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Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT00175487
Recruitment Status : Unknown
Verified March 2014 by University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.

Condition or disease Intervention/treatment Phase
Osteoarthritis Avascular Necrosis Procedure: Hip replacement Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial
Study Start Date : September 2007
Actual Primary Completion Date : September 2008
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Hip replacement
    This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.
    Other Name: Durom Total Hip System


Primary Outcome Measures :
  1. To estimate the difference in postoperative quality of life between patients with Durom® hip resurfacing versus those with total hip arthroplasty (THA) using a large-head, metal-on-metal articulation [ Time Frame: at 2 years ]

Secondary Outcome Measures :
  1. To estimate the difference in concentrations of cobalt and chromium ions in serum
  2. To estimate the difference in gait (pelvic tilt, forward velocity, and cadence) [ Time Frame: at 12 and 52 weeks ]
  3. To estimate the lower limb functional instability by a test of postural balance


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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Indication for hip resurfacing because of osteoarthritis or avascular necrosis
  2. Aged 19 to 65 years old
  3. Ability to give informed consent

Exclusion Criteria:

  1. Previous fracture requiring internal fixation of the hip
  2. Previous hip osteotomy (pelvic or femoral)
  3. Dysplasia requiring structural bone graft
  4. Inability to respond to questionnaires in English (or French, Montreal centre only)
  5. The presence of osteopenia or osteoporosis
  6. Evidence of hepatic/renal insufficiency or failure from medical history or laboratory assessment

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): NCT00175487


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Donald Garbuz, MD University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175487     History of Changes
Other Study ID Numbers: H05-70105
C05-0105
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by University of British Columbia:
Osteoarthritis/Avascular Necrosis
Hip

Additional relevant MeSH terms:
Osteoarthritis
Necrosis
Osteonecrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Bone Diseases