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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38962
Enrollment
54
Registered
2013-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ankle fracture trimalleolar fracture

Interventions

The first group will be treated according to the current directives. If present, medial and distal fibular shaft fractures are fixed according to AO principles. Treatment of syndesmotic injury will

Sponsors

Medisch Centrum Haaglanden
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)