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. 2018 Dec 19;2018(12):CD012470. doi: 10.1002/14651858.CD012470.pub2

FORCE 2018.

Trial name or title FORCE The FOrearm fracture Recovery in Children Evaluation. A multi‐centre prospective randomised equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilisation for torus fractures of the distal radius in children
Methods A UK multi‐centre prospective randomised equivalence trial (minimum of 10 centres)
Participants Target: 696 children with a torus fracture of the distal radius (minimum of 348 in the 4‐ to 7‐year age group and 348 in the 8‐ to 16‐year age group)
Inclusion criteria: age 4 to 16 years, torus fracture of the distal radius
Exclusion criteria: unknown
Interventions 1. Treatment with soft bandage, simple analgesia and immediate discharge with no hospital follow‐up
2. Rigid splint immobilisation and usual follow‐up
Outcomes Follow‐up: 3 days and 6 weeks
Primary outcome: pain (Wong Baker FACES Pain Scale measured at 3 days)
Secondary outcomes:

  1. functional recovery (Patient Report Outcomes Measurement System (PROMIS) Upper Extremity Score for Children;

  2. analgesia use;

  3. EQ‐5DY;

  4. school absence;

  5. complications;

  6. healthcare utilisation


Text messages (with hyperlinks) will be sent to parents/ children at days 1, 3, 7, 21 and 42, with slightly different information collected at each time point
Starting date Open to recruitment: November 2018
Recruitment end: December 2019
Estimated date of follow‐up completion: February 2020
Contact information Associate Professor Daniel Perry
University of Oxford
Notes The trial will take place over 24 months: 4 months set‐up, 4 months internal pilot, 8 months recruitment, 3 months follow‐up respectively, and 5 months for data analysis and reporting
NIHR funding, project 17/23/02
Information on trial recruitment available at the trial's website