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临床试验/NCT06897293
NCT06897293招募中不适用

Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for Chronic Lateral Ankle Instability : A Prospective Cohort Study

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年6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
86
试验地点
1
主要终点
The American Orthopaedic Foot and Ankle Society (AOFAS) score

研究概览

简要总结

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. Additional suture tape augmentation has been suggested to provide more strength and stability. However, the outcomes of the MBP with suture tape augmentation were unknown, which requires further exploration.

详细描述

Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape. In addition, the outcomes of the MBP with suture tape augmentation were unknown.

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
15 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of lateral ankle instability
  • Beighton score ≥4
  • Age with 18 to 60 years

排除标准

  • Patients with an acute or subacute ankle injury
  • 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

The American Orthopaedic Foot and Ankle Society (AOFAS) score

时间窗: postoperative AOFAS score at 3 months

This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.

次要结局

  • Anterior displacement and talar tilt angle in stress radiography(postoperative radiographic measures at 2 years)
  • Rate of re-injury(the rate of re-injury 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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