A Study of Collagen Scaffold for the Repair of Elbow Cartilage Injury (NCT07149896) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Collagen Scaffold for the Repair of Elbow Cartilage Injury
China90 participantsStarted 2025-08
Plain-language 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 patients (aged 18-55) with elbow 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 and 6 months)?
* Do patients experience better pain relief and elbow 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, and 6 months
* Have MRI scans and functional assessments
* Report pain levels and daily activity limitations through questionnaires
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subjects are between the ages of 18 and 55 (including 18 and 55 years old);
✓. 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 criteria
✕. Obvious narrowing of the elbow joint space or bone ankylosis formed between joints;
What they're measuring
1
MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score
Timeframe: Preoperatively, 3rd and 6th months postoperatively
. 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;