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

Osteoarthritis Clinical Trial

Official title:

A Comparison of Two Metal Surface Finishes (Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface) on Femoral Components in Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116038
• Other study ID #: 20030192
• Status: Completed
• Phase: N/A
• First received: June 26, 2005
• Last updated: July 6, 2009
• Start date: January 2004
• Est. completion date: January 2007

Study information

• Verified date: July 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Femoral implant (Versys Fiber Metal Taper®)

Locations

Country	Name	City	State
Denmark	Orthopaedic Center, Aarhus University Hospital,	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Kolding Sygehus, Zimmer, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	migration of femoral components evaluated by RSA
Secondary	BMD in the surrounding bone tissue of femoral components