This trial is active, not recruiting.

Condition osteoarthritis
Treatment bi-metric femoral implant (titanium versus cobalt-chromium)
Sponsor University of Aarhus
Start date January 2003
End date October 2009
Trial size 40 participants
Trial identifier NCT00120952, M-2351-02


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Migration of femoral components evaluated by RSA
time frame:

Secondary Outcomes

Periprosthetic BMD changes evaluated by DEXA
time frame:

Eligibility Criteria

Male or female participants from 60 years up to 75 years old.

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

Additional Information

Official title A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.
Trial information was received from ClinicalTrials.gov and was last updated in August 2006.
Information provided to ClinicalTrials.gov by University of Aarhus.