Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure. Pilot Study, a New Surgical Procedure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The recurrence rate of shoulder dislocation after the subscapular sling
研究概览
简要总结
The arthroscopic subscapular sling procedure is a new technique for shoulder stabilization, which has been developed in human cadaveric studies by Klungsøyr et al, but has yet to be tested clinically. The procedure stabilizes the shoulder by using a semitendinosus graft that makes a new labrum and a sling around the subscapular tendon. Extensive biomechanical robotic testing of the procedure shows significant less translation and thus better stability of the humeral head with the sling compared to a normal Bankart repair. The investigators consider the biomechanical results after robotic testing sufficient to advocate a planned pilot study in humans. In this pilot study the clinical and radiological results of the sling will be investigated in a small number of cases. The safety of the subscapular sling procedure will be assessed. This studies results are expected to be a further step towards implementation of the sling procedure as a surgical option for shoulder instability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical anterior instability of the shoulder and/or previous failed Bankart repair or arthroscopic findings concluding with too weak anterior structures to perform capsulolabral or labrum repair
- •Be able to understand oral and written Norwegian /English
排除标准
- •Cuff injury or previous cuff repair
- •Surgical fracture treatment of the glenoid or humeral head
- •Other instability procedures in the shoulder except Bankart repair and anterior capsular plications
- •Previous infections in the shoulder
- •MRI detectable fatty infiltration of the subscapularis or partial/total tendon rupture
- •Severe glenohumeral arthrosis
- •Multidirectional or posterior instability
- •Not able to comply fully with the protocol due to psychosocial and physical conditions
研究组 & 干预措施
subscapular sling
semitendinosus subscapular sling procedure
干预措施: subscapular sling (Procedure)
结局指标
主要结局
The recurrence rate of shoulder dislocation after the subscapular sling
时间窗: 2 , 5 and 10 years follow up.
Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations
次要结局
- Changes in the Western Ontario Shoulder Instability index (WOSI) score(2, 5 and 10 years follow up.)
- Changes in the range of motions(2, 5 and 10 years follow up.)