Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK

Perry, DC; Achten, J; Knight, R; Appelbe, D; Dutton, SJ; Dritsaki, M; Mason, JM; Roland, DT; Messahel, S; Widnall, J; Costa, ML

Journal article

Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK

Abstract:: Background
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.
Methods
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.
Findings
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.
Interpretation
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.
Funding
UK National Institute for Health and Care Research.

Publication status:: Published

Peer review status:: Peer reviewed

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APA Style

Perry, D. C., Achten, J., Knight, R., Appelbe, D., Dutton, S. J., Dritsaki, M., Mason, J. M., Roland, D. T., Messahel, S., Widnall, J., & Costa, M. L. (2022). Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK. Lancet, 400(10345), 39–47.

MLA Style

Perry, D. C., et al. “Immobilisation of Torus Fractures of the Wrist in Children (FORCE): a Randomised Controlled Equivalence Trial in the UK.” Lancet, vol. 400, no. 10345, Elsevier, 2022, pp. 39–47.

Chicago Style

Perry, DC, J Achten, R Knight, D Appelbe, SJ Dutton, M Dritsaki, JM Mason, et al. 2022. “Immobilisation of Torus Fractures of the Wrist in Children (FORCE): a Randomised Controlled Equivalence Trial in the UK.” Lancet 400 (10345): 39–47.
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