ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00120952
Recruitment Status : Unknown
Verified August 2006 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2005
Last Update Posted : August 7, 2006
Sponsor:
Information provided by:
University of Aarhus

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Device: Bi-Metric femoral implant (titanium versus cobalt-chromium) Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : January 2003
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Migration of femoral components evaluated by RSA

Secondary Outcome Measures :
  1. Periprosthetic BMD changes evaluated by DEXA

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00120952     History of Changes
Other Study ID Numbers: M-2351-02
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: August 7, 2006
Last Verified: August 2006

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
Cobalt
 Chromium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs