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

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ClinicalTrials.gov Identifier: NCT00911599
Recruitment Status : Completed
First Posted : June 2, 2009
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
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 or disease Intervention/treatment
Hip Joint Osteoarthritis Arthroplasty Device: A Class BFH Device: Metal on Polyethylene

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : August 2006
Primary Completion Date : May 2012
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT00911599


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

Publications:
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00911599     History of Changes
Other Study ID Numbers: 2006-506
First Posted: June 2, 2009    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

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