{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T20:11:08Z","timestamp":1788207068510,"version":"build-2803163510"},"reference-count":65,"publisher":"National Institute for Health and Care Research","issue":"33","license":[{"start":{"date-parts":[[2022,7,1]],"date-time":"2022-07-01T00:00:00Z","timestamp":1656633600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["17\/23\/02"],"award-info":[{"award-number":["17\/23\/02"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>Torus (buckle) fractures of the wrist are the most common fractures in children involving the distal radius and\/or ulna. It is unclear if children require rigid immobilisation and follow-up or would recover equally as well by being discharged without any immobilisation or a bandage. Given the large number of these injuries, identifying the optimal treatment strategy could have important effects on the child, the number of days of school absence and NHS costs.<\/jats:p><\/jats:sec>Objectives<\/jats:title>To establish whether or not treating children with a distal radius torus fracture with the offer of a soft bandage and immediate discharge (i.e. offer of a bandage) provides the same recovery, in terms of pain, function, complications, acceptability, school absence and resource use, as treatment with rigid immobilisation and follow-up as per usual practice (i.e. rigid immobilisation).<\/jats:p><\/jats:sec>Design<\/jats:title>A pragmatic, multicentre, randomised controlled equivalence trial.<\/jats:p><\/jats:sec>Setting<\/jats:title>Twenty-three UK emergency departments.<\/jats:p><\/jats:sec>Participants<\/jats:title>A total of 965 children (aged 4\u201315 years) with a distal radius torus fracture were randomised from January 2019 to July 2020 using a secure, centralised, online-encrypted randomisation service. Exclusion criteria included presentation >\u200936 hours after injury, multiple injuries and an inability to complete follow-up.<\/jats:p><\/jats:sec>Interventions<\/jats:title>A bandage was offered to 489 participants and applied to 458, and rigid immobilisation was carried out in 476 participants. Participants and clinicians were not blinded to the treatment allocation.<\/jats:p><\/jats:sec>Main outcome measures<\/jats:title>The pain at 3 days post randomisation was measured using the Wong\u2013Baker FACES Pain Rating Scale. Secondary outcomes were the patient-reported outcomes measurement system upper extremity limb score for children, health-related quality of life, complications, school absence, analgesia use and resource use collected up to 6 weeks post randomisation.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 94% of participants provided primary outcome data. At 3 days, the primary outcome of pain was equivalent in both groups. With reference to the prespecified equivalence margin of 1.0, the adjusted difference in the intention-to-treat population was \u20130.10 (95% confidence interval \u20130.37 to 0.17) and the per-protocol population was \u20130.06 (95% confidence interval \u20130.34 to 0.21). There was equivalence of pain in both age subgroups (i.e. 4\u20137 years and 8\u201315 years). There was no difference in the rate of complications, with five complications (1.0%) in the offer of a bandage group and three complications (0.6%) in the rigid immobilisation group. There were no differences between treatment groups in functional recovery, quality of life or school absence at any point during the follow-up. Analgesia use was marginally higher at day 1 in the offer of a bandage group than it was in the rigid immobilisation group (83% vs. 78% of participants), but there was no difference at other time points. The offer of a bandage significantly reduced the cost of treatment and had a high probability of cost-effectiveness at a willingness-to-pay threshold of \u00a330,000 per quality-adjusted life-year.<\/jats:p><\/jats:sec>Limitations<\/jats:title>Families had a strong pre-existing preference for the rigid immobilisation treatment. Given this, and the inability to blind families to the treatment allocation, observer bias was a concern. However, there was clear evidence of equivalence.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>The study findings support the offer of a bandage in children with a distal radius torus fracture.<\/jats:p><\/jats:sec>Future work<\/jats:title>A clinical decision tool to determine which children require radiography is an important next step to prevent overtreatment of minor wrist fractures. There is also a need to rationalise interventions for other common childhood injuries (e.g. \u2018toddler\u2019s fractures\u2019 of the tibia).<\/jats:p><\/jats:sec>Trial registration<\/jats:title>This trial is registered as ISRCTN13955395 and UKCRN Portfolio 39678.<\/jats:p><\/jats:sec>Funding<\/jats:title>This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment<\/jats:italic>; Vol. 26, No. 33. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/bdns6122","type":"journal-article","created":{"date-parts":[[2022,7,29]],"date-time":"2022-07-29T14:32:31Z","timestamp":1659105151000},"page":"1-78","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Offer of a bandage versus rigid immobilisation in 4- to 15-year-olds with distal radius torus fractures: the FORCE equivalence RCT"],"prefix":"10.3310","volume":"26","clinical-trial-number":[{"clinical-trial-number":"isrctn13955395","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8420-8252","authenticated-orcid":true,"given":"Daniel C","family":"Perry","sequence":"first","affiliation":[{"name":"Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, 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