Status:
NOT_YET_RECRUITING
A Study of Collagen Scaffold for the Repair of Elbow Cartilage Injury
Lead Sponsor:
Beijing Jishuitan Hospital
Conditions:
Cartilage Defect
Elbow Injury
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair in elbow joint injuries, compared to standard surgery alone. The study will enroll 90...
Eligibility Criteria
Inclusion
- 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 0.5cm²-2cm²;
- BMI 18≤BMI≤30;
- Clinically diagnosed cartilage defect requiring arthroscopic microfracture;
- Have not participated in other clinical trials within 3 months;
- Conservative treatment such as rest/topical/oral non-steroidal anti-inflammatory drugs 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.
Exclusion
- Obvious narrowing of the elbow joint space or bone ankylosis formed between joints;
- Severe subchondral bone injury that cannot be undergoing microfracture surgery;
- Those with severe elbow deformity or systemic osteoarticular diseases;
- Secondary elbow arthritis with psoriasis, syphilitic neuropathy, brown yellow disease, metabolic bone disease;
- Elbow joint cartilage damage caused by joint fractures, infections, tumors, and immune diseases;
- Elbow joint tumors, rheumatoid, tuberculosis, suppuration and complications affecting the joint structure;
- Those who have undergone cartilage defect transplantation from bone marrow mesenchymal stem cell transplantation or other cartilage regeneration surgery within 12 months before surgery;
- Allergies, such as porcine protein allergy, past history or family history of autoimmune diseases;
- Those who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs;
- Combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases, mental illness;
- Those who cannot receive long-term and complex rehabilitation training after surgery;
- Women who are planning to have children, breastfeeding and pregnant women within 12 months;
- Those who have contraindications to MRI examination;
- Those who have special beliefs and cannot accept it (the product source is pig source);
- Those who are not suitable for inclusion by other researchers, such as those who cannot be judged for efficacy.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07149896
Start Date
August 1 2025
End Date
December 1 2026
Last Update
September 2 2025
Active Locations (1)
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1
Beijing Jishuitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100035