Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215293
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-09-13
Brief Title:
Cervical IF Cage for Anterior Cervical Fusion
Sponsor:
DePuy Spine
Organization:
DePuy Spine
Study Overview
Official Title:
A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical IF Cage for Anterior Cervical Fusion
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 the Cervical IF Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft autograft with a plate or allograft with a plate
Detailed Description:
This is a prospective randomized multi-center clinical trial to assess the safety and efficacy of the investigational device Cervical IF Cage for fusion in one or two adjacent levels of the cervical spine Patients will be randomly assigned in a ration of 11 between the investigational and control groups
Comparison The device will be compared to a control group consisting of the 3 accepted standard of care treatments autograft autograft with an anterior plate or allograft with an anterior plate For two level fusions the control group will be limited to autograft with a plate or allograft with a plate Based on the current literature it is believed that there is no difference between the three treatments in terms of clinical success fusion success or safety issues However amongst the investigators there are preferred treatments Each investigator will choose one or more of the control treatments at study initiation Patients will then be randomized in a 11 Cagecontrol randomization schema Approximately 240 subjects will be enrolled at 20 sites Eligible patients will have symptomatic degeneration of one or two adjacent cervical discs have failed six weeks of non-surgical treatment have sufficiently severe enough symptoms to warrant surgery and have had no prior fusion surgery on the cervical spine
Comparison The device will be compared to a control group consisting of the 3 accepted standard of care treatments autograft autograft with an anterior plate or allograft with an anterior plate For two level fusions the control group will be limited to autograft with a plate or allograft with a plate Based on the current literature it is believed that there is no difference between the three treatments in terms of clinical success fusion success or safety issues However amongst the investigators there are preferred treatments Each investigator will choose one or more of the control treatments at study initiation Patients will then be randomized in a 11 Cagecontrol randomization schema Approximately 240 subjects will be enrolled at 20 sites Eligible patients will have symptomatic degeneration of one or two adjacent cervical discs have failed six weeks of non-surgical treatment have sufficiently severe enough symptoms to warrant surgery and have had no prior fusion surgery on the cervical spine
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