Research Study

A Prospective Randomized Multi Center Study to Compare Open Reduction, TightRope Fixation (OT) Versus Open Reduction Screw Fixation (OS) of the Tibia - Fibular Syndesmosis
Principal Investigator 
Pierre Guy


Body Locations and Systems 
Closed for Recruitment
Study Start/End 
Aug 5, 2015 to Jun 29, 2017
Vancouver General Hospital
Irene Leung, Research Assistant
604-875-4111 ext. 61020
Email Address
Purpose of Study 

Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments.

The goal of operative treatment is to reduce the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed using either open or closed reduction, combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than 40%; therefore, open reduction will be performed in this study. Screw fixation is stable but concerns exist regarding potential excess rigidity.

Recently, flexible fixation techniques combined with anatomic reduction have demonstrated improvements in functional outcomes and reduction quality. Both open reduction and flexible TightRope fixation have considerable support in the literature in cohort studies but have not been compared to open screw fixation in a randomized controlled trial.

In this multi centre randomized study, radiographic, economic and functional outcomes are compared between [open reduction, flexible Tightrope syndesmosis fixation (OT)] and [open reduction screw fixation (OS)] of the syndesmosis.


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