Radiostereometric Analysis, Vitamin E Liner, Zimmer® Continuum® Acetabular Cup
Conditions
Keywords
Vitamin E, Zimmer, RSA, Radiostereometric Analysis
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.
Interventions
RADIATIONRSA images
All subjects will have the Vitamin E polyethylene and RSA beads placed during surgery. Subjects will then have standard x-ray images and RSA images taken at specific time points up until 2 years post-operatively.
Sponsors
Zimmer Biomet
Halifax Biomedical Inc.
Central DuPage Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 * Patients with known allergy to metals * Pregnancy * Patients with compromised kidney function * Patient is immuno-suppressed * Patients that require a femoral head less than 32 mm or greater than 40mm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt | 2 years |
| Assessing the migration pattern of the Continuum® Cup | 2 years |
| Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA | 2 years |
| Determine if inducible displacement is indicative of adequate fixation | 2 years |
| Assess the health status and functional outcome of patients with the Continuum® Cup | 2 years |
| Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head | 2 years |
| Determine if the wear rate of the Vitamin E liner is the same in-vivo as it is in simulation testing | 2 years |
Countries
United States
Contacts
Primary ContactStefanie Miller
Backup ContactJudy Guerreiro
Outcome results
None listed