Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175487

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

MedlinePlus related topics: Osteoarthritis Osteonecrosis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial

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 ]

Estimated Enrollment:	108
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Contacts and Locations

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

Responsible Party:	University of British Columbia ( Dr. Donald Garbuz )
Study ID Numbers:	C05-0105
Study First Received:	September 11, 2005
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00175487
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Osteoarthritis/Avascular Necrosis
Hip

Study placed in the following topic categories:

Necrosis
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases
Bone Diseases

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009