Operative treatment of AO Weber C fibular fractures with additional medium-sized posterior malleolar fragment: SYNdesmotic positioning screws or POSTerior fragment fixation? SYNPOST trial.

Withdrawn

Conditions: ankle fracture
trimalleolar fracture
10017322
10005944

Registration Number: NL-OMON38962

Lead Sponsor: Medisch Centrum Haaglanden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 54

Inclusion Criteria

1. Age between 18 and 75 years
2. First ankle fracture of the affected side
3. Fibular fracture proximal to the syndesmosis with a posterior malleolar fragment between 5% and 25% of the involved articular surface(AO type 44-C1, 44-C2, 44-C3)

Exclusion Criteria

multiple fractures
pre-existent impaired mobility
pre-existent impaired disability
Patients living in another region and follow-up will take place in another hospital
Inability to speak the dutch language

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The accuracy of syndesmotic reduction on an axial CT-scan postoperatively.<br /><br><br /><br>2. The functional outcome of the ankle will be evaluated 1 year after surgery<br /><br>using the American Academy of Orthopaedic Surgeons foot and ankle score (AAOS).<br /><br>This scoring system is exclusively developed for injury of the ankle and is<br /><br>worldwide the most used and best scoring system for long-term functional<br /><br>outcome. The AAOS questionnaire will be answered 26 and 52 weeks after surgery.<br /><br>In this questionnaire the aspects of pain, function, stiffness, swelling and<br /><br>the rate of giving way of the ankle will be evaluated in 25 questions. After<br /><br>completion of this questionnaire the obtained score will be between 0 and 100.<br /><br>The lower the obtained score, the worser the ankle function.The scoring system<br /><br>is validated and patient-friendly. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. VAS-pain<br /><br>2. Olerud & Molander ankle score (short term)<br /><br>3. AOFAS foot and ankle score (long term)<br /><br>4. Range of motion<br /><br>5. Euroqol-5D<br /><br>6. Osteoarthritis (AO-scale)<br /><br>7. Complications<br /><br>8. Secondary interventions/reoperations<br /><br>9. Tibiotalar gap or step-off (CT scan post-operatively)</p><br>