Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT07917806
Enrolling by invitation Phase 3

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

NCT07917806 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Jishuitan Hospital
Phase
Phase 3
Started
2026-10-01
Last updated
2026-11-05

Condition(s) studied

Cartilage DefectsTalus Osteochondral Defect

Investigational drug(s) / intervention(s)

Collagen Scaffold (Colla-Plug)microfracture

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.

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.

Study 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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • MOCART score — 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.

Trial sites (1)

FacilityCityRegionStatus
Beijing Jishuitan Hospital, Capital Medical University Beijing Beijing Municipality

More Beijing Jishuitan Hospital trials in China

Chinese Second Hip Fracture Evaluation Recruiting
The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Distal Femoral Fractures Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures Recruiting
Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07917806 on ClinicalTrials.gov ↗ ← All trials in China