Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116051
Status:
COMPLETED
Last Update Posted:
2009-07-07
First Post:
2005-06-26
Brief Title:
A Comparison of Two Surface Materials Tantalum Versus Titanium Fiber Mesh of Acetabular Components in Hip Arthroplasty
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
A Comparison of Two Surface Materials Tantalum Versus Titanium Fiber Mesh of Acetabular 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 two surface materials tantalum versus titanium fiber mesh of acetabular components in hip arthroplasty
Detailed Description:
In younger patients acetabulum 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 A new implant material tantalum has shown better properties than the implant material which is in use today titanium The advantages of tantalum implants are greater porosity reduced stiffness and a higher friction coefficient than with titanium implants
Hypothetically the higher porosity of tantalum should enhance bone ingrowth due to better osteoconductivity in terms of
1 less migration of the acetabulum component as evaluated by RSA
2 increased BMD in the bone surrounding acetabulum components
3 fewer postoperative complaints on the Harris Hip Score and visual analog scale scores
The migration of acetabulum components will be evaluated by RSA 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
Hypothetically the higher porosity of tantalum should enhance bone ingrowth due to better osteoconductivity in terms of
1 less migration of the acetabulum component as evaluated by RSA
2 increased BMD in the bone surrounding acetabulum components
3 fewer postoperative complaints on the Harris Hip Score and visual analog scale scores
The migration of acetabulum components will be evaluated by RSA 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