Ignite Creation Date:
2025-12-18 @ 3:46 AM
Ignite Modification Date:
2025-12-23 @ 9:56 PM
Study NCT ID:
NCT00722007
Status:
None
Last Update Posted:
2019-07-02 00:00:00
First Post:
2008-07-23 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cormet Post-PMA Study: New Enrollment
Sponsor:
None
Organization:
Study Overview
Official Title:
Cormet Hip Resurfacing System Post-PMA Study Group (New Enrollment)
Status:
None
Status Verified Date:
2019-05
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:
PASNew
Brief Summary:
This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).
Detailed Description:
None
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?: