Medium sized POSTerior fragments in AO Weber-B fractures, does open reduction and FIXation improve outcome? A multicenter randomized controlled trial.

Medium sized POSTerior fragments in AO Weber-B fractures, does open reduction and FIXation improve outcome? A multicenter randomized controlled trial. - POSTFIX

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47804

Enrollment

Registered

2013-11-13

Start date

2014-02-03

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: Open reposition and fixation of the medial and lateral malleolus will take place. Additionally, closed reduction of the posterior malleolus will take place without internal fixation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: AO-Weber B ankle fracture with involvement of a medium-sized posterior fragment (5-25% of the involved artricular surface) between the age of 18 and 75 years.

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

Measure	Time frame
AAOS-questionaire after 1 year. 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.	—

Measure

Time frame

AAOS-questionaire after 1 year. 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

Measure	Time 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)