A Comparison of Two Metal Surface Finishes on Femoral Components in Hip Arthroplasty - Full Text View

Sponsors and Collaborators:	University of Aarhus Kolding Sygehus Aarhus University Hospital Zimmer, Inc.
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00116038

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

U.S. FDA Resources

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 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
Estimated Study Completion Date:	January 2007

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

Study ID Numbers:	20030192
Study First Received:	June 26, 2005
Last Updated:	November 20, 2006
ClinicalTrials.gov Identifier:	NCT00116038 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

RSA
Osteoarthritis
Hip arthroplasty
DEXA

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009