A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures

Distal Radial Buckle Fractures Clinical Trial

Official title:

A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010347
• Other study ID #: 05-1088
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2009
• Last updated: September 22, 2011
• Start date: December 2005
• Est. completion date: April 2011

Study information

• Verified date: September 2011
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radial Buckle Fractures
• Fractures, Bone

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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