Postoperative Computed Tomography Detection of Syndesmotic Malreduction in Ankle Fractures

NCT ID: NCT07338149

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-06-30

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.

Conditions

Ankle Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Ahmed El-Desouky

Professor of Orthopedic Sugery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-310-2021

Identifier Type: -

Identifier Source: org_study_id