Skip to content Skip to navigation
University of Warwick
  • Study
  • |
  • Research
  • |
  • Business
  • |
  • Alumni
  • |
  • News
  • |
  • About

University of Warwick
Publications service & WRAP

Highlight your research

  • WRAP
    • Home
    • Search WRAP
    • Browse by Warwick Author
    • Browse WRAP by Year
    • Browse WRAP by Subject
    • Browse WRAP by Department
    • Browse WRAP by Funder
    • Browse Theses by Department
  • Publications Service
    • Home
    • Search Publications Service
    • Browse by Warwick Author
    • Browse Publications service by Year
    • Browse Publications service by Subject
    • Browse Publications service by Department
    • Browse Publications service by Funder
  • Help & Advice
University of Warwick

The Library

  • Login
  • Admin

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

Tools
- Tools
+ Tools

FORCE Collaborators, PERUKI Collaborators (Including: Perry, Daniel C., Achten, Juul, Knight, Ruth, Appelbe, Duncan, Dutton, Susan J., Dritsak, Melina, Mason, James, Roland, Damian T., Messahel, Shrouk, Widnall, James and Costa, Matthew L.). (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. doi:10.1016/S0140-6736(22)01015-7 ISSN 0140-6736.

[img]
Preview
PDF
WRAP-Do-torus-fractures-wrist-children-immobilisation-randomised-equivalence-trial-2022.pdf - Published Version - Requires a PDF viewer.
Available under License Creative Commons Attribution 4.0.

Download (681Kb) | Preview
Official URL: https://doi.org/10.1016/S0140-6736(22)01015-7

Request Changes to record.

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.

Item Type: Journal Article
Subjects: R Medicine > RD Surgery
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Radius (Anatomy) -- Fractures -- Treatment, Fractures in children -- Treatment, Splints (Surgery), Surgical casts
Journal or Publication Title: Lancet
Publisher: The Lancet Publishing Group
ISSN: 0140-6736
Official Date: 2 July 2022
Dates:
DateEvent
2 July 2022Published
20 May 2022Accepted
Volume: 400
Number: 10345
Page Range: pp. 39-47
DOI: 10.1016/S0140-6736(22)01015-7
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 23 May 2022
Date of first compliant Open Access: 1 July 2022
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
Health Technology Assessment Programme (17/23/02)[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
CS-2014-14-012[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
UNSPECIFIEDNIHR Oxford Biomedical Research Centrehttp://dx.doi.org/10.13039/501100013373
UNSPECIFIEDUniversity Of Oxfordhttp://dx.doi.org/10.13039/501100000769
Related URLs:
  • Publisher

Request changes or add full text files to a record

Repository staff actions (login required)

View Item View Item

Downloads

Downloads per month over past year

View more statistics

twitter

Email us: wrap@warwick.ac.uk
Contact Details
About Us