A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiostereometric Analysis
- Sponsor
- Central DuPage Hospital
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Determine if inducible displacement is indicative of adequate fixation
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome measures to evaluate early, post-operative implant stability, post-operative implant fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E stabilized polyethylene.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptomatic osteoarthritis of the hip indicating surgical intervention
- •Scheduled to undergo an uncemented total hip arthroplasty (THA)
- •Patients between the ages of 18 and 65, inclusive
- •Ability to give informed consent
- •Patients will be available for follow-up for a minimum of 2 years after surgery
Exclusion Criteria
- •Patients less than 18 years of age, or older than 65 years of age.
- •Post-traumatic arthritis in the affected hip
- •Rheumatoid arthritis in the affected hip
- •Hip dysplasia in the affected hip
- •Prior arthroplasty of the affected hip
- •Active or prior infection of the affected hip
- •Morbid obesity (BMI \> 35)
- •Medical condition precluding major surgery
- •Severe osteoporosis or osteopenia
- •Neuromuscular impairment
Outcomes
Primary Outcomes
Determine if inducible displacement is indicative of adequate fixation
Time Frame: 2 years
Assess the health status and functional outcome of patients with the Continuum® Cup
Time Frame: 2 years
Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA
Time Frame: 2 years
Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt
Time Frame: 2 years
Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head
Time Frame: 2 years
Determine if the wear rate of the Vitamin E liner is the same in-vivo as it is in simulation testing
Time Frame: 2 years
Assessing the migration pattern of the Continuum® Cup
Time Frame: 2 years