Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures

The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.

Study Overview

• Status: Enrolling by invitation
• Conditions: Fracture of Radius and Ulna
• Intervention / Treatment: Other: Cast

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth C Marks, MS; Phone Number: 2053838665; Email: lizcmarks@gmail.com
• Study Contact Backup: Name: Philip A Ashley, MD; Phone Number: 2056389146; Email: philipashley@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's of Alabama
      • Contact: Philip A Ashley, MD; Phone Number: 2056389146; Email: philipashley@uabmc.edu
      • Contact: Elizabeth C Marks, MS; Phone Number: 205-383-8665; Email: lizmarks@uab.edu
      • Principal Investigator: Philip A Ashley, MD
      • Sub-Investigator: Elizabeth C Marks, MS
      • Sub-Investigator: Jun K He, MD
      • Sub-Investigator: Andrew Padgett, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elbow Flexion Cast; This cohort will be placed in a long arm flexion cast.	Other: Cast; Application of fiberglass long arm cast.
Experimental: Elbow Extension Cast; This cohort will be placed in a long arm extension cast.	Other: Cast; Application of fiberglass long arm cast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This will be accessed in clinic via x-rays until 8 weeks status post cast application.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Casting complications will be followed the full duration of the patient wearing a cast, which is expected to be around 6-8 weeks.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pediatric; cast; both bone forearm fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: BBFARCT; T35HL007473 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No