RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement

This study has been completed.
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00911599
First received: May 29, 2009
Last updated: January 21, 2014
Last verified: January 2014

May 29, 2009
January 21, 2014
August 2006
May 2012   (final data collection date for primary outcome measure)
The primary purpose of this study is therefore, to compare the metal ion levels between the advanced metal system and the traditional metal on polyethylene total hip replacement system. [ Time Frame: Multiple time points out to (2) two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00911599 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement
A Prospective Randomized Clinical Trial Comparing Ion Levels and Clinical Outcomes of the CONSERVE® A-Class Total Hip System With BFH® Technology to Metal on Polyethylene Total Hip Replacement

The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium) are lower at one year in patients who receive a metal on polyethylene total hip as compared to CONSERVE® A-Class Total Hip with BFH® technology. Secondary aims include the gathering of clinical data regarding survival and dislocation rates at two years post surgery, as well as the assessment of pain, physical function, radiographic and clinical outcome at the two year interval.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Hip Joint
  • Osteoarthritis
  • Arthroplasty
  • Device: A Class BFH
    A Class BFH versus Metal on Poly
  • Device: Metal on Polyethylene
    A Class BFH versus Metal on Poly
  • Active Comparator: BFH
    BFH
    Intervention: Device: A Class BFH
  • Active Comparator: Metal with Polyethylene Liner
    Metal with Polyethylene Liner
    Intervention: Device: Metal on Polyethylene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2013
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals undergoing unilateral total hip replacement.
  • Patients 50 to 70 years of age.

Exclusion Criteria:

  • Patients who have previously undergone any type of joint replacement.
  • Patients with evidence of active infection.
  • Patients with a documented allergy to cobalt chromium molybdenum.
Both
50 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00911599
2006-506
No
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Wright Medical Technology
Principal Investigator: Paul E Beaule, MD, FRCSC University of Ottawa / The Ottawa Hospital
Ottawa Hospital Research Institute
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP