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

NCT05470257 | Terminated

• 2 other identifiers: BBFARCTT35HL007473
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fracture of Radius and Ulna

Keywords

both bone forearm fracture; cast; pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cast Complications

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

Study Arms (2)

Elbow Flexion Cast

EXPERIMENTAL

This cohort will be placed in a long arm flexion cast.

Other: Cast

Elbow Extension Cast

EXPERIMENTAL

This cohort will be placed in a long arm extension cast.

Other: Cast

Interventions

Cast OTHER

Application of fiberglass long arm cast.

Elbow Extension Cast; Elbow Flexion Cast

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 3-18
• Skeletally immature
• Unilateral Radius and Ulna Fracture located within the proximal ½ of each bone
• Fracture requires reduction and casting

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Radius Fractures

Interventions

POLR1G protein, human

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Casting is an external treatment that cannot be masked from investigators or participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two cohorts will be established. One will include patients casted in elbow extension. The other cohort will include patients casted in elbow flexion.

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: April 7, 2023
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)