Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510458
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2007-08-01
Brief Title:
LFIT Anatomic CoCr Femoral Heads With X3 Polyethylene Insert Study
Sponsor:
Stryker Orthopaedics
Organization:
Stryker Orthopaedics
Study Overview
Official Title:
LFIT Anatomic CoCr Femoral Heads With X3 Polyethylene Insert Study - An Open Label Prospective Post-market Multi-center Clinical Evaluation of the LFIT Anatomic CoCr Femoral Heads With X3 Inserts
Status:
COMPLETED
Status Verified Date:
2018-01
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:
LFIT
Brief Summary:
Total hip replacement surgery is considered to be a very successful surgical procedure for the treatment of degenerative joint disease The purpose of the study is to evaluate a large size 36mm 40mm or 44mm femoral hip head called the LFIT Anatomic CoCr Femoral Head Low Friction Ion Treatment The large size femoral heads will be used with the Trident X3 polyethylene plastic inserts and will be compared with a historical control Study Hypothesis The linear wear rate for hips implanted with the LFIT Anatomic CoCr Femoral Head is no worse than 008 mm wear per year at 5 years post-surgery
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?:
None