SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- WOSI score Constant score EQ-5D Rowe score Patient Satisfaction
研究概览
简要总结
The purpose of this study is to evaluate whether there is a difference between conservative and operative treatment of Superior Labral Lesions(SLAP)of the shoulder.
详细描述
Treatment of superior labral lesions is controversial. Some authors advocate labral repair, some advocate biceps tenodesis,and others again questions whether these lesions should be repaired at all. There are no randomized studies comparing operative treatment and conservative treatment(i.e. physical rehabilitation), and likewise no randomized studies comparing labral repair and biceps tenodesis.
In this study;all patients who have a patient history, clinical signs of a SLAP lesion,a MRI study revealing an isolated superior labral lesion and have agreed to participate in the study, will have a diagnostic arthroscopy performed.
If a SLAP lesion is diagnosed, the patients are randomized to three different groups:1) SLAP repair with suture anchors 2) Biceps tenodesis 3) Physical therapy
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history and signs of superior labral lesion
- •MRI study revealing an isolated superior labral lesion
排除标准
- •earlier shoulder procedures,
- •Other accompanying shoulderpathologies(such as cufflesions, instability, ac-joint pain, arthritis)
结局指标
主要结局
WOSI score Constant score EQ-5D Rowe score Patient Satisfaction
时间窗: 6 and 24 months
次要结局
- Sick leave Time back to sports at preoperative level(6 and 24 months)