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Randomized Controlled Trial
. 2020 Feb;46(1):121-130.
doi: 10.1007/s00068-018-1016-6. Epub 2018 Sep 24.

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

Diederik Pieter Johan Smeeing  1   2 , Roderick Marijn Houwert  3   4 , Jan Paul Briet  5 , Rolf Hendrik Herman Groenwold  6 , Koen Willem Wouter Lansink  7 , Luke Petrus Hendrikus Leenen  4 , Peer van der Zwaal  8 , Jochem Maarten Hoogendoorn  9 , Mark van Heijl  5 , Egbert Jan Verleisdonk  5 , Michiel Joseph Marie Segers  10 , Falco Hietbrink  4
Affiliations
Randomized Controlled Trial

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

Diederik Pieter Johan Smeeing et al. Eur J Trauma Emerg Surg. 2020 Feb.

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.

Keywords: Ankle fracture; Mobilization; Postoperative care; Randomized controlled trial; Weight-bearing.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Flowchart of patient selection in the WOW! Study. Flowchart indicating patient selection. Three patients crossed over due to cast irritation. SE Supination external rotation
Fig. 2
Fig. 2
Functional outcome using the Olerud Molander Ankle Score based on the postoperative treatment of ankle fractures. This figure shows the functional outcome using the Olerud Molander Ankle Score based on the postoperative treatment of ankle fractures. The Olerud Molander Ankle Score ranges from 0 to 100. A higher score indicates a better functional outcome. Mean Olerud Molander Ankle Scores are shown with corresponding 95% confidence intervals of the means on the different time points
See this image and copyright information in PMC

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