Perry, Daniel C 
ORCID: 0000-0001-8420-8252, Achten, Juul, Knight, Ruth ORCID: 0000-0001-6810-2845, Dutton, Susan J, Dritsaki, Melina, Mason, James M, Appelbe, Duncan E, Roland, Damian T, Messahel, Shrouk, Widnall, James et al (show 5 more authors)
(2022)
Offer of a bandage versus rigid immobilisation in 4-to 15-year-olds with distal radius torus fractures: the FORCE equivalence RCT.
HEALTH TECHNOLOGY ASSESSMENT, 26 (33).
1-+.
Abstract
<h4>Background</h4>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.<h4>Objectives</h4>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).<h4>Design</h4>A pragmatic, multicentre, randomised controlled equivalence trial.<h4>Setting</h4>Twenty-three UK emergency departments.<h4>Participants</h4>A total of 965 children (aged 4-15 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 > 36 hours after injury, multiple injuries and an inability to complete follow-up.<h4>Interventions</h4>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.<h4>Main outcome measures</h4>The pain at 3 days post randomisation was measured using the Wong-Baker 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.<h4>Results</h4>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 -0.10 (95% confidence interval -0.37 to 0.17) and the per-protocol population was -0.06 (95% confidence interval -0.34 to 0.21). There was equivalence of pain in both age subgroups (i.e. 4-7 years and 8-15 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 £30,000 per quality-adjusted life-year.<h4>Limitations</h4>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.<h4>Conclusions</h4>The study findings support the offer of a bandage in children with a distal radius torus fracture.<h4>Future work</h4>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. 'toddler's fractures' of the tibia).<h4>Trial registration</h4>This trial is registered as ISRCTN13955395 and UKCRN Portfolio 39678.<h4>Funding</h4>This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in <i>Health Technology Assessment</i>; Vol. 26, No. 33. See the NIHR Journals Library website for further project information.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | FORCE Trial Collaborators, PERUKI, Radius, Humans, Pain, Bandages, Quality-Adjusted Life Years, Quality of Life, Child, Cost-Benefit Analysis, Fractures, Bone |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Clinical Directorate Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences Faculty of Health and Life Sciences > Institute of Population Health |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 08 Sep 2022 07:49 |
| Last Modified: | 21 Aug 2023 02:47 |
| DOI: | 10.3310/BDNS6122 |
| Open Access URL: | https://doi.org/10.3310/BDNS6122 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3163840 |
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