Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial

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

• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Osteonecrosis

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