Randomized Trial of Casting Techniques for Displaced Forearm Fractures

Boston Children's Hospital

Status: Completed

Conditions: Displaced Forearm Fractures

Treatments: Other: Bivalved cast; Other: Circumferential cast

Study type: Interventional

Funder types: Other

Identifiers

NCT00823823

08-09-0430

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

Bivalved cast

Active Comparator group

Description:

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

Treatment:

Other: Bivalved cast

Circumferential cast

Active Comparator group

Description:

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

Treatment:

Other: Circumferential cast