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European Journal of Trauma and Emergency Surgery
Published in: European Journal of Trauma and Emergency Surgery 1/2020

Open Access 01-02-2020 | Original Article

Weight-bearing or non-weight-bearing after surgical treatment of ankle fractures: a multicenter randomized controlled trial

Authors: Diederik Pieter Johan Smeeing, Roderick Marijn Houwert, Jan Paul Briet, Rolf Hendrik Herman Groenwold, Koen Willem Wouter Lansink, Luke Petrus Hendrikus Leenen, Peer van der Zwaal, Jochem Maarten Hoogendoorn, Mark van Heijl, Egbert Jan Verleisdonk, Michiel Joseph Marie Segers, Falco Hietbrink

Published in: European Journal of Trauma and Emergency Surgery | Issue 1/2020

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Abstract

Purpose

The goal of this study was to assess if unprotected weight-bearing as tolerated is superior to protected weight-bearing and unprotected non-weight-bearing in terms of functional outcome and complications after surgical fixation of Lauge-Hansen supination external rotation stage 2–4 ankle fractures.

Methods

A multicentered randomized controlled trial was conducted in patients ranging from 18 to 65 years of age without severe comorbidities. Patients were randomized to unprotected non-weight-bearing, protected weight-bearing, and unprotected weight-bearing as tolerated. The primary endpoint of the study was the Olerud Molander Ankle Score (OMAS) 12 weeks after randomization. The secondary endpoints were health-related quality of life using the SF-36v2, time to return to work, time to return to sports, and the number of complications.

Results

The trial was terminated early as advised by the Data and Safety Monitoring Board after interim analysis. A total of 115 patients were randomized. The O’Brien–Fleming threshold for statistical significance for this interim analysis was 0.008 at 12 weeks. The OMAS was higher in the unprotected weight-bearing group after 6 weeks c(61.2 ± 19.0) compared to the protected weight-bearing (51.8 ± 20.4) and unprotected non-weight-bearing groups (45.8 ± 22.4) (p = 0.011). All other follow-up time points did not show significant differences between the groups. Unprotected weight-bearing showed a significant earlier return to work (p = 0.028) and earlier return to sports (p = 0.005). There were no differences in the quality of life scores or number of complications.

Conclusions

Unprotected weight-bearing and mobilization as tolerated as postoperative care regimen improved short-term functional outcomes and led to earlier return to work and sports, yet did not result in an increase of complications.
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Metadata
Title
Weight-bearing or non-weight-bearing after surgical treatment of ankle fractures: a multicenter randomized controlled trial
Authors
Diederik Pieter Johan Smeeing
Roderick Marijn Houwert
Jan Paul Briet
Rolf Hendrik Herman Groenwold
Koen Willem Wouter Lansink
Luke Petrus Hendrikus Leenen
Peer van der Zwaal
Jochem Maarten Hoogendoorn
Mark van Heijl
Egbert Jan Verleisdonk
Michiel Joseph Marie Segers
Falco Hietbrink
Publication date
01-02-2020
Publisher
Springer Berlin Heidelberg
Published in
European Journal of Trauma and Emergency Surgery / Issue 1/2020
Print ISSN: 1863-9933
Electronic ISSN: 1863-9941
DOI
https://doi.org/10.1007/s00068-018-1016-6

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