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

This study is currently recruiting patients.

Sponsors and Collaborators: University of Aarhus
Kolding Hospital
Zimmer
Information provided by: University of Aarhus

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®)

MedlinePlus related topics:  Osteoarthritis

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

Further Study Details: 
Primary Outcomes: migration of femoral components evaluated by RSA
Secondary Outcomes: BMD in the surrounding bone tissue of femoral components
Expected Total Enrollment:  50

Study start: January 2004;  Expected completion: January 2010
Last follow-up: January 2007;  Data entry closure: January 2009

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   -   70 Years,  Genders Eligible for Study:  Both
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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00116038

Thomas Baad-Hansen, MD      89497781  Ext. 45    baadhansen@dadlnet.dk

Denmark
      Orthopaedic Center, Aarhus University Hospital,, Aarhus,  8000,  Denmark; Recruiting
Thomas Baad-Hansen, MD.  89497781  Ext. 45    baadhansen@dadlnet 
Kjeld Søballe, MD.,Prof.  89497425  Ext. 45    OVL09KS@as.aaa.dk.dk 
Thomas Baad-Hansen, MD,  Sub-Investigator
Kjeld Søballe, MD. Prof.,  Principal Investigator
Søren Kold, MD. Phd.,  Sub-Investigator
Finn Christensen, MD.,  Sub-Investigator

Study chairs or principal investigators

Kjeld Søballe, MD., Prof.,  Principal Investigator,  Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark   

More Information

Study ID Numbers:  20030192
Record last reviewed:  January 2005
Last Updated:  June 30, 2005
Record first received:  June 26, 2005
ClinicalTrials.gov Identifier:  NCT00116038
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on 2005-07-05

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