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

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

1. 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

2. Generic exclusion: "Subjects not meeting all inclusion criteria."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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