A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty|
- Acetabular component migration evaluated by RSA
- BMD in the surrounding bone of the acetabular implant
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
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:
- less migration of the acetabulum component, as evaluated by RSA;
- increased BMD in the bone surrounding acetabulum components;
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116051
|Orthopaedic Center, Aarhus University Hospital,|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Kjeld Søballe, MD., Prof.||Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark|