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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by University of Aarhus.
Recruitment status was:  Active, not recruiting
Information provided by:
University of Aarhus Identifier:
First received: July 12, 2005
Last updated: August 4, 2006
Last verified: August 2006
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Migration of femoral components evaluated by RSA

Secondary Outcome Measures:
  • Periprosthetic BMD changes evaluated by DEXA

Estimated Enrollment: 40
Study Start Date: January 2003
Estimated Study Completion Date: October 2009

Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00120952

Orthopaedic Department, Ribe County Hospital
Esbjerg, Denmark, 6700
Sponsors and Collaborators
University of Aarhus
Study Chair: Kjeld Søballe, MD, DMSc Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
  More Information Identifier: NCT00120952     History of Changes
Other Study ID Numbers: M-2351-02
Study First Received: July 12, 2005
Last Updated: August 4, 2006

Keywords provided by University of Aarhus:
Hip arthroplasty
Cobalt chromium
Bone cement

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on May 24, 2017