Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures
NCT ID: NCT01234493
Last Updated: 2016-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2007-06-30
2010-08-31
Brief Summary
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Detailed Description
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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 were considered eligible for the present study. Exclusion criteria were 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.
After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixation with 3.5-mm tricortical screws or no syndesmotic fixation.
Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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fixation
Syndesmosis fixation with one 3.5mm fully threaded screw
fixation
Syndesmosis fixation with one 3.5mm fully threaded three cortical screw
no fixation
No syndesmosis fixation
no fixation
No syndesmosis fixation.
Interventions
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fixation
Syndesmosis fixation with one 3.5mm fully threaded three cortical screw
no fixation
No syndesmosis fixation.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
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University of Oulu
OTHER
Responsible Party
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Harri Pakarinen
Orthopedic surgeon
Principal Investigators
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Harri J Pakarinen, MD
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Locations
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Oulu University Hospital
Oulu, Oulu, Finland
Countries
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Other Identifiers
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SE4rand1
Identifier Type: -
Identifier Source: org_study_id
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