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

Abstract

ABSTRACTIntroductionWeil osteotomies are performed to surgically treat metatarsalgia, by shortening the metatarsal via either a single distal oblique cut (flat-cut) with translation of the metatarsal head, or through 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 is 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 and analysisPatient, 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.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12620001251910. Registered on 23 November 2020.Ethics and disseminationEthics approval for this study was provided through the NSW/VIC branch of the Ramsay Health Care Human Research Ethics Committee (HREC approval number 2020-007). The results of this study will be disseminated through peer-reviewed journals and conference presentations.Strengths and limitations of this studyTo the best of the authors knowledge, the trial will be the first to examine clinical efficacy of the wedge-cut Weil osteotomy compared to the flat-cut technique with a prospective, randomised control design.A sample size of N=80 participants will ensure adequate power to detect differences between the control and experimental groups, with an allowance for a dropout rate of 10%.A limitation in the methods is the routine performance of adjunct surgical procedures for lesser toe or soft tissue correction. The statistical plan aims to control for this by treating adjunct procedures as potential confounders of the effect of the intervention, along with prognostic factors identified from available literature on pain ratings in metatarsalgia. These confounders will be included in the models used to analyse the primary and secondary outcomes.