Osteoarthritis Clinical Trial
Official title:
A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty
The purpose of this study is to compare two surface materials (tantalum versus titanium fiber mesh) of acetabular components in hip arthroplasty.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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