Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116038
Status:
COMPLETED
Last Update Posted:
2009-07-07
First Post:
2005-06-26
Brief Title:
A Comparison of Two Metal Surface Finishes on Femoral Components in Hip Arthroplasty
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
A Comparison of Two Metal Surface Finishes Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface on Femoral Components in Hip Arthroplasty
Status:
COMPLETED
Status Verified Date:
2009-07
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 purpose of this study is to compare metal surface finishes proximal-coated titanium surface versus mid-coated titanium surface on femoral components in hip arthroplasty
Detailed Description:
In younger patients femoral components are most often implanted without the use of cement A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed
The construction of a femoral implant Versys Fiber Metal Taper by Zimmer includes a more extensive coating than previous femoral implants The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use
Theoretically the greater porous surface of mid-coated implants should
Encourage bone ingrowth through improved osteoconductive properties however more extensive coating might change the loss of bone due to stress shielding later in time
Improve anchorage of the implant due to the higher friction coefficient
Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores
The migration of femoral components will be evaluated by RSA performing radiostereometric analyses at the Orthopaedic Center Aarhus University Hospital The follow-up RSA will be scheduled for week 1 as well as 3 months 12 months and 2 years after surgery Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1 as well as 1 year and 2 years after surgery
The construction of a femoral implant Versys Fiber Metal Taper by Zimmer includes a more extensive coating than previous femoral implants The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use
Theoretically the greater porous surface of mid-coated implants should
Encourage bone ingrowth through improved osteoconductive properties however more extensive coating might change the loss of bone due to stress shielding later in time
Improve anchorage of the implant due to the higher friction coefficient
Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores
The migration of femoral components will be evaluated by RSA performing radiostereometric analyses at the Orthopaedic Center Aarhus University Hospital The follow-up RSA will be scheduled for week 1 as well as 3 months 12 months and 2 years after surgery Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1 as well as 1 year and 2 years after surgery
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