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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
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring ankle; fracture; syndesmosis;

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 2, 2010
Last Updated
May 13, 2016
Sponsor
University of Oulu
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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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