Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-02-22 @ 12:46 AM
Study NCT ID:
NCT00677950
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2008-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OP-1 Putty for Posterolateral Fusions
Sponsor:
Olympus Biotech Corporation
Organization:
Study Overview
Official Title:
OP-1 Putty for Posterolateral Fusions
Status:
COMPLETED
Status Verified Date:
2011-06
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:
The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.
Detailed Description:
A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.
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?: