Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Western Ontario Shoulder Instability Index (WOSI)
研究概览
简要总结
Randomized clinical trial, parallel 1:1, comparing Latarjet to Modified Eden-Hybinette (iliac bone crest + capsular repair) for recurrent traumatic anterior glenohumeral dislocation.
详细描述
The Latarjet technique has proven reliable for the treatment of dislocations, with lower recurrence rates (5%) even in the presence of bone lesions. This technique allows a stable fixation of the graft, with 2 screws, and the dynamic effect of the conjoint tendon, the sling effect. However, several complications are described, such as neurological injuries, nonunion and graft resorption. Hamel et al, showed that vascularization of the coracoid graft is impaired during the course of Latarjet procedure. Together with the small thickness of the coracoid, it may justify its high rate of resorption.
The Eden-Hybinette surgery does not have the potential advantages of the sling effect. However, it allows a better restoration of the area of the glenoid, without the risks related to the coracoid osteotomy. All clinical studies about the different bone grafting techniques have a low quality. Furthermore, there is no comparative study of the techniques of Latarjet and Eden-Hybinette.
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
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of one or more previous episodes of traumatic glenohumeral dislocation;
- •Anterior glenoid bone loss superior to 20% of its diameter, regardless of the ISIS score;
- •Recurrence of glenohumeral dislocation in cases previously treated with arthroscopic Bankart repair, regardless of the ISIS score and severity of bone lesion of the glenoid;
- •Borderline bipolar bone lesions:
- •Instability Severity Index Score of (ISIS) greater than or equal to 4 points, with anterior glenoid bone loss (bone Bankart lesion) greater than 13.5% of their diameter, measured by the method described by Sugaya et al.;
- •Hill-Sachs lesion and glenoid considered "off-track".
排除标准
- •Hill-Sachs lesion greater than 40% of the humeral head diameter (measured by the preoperative CT);
- •Untreated seizures;
- •Previously diagnosed rotator cuff complete tear;
- •Fractures of the proximal humerus (except for Hill-Sachs lesions);
- •Multidirectional instability;
- •Advanced glenohumeral osteoarthritis (grade 3 Samilson and Pietro)
研究组 & 干预措施
Latarjet procedure
Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws.
干预措施: Latarjet procedure (Procedure)
Modified Eden-Hybinette Procedure
Surgery. Modified Eden-Hybinette surgery, with capsular repair on the iliac bone Anterior glenoid bone graft from iliac bone. Fixation with 2 screws.
干预措施: Modified Eden-Hybinette (Procedure)
结局指标
主要结局
Western Ontario Shoulder Instability Index (WOSI)
时间窗: 2 years
Instability score
次要结局
- Visual analog scale (VAS) for shoulder pain(2 years)
- VAS for iliac pain(2 years)
- Categoric evaluation for scapular movement(2 years)
- Rate of complications and reoperations(2 years)
- Tomographic evaluation(2 years)
- Radiographic evaluation(2 years)
- ROWE score(2 years)
- Single Assessment Numeric Evaluation (SANE)(2 years)
- Dislocation recurrence rate(2 years)
- Degree of Shoulder Involvement in Sports (DOSIS ) scale(2 years)
- Kible scale for Scapular movement(2 years)
- VAS for iliac pain(6 weeks)
- VAS for iliac pain(3 months)
研究者
Mauro Gracitelli
PhD
University of Sao Paulo