NCT02614690

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Connecticut Children's Medical Center · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	No Split Cast of forearm fractures	Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "No Split Cast" will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.
PROCEDURE	Univalve Split Cast of forearm fractures	Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "Univalve Cast" will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.
PROCEDURE	Bivalve Split Cast of forearm fractures	Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "Bivalve Cast" will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2015-11-25
• Last updated: 2022-01-14
• Results posted: 2020-01-28

Locations

1 site across 1 country: United States