TY - JOUR
T1 - Weight-bearing or non-weight-bearing after surgical treatment of ankle fractures
T2 - a multicenter randomized controlled trial
AU - Smeeing, Diederik Pieter Johan
AU - Houwert, Roderick Marijn
AU - Briet, Jan Paul
AU - Groenwold, Rolf Hendrik Herman
AU - Lansink, Koen Willem Wouter
AU - Leenen, Luke Petrus Hendrikus
AU - van der Zwaal, Peer
AU - Hoogendoorn, Jochem Maarten
AU - van Heijl, Mark
AU - Verleisdonk, Egbert Jan
AU - Segers, Michiel Joseph Marie
AU - Hietbrink, Falco
N1 - Funding Information:
The authors have no commercial associations that might pose a conflict of interest in connection with the manuscript. We thank Johannes C. Kelder, Arjen J. Witkamp and Moyo C. Kruyt for participation in the Data Safety Monitoring Board. We thank Stephan W. van Zuthphen, Janity S. Pawiroredjo and Bas A. Twigt for their support of the study.
Publisher Copyright:
© 2018, The Author(s).
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/2/1
Y1 - 2020/2/1
N2 - 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.
AB - 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.
KW - Ankle fracture
KW - Mobilization
KW - Postoperative care
KW - Randomized controlled trial
KW - Weight-bearing
UR - https://www.scopus.com/pages/publications/85053842320
U2 - 10.1007/s00068-018-1016-6
DO - 10.1007/s00068-018-1016-6
M3 - Article
C2 - 30251154
SN - 1863-9933
VL - 46
SP - 121
EP - 130
JO - European Journal of Trauma and Emergency Surgery
JF - European Journal of Trauma and Emergency Surgery
IS - 1
ER -