First participant enrolled
March 10, 2023
CompletedFirst Posted
Study publicly available on registry
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedMarch 9, 2026
March 1, 2026
2.7 years
February 14, 2023
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
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.
24 months postoperative
Secondary Outcomes (7)
International Knee Documentation Committee (IKDC) score
before operation and at 3, 6, 12 and 24 months postoperative
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
6 and 12 months postoperative
Hyaline cartilage production (T2 mapping ratio)
12 and 24 months postoperative
Lysholm score
before operation and at 3, 6, 12 and 24 months postoperative
Device performance evaluation questionnaire
perioperative (after surgical intervention), on the day of surgery
- +2 more secondary outcomes
Study Arms (2)
Microfracture + Chondro-Gide®
EXPERIMENTALMicrofracture + Chondro-Gide® bilayer collagen membrane
Microfracture
ACTIVE COMPARATORMicrofracture
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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;
- 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;
- Patients with knee infection；
- Those with connective tissue diseases;
- Those with nervous system diseases or muscle degeneration;
- 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;
- Other circumstances which are considered by the investigator not suitable for enrollment in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geistlich Pharma AGlead
- TigerMedcollaborator
Study Sites (18)
Shen Zhen Secondary People hospital
Shenzhen, Guangdong, 518035, China
Peking University Shen Zhen hospital
Shenzhen, Guangdong, 518036, China
The Second People Hospital of Yi Bin
Yibin, Guangdong, 644000, China
The Second Hospital of Tang Shan
Tangshan, Hebei, 063016, China
Nan Chang First Hospital
Nanchang, Jiangxi, 330000, China
QiLu Hospital of Shan Dong University
Jinan, Shandong, 250002, China
The First People Hospital of Ka Shi
Kashgar, Xinjiang, 844000, China
Tai Zhou Hospital of Zhe Jiang Province
Taizhou, Zhejiang, 318013, China
Sino-Japanese Friendship Hospital
Beijing, 100013, China
Peking University Third Hospital
Beijing, 100191, China
The Second Hospital of Jilin University
Changchun, 130041, China
The First Affiliated Hospital of Jinan University
Guangzhou, 510632, China
The Third Affiliated Hospital of Southern Medical University
Guangzhou, 510640, China
The second affiliated hospital of Zhejiang University School of Medicine
Hanzhou, 310009, China
Inner Mongolia People's Hospital
Hohhot, 010011, China
The First Affiliated Hospital of Kunming Medical University
Kunming, 650051, China
The First Affiliated Hospital Of Nanchang University
Nanchang, 330209, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, 210008, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fabiana Martinelli
Geistlich Pharma AG
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessors will be blinded, i.e., the outcome assessors will not participate in the operation and do not know the subject grouping information. The outcome assessors will make efficacy judgment based on MRI results, so as to reduce study bias caused by subjective assessment error.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2023
First Posted
March 27, 2023
Study Start
March 10, 2023
Primary Completion
December 4, 2025
Study Completion
January 31, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share