Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Constant-Murley Shoulder Assessment score
研究概览
简要总结
The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.
详细描述
In clinical practice most patients with a traumatic acute rotator cuff tear are treated with operative repair. The results of surgery are in most cases good but there are also good results in the literature from conservative treatment. So far there has been no prospective randomized comparison between the two treatments. When it comes to degenerative non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of surgery.
This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to surgery or physiotherapy. Surgical intervention is mini-open repair.
Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a blinded independent physiotherapist. At 12 months a new MRI is conducted as well.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma to the shoulder
- •Full thickness cranial rotator cuff tear
- •Operation possible within 3 months
排除标准
- •2 or more rotator cuff tendons involved
- •Dislocation
- •Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor)
- •Malignancy
- •Rheumatic disease
- •Inability to understand swedish
- •Substance abuse
结局指标
主要结局
Constant-Murley Shoulder Assessment score
时间窗: Twelve months
次要结局
- Western Ontario Rotator Cuff score(Twelve months)
- MRI(Twelve months)
研究者
Hanna Bjornsson
PHD, Orthopeadic shouldersurgeon
University Hospital, Linkoeping
