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

March 6, 2026 updated by: Geistlich Pharma AG

A Prospective, Multicenter, Randomized, Parallel Controlled Study Evaluating the Safety and Efficacy of 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. The objective of this clinical trial is to evaluate the efficacy and safety of Chondro-Gide® bilayer collagen membrane in knee cartilage defect repair

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, China, 100013
        • Sino-Japanese Friendship Hospital
      • Changchun, China, 130041
        • The Second Hospital of Jilin University
      • Guangzhou, China, 510632
        • The First Affiliated Hospital of Jinan University
      • Guangzhou, China, 510640
        • The Third Affiliated Hospital of Southern Medical University
      • Hanzhou, China, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hohhot, China, 010011
        • Inner Mongolia People's Hospital
      • Kunming, China, 650051
        • The First Affiliated Hospital of Kunming Medical University
      • Nanchang, China, 330209
        • The First Affiliated Hospital of Nanchang University
      • Nanjing, China, 210008
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    • Guangdong
      • Shenzhen, Guangdong, China, 518035
        • Shen Zhen Secondary People hospital
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shen Zhen hospital
      • Yibin, Guangdong, China, 644000
        • The Second People Hospital of Yi Bin
    • Hebei
      • Tangshan, Hebei, China, 063016
        • The Second Hospital of Tang Shan
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Nan Chang First Hospital
    • Shandong
      • Jinan, Shandong, China, 250002
        • QiLu Hospital of Shan Dong University
    • Xinjiang
      • Kashgar, Xinjiang, China, 844000
        • The First People Hospital of Ka Shi
    • Zhejiang
      • Taizhou, Zhejiang, China, 318013
        • Tai Zhou Hospital of Zhe Jiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Microfracture
Procedure: 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.
Experimental: Microfracture + Chondro-Gide®
Microfracture + Chondro-Gide® bilayer collagen membrane
Procedure: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC) score
Time Frame: before operation and at 3, 6, 12 and 24 months postoperative
The therapeutic effect for subjects is evaluated based on the difference between IKDC score at the different timepoints. The score ranges from 0 - 87 points, where higher scores mean a better outcome.
before operation and at 3, 6, 12 and 24 months postoperative
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
Time Frame: 6 and 12 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. The Score ranges from 0 - 100, where higher scores mean a better outcome.
6 and 12 months postoperative
Hyaline cartilage production (T2 mapping ratio)
Time Frame: 12 and 24 months postoperative
Please refer to YY/T 1636-2018 Tissue engineering medical device products-In vivo evaluation of knee cartilage implanted tissue using MRI technique for the specific operation, measurement and evaluation method of T2 mapping technology of MRI.
12 and 24 months postoperative
Lysholm score
Time Frame: before operation and at 3, 6, 12 and 24 months postoperative
The Lysholm score is assessing patient's knee specific symptoms. The total Lysholm score is 100 (0: worst, 100: best).
before operation and at 3, 6, 12 and 24 months postoperative
Device performance evaluation questionnaire
Time Frame: perioperative (after surgical intervention), on the day of surgery

The investigator evaluates the performance of the device based on a questionnaire. The evaluation criteria are as follows. There are three answer options to every question:

  1. Is the product operation convenient?
  2. Is the product easy to trim?
  3. Is the product easy to fix?
  4. Is the product compliant after being fixed?
perioperative (after surgical intervention), on the day of surgery
Safety indicators; adverse events and device deficiencies
Time Frame: through study completion, an average of 2 years
  1. Incidence (%) and number of (serious) adverse events, and those of device-related (serious) adverse events;
  2. Incidence (%) and number of device deficiencies;
through study completion, an average of 2 years
Safety indicators; Laboratory examination
Time Frame: before operation, 7 days and 6 months postoperative
Determination of clinical significance of laboratory examination: 1) normal; 2) abnormal but without clinical significance; 3) abnormal with clinical significance; 4) not examined. If the clinical significance is judged as 3) abnormal with clinical significance, the abnormality is explained, followed up, and reexamined until normal or reaching baseline level or stable.
before operation, 7 days and 6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Geistlich Pharma AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TigerMed

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fabiana Martinelli, Geistlich Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13575-238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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