Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175487
First received: September 11, 2005
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Osteoarthritis
Avascular Necrosis
Procedure: Hip replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To estimate the difference in concentrations of cobalt and chromium ions in serum [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • To estimate the difference in gait (pelvic tilt, forward velocity, and cadence) [ Time Frame: at 12 and 52 weeks ] [ Designated as safety issue: No ]
  • To estimate the lower limb functional instability by a test of postural balance [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: September 2007
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175487     History of Changes
Other Study ID Numbers: H05-70105, C05-0105
Study First Received: September 11, 2005
Last Updated: March 17, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 28, 2014