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
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00120952
First received: July 12, 2005
Last updated: August 4, 2006
Last verified: August 2006
  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:

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
  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
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, see Learn About Clinical Studies.

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

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 September 18, 2014