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

This study is currently recruiting participants.
Verified October 2011 by Ottawa Hospital Research Institute
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: October 20, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hip Joint
Osteoarthritis
Arthroplasty
 Device: A Class BFH
Device: Metal on Polyethylene
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: August 2006
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BFH
BFH
 Device: A Class BFH
A Class BFH versus Metal on Poly
Active Comparator: Metal with Polyethylene Liner
Metal with Polyethylene Liner
 Device: Metal on Polyethylene
A Class BFH versus Metal on Poly

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911599

Contacts
Contact: Paul Beaule, MD 613-737-3265

Locations
Canada, Ontario
Ottawa Hospital - General Campus Recruiting
Ottawa, Ontario, Canada, K2B 6X1
Principal Investigator: Paul Beaul, MD, FRCSC            
Sub-Investigator: Paul Kim, MD, FRCSC            
Sponsors and Collaborators
Ottawa Hospital Research Institute
Wright Medical Technology
Investigators
Principal Investigator: Paul E Beaule, MD, FRCSC University of Ottawa / The Ottawa Hospital
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00911599     History of Changes
Other Study ID Numbers: 2006-506
Study First Received: May 29, 2009
Last Updated: October 20, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Individuals undergoing unilateral total hip replacement.

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013