Collagen for Treatment of Musculoskeletal Injuries (NCT06331741) | Clinical Trial Compass
UnknownNot Applicable
Collagen for Treatment of Musculoskeletal Injuries
Russia15 participantsStarted 2024-03-01
Plain-language summary
The purpose of the study:
Evaluation of the clinical efficacy and safety of the use of collagen matrix/membrane in the surgical treatment of the consequences of injuries and diseases of the musculoskeletal system (anterior cruciate ligament tears, rigid first toe) by using IKDC, KOOS, ACLOAS, VAS, AOFAS, SF-36 scales
Who can participate
Age range
18 Years – 60 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:
For ACL reconstruction groups:
* Type of damage (rupture of the anterior cruciate ligament (complete or partial);
* Availability of an informed consent form signed and dated by the patient.
* The patient's understanding of the strict requirements of the protocol, rehabilitation program and follow-up program and the desire to follow them.
* The patient's consent to the use of the following drugs: nonsteroidal anti-inflammatory drugs (NSAIDs) (according to indications); antibiotics; anticoagulants.
For collagen membrane of the first toe:
* The type of degenerative disease of the first metatarsophalangeal joint is Hallux rigidus of stage 3-4.
* Availability of an informed consent form signed and dated by the patient.
* The patient's understanding of the strict requirements of the protocol, rehabilitation program and follow-up program and the desire to follow them.
* The patient's consent to the use of the following drugs: nonsteroidal anti-inflammatory drugs (NSAIDs) (according to indications); antibiotics; anticoagulants
Non-inclusion criteria:
* Abuse of alcohol or narcotic substances (medicines).
* Any clinically significant or symptomatic vascular or neurological disease of the lower extremities.
* The presence of rheumatoid arthritis, parainfectious or infectious arthritis and the condition after the listed diseases, as well as the following diseases in the area of the damaged knee joint: septic arthritis, inflammatory joint disease, recurrent pseu…
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
The International Knee Documentation Committee score
Timeframe: 1,5 and 6 months postoperatively
2
The Knee injury and Osteoarthritis Outcome Score
Timeframe: 1,5 and 6 months postoperatively
3
Modified Lysholm scale
Timeframe: 1,5 and 12 months postoperatively
4
Anterior Cruciate Ligament OsteoArthritis Score
Timeframe: 6 months postoperatively
5
American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score
Timeframe: 2, 4 and 8 weeks postoperatively
6
36-Item Short Form Survey
Timeframe: 2, 4 and 8 weeks postoperatively
Trial details
NCT IDNCT06331741
SponsorI.M. Sechenov First Moscow State Medical University