A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures
Condition: Distal Radial Buckle Fractures
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Volar Splint; Cast
Intervention type(s): Procedure; Procedure
Intervention description(s): A velcro volar splint is compared to a circumferential cast for the treatment of distal radial buckle fractures in children. These are to be worn until Pediatric Orthopaedics follows up with the patients at 3 weeks.; A velcro volar splint is compared to a circumferential cast for the treatment of distal radial buckle fractures in children. These are to be worn until Pediatric Orthopaedics follows up with the patients at 3 weeks.
Other intervention name(s): Biomed Volar Splint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fractures; casting; splinting; pediatrics