Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures
Primary Purpose
Trauma
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
fixation
no fixation
Sponsored by
About this trial
This is an interventional treatment trial for Trauma focused on measuring ankle; fracture; syndesmosis;
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
fixation
no fixation
Arm Description
Syndesmosis fixation with one 3.5mm fully threaded screw
No syndesmosis fixation
Outcomes
Primary Outcome Measures
Olerud-Molander score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01234493
Brief Title
Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures
Official Title
Syndesmotic Injury and Fixation in SE Ankle Fractures: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 heal at the proper length after malleolar reduction and that syndesmotic transfixation is not needed in supination-external rotation fracture types.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
ankle; fracture; syndesmosis;
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fixation
Arm Type
Active Comparator
Arm Description
Syndesmosis fixation with one 3.5mm fully threaded screw
Arm Title
no fixation
Arm Type
Active Comparator
Arm Description
No syndesmosis fixation
Intervention Type
Procedure
Intervention Name(s)
fixation
Intervention Description
Syndesmosis fixation with one 3.5mm fully threaded three cortical screw
Intervention Type
Procedure
Intervention Name(s)
no fixation
Intervention Description
No syndesmosis fixation.
Primary Outcome Measure Information:
Title
Olerud-Molander score
Time Frame
minimum one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harri J Pakarinen, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90650
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures
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