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Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture

NCT01109303 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2012-12-20

No results posted yet for this study

Summary

Ankle fracture is frequent and its number is increasing. In Canada, surgical treatment of these lesions is advised and the options currently used all have in common a rigid fixation of the syndesmosis which results in residual stiffness and a high level of secondary surgery, mostly to remove the implant.

The purpose of the study is to compare the treatment of ankle syndesmotic rupture by a dynamic fixation to a static fixation suggesting that the dynamic fixation method will improve the Olerud-Molander functional score of more than 15 points at the 3 months follow-up.

Conditions

  • Ankle Syndesmosis Rupture

Interventions

PROCEDURE

TightRope System- Arthrex® / Dynamic Implant

Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.

PROCEDURE

Screw fixation - Synthes® / Static Implant

Patients are operated on using a static implant, the rigid four-cortices 3,5 mm screw fixation by Synthes®. The ankle is immobilized in a plaster boot for 6 weeks.

Sponsors & Collaborators

  • Arthrex, Inc.

    collaborator INDUSTRY

  • Hopital de l'Enfant-Jesus

    lead OTHER

Principal Investigators

  • Stéphane Pelet, MD, PhD · Hôpital Enfant-Jésus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-02-28
Completion
2012-01-31

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 NCT01109303 on ClinicalTrials.gov