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A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures

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ClinicalTrials.gov Identifier: NCT01010347
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : September 26, 2011
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

November 4, 2009
November 10, 2009
September 26, 2011
December 2005
December 2010   (Final data collection date for primary outcome measure)
The primary outcome measure will be the Peds QL questionnaire to assess impact on daily function. [ Time Frame: Patients are followed for 3 weeks after the initial emergency encounter. They complete the PedsQL and answer questions by telephone. ]
Same as current
Complete list of historical versions of study NCT01010347 on ClinicalTrials.gov Archive Site
Pain and satisfaction. [ Time Frame: Patients and parents are queried via telephone at days 1, 3, and 7 after the initial emergency visit. They are questioned about pain scores and satisfaction with the immobilization device. ]
Same as current
Not Provided
Not Provided
 
A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures
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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Distal Radial Buckle Fractures
  • Procedure: Volar Splint
    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 Name: Biomed Volar Splint
  • Procedure: Cast
    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.
  • Active Comparator: Splint
    Preformed velcro volar splints are compared to traditional circumferential casting.
    Intervention: Procedure: Volar Splint
  • Placebo Comparator: Cast
    The circumferential cast is the standard of treatment against which the splint is compared.
    Intervention: Procedure: Cast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
April 2011
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 2 - 17 years
  • radiographically confirmed distal radial buckle fracture

Exclusion Criteria:

  • skeletal maturity
  • previous distal radius fracture
  • concurrent other fracture
  • osteogenesis imperfecta or other metabolic bone disease
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01010347
05-1088
Yes
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Kristine Williams, MD Washington University School of Medicine
Washington University School of Medicine
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP