A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene
Status unconfirmed · Not applicable
Conditions studied: Radiostereometric Analysis, Vitamin E Liner, Zimmer® Continuum® Acetabular Cup
In brief
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.
Key facts
- Study ID
- NCT01754155
- Run by
- Central DuPage Hospital
- People needed
- 55
- Starts
- 2013-01-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2017-08-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Central DuPage Hospital — Winfield, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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