Trials · 2022
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.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Fatima Manaal, Ektas Nalan, Scholes Corey, Symes Michael, Wines Andrew
Аннотация
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.
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.