Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510575
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2007-07-31
Brief Title:
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
Sponsor:
Shriners Hospitals for Children
Organization:
Shriners Hospitals for Children
Study Overview
Official Title:
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis 55mm and 635mm 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 55mm versus the 635mm 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 55mm versus the 635mm 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
Comparisons 55mm stainless steel spinal rod versus 635mm stainless steel spinal rod for correction of juvenile and idiopathic scoliosis curves
Comparisons 55mm stainless steel spinal rod versus 635mm stainless steel spinal rod for correction of juvenile and idiopathic scoliosis curves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None