Should Ankle Syndesmosis Screws be Removed? - Medium Term Outcomes with a Minimum of Five Years Follow-up

Not Applicable

• Conditions: Ankle fractures requiring syndesmosis screw fixation; Injuries and Accidents - Fractures; Surgery - Surgical techniques; Musculoskeletal - Normal musculoskeletal and cartilage development and function

• Registration Number: ACTRN12618001971224
• Lead Sponsor: Middlemore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-06
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Patients will be identified from the previous study database from the original randomised control trial (Boyle, M, Gao, R, Frampton, C et al. Removal of the syndesmotic screw after the surgical treatment of a fracture of the ankle in adult patients does not affect one-year outcomes (2014) Bone and Joint Journal. 96 (12).) and invited by telephone to return for follow-up. Our original inclusion criteria were patients who were between the ages of 16 and 65 with a displaced fibular fracture with associated tibiofibular diastasis.

Exclusion Criteria

Our original exclusion criteria was open fractures, preceding ankle abnormality, neurovascular injury, plafond injury or posterior maleollar fracture involving >10% of joint surface, polytrauma, diaphysial tibia fracture, pathological fracture, cognitive impairment or pregnancy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Olerud-Molander ankle score (OMAS)[Assessment performed five years postoperatively ]

Secondary Outcome Measures

Name	Time	Method
American Academy of Orthopaedic Surgeons foot and ankle core score (AAOSFACS)[Assessment performed five years postoperatively ];Pain on visual analogue scale (VAS)[Assessment performed five years postoperatively ];Range of motion with goniometer [Assessment performed five years postoperatively ];American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot[Assessment performed five years postoperatively ];Muscular trophicity measure of the leg (Calf girth)[Assessment performed five years postoperatively ];Radiological loss of reduction[Assessment performed five years postoperatively ];Implant failure. This will be checked with x-ray imaging at the time of clinical consultation [Assessment performed five years postoperatively ];Rate of secondary surgery. This will be checked by assessing patient records and from patient-reporting. [Assessment performed five years postoperatively ]