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

This study has been completed.
Sponsor:
Collaborators:
Kolding Sygehus
Aarhus University Hospital
Zimmer, Inc.
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00116038
First received: June 26, 2005
Last updated: July 6, 2009
Last verified: July 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116038

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

No publications provided

Responsible Party: Professor Kjeld Soballe, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C
ClinicalTrials.gov Identifier: NCT00116038     History of Changes
Other Study ID Numbers: 20030192
Study First Received: June 26, 2005
Last Updated: July 6, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
RSA
Osteoarthritis
Hip arthroplasty
DEXA

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013