The effect of osteotomy technique (flat-cut vs wedge-cut Weil) on pain relief and complication incidence following surgical treatment for metatarsalgia in a private metropolitan clinic: protocol for a randomised controlled trial

Abstract

Abstract Background Weil osteotomies are performed to surgically treat metatarsalgia, by shortening the metatarsal via either a single distal oblique cut with translation of the metatarsal head (flat-cut) or through the removal of a slice of bone (wedge-cut). The wedge-cut technique purportedly has functional and mechanical advantages over the flat-cut procedure; however, in vivo data and quality of evidence are currently lacking. This study aims to investigate whether wedge-cut Weil osteotomy compared to traditional flat-cut Weil is associated with increased pain relief and fewer complications up to 12 months postoperatively. Methods Patient, surgical and clinical data will be collected for 80 consecutive consenting patients electing to undergo surgical treatment of propulsive metatarsalgia in a randomised control trial, embedded within a clinical registry. The primary outcome is patient-reported pain as assessed by the Foot and Ankle Outcome Score (FAOS) - Pain subscale, and the secondary outcome is the incidence of procedure-specific complications at up to 12 months postoperatively. The groups will be randomised using a central computer-based simple randomisation system, with a 1:1 allocation without blocking and allocation concealment. A mixed-effects analysis of covariance will be used to assess the primary outcome, with confounders factored into the model. A binary logistic regression will be used to assess the secondary outcome in a multivariable model containing the same confounders. Discussion To the best of the authors’ knowledge, the trial will be the first to examine the clinical efficacy of the wedge-cut Weil osteotomy compared to the flat-cut technique with a prospective, randomised control design. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12620001251910. Registered on 23 November 2020.