Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
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Study type
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Identifiers
Details and patient eligibility
About
The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
75 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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