{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T18:15:04Z","timestamp":1777659304371,"version":"3.51.4"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,8,9]],"date-time":"2021-08-09T00:00:00Z","timestamp":1628467200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,8,9]],"date-time":"2021-08-09T00:00:00Z","timestamp":1628467200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100009128","name":"research for patient benefit programme","doi-asserted-by":"publisher","award":["PB-PG-1217-20029"],"award-info":[{"award-number":["PB-PG-1217-20029"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Musculoskelet Disord"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Unstable ankle fractures represent a substantial burden of disease, accounting for a mean hospital stay of nine days, a mean cost of \u00a34,491 per patient and 20,000 operations per year. There is variation in UK practice around weight-bearing instructions after operatively managed ankle fracture. Early weight-bearing may reduce reliance on health services, time off work, and improve functional outcomes. However, concerns remain about the potential for complications such as implant failure. This is the protocol of a multicentre randomised non-inferiority clinical trial of weight-bearing following operatively treated ankle fracture.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adults aged 18 years and over who have been managed operatively for ankle fracture will be assessed for eligibility. Baseline function (Olerud and Molander Ankle Score [OMAS]), health-related quality of life (EQ-5D-5L), and complications will be collected after informed consent has been obtained. A randomisation sequence has been prepared by a trial statistician to allow for 1:1 allocation to receive either instruction to weight-bear as pain allows from the point of randomisation, two weeks after the time of surgery (\u2018<jats:italic>early weight-bearing<\/jats:italic>\u2019 group) or to not weight-bear for a further four weeks (\u2018<jats:italic>delayed weight -bearing\u2019 group<\/jats:italic>). All other treatment will be as per the guidance of the treating clinician.<\/jats:p><jats:p>Participants will be asked about their weight-bearing status weekly until four weeks post-randomisation. At four weeks post-randomisation complications will be collected. At six weeks, four months, and 12 months post-randomisation, the OMAS, EQ-5D-5L, complications, physiotherapy input, and resource use will be collected. The primary outcome measure is ankle function (OMAS) at four months post-randomisation.<\/jats:p><jats:p>A minimum of 436 participants will be recruited to obtain 80% power to detect a non-inferiority margin of -6 points on the OMAS 4 months post-randomisation. A within-trial health economic evaluation will be conducted to estimate the cost-effectiveness of the treatment options.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The results of this study will inform national guidance with regards to the most clinically and cost-effective strategy for weight-bearing after surgery for unstable ankle fractures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.isrctn.com\/ISRCTN12883981\">ISRCTN12883981<\/jats:ext-link>, Registered 02 December 2019.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12891-021-04560-7","type":"journal-article","created":{"date-parts":[[2021,8,9]],"date-time":"2021-08-09T19:03:09Z","timestamp":1628535789000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Protocol for the Weight-bearing in Ankle Fractures (WAX) trial: a multicentre prospective non-inferiority trial of early versus delayed weight-bearing after operatively managed ankle fracture"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9569-0734","authenticated-orcid":false,"given":"C. P.","family":"Bretherton","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H. A.","family":"Claireaux","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Achten","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Athwal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. J.","family":"Dutton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N.","family":"Peckham","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Petrou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R. S.","family":"Kearney","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Appelbe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"X. L.","family":"Griffin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,8,9]]},"reference":[{"key":"4560_CR1","unstructured":"Hospital Admitted Patient Care Activity 2019-20 [Internet]. NHS Digital. [cited 2021 Aug 4]. Available from: https:\/\/digital.nhs.uk\/data-and-information\/publications\/statistical\/hospital-admitted-patient-care-activity\/2019-20."},{"key":"4560_CR2","volume":"11","author":"CW Lin","year":"2012","unstructured":"Lin CW, Donkers NA, Refshauge KM, Beckenkamp PR, Khera K, Moseley AM. Rehabilitation for ankle fractures in adults. Cochrane Database Syst Rev. 2012;11:CD005595.","journal-title":"Cochrane Database Syst Rev"},{"key":"4560_CR3","first-page":"28","volume":"39","author":"B Collaborative","year":"2019","unstructured":"Collaborative B. Weight-bearing in ankle fractures: An audit of UK practice. Foot Edinb Scotl. 2019;39:28\u201336.","journal-title":"Foot Edinb Scotl"},{"issue":"4","key":"4560_CR4","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1308\/147363512X13189526440717","volume":"94","author":"E Kheir","year":"2012","unstructured":"Kheir E, Charopoulos I, Dimitriou R, Ghoz A, Dahabreh Z, Giannoudis P. The Health Economics of Ankle Fracture Fixation. Bull R Coll Surg Engl. 2012;94(4):1\u20135.","journal-title":"Bull R Coll Surg Engl"},{"key":"4560_CR5","doi-asserted-by":"publisher","first-page":"95","DOI":"10.3109\/17453679308994541","volume":"64","author":"T Ahl","year":"1993","unstructured":"Ahl T, Dalen N, Lundberg A, Bylund C. Early mobilization of operated on ankle fractures. Prospective, controlled study of 40 bimalleolar cases. Acta Orthop Scand. 1993;64:95\u20139.","journal-title":"Acta Orthop Scand"},{"key":"4560_CR6","doi-asserted-by":"publisher","first-page":"224","DOI":"10.1186\/1471-2474-13-224","volume":"13","author":"SM McPhail","year":"2012","unstructured":"McPhail SM, Dunstan J, Canning J, Haines TP. Life impact of ankle fractures: qualitative analysis of patient and clinician experiences. BMC Musculoskelet Disord. 2012;13:224.","journal-title":"BMC Musculoskelet Disord"},{"issue":"4","key":"4560_CR7","doi-asserted-by":"publisher","first-page":"255","DOI":"10.1007\/s10195-013-0280-9","volume":"15","author":"MR McDonald","year":"2014","unstructured":"McDonald MR, Sathiyakumar V, Apfeld JC, Hooe B, Ehrenfeld J, Obremskey WT, et al. Predictive factors of hospital length of stay in patients with operatively treated ankle fractures. J Orthop Traumatol Off J Ital Soc Orthop Traumatol. 2014;15(4):255\u20138.","journal-title":"J Orthop Traumatol Off J Ital Soc Orthop Traumatol"},{"key":"4560_CR8","doi-asserted-by":"publisher","first-page":"108","DOI":"10.1097\/01.bot.0000197701.96954.8c","volume":"20","author":"CJ Simanski","year":"2006","unstructured":"Simanski CJ, Maegele MG, Lefering R, Lehnen DM, Kawel N, Riess P, et al. Functional treatment and early weightbearing after an ankle fracture: a prospective study. J Orthop Trauma. 2006;20:108\u201314.","journal-title":"J Orthop Trauma"},{"key":"4560_CR9","first-page":"360","volume":"73","author":"A Gul","year":"2007","unstructured":"Gul A, Batra S, Mehmood S, Gillham N. Immediate unprotected weight-bearing of operatively treated ankle fractures. Acta Orthop Belg. 2007;73:360\u20135.","journal-title":"Acta Orthop Belg"},{"key":"4560_CR10","volume-title":"National Institute of Health and Care Excellence. Fractures (non-complex): assessment and management","author":"NICE","year":"2016","unstructured":"NICE, National Institute of Health and Care Excellence. Fractures (non-complex): assessment and management. 2016."},{"key":"4560_CR11","doi-asserted-by":"publisher","first-page":"1","DOI":"10.3310\/hta20750","volume":"20","author":"DJ Keene","year":"2016","unstructured":"Keene DJ, Mistry D, Nam J, Tutton E, Handley R, Morgan L, et al. The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years. Health Technol Assess. 2016;20:1\u2013158.","journal-title":"Health Technol Assess"},{"key":"4560_CR12","doi-asserted-by":"crossref","unstructured":"Kearney R, McKeown R, Stevens S, Parsons N, Parsons H, Wells P, et al. Cast versus functional brace in the rehabilitation of patients treated for an ankle fracture: protocol for the UK study of ankle injury rehabilitation (AIR) multicentre randomised trial. BMJ Open. 2018;8(12):e027242.","DOI":"10.1136\/bmjopen-2018-027242"},{"key":"4560_CR13","doi-asserted-by":"publisher","first-page":"g1687","DOI":"10.1136\/bmj.g1687","volume":"348","author":"TC Hoffmann","year":"2014","unstructured":"Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.","journal-title":"BMJ."},{"key":"4560_CR14","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1186\/1471-2474-14-109","volume":"14","author":"GM Nilsson","year":"2013","unstructured":"Nilsson GM, Eneroth M, Ekdahl CS. The Swedish version of OMAS is a reliable and valid outcome measure for patients with ankle fractures. BMC Musculoskelet Disord. 2013;14:109.","journal-title":"BMC Musculoskelet Disord"},{"issue":"3","key":"4560_CR15","doi-asserted-by":"publisher","first-page":"190","DOI":"10.1007\/BF00435553","volume":"103","author":"C Olerud","year":"1984","unstructured":"Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg Arch Orthopadische Unf-Chir. 1984;103(3):190\u20134.","journal-title":"Arch Orthop Trauma Surg Arch Orthopadische Unf-Chir"},{"issue":"10","key":"4560_CR16","doi-asserted-by":"crossref","first-page":"1727","DOI":"10.1007\/s11136-011-9903-x","volume":"20","author":"M Herdman","year":"2011","unstructured":"Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res Int J Qual Life Asp Treat Care Rehab. 2011;20(10):1727\u201336.","journal-title":"Qual Life Res Int J Qual Life Asp Treat Care Rehab"},{"key":"4560_CR17","unstructured":"Position statement on use of the EQ-5D-5L value set for England (updated October 2019) | NICE technology appraisal guidance | NICE guidance | Our programmes | What we do | About [Internet]. NICE. [cited 2019 Dec 8]. Available from: https:\/\/www.nice.org.uk\/about\/what-we-do\/our-programmes\/nice-guidance\/technology-appraisal-guidance\/eq-5d-5l"},{"issue":"5","key":"4560_CR18","doi-asserted-by":"publisher","first-page":"353","DOI":"10.2165\/00019053-199304050-00006","volume":"4","author":"MC Reilly","year":"1993","unstructured":"Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics. 1993;4(5):353\u201365.","journal-title":"PharmacoEconomics."},{"issue":"3","key":"4560_CR19","doi-asserted-by":"publisher","first-page":"352","DOI":"10.1097\/00005131-199209000-00014","volume":"6","author":"MA Mont","year":"1992","unstructured":"Mont MA, Sedlin ED, Weiner LS, Miller AR. Postoperative radiographs as predictors of clinical outcome in unstable ankle fractures. J Orthop Trauma. 1992;6(3):352\u20137.","journal-title":"J Orthop Trauma"},{"issue":"11","key":"4560_CR20","doi-asserted-by":"publisher","first-page":"841","DOI":"10.2519\/jospt.2014.5199","volume":"44","author":"PR Beckenkamp","year":"2014","unstructured":"Beckenkamp PR, Lin C-WC, Chagpar S, Herbert RD, van der Ploeg HP, Moseley AM. Prognosis of physical function following ankle fracture: a systematic review with meta-analysis. J Orthop Sports Phys Ther. 2014;44(11):841\u201351 B2.","journal-title":"J Orthop Sports Phys Ther"},{"key":"4560_CR21","first-page":"582","volume":"41","author":"GR Norman","year":"2003","unstructured":"Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41:582\u201392.","journal-title":"Med Care"},{"issue":"2","key":"4560_CR22","doi-asserted-by":"publisher","first-page":"215824401453485","DOI":"10.1177\/2158244014534858","volume":"4","author":"ML Bell","year":"2014","unstructured":"Bell ML, King MT, Fairclough DL. Bias in Area Under the Curve for Longitudinal Clinical Trials With Missing Patient Reported Outcome Data: Summary Measures Versus Summary Statistics. SAGE Open. 2014;4(2):2158244014534858.","journal-title":"SAGE Open"},{"key":"4560_CR23","unstructured":"ICMJE | Recommendations | Defining the Role of Authors and Contributors [Internet]. [cited 2021 Jun 18]. Available from: http:\/\/www.icmje.org\/recommendations\/browse\/roles-and-responsibilities\/defining-the-role-of-authors-and-contributors.html"}],"container-title":["BMC Musculoskeletal Disorders"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12891-021-04560-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12891-021-04560-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12891-021-04560-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,1,7]],"date-time":"2023-01-07T00:18:43Z","timestamp":1673050723000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmusculoskeletdisord.biomedcentral.com\/articles\/10.1186\/s12891-021-04560-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8,9]]},"references-count":23,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["4560"],"URL":"https:\/\/doi.org\/10.1186\/s12891-021-04560-7","relation":{},"ISSN":["1471-2474"],"issn-type":[{"value":"1471-2474","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,8,9]]},"assertion":[{"value":"24 June 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 July 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 August 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"National Research Ethics Committee: South Central- Oxford A- Health Research Authority approved this study on the 22 November 2019 reference number 19\/SC\/0566 (Current protocol version: 3.0 approved 29 March 2021). Amendments to the trial protocol will be submitted to the sponsor and REC for approval and disseminated to relevant parties. All participants will provide written electronic consent. Once completed, a PDF of the signed consent form will be automatically emailed to the participant and a copy available for download and placing in the participant\u2019s medical notes by the local research team.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"672"}}