Overview

This trial is active, not recruiting.

Conditions osteoarthritis, avascular necrosis
Treatment hip replacement
Sponsor University of British Columbia
Start date September 2007
End date September 2008
Trial size 56 participants
Trial identifier NCT00175487, C05-0105, H05-70105

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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 Outcomes

Measure
To estimate the difference in concentrations of cobalt and chromium ions in serum
time frame: Unspecified
To estimate the difference in gait (pelvic tilt, forward velocity, and cadence)
time frame: at 12 and 52 weeks
To estimate the lower limb functional instability by a test of postural balance
time frame: Unspecified

Eligibility Criteria

Male or female participants from 19 years up to 65 years old.

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

Additional Information

Official title Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial
Principal investigator Donald Garbuz, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by University of British Columbia.