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Open Reduction Syndesmosis Tightrope Versus Screw Fixation

NCT02199249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2018-02-08

No results posted yet for this study

Summary

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.

Conditions

  • Ankle Fractures

Interventions

DEVICE

Open reduction Tightrope fixation

Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)

DEVICE

open reduction screw fixation

Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)

Sponsors & Collaborators

  • Orthopaedic Trauma Association

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • David Sanders, MD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02199249 on ClinicalTrials.gov