First Episode of Anterior Glenohumeral Dislocation in Adult Patients Under 25 Years of Age: Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization "
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of occurrence of a recurrence during the follow-up period of 2 years
研究概览
简要总结
The risk of recurrence and chronic instability after an initial episode of anterior glenohumeral dislocation is high, the risk is higher the younger the patient is.
Most patients with recurrences develop this instability during the first 2 years.
Several studies have shown that an initial arthroscopic surgical treatment (Bankart intervention) decreased the risk of recurrence and therefore of chronic instability, but this attitude is not usual in France and none randomized study comparing intervention of arthroscopic Bankart and immobilization was published by a French team.
The primary objective was to evaluate at 2 years the efficacy on the rate of recurrent instability of the first-line arthroscopic repair of prior capsulo-labral lesions compared to conservative treatment by immobilization for patients under 25 years having an initial episode of anterior glenohumeral dislocation
Material and method : We conducted a randomized controlled, open-label, parallel-group study (conservative treatment group by immobilizing VS surgical treatment group) in patients aged 18 to 25 with anterior glenohumeral primo luxation. Patients were clinically reassessed at 2 years with functional scores (WOSI, DuplayWalch, DASH), mobility and instability recurrence.
Hypothesis: reduction of the recurrence rate in the surgically treated group
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 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with inclusive on the day of dislocation.
- •First episode of anterior glenohumeral dislocation without associated humeral fracture confirmed by a standard radiograph.
排除标准
- •Dislocation without trauma, in a context of hyper laxity with a Beighton score ≥4 / 97.
- •In these patients post-dislocation MRI was performed in the Robinson study, which found no capsulo-labral lesion.
- •Bone glenoid defect> 25% at the scanner (Bony Bankart).
- •Delay greater than 15 days between luxation and surgical treatment
- •Against indication to anesthesia
- •Pregnant or nursing women
结局指标
主要结局
Number of occurrence of a recurrence during the follow-up period of 2 years
时间窗: at 2 years
次要结局
- Number of recidivism of dislocation with the necessity of reduction by a third person(at 3 months, 6 months, 1 years and 2 years)
- number of episodes of subluxations reported by the patient at the interview(at 3 months, 6 months, 1 years and 2 years)
- Goniometer measurement of the angle in the ankle joint(at 3 months, 6 months, 1 years and 2 years)
- Walch Duplay Score(at 3 months, 6 months, 1 years and 2 years)
- Disabilities of the Arm, Shoulder and Hand (DASH) Score(at 3 months, 6 months, 1 years and 2 years)
- Western Ontario Shoulder Instability (WOSI) Score.(at 3 months, 6 months, 1 years and 2 years)
- Likert Scale(at 2 years)
- The duration of work stoppage(at 2 years)
- Time lapse - resumption of sports activities and level of sport practiced(At 6 months, 1 years and 2 years)