Postoperative Computed Tomography Detection of Syndesmotic Malreduction in Ankle Fractures

NCT07338149 | Completed

• 1 other identifier: MS-310-2021
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures

Keywords

Syndesmotic malreduction, Ankle fracture fixation, Computed tomography, Postoperative imaging, Functional outcome, AOFAS score

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months postoperatively

Secondary Outcomes (1)

• Syndesmotic reduction accuracy assessed by postoperative computed tomography

  within 1 week after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy

Cairo, Egypt

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedic Sugery

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start: July 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)