A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/25/2017 |
| Start Date: | January 2013 |
| End Date: | December 2018 |
| Contact: | Stefanie Miller |
| Email: | Stefanie.Miller@CadenceHealth.org |
| Phone: | 630-933-6254 |
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.
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.
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.
We found this trial at
1
site
Winfield, Illinois 60190
Principal Investigator: Scott Sporer, MD
Phone: 630-933-6254
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