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

N/AEnrolling By InvitationNCT05470257

University of Alabama at Birmingham75 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fracture of Radius and Ulna

Interventions

CastOTHER

Application of fiberglass long arm cast.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's of Alabama

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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

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.

Data from ClinicalTrials.gov

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