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Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742650
First Posted: December 5, 2012
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 is to compare two different syndesmosis transfixation methods in AO/OTA Weber C ankle fractures. Our hypothesis is that 50% of screw fixed fibulas but only 5% of suture-button fixed fibulas are in malposition. All skeletally mature patients (16 years or older) with AO/OTA Weber C type fractures operated within a week after trauma are consecutively included into the study. The tibiofibular transfixation is randomly performed either by a 3,5 mm tricortical screw or a suture-button (TightRope). Malposition of the tibiofibular joint is assessed in an intraoperative computed tomography. Clinical outcome is assessed by using Olerud-Molander, RAND ja 36-Item Healt Survey after 1-year from the injury.

Condition Intervention
Trauma Procedure: Screw fixation Procedure: TightRope

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C 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:
  • Malreduction of the tibiofibular joint in the intraoperative computed tomography [ Time Frame: 2 years ]
    Malreduction in the tibiofibular joint is assessed post op from the intraoperative computed tomography. Both ankles are imaged and difference at least 2 mm is assessed to be significant


Secondary Outcome Measures:
  • Clinical outcome one year after the injury [ Time Frame: 2 year ]
    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 2-year of follow-up.


Enrollment: 38
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Screw fixation
3,5mm fully threaded cortical screw transfixation of syndesmosis
Procedure: Screw fixation
3,5mm fully threaded cortical screw transfixation of syndesmosis
Active Comparator: TightRope
TightRope transfixation of syndesmosis
Procedure: TightRope
TightRope transfixation of syndesmosis
Other Name: Tightrope Arthrex

Detailed Description:

The aim of our study is to compare two different syndesmosis transfixation methods in AO/OTA Weber C ankle fractures. Screw fixation is widely and mostly used transfixation but suture-button is also shown to be a biomechanically stable and probably more physiologic transfication method. It is shown that even 50 % of the syndesmosis srews and thus fibulas are in malposition. With more physiologic suture-button transfixation this malposition is thought to be less commmon. There is no studies comparing screw and suture-button syndesmosis transfixation methods in AO/OTA Weber C ankle fracture patients.

Our hypothesis is that 50% of screw fixed fibulas but only 5% of suture-button fixed fibulas are in malposition assessed in the intraoperative computed tomography. Malposition is assessed to present if difference between fractured and non-fractured side is at least 2 mm in the tibiofibular joint. Thus, the sample size is assessed to be 19 patients per group (alpha=0.05, Beta=0.2, 20% drop out).

All skeletally mature patients (16 years or older) with AO/OTA Weber C type fractures operated within a week after trauma are included into the study. Exclusion criteria are previous ankle fracture, concomitant tibial fracture, diabetes with peripheral neuropathy, pathological fracture or inadequate co-operation.

After bony fixation the tibiofibular transfixation is randomly performed either by a 3,5 mm tricortical screw or a suture-button (TightRope). An intraoperative computed tomography is imaged from the both ankles of all patients. The operation is continued with six weeks casting without weight-bearing.

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:   No
Criteria

Inclusion Criteria:

  • AO/OTA Weber C ankle fracture, operation within 7 days from the injury

Exclusion Criteria:

  • Bilateral or previous ankle fracture, tibial shaft fracture, diabetes wiht polyneuropathy, inadequate co-operation
  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): NCT01742650


Locations
Finland
Oulu University Hospital
Oulu, Finland, 90029
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Tero HJ Kortekangas, MD Oulu University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harri Pakarinen, MD, PhD, University of Oulu
ClinicalTrials.gov Identifier: NCT01742650     History of Changes
Other Study ID Numbers: OYS-7-2009
First Submitted: June 12, 2012
First Posted: December 5, 2012
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