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

Fracture of Shaft of Radius and/or Ulna Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614690
• Other study ID #: SRC118
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2022
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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."

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cast Index	The cast index is a measure of potential for cast failure described by Chess et al. in 1994. The cast index is calculated as the sagittal width measure divided by the coronal cast width measure at the fracture site. A ratio between these measures of 0.7 or greater for pediatric forearms is considered acceptable. For each patient in this study the cast index was calculated as described above. The average cast index for each of the 3 groups was then presented as the final result.	Immediately after cast application (<1 day)
Other	Number of Participants With Different Fracture Characteristics		Less than 1 day
Other	Pain Levels	Pain levels were assessed using the validated Wong-Baker FACES visual pain rating scale. This scale presents a total of 6 options for pain- none, 1, 2, 3, 4, and 5- with 5 corresponding to the greatest amount of pain. During the analysis it was decided to group these into 5 categories: No pain which was equal to those selecting none, Mild corresponding to those selecting 1, Moderate pain corresponding to those that selected either 2 or 3, and Severe pain corresponding to those that selected either 4 or 5. Patients with no response were placed into the group "no response".	one week
Other	Number of Patients With Different Fracture Treatments		4 weeks
Other	Number of Participants With Different Cast Complications		Day 1 to day 56
Other	Average Time for First Follow-up Appointment	Average time from reduction and casting to the first follow-up visit.	1-2 weeks
Primary	Complication Rate of the Cast Type	This data will be able to help physicians and ER personnel help this patient population with the least number of cast complications and therefore allow for a more efficient use of resources since cast modifications could be minimized. Metrics used to characterize complications are the radiographic union used to determine speed of healing and the number of unplanned ER or clinic visits for cast modifications.	<60 days corresponding to total study time and consistent with outcome 6