Should ankle syndesmosis screws be removed? A randomised, controlled trial.

Not Applicable

Completed

• Conditions: Ankle fractures requiring syndesmosis screw fixation.; Surgery - Surgical techniques; Injuries and Accidents - Fractures

• Registration Number: ACTRN12611000397910
• Lead Sponsor: Middlemore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Male or female patients; greater than or equal to 16 years of age; ankle fracture with diastasis for planned syndesmosis screw fixation; AP, lateral and mortise X-ray views of the ankle taken preoperatively; closed fractures; consent form signed.

Exclusion Criteria

Ankle fractures not requiring syndesmosis screw fixation; compound fractures; pathologic fractures; fracture in a polytraumatised patient; fracture of a bone in the same lower limb (other than ankle fracture complex); patients > 65 years of age; past history of fracture or significant injury or disability of the same ankle; medical conditions too serious for surgery; patients who are unfit to consent; pregnant women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Olerud-Molander ankle score (OMAS).[Assessments performed at 6 months and 12 months postoperatively.]

Secondary Outcome Measures

Name	Time	Method
American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot.[Assessments performed at 6 months and 12 months postoperatively.];Ankle range of motion (measured with goniometer).[Assessments performed at 6 months and 12 months postoperatively.];Radiological loss of reduction.[Assessments performed at 6 weeks, 6 months, and 12 months postoperatively.];Radiological implant failure. Rate of implant failure (e.g. screw breakage or loosening, with or without a second surgery for removal) will be measured for each group. Broken screws will be defined as those in which there is a fracture of the screw. Loosened screws will be defined as those surrounded by a radiolucent zone 1 mm in width extending the length of threads in either the fibula or tibia. For the group randomised for screw removal, the rate of implant failure will only be measured at 6 weeks postoperatively.[Assessments performed at 6 weeks, 6 months, and 12 months postoperatively.]