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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
| Halifax Biomedical Inc. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin E Polyethylene and RSA | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSA images | Radiation | 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefanie Miller | Contact | 630-933-6254 | Stefanie.Miller@CadenceHealth.org | |
| Judy Guerreiro | Contact | 630-933-2941 | Judy.Guerreiro@CadenceHealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Scott Sporer, MD | Central DuPage Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central DuPage Hospital | Recruiting | Winfield | Illinois | 60190 | United States |
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