Fracture of Radius and Ulna
Conditions
Keywords
both bone forearm fracture, cast, pediatric
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.
Interventions
OTHERCast
Application of fiberglass long arm cast.
Sponsors
University of Alabama at Birmingham
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Casting is an external treatment that cannot be masked from investigators or participants.
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alignment/Loss of Reduction | This will be accessed in clinic via x-rays until 8 weeks status post cast application. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed