Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-04 @ 6:37 PM
Study NCT ID:
NCT00252551
Status:
TERMINATED
Last Update Posted:
2015-03-17
First Post:
2005-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis
Sponsor:
University Hospital, Toulouse
Organization:
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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PHRC0300201 | OTHER_GRANT | French Ministry of Health | View |