Radius acute fracture Injury, Occupational Diseases, Poisoning
Conditions
Interventions
This trial will compare two approaches to treat displaced distal radius fractures in children aged 4-10 years old inclusive. Participants are randomised to either:
Non-surgical casting:
This techniqu
i.e. plaster cast alone, plaster cast and wires, plaster cast and plate. A record will be made of the operative details, the cast details and any cast changes. Following surgery, the usual practice is
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
4 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. Male and female children aged 4 to 10 years inclusive 2. Parents/guardians willing and able to give informed consent for their child’s participation in the study 3. There is radiographic evidence of a severely displaced wrist fracture at or adjacent to the physis (Salter-Harris II or a metaphyseal fracture); with or without a corresponding ulna fracture 4. The treating clinician believes that they may benefit from surgical reduction with or without fixation
Exclusion criteria
Exclusion criteria: 1. The injury is more than 7 days old 2. The injury is part of a more complex wrist fracture (i.e. open or fracture extending into the joint) 3. There are other fractured bones elsewhere in the body, in addition to the affected wrist injury 4. There is evidence that the patient and/or parent 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 mobile data/internet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional recovery assessed using the Patient Report Outcomes Measurement System (PROMIS Bank v2.0) Upper Extremity Score for Children Computer Adaptive Test (CAT) at 3 months post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Upper extremity function is measured using the PROMIS Upper Extremity Score during the first year post-treatment 2. Pain is measured using the Wong-Baker FACES Pain Scale (an ordinal assessment using a series of six facial-expressions to illustrate the degree of pain intensity) during the first year post-treatment 3. Health-related quality of life is measured using EQ-5D-Y (Youth version) between during the first year post-treatment 4. Complication rate, including re-fracture, the need for further operative fixation and the absence of radiographic remodelling, measured through a qualitative assessment of radiographs by a surgeon consensus group up to 1-year post-treatment 5. Cost-effectiveness of the treatments to the NHS and the broader economy is measured by collecting resource use information, including inpatient/outpatient hospital attendance, other NHS or private services and out of pocket expenses up to 1-year post-treatment 6. Parental satisfaction with the cosmetic appearance of the arm measured using a visual analogue score (VAS) during the first year post-treatment 7. Patient satisfaction with care measured using an ordinal satisfaction score during the first year post-treatment 8. An assessment of impact of injury, treatment and recovery on parent and child experience of daily life and the outcomes that are important to them will be measured through qualitative interview during the first year post-treatment 9. The barriers and facilitators to trial recruitment from parent/child and staff perspectives will be measured through qualitative interview during the first year post-treatment Long-term outcomes to be reported separately: 10. Longer-term pain, function and complications will be measured using the methods described above (i.e. Wong-Baker, PROMIS-UE and complications record) annually up until 3 years post-treatment | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed