Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
Primary Purpose
Fracture of Radius and Ulna
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cast
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of Radius and Ulna focused on measuring both bone forearm fracture, cast, pediatric
Eligibility Criteria
Inclusion Criteria:
- Ages 3-18
- Skeletally immature
- Unilateral Radius and Ulna Fracture located within the proximal ½ of each bone
- Fracture requires reduction and casting
Exclusion Criteria:
- Ages < 3
- Distal ½ Radius and Ulna Forearm Fracture
- Isolated radius or ulna fracture
- Humerus Fracture of the Ipsilateral Arm (including floating elbow)
- Metabolic Bone Disease
- Open Fractures
- Monteggia and Galeazzi Fractures
- Deformity or abnormality not allowing for standard casting (limb deficiency, contracture)
- Parent speaks language other than english
Sites / Locations
- Children's of Alabama
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Elbow Flexion Cast
Elbow Extension Cast
Arm Description
This cohort will be placed in a long arm flexion cast.
This cohort will be placed in a long arm extension cast.
Outcomes
Primary Outcome Measures
Alignment/Loss of Reduction
During clinic visits, xrays will be obtained to measure alignment of the radius and ulna fracture and asses for loss of reduction or malalignment. We will compare the number of patients with proximal both bone forearm fractures that have lost alignment after 8 weeks between the flexion elbow cast cohort compared to the extension elbow cast cohort.
Secondary Outcome Measures
Cast Complications
We will compare the casting complications between elbow extension versus elbow flexion casting cohorts. Casting complications we will observe will be cast saw burns, cast slipping, and need for bivalve of casts.
Full Information
NCT ID
NCT05470257
First Posted
July 20, 2022
Last Updated
May 7, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05470257
Brief Title
Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
Official Title
Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.
Detailed Description
After being informed of the study including potential risks and benefits, all patients giving assent and guardian/parents consent who meet eligibility will undergo randomization of the casting technique used (elbow extension or elbow flexion casting). Randomization will occur using a random umber generator. Even numbers generated will result in an extension cast and odd numbers generated will result in a flexion cast.
The patients will be followed in clinic with an examination and x-rays at 2, 3, 5, and 8 weeks after casting to evaluate alignment of the fracture maintained by each cast. The two cohorts will be compared at the end of the study to determine which casting technique is the superior immobilization for pediatric proximal half both bone forearm fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Radius and Ulna
Keywords
both bone forearm fracture, cast, pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two cohorts will be established. One will include patients casted in elbow extension. The other cohort will include patients casted in elbow flexion.
Masking
None (Open Label)
Masking Description
Casting is an external treatment that cannot be masked from investigators or participants.
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elbow Flexion Cast
Arm Type
Experimental
Arm Description
This cohort will be placed in a long arm flexion cast.
Arm Title
Elbow Extension Cast
Arm Type
Experimental
Arm Description
This cohort will be placed in a long arm extension cast.
Intervention Type
Other
Intervention Name(s)
Cast
Intervention Description
Application of fiberglass long arm cast.
Primary Outcome Measure Information:
Title
Alignment/Loss of Reduction
Description
During clinic visits, xrays will be obtained to measure alignment of the radius and ulna fracture and asses for loss of reduction or malalignment. We will compare the number of patients with proximal both bone forearm fractures that have lost alignment after 8 weeks between the flexion elbow cast cohort compared to the extension elbow cast cohort.
Time Frame
This will be accessed in clinic via x-rays until 8 weeks status post cast application.
Secondary Outcome Measure Information:
Title
Cast Complications
Description
We will compare the casting complications between elbow extension versus elbow flexion casting cohorts. Casting complications we will observe will be cast saw burns, cast slipping, and need for bivalve of casts.
Time Frame
Casting complications will be followed the full duration of the patient wearing a cast, which is expected to be around 6-8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 3-18
Skeletally immature
Unilateral Radius and Ulna Fracture located within the proximal ½ of each bone
Fracture requires reduction and casting
Exclusion Criteria:
Ages < 3
Distal ½ Radius and Ulna Forearm Fracture
Isolated radius or ulna fracture
Humerus Fracture of the Ipsilateral Arm (including floating elbow)
Metabolic Bone Disease
Open Fractures
Monteggia and Galeazzi Fractures
Deformity or abnormality not allowing for standard casting (limb deficiency, contracture)
Parent speaks language other than english
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
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