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临床试验/NCT07338149
NCT07338149已完成不适用

Detection of Syndesmotic Malreduction by Postoperative Computed Tomography in Ankle Fractures With Acceptable Radiographs: A Prospective Cohort Study

Cairo University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Functional outcome assessed by the American Orthopaedic Foot and Ankle Society ankle-hindfoot score

研究概览

简要总结

This prospective observational cohort study aims to evaluate the ability of postoperative plain radiographs to detect syndesmotic reduction accuracy in patients with ankle fractures requiring syndesmotic fixation. All included patients have acceptable postoperative radiographs according to standard radiographic criteria and undergo postoperative computed tomography to further assess syndesmotic reduction. Functional outcomes are assessed at one year following surgery using a standardized ankle functional score. The study seeks to explore the association between computed tomography-detected syndesmotic malreduction and postoperative functional outcome.

详细描述

Accurate reduction of the distal tibiofibular syndesmosis is essential for restoring ankle stability and achieving favorable functional outcomes after ankle fracture fixation. Plain radiographs are routinely used to assess postoperative syndesmotic reduction; however, subtle malreductions may not be detected using standard radiographic views alone.

This prospective observational cohort study includes adult patients with ankle fractures requiring operative fixation and syndesmotic stabilization who demonstrate acceptable postoperative plain radiographs. As part of postoperative evaluation, all included patients undergo computed tomography imaging to provide a more detailed assessment of syndesmotic reduction, particularly with respect to rotational and translational alignment of the distal fibula relative to the tibia.

Based on computed tomography findings, syndesmotic reduction is categorized according to predefined criteria. Functional outcomes are assessed at 12 months postoperatively using the American Orthopaedic Foot and Ankle Society ankle-hindfoot score. The study is observational in nature, and imaging findings do not influence postoperative management or treatment decisions.

The objective of this study is to assess the limitations of plain radiographs in detecting syndesmotic malreduction and to evaluate the association between computed tomography findings and functional outcomes following ankle fracture fixation.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 65 years
  • Acute ankle fractures requiring operative fixation with syndesmotic stabilization
  • Acceptable postoperative plain radiographs based on standard radiographic criteria
  • Ability to comply with follow-up and functional assessment

排除标准

  • Open ankle fractures
  • Previous surgery on the affected ankle
  • Polytrauma patients
  • Pathological fractures
  • Incomplete imaging or follow-up data

研究组 & 干预措施

Ankle Fracture Patients With Syndesmotic Fixation

Adult patients with ankle fractures requiring operative fixation and syndesmotic stabilization who demonstrated acceptable postoperative plain radiographs and were followed prospectively for imaging and functional outcome assessment.

结局指标

主要结局

Functional outcome assessed by the American Orthopaedic Foot and Ankle Society ankle-hindfoot score

时间窗: 12 months postoperatively

Functional outcome of the affected ankle assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, which evaluates pain, function, and alignment on a 0-100 point scale, with higher scores indicating better function.

次要结局

  • Syndesmotic reduction accuracy assessed by postoperative computed tomography(within 1 week after surgery)

研究者

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

Mahmoud Ahmed El-Desouky

Professor of Orthopedic Sugery

Cairo University

研究点 (1)

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