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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2017

Open Access 01-12-2017 | Study protocol

Medium-sized posterior fragments in AO Weber-B fractures, does open reduction and fixation improve outcome? the POSTFIX-trial protocol, a multicenter randomized clinical trial

Authors: Sander Verhage, Peer van der Zwaal, Maarten Bronkhorst, Huub van der Meulen, Sanne Kleinveld, Sven Meylaerts, Steven Rhemrev, Pieta Krijnen, Inger Schipper, Jochem Hoogendoorn

Published in: BMC Musculoskeletal Disorders | Issue 1/2017

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Abstract

Background

Guidelines for treatment of the posterior fracture fragment in trimalleolar fractures are scarce and show varying advices. Did the increasing size of the posterior fragment seem to relate to worse outcome in the past, nowadays this has changed to the amount of dislocation of the posterior fragment post-operatively. Despite many retrospective cohort studies and some prospective cohort studies, no consistent guideline could be derived from the current literature.

Methods

The POSTFIX-study is designed as a multicenter randomized clinical trial to analyse the effects of anatomical reduction and fixation of the posterior fragment in AO 44-B3 fractures with medium-sized posterior fragment. A total of 84 patients will be included and online allocated to either anatomical reduction and fixation of the posterior fragment via the posterolateral approach (n = 42) or no fixation of the posterior fragment (n = 42). The concomitant fractured medial and lateral malleoli are treated according to the AO-principles. Functionality of the ankle as measured by the AAOS-questionnaire (American Association of Orthopaedic Surgeons) 1 year post-operatively was set as primary outcome. Main secondary outcome measures are the AAOS-questionnaire 5 years postoperatively and osteoarthritis as measured on plain radiographs 1 year and 5 years post-operatively. The Olerud and Molander score, the AOFAS-score, the VAS-pain, the Euroqol-5D and Range of Motion by physical examination will also be evaluated during the follow-up period.

Discussion

The POSTFIX-trial is the first high quality multicenter randomized clinical trial worldwide to analyse the effects of anatomical fixation of the posterior fragment in trimalleolar fractures. New guidelines on anatomical reduction and fixation of the posterior fragment can in future be based on the results of this trial.

Trial registration

This trial is registered on ClinicalTrials.gov with reference number: NCT02596529. Registered 3 November 2015, retrospectively registered.
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Metadata
Title
Medium-sized posterior fragments in AO Weber-B fractures, does open reduction and fixation improve outcome? the POSTFIX-trial protocol, a multicenter randomized clinical trial
Authors
Sander Verhage
Peer van der Zwaal
Maarten Bronkhorst
Huub van der Meulen
Sanne Kleinveld
Sven Meylaerts
Steven Rhemrev
Pieta Krijnen
Inger Schipper
Jochem Hoogendoorn
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2017
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-017-1445-0

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