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Clinical Trials/NCT07338149
NCT07338149CompletedNot Applicable

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

Cairo University1 site in 1 country86 target enrollmentStarted: July 1, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
1
Primary Endpoint
Functional outcome assessed by the American Orthopaedic Foot and Ankle Society ankle-hindfoot score

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Arms & Interventions

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.

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Ahmed El-Desouky

Professor of Orthopedic Sugery

Cairo University

Study Sites (1)

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