Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- MRI integrity
研究概览
简要总结
Randomized clinical study involving 44 patients, evaluating the effect of mesenchymal cells on rotator cuff repair. The primary outcome will be post-operative MRI tendon integrity and secondary outcomes clinical assessment by the UCLA and American Shoulder and Elbow Surgeons (ASES) scales and pain by visual analog scale (VAS).
详细描述
Rotator cuff tendinopathy is the main cause of shoulder pain and tear of these tendons affects 20% of the population. Although arthroscopic repair leads to satisfactory clinical results, the retear rates varies from 4 to 94%. The main cause of failure after rotator cuff repair is not related to the material used, but to the tissue deficiency and the healing process between the tendon and the bone. After the intervention, the rotator cuff does not restore its original histological characteristics and its fixation occurs through scar tissue with lower biomechanical resistance. There are few clinical studies on the use of mesenchymal cells in rotator cuff repair,, with good results.
The investigators will perform a randomized clinical study involving 44 patients, evaluating the effect of mesenchymal cells on rotator cuff repair. The primary outcome will be post-operative MRI tendon integrity and secondary outcomes clinical assessment by the UCLA and American Shoulder and Elbow Surgeons (ASES) scales and pain by visual analog scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Surgeon and patients not blinded
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full thickness posterosuperior rotator cuff tear, of small or medium size, fully repairable at the time of surgery, regardless of size;
- •Pain and / or decreased shoulder function for at least 3 months, with no improvement with non-surgical treatment;
- •Absence of the following changes in MRI:
- •Fat degeneration of the rotator cuff musculature of grade 3 according to the classification of Fuchs (presence of equal or superior amount of fat compared to muscle fibers);
- •Absence of the following changes in radiographs
- •Advanced glenohumeral arthrosis (grades 2, 3 and 4 of Samilson and Prieto
- •Signs of rotator cuff arthropathy, according to Seebauer classification;
- •Skeletal maturity;
- •Absence of surgeries or previous fractures in the shoulder in question;
- •Absence of psychiatric illnesses, fibromyalgia or painful pathologies of the cervical spine;
- •Absence of rheumatic diseases or chronic use of corticosteroids;
- •Absence of active or recent infection;
- •Absence of thrombocytopenia, coagulopathies or chronic use of anticoagulants;
- •Absence of vascular or neurological lesions affecting the upper limb;
- •Absence of pregnancy;
- •Clinical non-compensated comorbidities;
- •Chronic use of corticosteroids;
- •Consent to free and informed consent;
- •Live in Brazil.
排除标准
- •Visualization during the operative event of one or more of the findings:
- •Irreparable rupture of rotator cuff;
- •Subsecapularis tear involving two thirds or more of its extension;
- •Need to open surgery.
结局指标
主要结局
MRI integrity
时间窗: 6 months
Sugaya classification
次要结局
- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)(6, 12 and 24-months)
- University at California at Los Angeles Shouder Rating Scale (UCLA)(6, 12 and 24-months)
- Visual Analog Scale for Pain (VAS)(6, 12 and 24-months)
研究者
Eduardo Angeli Malavolta
Principal investigator
University of Sao Paulo