Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?

C

Connecticut Children's Medical Center

Status

Completed

Conditions

Metaphyseal Fracture of Bone of Upper Limb
Fracture of Shaft of Radius and/or Ulna
Fracture of Upper Limb, Level Unspecified

Treatments

Procedure: Univalve Split Cast of forearm fractures
Procedure: Bivalve Split Cast of forearm fractures
Procedure: No Split Cast of forearm fractures

Study type

Interventional

Funder types

Other

Identifiers

NCT02614690
SRC118

Details and patient eligibility

About

This study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion.

Full description

Following cast application, little is known regarding the need to split the cast, either in a univalve (a split along a single side of the cast) or bivalve (a split along both sides of the cast) fashion. Theoretically, the splitting of the cast allows for expansion and soft tissue swelling. However, review of the literature yields a paucity of evidence demonstrating the efficacy of splitting a cast. In a study by Nietosvaara et. al, a retrospective examination of 109 pediatric patients initially treated with closed cylindrical casting for closed forearm fractures were evaluated. Of these 109 patients, one-sixth required the initial cast to be split, trimmed, or removed secondary to post-traumatic swelling. However, the splitting of a cast is not without risks in itself. Once the initial swelling dissipates, a univalved or bivalved cast can become excessively loose. This loosening has been associated with a loss of reduction. If the loss or reduction is substantial, it may require a re-reduction or operation to correct. In addition, with every use of the cast saw a patient is placed at risk for iatrogenic cast saw injury. Thermal burns and abrasions from cast saws can cause lifelong emotional and physical scars for a patient. They can also be an inciting event for litigation against the hospital and or provider, with settlements averaging greater than $12,000 per centimeter of cast saw injury.

Enrollment

60 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A closed isolated radial and/or ulna fracture of the forearm inclusive of metaphyseal and/or shaft level fractures.
  • Forearm fractures that require closed reduction (with or without conscious sedation)
  • Patients between the ages of 3 and 12 years old

Exclusion criteria

Specific exclusions

  • Age less than 3 or greater than 12
  • Patients presenting with an associated neurological or vascular injury caused by the fracture
  • Patients presenting with an open fracture
  • Patients requiring operative treatment following the initial fracture evaluation
  • Ipsilateral upper extremity fracture
  • Patients intubated or with a pre-existing condition that prevents them from verbalizing symptoms of discomfort
  • Generic exclusion: "Subjects not meeting all inclusion criteria."

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

No split Cast of forearm fractures
Active Comparator group
Description:
Patient will have a "No split cast" long arm cast applied after a closed reduction of forearm fractures. The cast will not be split. 20 patients will be randomized to this arm.
Treatment:
Procedure: No Split Cast of forearm fractures
Univalve Split Cast of forearm fractures
Active Comparator group
Description:
Patients will have a "Univalve Split Cast" long arm cast applied after undergoing closed reduction of of forearm fractures. This is a cast that is split on only one side of the cast. 20 patients will be randomized to this arm
Treatment:
Procedure: Univalve Split Cast of forearm fractures
Bivalve Split Cast of forearm fractures
Active Comparator group
Description:
Patients will have a "Bivalve Split Cast" long arm cast applied after they have undergone a closed reduction of of forearm fractures. This is a cast that will be split on both sides of the cast. 20 patients will be randomized to the bivalve split arm cast.
Treatment:
Procedure: Bivalve Split Cast of forearm fractures

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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