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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: study protocol for a randomized controlled trial

Authors: Jan Paul Briet, Roderick M Houwert, Diederik PJ Smeeing, Janity S Pawiroredjo, Johannes C Kelder, Koen W Lansink, Luke PH Leenen, Peer van der Zwaal, Stephan WAM van Zutphen, Jochem M Hoogendoorn, Mark van Heijl, Egbert JMM Verleisdonk, Guus W van Lammeren, Michiel J Segers, Falco Hietbrink

Published in: Trials | Issue 1/2015

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Abstract

Background

The optimal post-operative care regimen after surgically fixed Lauge Hansen supination exorotation injuries remains to be established. This study compares whether unprotected weight bearing as tolerated is superior to protected weight bearing and unprotected non-weight bearing in terms of functional outcome and safety.

Methods/Design

The WOW! Study is a prospective multicenter clinical trial. Patients between 18 and 65 years of age with a Lauge Hansen supination exorotation type 2, 3 or 4 ankle fractures requiring surgical treatment are eligible for inclusion. An expert panel validates the classification and inclusion eligibility. After surgery, patients are randomized to either the 1) unprotected non-weight-bearing, 2) protected weight-bearing, or 3) unprotected weight-bearing group.
The primary outcome measure is ankle-specific disability measured by the Olerud-Molander ankle score. Secondary outcomes are 1) quality of life (e.g., return to work and resumption of sport), 2) complications, 3) range of motion, 4) calf wasting, and 5) maximum pressure load after 3 months and 1 year.

Discussion

This trial is designed to compare the effectiveness and safety of unprotected weight bearing with two commonly used post-operative treatment regimens after internal fixation of specified, intrinsically stable but displaced ankle fractures. An expert panel has been established to evaluate every potential subject, which ensures that every patient is strictly screened according to the inclusion and exclusion criteria and that there is a clear indication for surgical fixation.

Trial registration

The WOW! Study is registered in the Dutch Trial Register (NTR3727). Date of registration: 28-11-2012.
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Metadata
Title
Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: study protocol for a randomized controlled trial
Authors
Jan Paul Briet
Roderick M Houwert
Diederik PJ Smeeing
Janity S Pawiroredjo
Johannes C Kelder
Koen W Lansink
Luke PH Leenen
Peer van der Zwaal
Stephan WAM van Zutphen
Jochem M Hoogendoorn
Mark van Heijl
Egbert JMM Verleisdonk
Guus W van Lammeren
Michiel J Segers
Falco Hietbrink
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0714-1

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