Operative treatment of AO Weber C fibular fractures with additional posterior malleolar fragment: functional outcome after SYNdesmotic positioning screws or POSTerior fragment fixation. POSTFIX-C trial: a prospective comparative observational study.

Recruiting

• Conditions: ankle fracture; Trimalleolar fracture; 10017322

• Registration Number: NL-OMON50689
• Lead Sponsor: Heelkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

1. Age between 18 and 70 years
2. First ankle fracture of the affected side
3. Fibular fracture proximal to the syndesmosis with a posterior malleolar
fragment larger than 5% of the involved articular surface(AO type 44-C1, 44-C2,
44-C3)

Exclusion Criteria

multiple fractures
multi-traumatized patients
history of fracture of the same ankle
Patients with pre-existent mobility problems
pre-existent 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: Observational non invasive
• 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>2. The functional outcome of the ankle will be evaluated 1 year after surgery<br /><br>using the American Academy of Orthopaedic<br /><br>Surgeons foot and ankle score (AAOS). This scoring system is exclusively<br /><br>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<br /><br>answered 26 and 52 weeks after surgery. In this questionnaire the aspects of<br /><br>pain, function, stiffness, swelling and the<br /><br>rate of giving way of the ankle will be evaluated in 25 questions. After<br /><br>completion of this questionnaire the obtained score<br /><br>will be between 0 and 100. The lower the obtained score, the worser the ankle<br /><br>function.The scoring system is validated<br /><br>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>