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Sponsors and Collaborators: |
University of Aarhus Kolding Hospital Aarhus University Hospital Zimmer, Inc. |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00116038 |
The purpose of this study is to compare metal surface finishes (proximal-coated titanium surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.
Condition | Intervention |
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Osteoarthritis |
Device: Femoral implant (Versys Fiber Metal Taper®) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of Two Metal Surface Finishes (Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface) on Femoral Components in Hip Arthroplasty |
Estimated Enrollment: | 50 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | January 2007 |
In younger patients femoral 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.
The construction of a femoral implant, Versys Fiber Metal Taper®, by Zimmer includes a more extensive coating than previous femoral implants. The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use.
Theoretically, the greater porous surface of mid-coated implants should:
The migration of femoral components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. 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: | 20030192 |
Study First Received: | June 26, 2005 |
Last Updated: | November 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00116038 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
RSA Osteoarthritis Hip arthroplasty DEXA |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |