Status:
COMPLETED
Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures
Lead Sponsor:
University of Oulu
Conditions:
Trauma
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The aim of our study was to determine whether transfixation of unstable syndesmosis is necessary in supination-external rotation type ankle fractures. Our hypothesis was that syndesmotic ligaments hea...
Detailed Description
A prospective randomized study comparing syndesmotic transfixation to no fixation in AO/OTA Weber B-type ankle fractures was designed. To show a clinically significant difference (Olerud-Molander ankl...
Eligibility Criteria
Inclusion
- All skeletally mature patients (≥16 years old) with a unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures treated within one week after injury at our hospital
Exclusion
- Bilateral ankle fractures, pathologic fractures, concomitant tibial shaft fractures, previous significant injury or a fracture of either ankle, significant peripheral neuropathy, soft tissue infection in the region on either injured ankle, or inability to complete the study protocol.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01234493
Start Date
June 1 2007
End Date
August 1 2010
Last Update
May 16 2016
Active Locations (1)
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1
Oulu University Hospital
Oulu, Oulu, Finland, 90650