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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.

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.

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

Conditions
-----------------
Fracture of Radius and Ulna

Intervention / Treatment
-----------------
* Other: Cast


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
both bone forearm fracture, cast, pediatric