Ignite Creation Date:
2025-12-17 @ 8:28 PM
Ignite Modification Date:
2025-12-18 @ 1:31 AM
Study NCT ID:
NCT00746616
Status:
None
Last Update Posted:
2013-04-10 00:00:00
First Post:
2008-09-02 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Durom(R) Hip Resurfacing System Multicenter Trial
Sponsor:
None
Organization:
Study Overview
Official Title:
Durom(R) Hip Resurfacing System Multicenter Trial
Status:
None
Status Verified Date:
2013-04
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:
Safety will be evaluated based on the frequency and incidence of any device related adverse events or unanticipated adverse device events. The efficacy will be measured by comparing the overall functional performance based on the Harris Hip Score, implant survivorship, and radiographic parameters, including radiolucencies, osteolysis, stem subsidence, cup migration, and change in cup angle and a change in the femoral shaft angle.
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?: