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Randomized Controlled Trial
. 2022 Jul 2;400(10345):39-47.
doi: 10.1016/S0140-6736(22)01015-7.

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

Daniel C Perry  1 , Juul Achten  2 , Ruth Knight  3 , Duncan Appelbe  2 , Susan J Dutton  3 , Melina Dritsaki  4 , James M Mason  5 , Damian T Roland  6 , Shrouk Messahel  7 , James Widnall  7 , Matthew L Costa  2 ; FORCE Collaborators in collaboration with PERUKI
Collaborators, Affiliations
Free article
Randomized Controlled Trial

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

Daniel C Perry et al. Lancet. .
Free article

Erratum in

  • Department of Error.
    [No authors listed] [No authors listed] Lancet. 2022 Jul 23;400(10348):272. doi: 10.1016/S0140-6736(22)01342-3. Lancet. 2022. PMID: 35871810 No abstract available.
  • Department of Error.
    [No authors listed] [No authors listed] Lancet. 2022 Oct 1;400(10358):1102. doi: 10.1016/S0140-6736(22)01734-2. Lancet. 2022. PMID: 36183726 No abstract available.

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.

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Conflict of interest statement

Declaration of interests All authors received a grant from National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (17/23/02) during the conduct of the trial. DCP is a NIHR Research Professor and a member of the Commissioning Board for the NIHR HTA funding stream. DTR was chair of Paediatric Emergency Research United Kingdom and Ireland (PERUKI), which was a partner organisation for the study. SM receives financial support from the NIHR Research Scholar North West Coast and is the secretary of PERUKI. MLC is a NIHR Senior Investigator and a member of the General Board for the NIHR HTA funding stream. The views expressed in this report are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

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