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.
|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|