Peking University People's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- AOFAS ankle-hindfoot score
研究概览
简要总结
This study mainly evaluated the clinical effect of total arthroscopic repair of the anterior talofibular ligament in the treatment of chronic instability of the lateral ankle. For patients with chronic instability of the lateral ankle, a randomized controlled trial was used to compare the curative effect, operation time, surgical complications, postoperative recurrence rate, postoperative recovery time and patients' satisfaction of the total arthroscopic repair of the anterior talofibular ligament surgery and the modified BrostrÖm surgery.
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 (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of acute lateral ankle sprain.
- •The patient has chronic instability of the lateral ankle joint, including functional instability or mechanical instability; functional instability refers to the patient's subjective ankle joint looseness or instability; mechanical instability refers to the presence of the ankle joint History of repeated sprains, positive examination of the front drawer test or positive X-ray examination of the stress position (inversion stress, anterior axial stress).
- •The ankle MRI suggested the anterior talofibular ligament injury.
- •It is invalid after 3 months of formal conservative treatment.
排除标准
- •Co-infection.
- •There was a previous ankle fracture in the affected limb.
- •The affected limb has previously undergone foot and ankle surgery.
- •Ankle inverted arthritis or Charcot joint disease.
- •Suffer from mental illness.
研究组 & 干预措施
Control group
The patients who receive BrostrÖm surgery.
干预措施: BrostrÖm surgery (Procedure)
Trial group
The patients who receive arthroscopic surgery.
干预措施: Arthroscopy surgery (Procedure)
结局指标
主要结局
AOFAS ankle-hindfoot score
时间窗: At 12 months after surgery
次要结局
- Visual Analog Scale for Pain(At 12 months after surgery)
- SF-36 Quality of Life Scale(At 12 months after surgery)
- Complications(At 12 months after surgery)
研究者
Hailin Xu
Associate Professor
Peking University People's Hospital