Distal Radial Buckle Fractures Clinical Trial
Official title:
A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures
Background: distal radial buckle fractures are common injuries in children. the ideal
immobilization technique is controversial. Few, retrospective studies have been conducted to
evaluate bone healing after casting versus splinting. However, the impact of the
immobilization technique on daily function and comfort has not been evaluated.
Objective: To compare the impact on daily function, comfort and satisfaction of casting
versus splinting in children with distal radial buckle fractures.
Primary Hypothesis: Children with short arm casts to immobilize a distal radial buckle
fracture will have a greater reduction in daily activities compared to those immobilized
with a volar splint.
Secondary Hypothesis: Children who are immobilized in a short arm cast will have less pain,
less patient/parental satisfaction, more adverse effects, fewer follow-up visits, longer
emergency department (ED) treatment time. Furthermore, we hypothesize that all fractures
will have acceptable alignment/healing at the follow-up orthopaedic clinic evaluation.
Methods: A randomized controlled trial will be conducted in children 2 to 17 years old with
a radio graphically confirmed distal radial buckle fracture. Exclusion criteria will include
skeletal maturity, previous distal radius fracture, concurrent other fracture(s),
osteogenesis imperfecta or other metabolic bone disease. Enrolled subjects will be
randomized to receive either a short arm cast or a volar wrist splint. The pediatric
emergency department attending physician will be responsible for applying or directly
supervising the immobilization technique. All subjects' radiographs will be reviewed by a
pediatric orthopaedic surgeon with 1 day to confirm diagnosis and measure fracture
angulation. Those subjects with unacceptable angulation will be called and asked to return
to the ED or orthopaedic clinic for re-evaluation.
Outcomes Measures: The primary outcome measure will be the Peds QL questionnaire to assess
impact on daily function. This will be assessed at baseline in the ED, by phone at 1 day, 3
days and 1 week after the ED visit, and at the orthopaedic clinic follow-up visit 3 weeks
after the ED visit. Secondary outcome measures will include questionnaires assessing
demographic data (baseline), pain, satisfaction, adverse effects (baseline, immediately
after immobilization applied, 1 day, 3days and 1 week after ED visit by phone, and at the 3
week orthopaedic clinic follow-up visit), and ED treatment time (in ED prior to discharge).
At the 3 week orthopaedic surgery clinic follow-up visit, an assessment of the integrity of
the immobilization technique will be conducted by a cast technician and fracture
alignment/healing and range of motion of affected arm will be conducted by the pediatric
orthopaedic surgeon who will be blinded to treatment group.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment