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NCT Number: NCT07338149

Postoperative Computed Tomography Detection of Syndesmotic Malreduction in Ankle Fractures

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr Alainy

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Syndesmotic reduction accuracy assessed by postoperative computed tomography

    Time frame: within 1 week after surgery

    Accuracy of distal tibiofibular syndesmotic reduction assessed using postoperative computed tomography imaging, based on predefined radiological criteria evaluating translational and rotational alignment of the distal fibula relative to the tibia.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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