The Role of Rotator Interval Closure in Bankart Lesion Repair
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Western Ontario Shoulder Instability Index
研究概览
简要总结
The null hypothesis is that there is no statistical difference between the two treatment groups for any outcome. The investigators suspect that patients who undergo a Bankart lesion repair with rotator interval closure will have lower quality of life and less external rotation compared to patients who undergo a Bankart lesion repair alone. No difference will be observed for recurrence rate between the two treatment groups
详细描述
Research assessing the role and effectiveness of rotator interval closure is important to attempt to determine the most beneficial and efficient treatment for Bankart lesions and anterior shoulder instability. To date there is only weak evidence supporting the superiority of Bankart lesion repair in addition to rotator interval closure compared to Bankart lesion repair alone.
Does Bankart lesion repair with rotator interval closure result in differences in quality of life, range of motion and recurrence at 3 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years in similar patients with Bankart lesions who are treated with Bankart lesion repair alone?
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, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 51 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 15 to 50 years
- •At least one episode of demonstrated dislocation
- •Bankart lesion of the anterior glenoid labrum
- •Absence of other capsular and tendon injuries
- •Absence of glenoid fractures or divots
排除标准
- •Posterior instability or the need for posterior surgical reconstruction
- •Significant bone lesions greater than 3mm of the humeral head anterior-to- posterior (Hill-Sachs lesions)
- •Presence of other pathologic conditions of the shoulder (excluding SLAP lesions)
研究组 & 干预措施
Arthroscopic Bankart Repair & Rotator Interval Closure
干预措施: Closure of rotator interval (Procedure)
Arthoscopic Bankart Repair alone
干预措施: Arthroscopic Bankart Repair alone (Other)
结局指标
主要结局
Western Ontario Shoulder Instability Index
时间窗: 3,6 weeks;3,6 months; 1,2 years
Disease-specific quality of life measurement tool (21 questions, 4 domains)
次要结局
- 4-Item Pain Intensity Measure(3,6, weeks; 3, 6 months; 1,2 years)
- Upper Extremity Functional Index(3,6 weeks; 3,6 months; 1,2 years)
- Recurrence(3,6 weeks; 3,6 months; 1,2 years)
- Range of Motion(3,6 months; 1-2 years)
研究者
Dianne Bryant
Associate Professor
University of Western Ontario, Canada