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Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234493
First Posted: November 4, 2010
Last Update Posted: May 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Harri Pakarinen, University of Oulu
  Purpose
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.

Condition Intervention
Trauma Procedure: fixation Procedure: no fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Syndesmotic Injury and Fixation in SE Ankle Fractures: A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Harri Pakarinen, University of Oulu:

Primary Outcome Measures:
  • Olerud-Molander score [ Time Frame: minimum one year ]

Enrollment: 140
Study Start Date: June 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fixation
Syndesmosis fixation with one 3.5mm fully threaded screw
Procedure: fixation
Syndesmosis fixation with one 3.5mm fully threaded three cortical screw
Active Comparator: no fixation
No syndesmosis fixation
Procedure: no fixation
No syndesmosis fixation.

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.

  Eligibility

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234493


Locations
Finland
Oulu University Hospital
Oulu, Finland, 90650
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Harri J Pakarinen, MD Oulu University Hospital
  More Information

Responsible Party: Harri Pakarinen, Orthopedic surgeon, University of Oulu
ClinicalTrials.gov Identifier: NCT01234493     History of Changes
Other Study ID Numbers: SE4rand1
First Submitted: November 2, 2010
First Posted: November 4, 2010
Last Update Posted: May 16, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Harri Pakarinen, University of Oulu:
ankle; fracture; syndesmosis;

Additional relevant MeSH terms:
Ankle Fractures
Ankle Injuries
Fractures, Bone
Wounds and Injuries
Leg Injuries