跳至主要内容
临床试验/NCT05698446
NCT05698446招募中不适用

Comparison of Modified Broström Repair + Suture Tape and Anatomic Reconstruction for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2021年11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
114
试验地点
1
主要终点
Karlsson-Peterson score

研究概览

简要总结

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

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 and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction 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
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-Peterson score

时间窗: postoperative Karlsson score at 2 years

This score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.

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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