Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00743717
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2008-08-27
Brief Title:
Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement
Sponsor:
Kinamed Incorporated
Organization:
Kinamed Incorporated
Study Overview
Official Title:
Clinical Trial on the Zirconia Femoral Component for the Gem Total Knee System
Status:
COMPLETED
Status Verified Date:
2013-05
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:
The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate
Detailed Description:
Due to excellent biocompatibility and wear characteristics ceramics have a long history of success in total hip arthroplasty THA Use of a ceramic-polyethylene wear couple in total knee arthroplasty TKA has shown promising laboratory and early clinical results The use of ceramics in this study is intended to address long-term failure of TKA due to osteolysis associated with polyethylene wear debris
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