A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by University of Aarhus.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Aarhus
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00120952
First received: July 12, 2005
Last updated: August 4, 2006
Last verified: August 2006
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Purpose
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 |
---|---|
Osteoarthritis |
Device: Bi-Metric femoral implant (titanium versus cobalt-chromium) |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:
Eligibility
Ages Eligible for Study: | 60 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120952
Locations
Denmark | |
Orthopaedic Department, Ribe County Hospital | |
Esbjerg, Denmark, 6700 |
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: | Kjeld Søballe, MD, DMSc | Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark |
More Information
No publications provided
Keywords provided by University of Aarhus:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00120952 History of Changes |
Other Study ID Numbers: | M-2351-02 |
Study First Received: | July 12, 2005 |
Last Updated: | August 4, 2006 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by University of Aarhus:
RSA Osteoarthritis Hip arthroplasty DEXA |
Titanium Cobalt chromium Bone cement |
Additional relevant MeSH terms:
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Chromium |
Cobalt Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012