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Sponsors and Collaborators: |
University of Aarhus Aalborg Hospital Aarhus University Hospital Zimmer, Inc. |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00116051 |
The purpose of this study is to compare two surface materials (tantalum versus titanium fiber mesh) of acetabular components in hip arthroplasty.
Condition | Intervention |
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Osteoarthritis |
Device: Acetabular implant, Monoblock cup |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of Two Surface Materials (Tantalum Versus Titanium Fiber Mesh) of Acetabular Components in Hip Arthroplasty |
Estimated Enrollment: | 50 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | January 2006 |
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:
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.
Ages Eligible for Study: | 50 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Orthopaedic Center, Aarhus University Hospital, | |
Aarhus, Denmark, 8000 |
Principal Investigator: | Kjeld Søballe, MD., Prof. | Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark |
Study ID Numbers: | 200330159 |
Study First Received: | June 26, 2005 |
Last Updated: | November 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00116051 History of Changes |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
RSA DEXA Osteoarthritis Hip arthroplasty |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |