Scoliosis Clinical Trial
Official title:
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
There are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no scientific evidence supporting the superiority of one size rod relative to the other. This study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.
For the correction of Juvenile and Adolescent idiopathic scoliosis, companies offer and
surgeons use varying rod sizes not based on scientific evidence, but because of personal
preference, availability and company loyalty. To date there has been no literature
evaluating the benefit or harm of one rod size versus the other. Our dual-arm prospective
study will evaluate the amount of radiographic correction obtained using the 5.5mm versus
the 6.35mm stainless steel instrumentation rods. These are both standard rods used in the
community for this particular procedure, thus no additional risk exists for the patient. The
results of this study will help guide surgeons in their decision making process when faced
with the multitude of options offered by implant manufactures.
Comparison(s): 5.5mm stainless steel spinal rod versus 6.35mm stainless steel spinal rod for
correction of juvenile and idiopathic scoliosis curves.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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