A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01010347
First received: November 4, 2009
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Distal Radial Buckle Fractures
Procedure: Volar Splint
Procedure: Cast
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2005
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Splint
Preformed velcro volar splints are compared to traditional circumferential casting.
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
Placebo Comparator: Cast
The circumferential cast is the standard of treatment against which the splint is compared.
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.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01010347

Locations
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kristine Williams, MD Washington University Early Recognition Center
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01010347     History of Changes
Other Study ID Numbers: 05-1088
Study First Received: November 4, 2009
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
fractures
casting
splinting
pediatrics

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on August 26, 2014