Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty

NCT00175487 | Unknown

• 2 other identifiers: H05-70105C05-0105
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis; Avascular Necrosis

Keywords

Osteoarthritis/Avascular Necrosis; Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Interventions

Hip replacement PROCEDURE

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

Also known as: Durom Total Hip System

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1L8, Canada

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Donald Garbuz, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: June 1, 2014
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

CA (1)