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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Split Cast of forearm fractures
Univalve Split Cast of forearm fractures
Bivalve Split Cast of forearm fractures
Sponsored by
Connecticut Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Shaft of Radius and/or Ulna focused on measuring Fracture of the upper limb

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept 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."

Sites / Locations

  • Connecticut Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

No split Cast of forearm fractures

Univalve Split Cast of forearm fractures

Bivalve Split Cast of forearm fractures

Arm 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.

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2015
Last Updated
January 5, 2022
Sponsor
Connecticut Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02614690
Brief Title
Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?
Official Title
Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Connecticut Children's Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Shaft of Radius and/or Ulna, Metaphyseal Fracture of Bone of Upper Limb, Fracture of Upper Limb, Level Unspecified
Keywords
Fracture of the upper limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No split Cast of forearm fractures
Arm Type
Active Comparator
Arm 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.
Arm Title
Univalve Split Cast of forearm fractures
Arm Type
Active Comparator
Arm 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
Arm Title
Bivalve Split Cast of forearm fractures
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
No Split Cast of forearm fractures
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Univalve Split Cast of forearm fractures
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bivalve Split Cast of forearm fractures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complication Rate of the Cast Type
Description
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.
Time Frame
<60 days corresponding to total study time and consistent with outcome 6
Other Pre-specified Outcome Measures:
Title
Cast Index
Description
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.
Time Frame
Immediately after cast application (<1 day)
Title
Number of Participants With Different Fracture Characteristics
Time Frame
Less than 1 day
Title
Pain Levels
Description
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".
Time Frame
one week
Title
Number of Patients With Different Fracture Treatments
Time Frame
4 weeks
Title
Number of Participants With Different Cast Complications
Time Frame
Day 1 to day 56
Title
Average Time for First Follow-up Appointment
Description
Average time from reduction and casting to the first follow-up visit.
Time Frame
1-2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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."
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Lee, MD
Organizational Affiliation
Connecticut Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not sharing individual data. Plan is to publish the data.

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

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