search
Back to results

Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty

Primary Purpose

Osteoarthritis, Avascular Necrosis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hip replacement
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis/Avascular Necrosis, Hip

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Indication for hip resurfacing because of osteoarthritis or avascular necrosis Aged 19 to 65 years old Ability to give informed consent 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

Sites / Locations

  • Vancouver General Hospital

Outcomes

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

Secondary Outcome Measures

To estimate the difference in concentrations of cobalt and chromium ions in serum
To estimate the difference in gait (pelvic tilt, forward velocity, and cadence)
To estimate the lower limb functional instability by a test of postural balance

Full Information

First Posted
September 11, 2005
Last Updated
March 17, 2014
Sponsor
University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT00175487
Brief Title
Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty
Official Title
Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Avascular Necrosis
Keywords
Osteoarthritis/Avascular Necrosis, Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Hip replacement
Other Intervention Name(s)
Durom Total Hip System
Intervention Description
This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To estimate the difference in concentrations of cobalt and chromium ions in serum
Title
To estimate the difference in gait (pelvic tilt, forward velocity, and cadence)
Time Frame
at 12 and 52 weeks
Title
To estimate the lower limb functional instability by a test of postural balance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for hip resurfacing because of osteoarthritis or avascular necrosis Aged 19 to 65 years old Ability to give informed consent 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Garbuz, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty

We'll reach out to this number within 24 hrs