Randomized Trial of Casting Techniques for Displaced Forearm Fractures

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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