Comparison of the results of two treatment systems in ankle injuries

Phase 4

• Conditions: Treatment of syndesmosis injury; Musculoskeletal Diseases

• Registration Number: ISRCTN71276902
• Lead Sponsor: Hospital Universitario Infanta Sofía

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-01
• Last Update Posted: 15 November 2021
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients over 16 years all with physis closed
2. Patients with acute isolated syndesmosis disruption and patients with ankle fracture associated with syndesmosis disruption

Exclusion Criteria

1. Patients with physis opened
2. Patients with previus injuries about ankle
3. Patients unable to perform postoperative treatment adequately

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Pain is measured using Visual Analogue Scale (VAS) at 3, 6 and 12 months<br> 2. Functional outcome is measured using AOFAS Scale and Olerud-Molander scale at 3, 6 and 12 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Ankle range motion measured using manual goniometer at 3, 6 and 12 months<br> 2. Syndesmosis reduction measured usind rx at 3, 6 and 12 months and CT at baseline<br> 3. Complications are collected during follow-up<br>