Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study

Study protocol for a randomized controlled trial

Jan Paul Briet, Roderick M. Houwert, Diederik P. J. Smeeing, Janity S. Pawiroredjo, Johannes C. Kelder, Koen W. Lansink, Luke P. H. Leenen, Peer van der Zwaal, Stephan W. A. M. van Zutphen, Jochem M. Hoogendoorn, Mark van Heijl, Egbert J. M. M. Verleisdonk, Guus W. van Lammeren, Michiel J. Segers, Falco Hietbrink

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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.
Keywords: Ankle, Ankle fracture, Lauge Hansen, Post-operative care regimen, Weight bearing
Original languageEnglish
Article number175
JournalTrials
Volume16
DOIs
Publication statusPublished - 18 Apr 2015

Keywords

  • Ankle
  • Ankle fracture
  • Lauge Hansen
  • Post-operative care regimen
  • Weight bearing

Cite this

Briet, J. P., Houwert, R. M., Smeeing, D. P. J., Pawiroredjo, J. S., Kelder, J. C., Lansink, K. W., ... Hietbrink, F. (2015). Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: Study protocol for a randomized controlled trial. Trials, 16, [175]. https://doi.org/10.1186/s13063-015-0714-1
Briet, Jan Paul ; Houwert, Roderick M. ; Smeeing, Diederik P. J. ; Pawiroredjo, Janity S. ; Kelder, Johannes C. ; Lansink, Koen W. ; Leenen, Luke P. H. ; van der Zwaal, Peer ; van Zutphen, Stephan W. A. M. ; Hoogendoorn, Jochem M. ; van Heijl, Mark ; Verleisdonk, Egbert J. M. M. ; van Lammeren, Guus W. ; Segers, Michiel J. ; Hietbrink, Falco. / Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study : Study protocol for a randomized controlled trial. In: Trials. 2015 ; Vol. 16.
@article{3411a5197ed34ce89ea23dc03fa727b1,
title = "Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: Study protocol for a randomized controlled trial",
abstract = "BackgroundThe 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/DesignThe 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.DiscussionThis 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.Keywords: Ankle, Ankle fracture, Lauge Hansen, Post-operative care regimen, Weight bearing",
keywords = "Ankle, Ankle fracture, Lauge Hansen, Post-operative care regimen, Weight bearing",
author = "Briet, {Jan Paul} and Houwert, {Roderick M.} and Smeeing, {Diederik P. J.} and Pawiroredjo, {Janity S.} and Kelder, {Johannes C.} and Lansink, {Koen W.} and Leenen, {Luke P. H.} and {van der Zwaal}, Peer and {van Zutphen}, {Stephan W. A. M.} and Hoogendoorn, {Jochem M.} and {van Heijl}, Mark and Verleisdonk, {Egbert J. M. M.} and {van Lammeren}, {Guus W.} and Segers, {Michiel J.} and Falco Hietbrink",
year = "2015",
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doi = "10.1186/s13063-015-0714-1",
language = "English",
volume = "16",
journal = "Trials",
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Briet, JP, Houwert, RM, Smeeing, DPJ, Pawiroredjo, JS, Kelder, JC, Lansink, KW, Leenen, LPH, van der Zwaal, P, van Zutphen, SWAM, Hoogendoorn, JM, van Heijl, M, Verleisdonk, EJMM, van Lammeren, GW, Segers, MJ & Hietbrink, F 2015, 'Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: Study protocol for a randomized controlled trial', Trials, vol. 16, 175. https://doi.org/10.1186/s13063-015-0714-1

Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study : Study protocol for a randomized controlled trial. / Briet, Jan Paul; Houwert, Roderick M.; Smeeing, Diederik P. J.; Pawiroredjo, Janity S.; Kelder, Johannes C.; Lansink, Koen W.; Leenen, Luke P. H.; van der Zwaal, Peer; van Zutphen, Stephan W. A. M.; Hoogendoorn, Jochem M.; van Heijl, Mark; Verleisdonk, Egbert J. M. M.; van Lammeren, Guus W.; Segers, Michiel J.; Hietbrink, Falco.

In: Trials, Vol. 16, 175, 18.04.2015.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study

T2 - Study protocol for a randomized controlled trial

AU - Briet, Jan Paul

AU - Houwert, Roderick M.

AU - Smeeing, Diederik P. J.

AU - Pawiroredjo, Janity S.

AU - Kelder, Johannes C.

AU - Lansink, Koen W.

AU - Leenen, Luke P. H.

AU - van der Zwaal, Peer

AU - van Zutphen, Stephan W. A. M.

AU - Hoogendoorn, Jochem M.

AU - van Heijl, Mark

AU - Verleisdonk, Egbert J. M. M.

AU - van Lammeren, Guus W.

AU - Segers, Michiel J.

AU - Hietbrink, Falco

PY - 2015/4/18

Y1 - 2015/4/18

N2 - BackgroundThe 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/DesignThe 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.DiscussionThis 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.Keywords: Ankle, Ankle fracture, Lauge Hansen, Post-operative care regimen, Weight bearing

AB - BackgroundThe 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/DesignThe 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.DiscussionThis 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.Keywords: Ankle, Ankle fracture, Lauge Hansen, Post-operative care regimen, Weight bearing

KW - Ankle

KW - Ankle fracture

KW - Lauge Hansen

KW - Post-operative care regimen

KW - Weight bearing

U2 - 10.1186/s13063-015-0714-1

DO - 10.1186/s13063-015-0714-1

M3 - Article

VL - 16

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 175

ER -