A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene

Conditions
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Radiostereometric Analysis, Vitamin E Liner, Zimmer® Continuum® Acetabular Cup

Intervention / Treatment
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* Radiation: RSA images


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vitamin E Polyethylene and RSA<br>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. | Radiation: RSA images<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin E, Zimmer, RSA, Radiostereometric Analysis