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A Comparison of Two Metal Surface Finishes on Femoral Components in Hip Arthroplasty

This study has been completed.
Kolding Sygehus
Aarhus University Hospital
Zimmer Biomet
Information provided by:
University of Aarhus Identifier:
First received: June 26, 2005
Last updated: July 6, 2009
Last verified: July 2009
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
Osteoarthritis Device: Femoral implant (Versys Fiber Metal Taper®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Comparison of Two Metal Surface Finishes (Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface) on Femoral Components in Hip Arthroplasty

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • migration of femoral components evaluated by RSA

Secondary Outcome Measures:
  • BMD in the surrounding bone tissue of femoral components

Estimated Enrollment: 50
Study Start Date: January 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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:

  • Encourage bone ingrowth through improved osteoconductive properties, however more extensive coating might change the loss of bone due to stress shielding later in time
  • Improve anchorage of the implant due to the higher friction coefficient
  • Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with primary arthritis in the hip.
  • Patients with sufficient bone density to allow uncemented implantation of a femoral component.
  • Informed patient consent in writing.

Exclusion Criteria:

  • Patients with neuromuscular or vascular disease in the affected leg.
  • Patients found upon operation to be unsuited for uncemented acetabulum component.
  • Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
  • Patients with fracture sequelae.
  • Female patients of childbearing capacity.
  • Hip joint dysplasia.
  • Sequelae to previous hip joint disorder in childhood.
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Please refer to this study by its identifier: NCT00116038

Orthopaedic Center, Aarhus University Hospital,
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Kolding Sygehus
Aarhus University Hospital
Zimmer Biomet
Principal Investigator: Kjeld Søballe, MD., Prof. Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
  More Information

Responsible Party: Professor Kjeld Soballe, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C Identifier: NCT00116038     History of Changes
Other Study ID Numbers: 20030192
Study First Received: June 26, 2005
Last Updated: July 6, 2009

Keywords provided by University of Aarhus:
Hip arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on September 21, 2017