Torus (buckle) fractures of the distal radius in children Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Each patient will be randomly allocated (1:1) with a randomisation sequence stratified by centre and age group (4-7 years and =8 years):
1. Soft bandage immobilisation and immediate di
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured using the Wong-Baker FACES Pain Rating Scale at three days post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain measured using the Wong-Baker FACES Pain Rating Scale at 1 day, 1, 3 and 6 weeks post randomisation 2. Use of regular analgesia assessed by questionnaire/survey via text at 1, 3 and 7 days post randomisation 3. Functional recovery measured using the Patient Report Outcomes Measurement System (PROMIS) Upper Extremity Limb Score for Children Computer Adaptive Test at 3 days, 1, 3 and 6 weeks post randomisation 4. Health-related quality of life measured using EQ-5DY at 3 days, 7 days, 3 and 6 weeks post randomisation 5. Number of days of school absence assessed by questionnaire/survey via text up to 3 and 6 weeks post randomisation 6. Complications, including the need for further hospital attendance, assessed by questionnaire/survey via text at 3 and 6 weeks post-randomisation 7. Resource use and comparative cost effectiveness assessed by questionnaire/survey via text at 3 and 6 weeks post randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactLouise Spoors
Outcome results
None listed