Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: study protocol for a randomized controlled trial.
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
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.


CONCLUSIONS
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.


BACKGROUND
The WOW! Study is registered in the Dutch Trial Register ( NTR3727 ). Date of registration: 28-11-2012.
Department of Surgery, Diakonessenhuis Utrecht, Bosboomstraat 1, Postbus 80250, 3508 TG, Utrecht, The Netherlands. jp.briet@gmail.com.
Jan Paul
JP
Briet
Utrecht Traumacenter, Utrecht, The Netherlands. marijnhouwert@hotmail.com.
Roderick M
RM
Houwert
Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. diederiksmeeing@hotmail.com.
Diederik P J
DP
Smeeing
Department of Surgery, St. Antonius Hospital Nieuwegein, Postbus 2500, 3430 EM, Nieuwegein, The Netherlands. j.pawiroredjo@hotmail.com.
Janity S
JS
Pawiroredjo
Department of Epidemiology, St. Antonius Hospital Nieuwegein, Postbus 2500, 3430 EM, Nieuwegein, The Netherlands. keld01@antoniusziekenhuis.nl.
Johannes C
JC
Kelder
Department of Surgery, St Elisabeth Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands. k.lansink@elisabeth.nl.
Koen W
KW
Lansink
Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. lleenen@umcutrecht.nl.
Luke P H
LP
Leenen
Department of Orthopaedics, Medisch Centrum Haaglanden, Lijnbaan 32, Postbus 432, 2512 VA, Den Haag, The Netherlands. peerzwaal@hotmail.com.
Peer
P
van der Zwaal
Department of Surgery, Twee Steden Ziekenhuis Doctor, Deelenlaan 5, 5042AD, Tilburg, The Netherlands. s.v.zuthpen@elisabeth.nl.
Stephan W A M
SW
van Zutphen
Department of Surgery, Medisch Centrum Haaglanden, Lijnbaan 32, Postbus 432, 2512 VA, Den Haag, The Netherlands. j.hoogendoorn@mchaaglanden.nl.
Jochem M
JM
Hoogendoorn
Department of Surgery, Diakonessenhuis Utrecht, Bosboomstraat 1, Postbus 80250, 3508 TG, Utrecht, The Netherlands. markvanheijl@gmail.com.
Mark
M
van Heijl
Department of Surgery, Diakonessenhuis Utrecht, Bosboomstraat 1, Postbus 80250, 3508 TG, Utrecht, The Netherlands. ejverlei@diakhuis.nl.
Egbert J M M
EJ
Verleisdonk
Department of Surgery, St. Antonius Hospital Nieuwegein, Postbus 2500, 3430 EM, Nieuwegein, The Netherlands. g.van.lammeren@antoniusziekenhuis.nl.
Guus W
GW
van Lammeren
Department of Surgery, St. Antonius Hospital Nieuwegein, Postbus 2500, 3430 EM, Nieuwegein, The Netherlands. m.segers@antoniusziekenhuis.nl.
Michiel J
MJ
Segers
Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. f.hietbrink@hotmail.com.
Falco
F
Hietbrink
D000293:Adolescent; D000328:Adult; D000368:Aged; D064386:Ankle Fractures / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D000843:Ankle Joint / Q000503:physiopathology / Q000601:surgery*; D001696:Biomechanical Phenomena; D002370:Casts, Surgical; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003446:Crutches; D004185:Disability Evaluation; D005260:Female; D005593:Fracture Fixation, Internal; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D026741:Physical Therapy Modalities; D011182:Postoperative Care / Q000295:instrumentation / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D016059:Range of Motion, Articular; D020127:Recovery of Function; D012107:Research Design; D062707:Return to Work; D013997:Time Factors; D016896:Treatment Outcome; D016474:Weight-Bearing; D055815:Young Adult