Cartilage DefectsPhase 3NCT07917806
A RCT of Collagen Scaffold for the Repair of Talus Cartilage Injury
A Phase 3 study testing Collagen Scaffold (Colla-Plug) and microfracture in people with Cartilage Defects and Talus Osteochondral Defect, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair of talus injury, compared to standard surgery alone. The study will enroll 40 patients (aged 18-55) with talus cartilage damage who haven't responded to conservative treatments. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Defects, Talus Osteochondral Defect
- What is being tested?
- Collagen Scaffold (Colla-Plug) and microfracture
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 1 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Subjects are between the ages of 18 and 55 (including 18 and 55 years old);
- Articular cartilage defect reaches Outerbridge grade III/IV;
- The area of cartilage defect in a single site is 1cm²-3cm²;
- BMI 18≤BMI≤30;
- Clinically diagnosed cartilage defect requiring arthroscopic microfracture;
- Have not participated in other clinical trials within 3 months;
- Conservative treatment for more than 3 months has not been effective
- Subjects fully understand the benefits and risks of this trial, are willing to participate and sign the informed consent form, and are able to cooperate with clinical follow-up
Who cannot join
- Subjects with significant narrowing of the ankle joint space or bony ankylosis (bone bridge formation).
- Subjects with severe subchondral bone damage unsuitable for microfracture surgery.
- Subjects with severe ankle deformity or systemic bone/joint diseases.
- Subjects with allergic predisposition (e.g., porcine protein allergy) or personal/family history of autoimmune diseases.
- Subjects who received autologous bone marrow mesenchymal stem cell transplantation or other cartilage regeneration surgery for cartilage defects in the affected ankle within 12 months prior to surgery.
- Subjects whose ankle cartilage injury was caused by articular fractures, infections, tumors, or immune-mediated diseases.
Show all 14Show fewer
- Subjects with ankle tumors, rheumatoid arthritis, tuberculosis, suppurative arthritis, or complications affecting joint structure.
- Subjects with secondary ankle arthritis accompanied by psoriasis, syphilitic neuropathy, ochronosis, or metabolic bone diseases.
- Subjects with frequent use of sedatives, hypnotics, tranquilizers, or other addictive drugs.
- Subjects with severe primary cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic system diseases, or psychiatric disorders.
- Subjects unable to comply with long-term intensive postoperative rehabilitation.
- Female subjects planning pregnancy within 12 months, or currently pregnant or lactating.
- Subjects with specific religious beliefs prohibiting porcine-derived products.
- Other subjects deemed ineligible by investigators (e.g., inability to evaluate treatment efficacy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: A Prospective Randomized Controlled Study Of Collagen Scaffold For The Repair Of Talus Cartilage Injury
The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair of talus injury, compared to standard surgery alone. The study will enroll 40 patients (aged 18-55) with talus cartilage damage who haven't responded to conservative treatments.
The main questions it aims to answer are:
Read more
- Does the collagen scaffold help regenerate better-quality cartilage (measured by MRI scans at 3/6 months and 1/2 years)?
- Do patients experience better pain relief and ankle function after this combined treatment?
Researchers will compare two groups:
- Experimental group: Receives microfracture surgery + collagen scaffold implant
- Active Comparator group: Receives microfracture surgery alone
Participants will:
- Undergo arthroscopic surgery (either procedure)
- Complete follow-up visits at 1 week, 1 month, 3 months, 6 months, 1 year and 2 years
- Have MRI scans and functional assessments
- Report pain levels and daily activity limitations through questionnaires
- Conditions
- Cartilage Defects, Talus Osteochondral Defect
- Being tested
- Collagen Scaffold (Colla-Plug), microfracture
- Keywords
- cartilage scaffold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Scaffold (Colla-Plug)Device
The collagen cartilage scaffold(COLTRIX® CartiRegen) used in this study consist of an injection needle, a syringe, and a collagen gel prefilled in a syringe. The collagen gel contains phosphate buffer and type I collagen which the telopeptides are removed.. After the product is implanted in the body, it forms a degradable three-dimensional scaffold to provide an environment for cells to adhere, proliferate, migrate, differentiate and secrete, thereby promoting cartilage repair. At present, it has been commercially applied to clinical repair of knee cartilage defect.
microfractureProcedure or surgery
Microfracture to repair cartilage defect is a minimally invasive procedure that is usually done arthroscopically. The doctor first cleans the damaged cartilage area, and then uses a special microfracture cone to drill vertically in the subchondral bone plate, forming multiple tiny holes, allowing mesenchymal stem cells and growth factors in the bone marrow to overflow, forming a blood clot rich in repair components, and finally stimulating fibrocartilage regeneration to fill the defect area.
| Study group | Role | What they receive |
|---|---|---|
| Microfracture + Collagen scaffold | Experimental | Not described Receives: Device: Collagen Scaffold (Colla-Plug); Procedure: microfracture |
| Microfracture | Active comparator | Not described Receives: Procedure: microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOCART score
The MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scoring system includes multiple dimensions such as the morphology of the repaired tissue, the thickness of the repaired cartilage, the signal intensity of the repaired tissue, the integration of the repaired cartilage with normal cartilage, the bone quality under the repaired cartilage, the accumulation or inflammation of the joint cavity, and the coverage of cartilage defects. Morphology and its integration with the surrounding normal cartilage.
Measured: Preoperatively, 3rd and 6th months and 1st and 2nd postoperatively
Secondary outcomes (5)
Range of motion
The range of motion (ROM), measured in degrees (°) using the neutral-zero method, includes: sagittal plane dorsiflexion (0°-20°) and plantarflexion (0°-50°) at the talocrural joint, and frontal plane/horizontal plane inversion (0°-35°) and eversion (0°-15° to 20°) at the subtalar joint. Anatomically, the neutral reference position is 90° between the foot and leg, with the goniometer axis placed inferior to the lateral malleolus or midpoint of the bimalleolar line, the stationary arm aligned with the fibular/leg axis, and the moving arm aligned with the 5th metatarsal or calcaneus axis. Active and passive ROM should be documented separately, with unilateral findings compared to the contralateral side to assess restriction.
Measured: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
Visual Analogue Scale(VAS)
A Visual Analogue Scale (VAS) is a straight-line measurement tool where respondents mark their perceived intensity of a symptom-such as pain-along a continuous 0-100 mm continuum.
Measured: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
Kellgren-Lawrence Grade
The Kellgren-Lawrence (KL) grade is a standardized radiological scoring system (grades 0-4) used to classify the severity of osteoarthritis based on features such as joint space narrowing, osteophytes, and subchondral sclerosis.
Measured: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
Tegner score
The Tegner score is a clinician-reported scale (0-10) that rates a patient's activity level by linking knee function to the demands of specific sports and occupational activities.
Measured: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
American Orthopedic Foot and Ankle Society Score (AOFAS)
The AOFAS score is a clinician-based 100-point ankle-foot rating system that evaluates pain, function, and alignment to assess outcomes in foot and ankle disorders.
Measured: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Oct 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917806
- Sponsor's protocol ID
- K20250509-01
- Status last verified
- Nov 2026
- First submitted
- 18 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will share the medical history and physical examination, imaging data (X-ray, CT, MRI, etc.) , functional scores, laboratory test results and complications of the two groups of patients with talus cartilage defect.
Publications
Kim SJ, Shetty AA, Kurian NM, Ahmed S, Shetty N, Stelzeneder D, Shin YW, Cho YJ, Lee SH. Articular cartilage repair using autologous collagen-induced chondrogenesis (ACIC): a pragmatic and cost-effective enhancement of a traditional technique. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2598-2603. doi: 10.1007/s00167-020-05884-y. Epub 2020 Feb 17.
PubMed 32064573Shetty AA, Kim SJ, Shetty V, Jang JD, Huh SW, Lee DH. Autologous collagen induced chondrogenesis (ACIC: Shetty-Kim technique) - A matrix based acellular single stage arthroscopic cartilage repair technique. J Clin Orthop Trauma. 2016 Jul-Sep;7(3):164-9. doi: 10.1016/j.jcot.2016.05.003. Epub 2016 Jun 14.
PubMed 27489411Shetty AA, Kim SJ, Bilagi P, Stelzeneder D. Autologous collagen-induced chondrogenesis: single-stage arthroscopic cartilage repair technique. Orthopedics. 2013 May;36(5):e648-52. doi: 10.3928/01477447-20130426-30.
PubMed 23672920
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study Of Collagen Scaffold For The Repair Of Talus Cartilage Injury
- ClinicalTrials.gov ID
- NCT07917806
- Acronym / sponsor ID
- K20250509-01
- Conditions
- Cartilage Defects, Talus Osteochondral Defect
- Keywords
- cartilage scaffold
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 5 Nov 2026 (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.
The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair of talus injury, compared to standard surgery alone. The study will enroll 40 patients (aged 18-55) with talus cartilage damage who haven't responded to conservative treatments.
The main questions it aims to answer are:
- Does the collagen scaffold help regenerate better-quality cartilage (measured by MRI scans at 3/6 months and 1/2 years)?
- Do patients experience better pain relief and ankle function after this combined treatment?
Researchers will compare two groups:
- Experimental group: Receives microfracture surgery + collagen scaffold implant
- Active Comparator group: Receives microfracture surgery alone
Participants will:
- Undergo arthroscopic surgery (either procedure)
- Complete follow-up visits at 1 week, 1 month, 3 months, 6 months, 1 year and 2 years
- Have MRI scans and functional assessments
- Report pain levels and daily activity limitations through questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microfracture + Collagen scaffold | Experimental | Device: Collagen Scaffold (Colla-Plug), Procedure: microfracture |
| Microfracture | Active comparator | Procedure: microfracture |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects are between the ages of 18 and 55 (including 18 and 55 years old);
- Articular cartilage defect reaches Outerbridge grade III/IV;
- The area of cartilage defect in a single site is 1cm²-3cm²;
- BMI 18≤BMI≤30;
- Clinically diagnosed cartilage defect requiring arthroscopic microfracture;
Key exclusion criteria (14 listed)
- Subjects with significant narrowing of the ankle joint space or bony ankylosis (bone bridge formation).
- Subjects with severe subchondral bone damage unsuitable for microfracture surgery.
- Subjects with severe ankle deformity or systemic bone/joint diseases.
- Subjects with allergic predisposition (e.g., porcine protein allergy) or personal/family history of autoimmune diseases.
- Subjects who received autologous bone marrow mesenchymal stem cell transplantation or other cartilage regeneration surgery for cartilage defects in the affected ankle within 12 months prior to surgery.
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 |
|---|---|---|
| Collagen Scaffold (Colla-Plug)The collagen cartilage scaffold(COLTRIX® CartiRegen) used in this study consist of an injection needle, a syringe, and a collagen gel prefilled in a syringe. The collagen gel contains phosphate buffer and type I collagen which the telopeptides are removed.. After the product is implanted in the body, it forms a degradable three-dimensional scaffold to provide an environment for cells to adhere, proliferate, migrate, differentiate and secrete, thereby promoting cartilage repair. At present, it has been commercially applied to clinical repair of knee cartilage defect. | Device | Microfracture + Collagen scaffold |
| microfractureMicrofracture to repair cartilage defect is a minimally invasive procedure that is usually done arthroscopically. The doctor first cleans the damaged cartilage area, and then uses a special microfracture cone to drill vertically in the subchondral bone plate, forming multiple tiny holes, allowing mesenchymal stem cells and growth factors in the bone marrow to overflow, forming a blood clot rich in repair components, and finally stimulating fibrocartilage regeneration to fill the defect area. | Procedure or surgery | Microfracture, Microfracture + Collagen scaffold |
Primary outcome
MOCART score
Time frame: Preoperatively, 3rd and 6th months and 1st and 2nd postoperatively
The MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scoring system includes multiple dimensions such as the morphology of the repaired tissue, the thickness of the repaired cartilage, the signal intensity of the repaired tissue, the integration of the repaired cartilage with normal cartilage, the bone quality under the repaired cartilage, the accumulation or inflammation of the joint cavity, and the coverage of cartilage defects. Morphology and its integration with the surrounding normal cartilage.
5 secondary outcomes
Range of motion
Time frame: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
Visual Analogue Scale(VAS)
Time frame: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
Kellgren-Lawrence Grade
Time frame: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
Tegner score
Time frame: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
American Orthopedic Foot and Ankle Society Score (AOFAS)
Time frame: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Results publication: PubMed 32064573Kim SJ, Shetty AA, Kurian NM, Ahmed S, Shetty N, Stelzeneder D, Shin YW, Cho YJ, Lee SH. Articular cartilage repair using autologous collagen-induced chondrogenesis (ACIC): a pragmatic and cost-effective enhancement of a traditional technique. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2598-2603. doi: 10.1007/s00167-020-05884-y. Epub 2020 Feb 17.
- Results publication: PubMed 27489411Shetty AA, Kim SJ, Shetty V, Jang JD, Huh SW, Lee DH. Autologous collagen induced chondrogenesis (ACIC: Shetty-Kim technique) - A matrix based acellular single stage arthroscopic cartilage repair technique. J Clin Orthop Trauma. 2016 Jul-Sep;7(3):164-9. doi: 10.1016/j.jcot.2016.05.003. Epub 2016 Jun 14.
- Results publication: PubMed 23672920Shetty AA, Kim SJ, Bilagi P, Stelzeneder D. Autologous collagen-induced chondrogenesis: single-stage arthroscopic cartilage repair technique. Orthopedics. 2013 May;36(5):e648-52. doi: 10.3928/01477447-20130426-30.
- Individual participant dataSharing planned: Yes. This study will share the medical history and physical examination, imaging data (X-ray, CT, MRI, etc.) , functional scores, laboratory test results and complications of the two groups of patients with talus cartilage defect.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collagen Scaffold (Colla-Plug) and microfracture in people with Cartilage Defects and Talus Osteochondral Defect, run by Beijing Jishuitan Hospital at 1 site 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 8 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
MOCART score (time frame: Preoperatively, 3rd and 6th months and 1st and 2nd postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07917806, which also lists 3 linked publications.
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 5 Nov 2026.