The forearm fracture recovery in children evaluation study

Not Applicable

Completed

• Conditions: Torus (buckle) fractures of the distal radius in children; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN13955395
• Lead Sponsor: niversity of Oxford

Brief Summary

2020 Protocol article in https://doi.org/10.1302/2046-3758.16.BJO-2020-0014.R1 protocol (added 05/08/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35780790/ (added 06/07/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35831055/ Does digital, multimedia information increase recruitment and retention in a children's wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT) (added 14/07/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35904496/ (added 01/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-12
• Study Completion: 2020-08-31
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 965

Inclusion Criteria

1. Radiographic evidence of a torus fracture of the distal radius whereby there is a cortical deformation within the distal third of the radius but no break in the cortex. These may be associated with an ipsilateral fracture to the ulna (the ulna fracture may be buckle, greenstick or otherwise)
2. Aged 4 to 15 years old inclusive
3. Randomisation must occur at the site able to definitively treat the injury (i.e. a centre able to take the decision regarding the definitive treatment approach, which will typically be the emergency department)

Exclusion Criteria

1. The injury is more than 36 hours old
2. The treating clinician judges that there is a cortical disruption of the radius on radiographs (i.e. a greenstick fracture)
3. They have sustained an additional fracture at the time of the index fracture (with the exception of ipsilateral ulna fractures)
4. There is evidence that the patient and/or parent/guardian would be unable to adhere to trial procedures or complete follow-up, such as insufficient English language comprehension, developmental delay or a developmental abnormality or no access by parents to a telephone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain measured using the Wong-Baker FACES Pain Rating Scale at three days post randomisation