Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures

Trauma Clinical Trial

Official title:

Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures. A Prospective Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742650
• Other study ID #: OYS-7-2009
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: May 13, 2016
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2016
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Trauma

Intervention

Procedure:
• Screw fixation
3,5mm fully threaded cortical screw transfixation of syndesmosis
• TightRope
TightRope transfixation of syndesmosis

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malreduction of the tibiofibular joint in the intraoperative computed tomography	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	2 years	No
Secondary	Clinical outcome one year after the injury	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.	2 year	No