Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215319
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-09-13
Brief Title:
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion
Sponsor:
DePuy Spine
Organization:
DePuy Spine
Study Overview
Official Title:
A Multi-center Study to Evaluate the Safety and Efficacy of DePuy AcroMed Titanium Surgical Mesh and MOSS-Miami Spinal Fixation System Pedicle Screws for Intradiscal Fusion in the Lumbar Spine
Status:
COMPLETED
Status Verified Date:
2014-05
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:
The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine The observed success rate at 24 months will be compared to an historical control group treated with the Lumbar IF Cage with VSP System
Detailed Description:
This is a single arm multi-center study to determine the clinical success of the DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two adjacent levels of degenerative disc disease of the lumbar spine L2 - S1
Study Success is as a compound endpoint requiring
Radiographic Fusion
Improvement in PainFunction
MaintenanceImprovement in Neurologic Status and
Freedom from Secondary Surgical Intervention
The rate of Adverse Events must be no worse than in the control group as well
Secondary Endpoints Include
Adverse Events
SF-36 Health Related Quality of Life
Disc Space Height
Work Status
Comparison
Results will be compared to an historical control group treated with the Lumbar IF Cage with VSP System
Study Success is as a compound endpoint requiring
Radiographic Fusion
Improvement in PainFunction
MaintenanceImprovement in Neurologic Status and
Freedom from Secondary Surgical Intervention
The rate of Adverse Events must be no worse than in the control group as well
Secondary Endpoints Include
Adverse Events
SF-36 Health Related Quality of Life
Disc Space Height
Work Status
Comparison
Results will be compared to an historical control group treated with the Lumbar IF Cage with VSP System
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