Collagen for Treatment of Musculoskeletal Injuries

Launched by I.M. SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the use of a collagen-based treatment to help heal injuries to the knee, specifically for patients with torn anterior cruciate ligaments (ACL) and a condition called Hallux Rigidus, which affects the big toe. The goal is to see if this collagen treatment is effective and safe for these types of musculoskeletal injuries. Researchers will evaluate the results using various assessment scales to measure changes in pain and function.

To participate in this study, potential volunteers should be between the ages of 18 and 75 and have either a complete or partial tear of the ACL or advanced Hallux Rigidus. Participants will need to provide consent and agree to follow specific rehabilitation and follow-up plans. They should also be willing to use certain medications, like anti-inflammatory drugs, if needed. It's important to note that individuals with certain medical conditions, like severe heart problems or uncontrolled diabetes, are not eligible for this trial. Participants can expect close monitoring and support throughout the study, allowing researchers to gather valuable information about the collagen treatment's effects.

Gender

ALL

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).