跳至主要内容
临床试验/NCT05196906
NCT05196906招募中不适用

The Clinical Outcomes Comparing the Modified Broström vs Anatomic Reconstruction Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Karlsson score

研究概览

简要总结

Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.

详细描述

The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. 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
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiang Dong

Chief physician

Peking University Third Hospital

研究点 (1)

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