Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252551
Status:
TERMINATED
Last Update Posted:
2015-03-17
First Post:
2005-11-10
Brief Title:
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEOS
Brief Summary:
Study to evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylolisthesis
Detailed Description:
Randomized comparative study on 152 patients with degenerative spondylolisthesis L4-L5 confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory treatment are not efficient for at least 3 months
Patients randomized in 2 parallel groups each group with 76 patients
one group with decompressive surgery osteosynthesis
one group with decompressive surgery Study duration 18 months including a selection visit an inclusion with the surgical intervention 3 12 18 months follow up visits and a follow up call at 6 months
Patients randomized in 2 parallel groups each group with 76 patients
one group with decompressive surgery osteosynthesis
one group with decompressive surgery Study duration 18 months including a selection visit an inclusion with the surgical intervention 3 12 18 months follow up visits and a follow up call at 6 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHRC0300201 | OTHER_GRANT | French Ministry of Health | None |