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  3. Open Reduction Syndesmosis Tightrope Versus Screw Fixation
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

Overview

Body Locations and Systems
Ankle
ClinicalTrials.gov#
NCT02199249
Status
Closed for Recruitment
Start/End Dates
Aug 5, 2015
Locations
Vancouver General Hospital
Name/Title
Irene Leung, Research Assistant
Phone
604-875-4111 ext. 61020
Email Address
irene.leung@vch.ca
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.

Eligibility

Visit ClinicalTrials.gov for more information.

Disclaimer

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.

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