Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01905930
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2013-07-18
Brief Title:
Post-Approval Clinical Trial of the PCM Cervical Disc
Sponsor:
NuVasive
Organization:
NuVasive
Study Overview
Official Title:
A Prospective Randomized Multi-Center Post-Approval Clinical Trial Evaluating the Long-Term 7 Year Safety and Effectiveness of the PCM Cervical Disc
Status:
COMPLETED
Status Verified Date:
2015-05
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:
On October 26 2012 the FDA granted Premarket Approval PMA for the PCM Cervical Disc PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy arm pain andor a neurological deficit with or without neck pain or myelopathy due to a single-level abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging CT MRI X-rays herniated nucleus pulposus spondylosis defined by the presence of osteophytes andor visible loss of disc height as compared to adjacent levels
The purpose of this post-approval study is to evaluate the long-term 7 year safety and effectiveness of the PCM Cervical Disc
The purpose of this post-approval study is to evaluate the long-term 7 year safety and effectiveness of the PCM Cervical Disc
Detailed Description:
A prospective multi-center post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical study and will to give consent to participate
All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study All patients who are actively participating in the pivotal IDE study will be asked to participate in this study
The study consists of follow-up periods only The follow-up period will last for seven years from each patients surgery date
All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study All patients who are actively participating in the pivotal IDE study will be asked to participate in this study
The study consists of follow-up periods only The follow-up period will last for seven years from each patients surgery date
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