Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Syndesmotic Injury and Fixation in SE Ankle Fractures: A Prospective Randomized Study|
- Olerud-Molander score [ Time Frame: minimum one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Active Comparator: fixation
Syndesmosis fixation with one 3.5mm fully threaded screw
Syndesmosis fixation with one 3.5mm fully threaded three cortical screw
Active Comparator: no fixation
No syndesmosis fixation
Procedure: no fixation
No syndesmosis fixation.
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 ankle score 20%, standard deviation (SD) 24 points, from our previous study) between the groups, the sample size was estimated (α=0.05, β=0.2, 20% drop out) to be 30 patients per group.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234493
|Oulu University Hospital|
|Oulu, Finland, 90650|
|Principal Investigator:||Harri J Pakarinen, MD||Oulu University Hospital|