A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty
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|ClinicalTrials.gov Identifier: NCT00116051|
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : July 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Acetabular implant, Monoblock cup||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||April 2006|
|Study Completion Date :||April 2006|
- Acetabular component migration evaluated by RSA
- BMD in the surrounding bone of the acetabular implant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116051
|Orthopaedic Center, Aarhus University Hospital,|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Kjeld Søballe, MD., Prof.||Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark|