Cartilage DefectsNCT05785949
Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair
A study testing Microfracture and Chondro-Gide bilayer collagen membrane in people with Cartilage Defects, run by Geistlich Pharma AG at 18 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Defects
- What is being tested?
- Microfracture and Chondro-Gide bilayer collagen membrane
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 18 sitesChina
- Study dates
- 10 Mar 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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;
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Sino-Japanese Friendship Hospital
Beijing, 100013
Peking University Third Hospital
Beijing, 100191
The Second Hospital of Jilin University
Changchun, 130041
The First Affiliated Hospital of Jinan University
Guangzhou, 510632
The Third Affiliated Hospital of Southern Medical University
Guangzhou, 510640
The second affiliated hospital of Zhejiang University School of Medicine
Hanzhou, 310009
Inner Mongolia People's Hospital
Hohhot, 010011
QiLu Hospital of Shan Dong University
Jinan, Shandong, 250002
The First People Hospital of Ka Shi
Kashgar, Xinjiang, 844000
The First Affiliated Hospital of Kunming Medical University
Kunming, 650051
Nan Chang First Hospital
Nanchang, Jiangxi, 330000
The First Affiliated Hospital Of Nanchang University
Nanchang, 330209
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, 210008
Shen Zhen Secondary People hospital
Shenzhen, Guangdong, 518035
Peking University Shen Zhen hospital
Shenzhen, Guangdong, 518036
Tai Zhou Hospital of Zhe Jiang Province
Taizhou, Zhejiang, 318013
The Second Hospital of Tang Shan
Tangshan, Hebei, 063016
The Second People Hospital of Yi Bin
Yibin, Guangdong, 644000
About this study
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
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
Read the 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
- Being tested
- Microfracture, Chondro-Gide bilayer collagen membrane
- Keywords
- Chondro-Gide®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrofractureProcedure or surgery
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 membraneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Microfracture + Chondro-Gide® | Experimental | Microfracture + Chondro-Gide® bilayer collagen membrane Receives: Procedure: Microfracture; Device: Chondro-Gide bilayer collagen membrane |
| Microfracture | Active comparator | Microfracture Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months postoperative
Secondary outcomes (7)
International Knee Documentation Committee (IKDC) score
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.
Measured: before operation and at 3, 6, 12 and 24 months postoperative
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. The Score ranges from 0 - 100, where higher scores mean a better outcome.
Measured: 6 and 12 months postoperative
Hyaline cartilage production (T2 mapping ratio)
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.
Measured: 12 and 24 months postoperative
Lysholm score
The Lysholm score is assessing patient's knee specific symptoms. The total Lysholm score is 100 (0: worst, 100: best).
Measured: before operation and at 3, 6, 12 and 24 months postoperative
Device performance evaluation questionnaire
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:
- Is the product operation convenient?
- Is the product easy to trim?
- Is the product easy to fix?
- Is the product compliant after being fixed?
Measured: perioperative (after surgical intervention), on the day of surgery
Safety indicators; adverse events and device deficiencies
- Incidence (%) and number of (serious) adverse events, and those of device-related (serious) adverse events;
- Incidence (%) and number of device deficiencies;
Measured: through study completion, an average of 2 years
Safety indicators; Laboratory examination
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.
Measured: before operation, 7 days and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start10 Mar 2023
- Primary completion4 Dec 2025
- Study completion31 Jan 2026
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TigerMed
- Responsible party
- Sponsor
- Investigators
- Fabiana Martinelli, Study director, Geistlich Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785949
- Sponsor's protocol ID
- 13575-238
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05785949
- Acronym / sponsor ID
- 13575-238
- Conditions
- Cartilage Defects
- Keywords
- Chondro-Gide®
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Collaborators
- TigerMed
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microfracture + Chondro-Gide® | Experimental | Procedure: Microfracture, Device: Chondro-Gide bilayer collagen membraneMicrofracture + Chondro-Gide® bilayer collagen membrane |
| Microfracture | Active comparator | Procedure: MicrofractureMicrofracture |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrofractureUse 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. | Procedure or surgery | Microfracture, Microfracture + Chondro-Gide® |
| Chondro-Gide bilayer collagen membraneAfter 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. | Device | Microfracture + Chondro-Gide® |
Primary outcome
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.
7 secondary outcomes
International Knee Documentation Committee (IKDC) score
Time frame: 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
Hyaline cartilage production (T2 mapping ratio)
Time frame: 12 and 24 months postoperative
Lysholm score
Time frame: 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
Safety indicators; adverse events and device deficiencies
Time frame: through study completion, an average of 2 years
Safety indicators; Laboratory examination
Time frame: before operation, 7 days and 6 months postoperative
Results and safety
The study was stopped early (reason given: The study was terminated early due to a change in business strategy at the sponsor, unrelated to any safety concerns with the medical device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabiana Martinelli study director
Geistlich Pharma AG
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfracture and Chondro-Gide bilayer collagen membrane in people with Cartilage Defects, run by Geistlich Pharma AG at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to a change in business strategy at the sponsor, unrelated to any safety concerns with the medical device.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) (time frame: 24 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.