None listed
Conditions
Brief summary
Children frequently fall over and fracture their forearm. Most forearm fractures are routinely put into a plaster cast and are sent to fracture clinic for follow-up. Recent studies show that removable wrist splints work well for stable fractures in that they provide rigidity but can be removed for comfort and hygiene purposes. This pilot study will explore the use of wrist splints to manage distal forearm fractures in children. It will primarily test whether we can successfully recruit enough families to participate in a larger trial but will also inform estimates on safety of wrist splints. If wrist splints are a suitable alternative to casts this could also help the health care service, which can better focus on children with more complex fractures. If this pilot study shows we can efficiently recruit participants and that the treatment appears to be safe, this would provide the foundation for a larger clinical trial to evaluate effectiveness of splints compared to casts. Given that upper arm fractures in children are a common reason for presentation, a change in practice to splint use could have global impact.
Interventions
Forearm splint. A prefabricated removable splint (any brand) made of contoured plastic with padding, elasticised fabric and velcro, that come in a range of sizes. This will be applied in the emergency department by the treating clinician and will be worn continuously throughout the day for 4-6 weeks, only removed for showering or hand hygiene. The treating clinician will administer the splint and then the family will manage it ongoing. Electronic surveys at 1, 4 and 8 weeks will capture the d
Forearm splint. A prefabricated removable splint (any brand) made of contoured plastic with padding, elasticised fabric and velcro, that come in a range of sizes. This will be applied in the emergency department by the treating clinician and will be worn continuously throughout the day for 4-6 weeks, only removed for showering or hand hygiene. The treating clinician will administer the splint and then the family will manage it ongoing. Electronic surveys at 1, 4 and 8 weeks will capture the duration of immobilisation.
Sponsors
Gold Coast University Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Isolated, acute (<72hrs), clinically non-deformed, distal radius +/- ulna incomplete (angulation <10 degrees) fracture per treating clinician X-ray interpretation..
Exclusion criteria
Soft tissue injuries (‘sprains’) or buckle fractures (buckling of the cortex but no cortical breach) of the distal forearm will be excluded, as the safety of minimal intervention for these groups has been established. Patients with complete, angulated >10 degrees or displaced fractures, fractures of the midshaft forearm, proximal forearm, or scaphoid (including suspected) will be excluded, as will patients with distal forearm fractures that are manipulated or have surgical intervention planned
Outcome results
None listed