Perry, Daniel C 
ORCID: 0000-0001-8420-8252, Achten, Juul, Knight, Ruth ORCID: 0000-0001-6810-2845, Appelbe, Duncan, Dutton, Susan J, Dritsaki, Melina, Mason, James M, Roland, Damian, Messahel, Shrouk, Widnall, James et al (show 1 more authors)
(2022)
Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK.
LANCET, 400 (10345).
pp. 39-47.
Abstract
<h4>Background</h4>The most common fractures in children are torus (buckle) fractures of the wrist. Controversy exists over treatment, which ranges from splint immobilisation and discharge to cast immobilisation, follow-up, and repeat imaging. This study compared pain and function in affected children offered a soft bandage and immediate discharge with those receiving rigid immobilisation and follow-up as per treating centre protocol.<h4>Methods</h4>In this randomised controlled equivalence trial we included 965 children (aged 4-15 years) with a distal radius torus fracture from 23 hospitals in the UK. Children were randomly allocated in a 1:1 ratio to the offer of bandage group or rigid immobilisation group using bespoke web-based randomisation software. Treating clinicians, participants, and their families could not be masked to treatment allocation. Exclusion criteria included multiple injuries, diagnosis at more than 36 h after injury, and inability to complete follow-up. The primary outcome was pain at 3-days post-randomisation measured using Wong-Baker FACES Pain Rating Scale. We performed a modified intention-to-treat and per protocol analysis. The trial was registered with ISRCTN registry, ISRCTN13955395.<h4>Findings</h4>Between Jan 16, 2019, and July 13, 2020, 965 children were randomly allocated to a group, 489 to the offer of a bandage group and 476 to the rigid immobilisation group, 379 (39%) were girls and 586 (61%) were boys. Primary outcome data was collected for 908 (94%) of participants, all of whom were included in the modified intention-to-treat analysis. Pain was equivalent at 3 days with 3·21 points (SD 2·08) in the offer of bandage group versus 3·14 points (2·11) in the rigid immobilisation group. With reference to a prespecified equivalence margin of 1·0, the adjusted difference in the intention-to-treat population was -0·10 (95% CI -0·37 to 0·17) and-0·06 (95% CI -0·34 to 0·21) in the per-protocol population.<h4>Interpretation</h4>This trial found equivalence in pain at 3 days in children with a torus fracture of the distal radius assigned to the offer of a bandage group or the rigid immobilisation group, with no between-group differences in pain or function during the 6 weeks of follow-up.<h4>Funding</h4>UK National Institute for Health and Care Research.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | FORCE Collaborators in collaboration with PERUKI, Wrist, Wrist Joint, Humans, Pain, Child, Female, Male, Fractures, Bone, United Kingdom |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Clinical Directorate Faculty of Health and Life Sciences > Institute of Population Health |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 07 Sep 2022 09:09 |
| Last Modified: | 18 Jan 2023 20:45 |
| DOI: | 10.1016/s0140-6736(22)01015-7 |
| Open Access URL: | https://doi.org/10.1016/S0140-6736(22)01015-7 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3163733 |
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