Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty

Not Applicable

• Conditions: Osteoarthritis; Avascular Necrosis

• Registration Number: NCT00175487
• Lead Sponsor: University of British Columbia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-15
• Study Start: 2007-09
• Primary Completion: 2008-09
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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)	at 12 and 52 weeks
To estimate the lower limb functional instability by a test of postural balance

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada