The Effectiveness and Cost-Effectiveness of Operative and Non-operative Management of Rotator Cuff Tear
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in pain (VAS) and objective shoulder function (Constant score)
研究概览
简要总结
This study aims at determining the effectiveness and cost-effectiveness of surgical management of full-thickness rotator cuff tears compared to conservative treatment. The research setting is prospective, randomised, and controlled.
The aim of the study is to search out evidence based data of indications for rotator cuff repair. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when rotator cuff tear is suspected.
The investigators hypothesize that there are subgroups of patients suffering from rotator cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.
详细描述
Subgroup analyses:
- age
- sex
- duration of symptoms
- presence of trauma before symptoms
- size of tear
- degenerative findings
- other findings in MRI or arthroscopy
- type of operation
- co-morbidities
- occupation
- pain (VAS)
- objective shoulder function
- activities of daily living
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 35 years old
- •duration of symptoms at least three months despite of non-operative treatment
- •the patient accepts both treatment options (operative and conservative)
- •a full-thickness rotator cuff tear in MRI arthrography
排除标准
- •previous shoulder operations
- •too high risk for operation
- •any disease or social problem reducing the ability to co-operate
- •rheumatoid arthritis
- •severe arthrosis of the glenohumeral or acromioclavicular joint
- •irreparable rotator cuff tear (including rotator cuff tear arthropathy)
- •progressive malign disease
- •adhesive capsulitis
- •high-energy trauma before symptoms
- •cervical syndrome
- •shoulder instability
结局指标
主要结局
Change in pain (VAS) and objective shoulder function (Constant score)
时间窗: 24 months
VAS (0 to 100 mm), Constant score (0 to 100 points)
次要结局
- Change in pain (VAS) and objective shoulder function (Constant score)(5 years)
研究者
Juha Paloneva
Md, PhD
Central Finland Hospital District