Trial record 19 of 98 for:
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
Information provided by:
University of Aarhus
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.
Device: Bi-Metric femoral implant (titanium versus cobalt-chromium)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.
Primary Outcome Measures:
- Migration of femoral components evaluated by RSA
Secondary Outcome Measures:
- Periprosthetic BMD changes evaluated by DEXA
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||60 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Primary osteoarthritis of the hip
- Spinal anesthesia
- Informed written consent
- 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120952
|Orthopaedic Department, Ribe County Hospital
|Esbjerg, Denmark, 6700 |
University of Aarhus
||Kjeld Søballe, MD, DMSc
||Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 12, 2005
||August 4, 2006
||Denmark: The Danish National Committee on Biomedical Research Ethics
Keywords provided by University of Aarhus:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 01, 2014
Physiological Effects of Drugs