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NCT00120952 Clinical Trial

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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00120952
Other study ID # M-2351-02
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Est. completion date January 2010

Study information
Verified date December 2022
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2010
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 60 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Bi-Metric femoral implant (titanium versus cobalt-chromium)

Locations
Country Name City State
Denmark Orthopaedic Department, Ribe County Hospital Esbjerg

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Migration of femoral components evaluated by RSA
Secondary Periprosthetic BMD changes evaluated by DEXA
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