FORCE - Forearm fracture Recovery in Children Evaluation
Research type
Research Study
Full title
FORCE - Forearm fracture Recovery in Children Evaluation: A multi-centre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilisation for torus fractures of the distal radius in children
IRAS ID
246654
Contact name
Daniel Perry
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Torus fractures of the wrist are the most common type of broken bone in children. There are 500,000 in the UK per year. They are the mildest form of broken bone, whereby the bone crushes instead of breaking. They heal well, and do not cause longterm problems. Despite being so common there is no ‘standard treatment’. The traditional treatment is to use a plaster cast, and arrange outpatient follow-up. Newer medical research suggests that children may return to normal more quickly if a bandage is used, and are likely to be similarly comfortable in a bandage to a cast. The ‘National Institute of Clinical Excellence’ has recommended that a study is needed to confirm that a bandage and early discharge is as effective as more traditional treatments.
Research Question:For children with this common type of broken wrist (torus fracture), is a bandage and prompt
discharge with no-hospital follow-up, as effective as treatment in a plaster cast or splint and usual
follow-up.All children over the age of four will be eligible for the study. It is hoped that 696 children will participate over a two year period from at least ten hospitals.
Children and their parents have suggested that pain in the initial days of injury is the factor most
important to them. Pain will be measured using a specific ‘pain scale’ which children chose from a
variety of different pain measuring scales. The use of their arm, school absences and the financial
costs to families and the NHS will be measured. The study will use text messages/emails to collect
information rather than paper questionnaires – parents have indicated this to be the preferred way to
be included in this study. Text messages/emails(with hyperlinks) will be sent to parents/children at days
1,3,7,21 and 42. The final follow-up will be at six weeks.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
18/WM/0324
Date of REC Opinion
16 Nov 2018
REC opinion
Further Information Favourable Opinion