Randomized Trial of Casting Techniques for Displaced Forearm Fractures

NCT ID: NCT00823823

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-08-31

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.

Conditions

Displaced Forearm Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bivalved cast

Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast

Group Type: ACTIVE_COMPARATOR

Bivalved cast

Intervention Type: OTHER

Circumferential cast will be applied following closed reduction and then bivalved using a cast saw

Circumferential cast

Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast

Group Type: ACTIVE_COMPARATOR

Circumferential cast

Intervention Type: OTHER

Circumferential cast will be applied following closed reduction

Interventions

Bivalved cast

Circumferential cast will be applied following closed reduction and then bivalved using a cast saw

Intervention Type: OTHER

Circumferential cast

Circumferential cast will be applied following closed reduction

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Donald Bae

Associate Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald Bae, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Hospital Boston

Locations

Childrens Hospital Boston

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

08-09-0430

Identifier Type: -

Identifier Source: org_study_id