Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Radiographic measurements of curve angles and balance.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Juvenile or Adolescent Idiopathic Scoliosis
- •Anticipated spinal fusion surgery
Exclusion Criteria
- •Individuals younger than 11 years and older than 18 years
- •Individuals with scoliosis carrying additional diagnoses of illness.
Outcomes
Primary Outcomes
Radiographic measurements of curve angles and balance.
Time Frame: Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
Secondary Outcomes
- Scoliosis Research Society-30 (SRS-30) questionnaire(Pre-operatively, 6 wks post-op, 1 & 2 year post-op.)
Investigators
Terri Green
Clinical Data Coordinator
Shriners Hospitals for Children