Overview

This trial is active, not recruiting.

Condition displaced forearm fractures
Treatments bivalved cast, circumferential cast
Sponsor Children's Hospital Boston
Start date January 2009
End date June 2011
Trial size 224 participants
Trial identifier NCT00823823, 08-09-0430

Summary

It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Though well-molded casts theoretically provide the best ability to maintain fracture alignment, risks of circumferential immobilization in acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce these risks, but the effect on fracture stability is unknown. The proposed investigation seeks to address the simple question of whether circumferential or bivalved casts provide the best outcomes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
bivalved cast
Circumferential cast will be applied following closed reduction and then bivalved using a cast saw
(Active Comparator)
Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
circumferential cast
Circumferential cast will be applied following closed reduction

Primary Outcomes

Measure
Loss of radius fracture reduction
time frame: 4 weeks post-randomization

Secondary Outcomes

Measure
Compartment syndrome or neurovascular compromise, Saw burns and/or lacerations
time frame: 4 weeks post-randomization

Eligibility Criteria

Male or female participants from 4 years up to 16 years old.

Inclusion Criteria: - Displaced distal radius or mid-diaphyseal forearm fracture - fracture requires closed reduction and cast immobilization - Age 4-16 years - Skeletally immature Exclusion Criteria: - Failed closed reduction - Acute fracture > 1 week old - Refracture injury - Fracture requires surgical treatment - Significant soft tissue swelling - Associated neurovascular compromise - Plastic deformation injuries

Additional Information

Official title Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children
Principal investigator Donald Bae, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.