Application of Collagen in Treatment of the Consequences of Injuries and Diseases of the Musculoskeletal System
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Anterior Cruciate Ligament OsteoArthritis Score
研究概览
简要总结
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
详细描述
Application of Collagen in Treatment of the Consequences of Injuries and Diseases of the Musculoskeletal System
Indications:
- Damage to the anterior cruciate ligament (ACL) of the knee joint
- Rigid first toe
Research centers:
University Clinical Hospital No. 1 of the First Sechenov Moscow State Medical University (Sechenov University)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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;
排除标准
- •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).
研究组 & 干预措施
The 1st group
ACL reconstruction + collagen membrane
干预措施: Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane (Procedure)
The 2nd group
ACL reconstruction (control)
干预措施: Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group) (Procedure)
The 3rd group
Hallux Rigidus + collagen membrane
干预措施: Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity (Procedure)
结局指标
主要结局
Anterior Cruciate Ligament OsteoArthritis Score
时间窗: 6 months postoperatively
Assessment of the condition of the transplant based on the results of control MRI data measured on Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS) for ACL groups values: min - 0 points; max - 3 points The higher score means worse outcome
American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score
时间窗: 2, 4 and 8 weeks postoperatively
American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score (AOFAS) for Hallux Rigidus group values: min - 0 points (0%); max - 100 points (100%) The higher score means better outcome
Modified Lysholm scale
时间窗: 1,5 and 12 months postoperatively
Change in the score of the Modified Lysholm scale for ACL groups values: min - 0%; max - 100% The higher score means better outcome
36-Item Short Form Survey
时间窗: 2, 4 and 8 weeks postoperatively
36-Item Short Form Survey (SF-36) for Hallux Rigidus group values: min - (0%); max - (100%) The higher score means better outcome
The International Knee Documentation Committee score
时间窗: 1,5 and 6 months postoperatively
Change in the score of the Form for registering the results of the knee joint examination of the The International Knee Documentation Committee (IKDC) for ACL groups values: min - 0 points (0%); max - 87 points (100%) The higher score means better outcome
The Knee injury and Osteoarthritis Outcome Score
时间窗: 1,5 and 6 months postoperatively
Change in the score of the Knee injury and Osteoarthritis Outcome Score (KOOS) for ACL groups values: min - 0%; max - 100% The higher score means better outcome
次要结局
未报告次要终点