NCT00901797Unknown不适用
Arthroscopic Rotator Interval Closure in Shoulder Instability Repair
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recurrent shoulder dislocation or instability symptoms
研究概览
简要总结
Study Title: Arthroscopic rotator interval closure in shoulder instability repair - a prospective study
Objective: To evaluate the effect of arthroscopic rotator interval closure (ARIC) on patients with recurrent shoulder dislocations undergoing arthroscopic bankart repair (ABR) in terms of recurrence, rehabilitation and function.
Hypothesis:
- Although Hyperlax patients undergoing ABR have higher incidence of recurrent shoulder dislocations than those without hyperlaxity, adding ARIC will lower the recurrent dislocation rate.
- Patients with arthroscopic bankart repair (ABR) and ARIC are slower in gaining the range of motion (ROM) but within 6 months are equal to those with ABR only.
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
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-40 years old
- •Anterior Shoulder instability
- •Hyperlaxity (general and shoulder laxity)
排除标准
- •Previous humerus/glenoid fracture
- •large bony "Bankart"
- •Previous shoulder operation
- •Adhesive capsulitis-Habitual dislocations
结局指标
主要结局
Recurrent shoulder dislocation or instability symptoms
时间窗: Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.
次要结局
- Post operative range of motion (ROM)(Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.)
- Activity level(Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.)
- Need for recurrent surgery(Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.)
- Pain(Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.)
研究者
研究点 (2)
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