Using collagen to treat musculoskeletal injuries

Application of Collagen in Treatment of the Consequences of Injuries and Diseases of the Musculoskeletal System

This study is testing if using a collagen membrane during surgery can help people with ACL tears and big toe joint problems recover better and feel less pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: I.M. Sechenov First Moscow State Medical University (Academic / other)
• Locations: 1 site (Moscow)
• Trial ID: NCT06331741 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical efficacy and safety of a collagen matrix/membrane in the surgical treatment of musculoskeletal injuries, specifically targeting anterior cruciate ligament (ACL) tears and hallux rigidus. Participants will undergo ACL reconstruction with or without the collagen membrane, or resection arthroplasty of the first metatarsophalangeal joint with collagen membrane implantation. The study will assess outcomes using various scales, including IKDC, KOOS, and VAS, to measure improvements in function and pain. The research is conducted at the University Clinical Hospital No. 1 of Sechenov University in Moscow.

Who should consider this trial

Good fit: Ideal candidates include individuals with complete or partial ACL tears or those suffering from stage 3-4 hallux rigidus.

Not a fit: Patients with other types of knee injuries or early-stage hallux rigidus may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance recovery and functional outcomes for patients with ACL injuries and hallux rigidus.

How similar studies have performed: While the use of collagen in surgical procedures has been explored, this specific application for ACL reconstruction and hallux rigidus is relatively novel.

Eligibility criteria

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 pseudopodagra, Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson-Konovalov disease, primary osteochondromatosis, hereditary diseases, mutation of collagen genes.
* Pregnancy and planned pregnancy (inability to perform MRI), lactation period.
* Obesity (body mass index \> 30 kg/m2).
* Uncontrolled diabetes mellitus.
* Significant cardiovascular diseases currently or within 12 months prior to screening, including: chronic heart failure of class III or IV (according to the classification of the New York Cardiological Association), severe arrhythmia requiring treatment with antiarrhythmic drugs of classes Ia, Ib, Ic or III, unstable angina pectoris, myocardial infarction, heart and coronary surgery blood vessels, significant diseases of the heart valves, uncontrolled arterial hypertension with systolic blood pressure \> 180 mmHg and diastolic blood pressure \> 110 mmHg, pulmonary embolism or deep vein thrombosis;
* Significant thyroid dysfunction in the decompensation stage;
* Any uncontrolled concomitant somatic disease, including through a stable therapy regimen;
* Nephrotic syndrome, moderate to severe chronic renal failure, or significant kidney disease with creatinine levels \> 1.5 mg/dl (132 mmol/l) in men and \> 1.4 mg/dl (123 mmol/l) in women or glomerular filtration rate (GFR) \< 60 ml/min;
* Current diagnosis of osteomyelitis and (or) infection with human immunodeficiency virus (HIV-1, HIV-2) and (or) hepatitis C virus (HCV) and (or) hepatitis B virus (HBV) and (or) syphilis. An increase in AST (aspartate transaminase), ALT (alanine transaminase) or alkaline phosphatase of serum ≥ 2.5 times from the upper limit of the norm; an increase in the level of total bilirubin ≥ 2 times from the upper limit of the norm;

Exclusion criteria:

* The patient's refusal to participate in the study;
* The development of an allergic reaction to the product;
* Loss of contact with the patient for further observation;
* The decision of the research physician to terminate the patient's participation in the study prematurely if, in the opinion of the researcher, the patient cannot continue further participation in the study for any reason.
* Inclusion in the study in violation of the inclusion/non-inclusion criteria.
* Significant protocol violations that may affect patient safety and/or the integrity of the study data (in consultation with the medical monitor).

Where this trial is running

Moscow

• university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery — Moscow, Russian Federation (Recruiting)

Study contacts

• Study coordinator: Marina M Lipina, MD, PhD

Conditions Anterior Cruciate Ligament Injuries; Hallux Rigidus; anterior cruciate ligament; hallux rigidus; ACL reconstruction; collagen membrane; collagen matrix