The Clinical Outcomes Comparing Open and Arthroscopic Modified Broström Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Karlsson score
研究概览
简要总结
Investigators designed this randomized controlled trial to compare the clinical outcomes of open and arthroscopic modified Broström operation for the treatment of CLAI and GJL.
详细描述
The open modified Broström operation is the first line to treat chronic lateral ligament instability (CLAI). Arthroscopic techniques gain popularity for less invasivity, quick recovery to normal and sports activities, and the possibility to treat other intraarticular disorders. Studies have shown significantly poor clinical and radiological outcomes and a higher rate of failure in patients with generalized joint laxity (GJL) than patients without after open modified Broström operation. However, there is no study to compare the open and arthroscopic modified Brostrom operation for patients with GJL and CLAI. So, investigators designed this randomized controlled trial. The primary outcomes are Karlsson, American Orthopaedic Foot & Ankle Society, and visual analogue scales. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.
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
盲法说明
Randomization was achieved using the opaque sealed envelopes, and each eligible patient was allocated to open or arthroscopic MBP in a 1:1 ratio with a random block assignment of 4 or 6. The envelopes were thoroughly shuffled and sequentially numbered and then opened before surgery. Patients were allowed to withdraw from this experiment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years
排除标准
- •Patients with an acute or subacute ankle injury (within 3 months) Injury of the deltoid ligament Alignment of lower extremity greater than 5 degrees Fractures of the lower extremity Stage III or IV osteoarthritis Patients who refused to participate in the study
结局指标
主要结局
Karlsson score
时间窗: postoperative Karlsson score at 2 years
This score is a primary scale for lateral ankle instability
次要结局
- Anterior displacement and talar tilt angle in stress radiography(postoperative radiographic measures at 2 years)
研究者
Jiang Dong
Chief physician
Peking University Third Hospital