CClinicalTrials.gg
TerminatedNCT05470257Updated Feb 17, 2026

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

An interventional study of Cast in Fracture of Radius and Ulna, sponsored by University of Alabama at Birmingham. Terminated at 1 site in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Why this study was terminated
Not able to enroll enough patients for analysis
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Fracture of Radius and Ulna

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Keywords

  • both bone forearm fracture
  • cast
  • pediatric
03

In context

Radius Fractures

272 studies on the registry are indexed under Radius Fractures; 35 are open to participants now.

This study's enrollment of 3 is below the median of 60 across 218 interventional studies indexed under Radius Fractures.

Browse Radius Fractures studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Elbow Flexion Cast

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

    Other: Cast

  • Experimental
    Elbow Extension Cast

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

    Other: Cast

Interventions

  • OtherCast

    Application of fiberglass long arm cast.

06

What researchers measure

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.

    Time frame: This will be accessed in clinic via x-rays until 8 weeks status post cast application.

Secondary outcomes

  1. 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.

    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.

07

Study locations

1 site
  • Children's of Alabama
    Birmingham, Alabama 35233, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05470257
Lead sponsor
University of Alabama at Birmingham
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Philip Ashley (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Jul 22, 2022
Start date
Apr 7, 2023
Primary completion
Feb 12, 2026
Completion
Feb 12, 2026
Last update
Feb 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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