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.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Years to 17 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | St. Louis Children's Hospital | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure will be the Peds QL questionnaire to assess impact on daily function. | Patients are followed for 3 weeks after the initial emergency encounter. They complete the PedsQL and answer questions by telephone. | No | |
Secondary | Pain and satisfaction. | 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. | No |