A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty
This trial is active, not recruiting.
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Migration of femoral components evaluated by RSA
Periprosthetic BMD changes evaluated by DEXA
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
|Official title||A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.|
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