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Could a collagen patch fix elbow cartilage better than surgery alone?

NCT ID NCT07149896

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether adding a collagen scaffold during elbow surgery helps repair damaged cartilage better than surgery alone. Ninety adults aged 18 to 55 with elbow cartilage defects will be randomly assigned to receive either microfracture surgery plus the scaffold or just the surgery. Researchers will use MRI scans and patient reports to compare healing and pain relief over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
collagen scaffold (Colla-Plug)
What this could lead to
If it works, this could provide a better way to repair elbow cartilage, reducing pain and improving joint function.
What could go wrong
This is a relatively small, early-phase trial, so results may not apply to everyone. The scaffold might not improve healing over standard surgery, and there are risks like infection or poor tissue integration.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 0.5cm²-2cm²; 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 such as rest/topical/oral non-steroidal anti-inflammatory drugs 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. Obvious narrowing of the elbow joint space or bone ankylosis formed between joints; 2. Severe subchondral bone injury that cannot be undergoing microfracture surgery; 3. Those with severe elbow deformity or systemic osteoarticular diseases; 4. Secondary elbow arthritis with psoriasis, syphilitic neuropathy, brown yellow disease, metabolic bone disease; 5. Elbow joint cartilage damage caused by joint fractures, infections, tumors, and immune diseases; 6. Elbow joint tumors, rheumatoid, tuberculosis, suppuration and complications affecting the joint structure; 7. Those who have undergone cartilage defect transplantation from bone marrow mesenchymal stem cell transplantation or other cartilage regeneration surgery within 12 months before surgery; 8. Allergies, such as porcine protein allergy, past history or family history of autoimmune diseases; 9. Those who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs; 10. Combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases, mental illness; 11. Those who cannot receive long-term and complex rehabilitation training after surgery; 12. Women who are planning to have children, breastfeeding and pregnant women within 12 months; 13. Those who have contraindications to MRI examination; 14. Those who have special beliefs and cannot accept it (the product source is pig source); 15. Those who are not suitable for inclusion by other researchers, such as those who cannot be judged for efficacy.

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Conditions

The condition(s) this trial relates to.

Elbow Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Jishuitan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100035, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.