A Comparison of Casting and Splinting in Pediatric Radial Buckle Fractures

NCT01010347 | Completed Phase 2 DMC

• 1 other identifier: 05-1088
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Distal Radial Buckle Fractures

Keywords

fractures; casting; splinting; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Splint

ACTIVE COMPARATOR

Preformed velcro volar splints are compared to traditional circumferential casting.

Procedure: Volar Splint

Cast

PLACEBO COMPARATOR

The circumferential cast is the standard of treatment against which the splint is compared.

Procedure: Cast

Interventions

Volar Splint PROCEDURE

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.

Also known as: Biomed Volar Splint

Splint

Cast PROCEDURE

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

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years
• radiographically confirmed distal radial buckle fracture

You may not qualify if:

• skeletal maturity
• previous distal radius fracture
• concurrent other fracture
• osteogenesis imperfecta or other metabolic bone disease

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

POLR1G protein, human

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kristine Williams, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 10, 2009
• Study Start: December 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: September 26, 2011

Record last verified: 2011-09

Locations

US (1)