Clinical Trial: A Comparison Between Titanium Femoral Stem and Chrome-Cobalt Femoral Stem in Cemented Hip Arthroplasty

This study is no longer recruiting patients.

Sponsored by: University of Aarhus
Information provided by: University of Aarhus Identifier: NCT00120952


In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented chrome-cobalt 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.
Condition Intervention
 Device: Bi-Metric femoral implant (titanium or cobalt-chrome)

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Migration of femoral components evaluated by RSA
Secondary Outcomes: Periprosthetic BMD changes evaluated by DEXA
Expected Total Enrollment:  40

Study start: January 2003


Ages Eligible for Study:  60 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Location Information

      Orthopaedic Department, Ribe County Hospital, Esbjerg,  6700,  Denmark

Study chairs or principal investigators

Kjeld Søballe, MD, Professor, DMSc,  Study Chair,  Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark   

More Information

Study ID Numbers:  M-2351-02
Last Updated:  August 1, 2005
Record first received:  July 18, 2005 Identifier:  NCT00120952
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics processed this record on 2005-08-02


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