Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture: a Randomized Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Efficacy in the rehabilitative therapy
研究概览
简要总结
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements.
详细描述
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will then perform only passive movements according to pain for the first 6 weeks supported by the physiotherapy, according to standard therapy. The following six weeks passive movements will be associated with active movements . No brace nor normal sling will be used anymore.
Patients are in study for 6 months. During this period quality of life and pain questionnaires are submitted to the patients and a MRI will be done at the end of the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between 18 and 65 years old;
- •Presence of an isolated lesion of supraspinatus that can be documented with the MRI and which can be treated surgically by arthroscopy;
- •Presence of a supraspinatus lesion according to the Patte criteria with stage 1, 2 or 3 frontal plane ;
- •Presence of adipose degeneration ≤ 2 according to Goutallier;
- •Written informed consent to participate in the study
排除标准
- •Presence of a lesion of other rotator cuff tendons;
- •Previous surgical procedures of the shoulder;
- •Presence of a massive lesion, therefore irreparable, of the cuff detected intra-operatively and not observed during preoperative MRI;
- •Presence of relapsing shoulder dislocations;
- •Presence of lesions of the glenoidine cercine that require intervention;
- •Difficulties to follow the rehabilitation programs;
- •Presence of neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases and immunosuppressed patients;
- •State of pregnancy (presumed or established) or breastfeeding.
结局指标
主要结局
Efficacy in the rehabilitative therapy
时间窗: 6 months
The primary objective of the study is to evaluate two different rehabilitative therapies. Efficacy is measured with a pre and post MRI
次要结局
- re-rupture rate of the supraspinatus tendon(6 months)
- Quality of life assessment(6 months)
研究者
Christian Candrian
Deputy Head of Surgery and Orthopedy
Ente Ospedaliero Cantonale, Bellinzona