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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05470257
Collaborator
National Institutes of Health (NIH) (NIH)
75
1
2
28
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cast
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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.
Primary Purpose:
Treatment
Official Title:
Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Alignment/Loss of Reduction [This will be accessed in clinic via x-rays at 2, 3, 5, and 8 weeks following the application of the cast.]

    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

  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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 18 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's of Alabama Birmingham Alabama United States 35233

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philip Ashley, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05470257
Other Study ID Numbers:
  • BBFARCT
  • T35HL007473
First Posted:
Jul 22, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Philip Ashley, Assistant Professor, University of Alabama at Birmingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022