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Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harri Pakarinen, University of Oulu
ClinicalTrials.gov Identifier:
NCT01742650
First received: June 12, 2012
Last updated: December 2, 2012
Last verified: December 2012
History of Changes
  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: Syndesmosis fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Malreduction of the tibiofibular joint in the intraoperative computed tomography [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Screw fixation
3,5mm fully threaded cortical screw transfixation of syndesmosis
 Procedure: Syndesmosis fixation
TightRope
TightRope transfixation of Syndesmosis
 Procedure: Syndesmosis fixation

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742650

Locations
Finland
Oulu University Hospital
Oulu, Finland, 90029
Sponsors and Collaborators
University of Oulu
  More Information

No publications provided

Responsible Party: Harri Pakarinen, MD, PhD, University of Oulu
ClinicalTrials.gov Identifier: NCT01742650     History of Changes
Other Study ID Numbers: OYS-7-2009
Study First Received: June 12, 2012
Last Updated: December 2, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by University of Oulu:
ankle; fracture; syndesmosis;

ClinicalTrials.gov processed this record on May 16, 2013