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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MOCART(Magnetic Resonance Observation of Cartilage Repair Tissue) score
Timeframe: Preoperatively, 3rd and 6th months postoperatively
. 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;
. 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;