Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00116038
Enrollment
50
Registered
2005-06-27
Start date
2004-01-31
Completion date
2007-01-31
Last updated
2009-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

RSA, Osteoarthritis, Hip arthroplasty, DEXA

Brief 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.

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.

Interventions

DEVICEFemoral implant (Versys Fiber Metal Taper®)

Sponsors

Kolding Sygehus
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Zimmer Biomet
CollaboratorINDUSTRY
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frame
migration of femoral components evaluated by RSA

Secondary

MeasureTime frame
BMD in the surrounding bone tissue of femoral components

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026