A RCT of Collagen Scaffold for the Repair of Talus Cartilage Injury

November 3, 2026 updated by: Beijing Jishuitan Hospital

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:

  • 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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.

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 (Estimated)

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.
40

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.
  • Phase 3

Contacts and Locations

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

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing Jishuitan Hospital, Capital Medical University

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects are between the ages of 18 and 55 (including 18 and 55 years old);
  2. Articular cartilage defect reaches Outerbridge grade III/IV;
  3. The area of cartilage defect in a single site is 1cm²-3cm²;
  4. BMI 18≤BMI≤30;
  5. Clinically diagnosed cartilage defect requiring arthroscopic microfracture;
  6. Have not participated in other clinical trials within 3 months;
  7. Conservative treatment for more than 3 months has not been effective
  8. 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

Exclusion Criteria:

  1. Subjects with significant narrowing of the ankle joint space or bony ankylosis (bone bridge formation).
  2. Subjects with severe subchondral bone damage unsuitable for microfracture surgery.
  3. Subjects with severe ankle deformity or systemic bone/joint diseases.
  4. Subjects with allergic predisposition (e.g., porcine protein allergy) or personal/family history of autoimmune diseases.
  5. 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.
  6. Subjects whose ankle cartilage injury was caused by articular fractures, infections, tumors, or immune-mediated diseases.
  7. Subjects with ankle tumors, rheumatoid arthritis, tuberculosis, suppurative arthritis, or complications affecting joint structure.
  8. Subjects with secondary ankle arthritis accompanied by psoriasis, syphilitic neuropathy, ochronosis, or metabolic bone diseases.
  9. Subjects with frequent use of sedatives, hypnotics, tranquilizers, or other addictive drugs.
  10. Subjects with severe primary cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic system diseases, or psychiatric disorders.
  11. Subjects unable to comply with long-term intensive postoperative rehabilitation.
  12. Female subjects planning pregnancy within 12 months, or currently pregnant or lactating.
  13. Subjects with specific religious beliefs prohibiting porcine-derived products.
  14. Other subjects deemed ineligible by investigators (e.g., inability to evaluate treatment efficacy).

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: Triple

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

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.
Experimental: Microfracture + Collagen scaffold
Device: 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.

Procedure: microfracture

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.

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
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.
Preoperatively, 3rd and 6th months and 1st and 2nd postoperatively

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
Range of motion
Time Frame: Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.

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.
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.

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.
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.

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.
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.

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.
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.

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.
Preoperatively, 1st week, 1st month, 3rd month, 6th month,1st year and 2nd year postoperatively.

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.
Beijing Jishuitan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 1, 2026

Primary Completion (Estimated)

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.
August 1, 2028

Study Completion (Estimated)

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.
August 1, 2028

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).
August 18, 2025

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.
November 3, 2026

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.
November 5, 2026

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.
November 5, 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.
November 3, 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.
November 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.
  • K20250509-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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