A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty

A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120952

Enrollment

Registered

2005-07-19

Start date

Unknown

Completion date

2010-01-31

Last updated

2022-12-27

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, Titanium, Cobalt chromium, Bone cement

Brief summary

In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.

Interventions

DEVICEBi-Metric femoral implant (titanium versus cobalt-chromium)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Primary osteoarthritis of the hip * Spinal anesthesia * Informed written consent

Exclusion criteria

* Neuromuscular disease in the affected leg * Vascular disease in the affected leg * Fracture sequelae in the affected hip * Weight over 100 kg * Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period

Design outcomes

Primary

Measure	Time frame
Migration of femoral components evaluated by RSA	—

Secondary

Measure	Time frame
Periprosthetic BMD changes evaluated by DEXA	—

Countries

Denmark

Outcome results

None listed

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