Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152152
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2005-09-08
Brief Title:
Use of Radiostereometric Analysis Beads RSA to Measure Motion in the Spine Following Lumbar Spinal Surgery
Sponsor:
State University of New York - Upstate Medical University
Organization:
State University of New York - Upstate Medical University
Study Overview
Official Title:
Use of Radiostereometric Analysis RSA for Measuring Spinal Motion Following Lumbar Spinal Surgery
Status:
COMPLETED
Status Verified Date:
2008-05
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:
Radiostereometric Analysis RSA is a new imaging technique used to measure motions in the spine It provides more accurate measurements that could help in diagnosing problems in the spine earlier than standard xray techniques
Detailed Description:
Assessment of segmental spinal motion has been and continues to be a difficult clinical problem X-ray measurement error of up to 10 degrees for simple measurements for flexion extension and side bending have been recorded It is extremely difficult to measure small changes in vertebral alignment that may prove to have clinical significance The measurement accuracy of the RSA technique far exceeds any manual techniques to date RSA allows the surgeon to monitor spatial relationships within the spine over time with a much higher accuracy then conventional techniques
This is a non-randomized prospective study design looking at the use of RSA in spinal surgery patients Subjects in this study will undergo their indicated surgery Prior to closure they will be implanted with tantalum beads which will serve as landmarks when the RSA film pairs are taken post-operatively The subjects will have standard post-operative x-rays 6 weeks-3 months post-op and again at 12 months post-op Yearly visits after this are anticipated for 5-10 years with proper funding
This is a non-randomized prospective study design looking at the use of RSA in spinal surgery patients Subjects in this study will undergo their indicated surgery Prior to closure they will be implanted with tantalum beads which will serve as landmarks when the RSA film pairs are taken post-operatively The subjects will have standard post-operative x-rays 6 weeks-3 months post-op and again at 12 months post-op Yearly visits after this are anticipated for 5-10 years with proper funding
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