Randomized Trial of Casting Techniques for Displaced Forearm Fractures

Not Applicable

Completed

• Conditions: Displaced Forearm Fractures
• Interventions: Other: Bivalved cast; Other: Circumferential cast

• Registration Number: NCT00823823
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Status Verified: 2014-09
• Results First Submitted: 2014-09-02
• Results First Submitted QC: 2014-09-02
• Last Update Submitted: 2014-09-02
• Results First Posted: 2014-09-09
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bivalved cast	Bivalved cast	Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
Circumferential cast	Circumferential cast	Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast

Primary Outcome Measures

Name	Time	Method
Loss of Radius Fracture Reduction	4 weeks post-randomization	The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.

Secondary Outcome Measures

Name	Time	Method
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations	Up to 4 weeks post-randomization	The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.

Trial Locations

Locations (1)

Childrens Hospital Boston; 🇺🇸 Boston, Massachusetts, United States