Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109213
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2005-04-26
Brief Title:
Greenwich Lumbar Stenosis SLIP Study
Sponsor:
Greenwich Hospital
Organization:
Greenwich Hospital
Study Overview
Official Title:
Greenwich Lumbar Stenosis SLIP Study A Multi-center Randomized Prospective Clinical Trial Comparing Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis
Status:
COMPLETED
Status Verified Date:
2015-12
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:
SLIP
Brief Summary:
The purpose of the study is to determine the proper use of lower back screws and rods instrumentation and bony fusion in subjects with one level of degenerative spinal narrowing stenosis compressing nerves to the legs with one spinal bone slipping forward on another spondylolisthesis There are two types of operations that surgeons perform for this problem Some spinal surgeons remove some bone in the back laminectomy to decompress the nerves Other surgeons perform a laminectomy decompression as above but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves decompression with instrumented fusion This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes
Detailed Description:
There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression This multi-center randomized prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes
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