{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T03:23:24Z","timestamp":1777951404612,"version":"3.51.4"},"reference-count":19,"publisher":"Danish Medical Association","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Dan Med J"],"abstract":"<jats:p>INTRODUCTION. Ankle fractures are common and debilitating injuries usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive ankle stirrup may accelerate recovery without increasing complications, and patients tend to prefer ankle stirrups. However, evidence supporting their non-inferiority is inconclusive. The aim of this study is to assess whether ankle stirrups are non-inferior to walkers in improving function and pain measured by the Manchester-Oxford Foot Questionnaire three months after ankle fracture.\n\nMETHODS. The trial will be a two-phase, multicentre, pragmatic, non-inferiority randomised controlled trial. Patients \u2265 18 years with surgically or non-surgically treated ankle fractures will be included. A three-month pilot phase will assess trial feasibility, including recruitment rates. The full trial will randomise a maximum of 1,400 patients. The sample size is estimated to be sufficient to assess non-inferiority in the overall population and to explore non-inferiority in six subgroups stratified by sex and age (males 18-39 years, males 40-59 years and 60+ years) and treatment (surgical or non-surgical).\n\nCONCLUSIONS. The bracing after ankle fracture trial will determine whether ankle stirrups are non-inferior to walkers in terms of patient-reported function and pain. Secondarily, the study will assess whether the ankle stirrup facilitates faster recovery of function, earlier return to work, and reduced healthcare costs. Findings will support evidence-based decision-making with respect to patient preferences.\n\nFUNDING. Independent Research Fund Denmark, Grant no. 10.46540\/4308-00191B.\n\nTRIAL REGISTRATION. Clinicaltrials: NCT07163091.<\/jats:p>","DOI":"10.61409\/a09250748","type":"journal-article","created":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T12:11:01Z","timestamp":1774959061000},"page":"1-9","source":"Crossref","is-referenced-by-count":0,"title":["A study protocol for a randomised trial of bracing after ankle fracture"],"prefix":"10.61409","author":[{"given":"Jonas Ammundsen","family":"Ipsen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anders","family":"Holsgaard-Larsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charlotte","family":"Abrahamsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Per Hviid","family":"Gundtoft","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Costa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stinus Storm","family":"Mikkelsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asbj\u00f8rn","family":"Hr\u00f3bjartsson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bjarke","family":"Viberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"40208","published-online":{"date-parts":[[2026,3]]},"reference":[{"key":"ref0","doi-asserted-by":"publisher","unstructured":"M\u00f6ller M, Wolf O, Bergdahl C, et al. 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