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
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Modified Lysholm scale
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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 1st group
ACL reconstruction + collagen membrane
干预措施: Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane (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
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
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
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