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.Trial registrationThe WOW! Study is registered in the Dutch Trial Register (NTR3727). Date of registration: 28-11-2012.
Highlights
The optimal post-operative care regimen after surgically fixed Lauge Hansen supination exorotation injuries remains to be established
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
This study compares three different post-operative care regimens after ankle surgery; all patients with a Lauge Hansen supination exorotation type 2, 3 or 4 ankle fractures requiring surgical treatment are eligible for inclusion
Summary
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. Direct postoperative weight bearing and early mobilization has the potential benefit of earlier functional recovery [8,9,10,11,12,13,14,16,23,24] Ankle fractures in this trial are described by the Lauge Hansen classification. This classification describes the intrinsic stability, demonstrates the trauma mechanism and incorporates ligament injuries [25] This trial aims to provide evidence for the optimal post-operative care regimen after surgical repair, solely for Lauge Hansen supination exorotation 2–3 and 4 ankle fractures. The use of strict termination criteria is important to ensure the safety of the patient This prospective randomized controlled trial compares three different post-operative care regimens after open reduction and internal fixation of ankle fractures. All authors read and approved the final version of the manuscript
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