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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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>To the best of the authors\u2019 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>Australian New Zealand Clinical Trials Registry ACTRN12620001251910. Registered on 23 November 2020.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-022-06591-4","type":"journal-article","created":{"date-parts":[[2022,8,19]],"date-time":"2022-08-19T07:04:34Z","timestamp":1660892674000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["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"],"prefix":"10.1186","volume":"23","author":[{"given":"Manaal","family":"Fatima","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nalan","family":"Ektas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6592-0738","authenticated-orcid":false,"given":"Corey","family":"Scholes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Symes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Wines","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,8,19]]},"reference":[{"key":"6591_CR1","doi-asserted-by":"publisher","first-page":"S29","DOI":"10.1016\/j.otsr.2016.06.020","volume":"103","author":"J-L Besse","year":"2017","unstructured":"Besse J-L. 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All participants will provide informed consent to participate in the trial.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate\u00a0{24}"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication\u00a0{32}"}},{"value":"AW declares institutional funding and fellowship payments from Zimmer Biomet and DePuy Synthes, for facilitating teaching workshops. AW and MS have employed EBM Analytics to assist with the trial conduct and management. CS is a shareholder and paid employee of EBM Analytics and in the last 3 years has received institutional payments from Exactech Inc., Stryker South Pacific, Headsafe Pty Ltd. and Naviswiss AG for work unrelated to this clinical trial or the primary investigators. CS is a past associate editor for the <i>Journal of Orthopaedic Surgery and Research<\/i>. MF and NE are paid employees of EBM Analytics.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests\u00a0{28}"}}],"article-number":"690"}}