Collagen for Treatment of Musculoskeletal Injuries (NCT06331741) | Clinical Trial Compass
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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 range18 Years – 60 Years
SexALL
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…
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