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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 : November 27, 2018
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The main purpose of this prospective randomized controlled trial is to compare the concentrations of metal ions in the blood and urine of patients receiving implants that are identical except for the acetabular component: one is a monoblock and all cobalt chrome, and the other is modular with a titanium acetabular shell with a polyethylene insert.

Condition or disease Intervention/treatment Phase
Hip Joint Osteoarthritis Arthroplasty Diagnostic Test: Blood metal ion levels Not Applicable

Detailed Description:
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.

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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
Actual Study Start Date : August 2006
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Active Comparator: Conserve Total Hip with BFH
CONSERVE® A-Class Total Hip with BFH technology. Blood and urine samples will be collected and blood metal ion levels will be analyzed and compared to samples from the other group.
Diagnostic Test: Blood metal ion levels
Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.

Active Comparator: Metal with Polyethylene Liner
Metal on polyethylene total hip replacement. Blood and urine samples will be collected and blood metal ion levels will be analyzed and compared to samples from the other group.
Diagnostic Test: Blood metal ion levels
Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.




Primary Outcome Measures :
  1. Metal ion levels [ Time Frame: 24 months ]
    To compare the metal ion levels between the advanced metal system and the traditional metal on polyethylene total hip replacement system.


Secondary Outcome Measures :
  1. Dislocation Rate [ Time Frame: 24 months ]
    Radiographic images will be taken to evaluate dislocation rate

  2. Complications [ Time Frame: 24 months ]
    All complications will be continually recorded.

  3. Hip Disability [ Time Frame: 24 months ]
    Hip disability will be assessed using the Harris Hip Score.

  4. Health Status [ Time Frame: 24 months ]
    Health status will be assessed using the RAND-36 Health Survey.

  5. Activity Level [ Time Frame: 24 months ]
    Patient-reported activity level will be assessed using the UCLA questionnaire.

  6. Hip Functionality [ Time Frame: 24 months ]
    Patient-reported hip functionality will be assessed using the WOMAC questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
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
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Canada, Ontario
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Wright Medical Technology
Investigators
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Principal Investigator: Paul E Beaule, MD, FRCSC University of Ottawa / The Ottawa Hospital

Publications of Results:
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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: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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