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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00175487
Other study ID # H05-70105
Secondary ID C05-0105
Status Active, not recruiting
Phase N/A
First received September 11, 2005
Last updated March 17, 2014
Start date September 2007
Est. completion date June 2014

Study information

Verified date March 2014
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 56
Est. completion date June 2014
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at 2 years No
Secondary To estimate the difference in concentrations of cobalt and chromium ions in serum Unspecified No
Secondary To estimate the difference in gait (pelvic tilt, forward velocity, and cadence) at 12 and 52 weeks No
Secondary To estimate the lower limb functional instability by a test of postural balance Unspecified No
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