Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT00867256
Status:
TERMINATED
Last Update Posted:
2023-09-22
First Post:
2008-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)
Sponsor:
Corin
Organization:
Study Overview
Official Title:
Large Diameter Metal-on-Metal Total Hip System IDE
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated for business reasons; study closed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint.
Detailed Description:
The results from the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System cohort will be compared to the historical results from a ceramic on ceramic (CoC) hip system cohort. The primary endpoint clinical composite success (CCS) criterion at 24 months postoperative is based on a Harris Hip Score ≥ 80 and the absence of any revision,replacement, or modification of any study component.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: