28mm Ceramic-on-Ceramic Total Hip Replacement Study



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA), Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:2/2/2019
Start Date:May 1, 2012
End Date:January 1, 2024
Contact:Tammy L O'Dell, BS CCRC CCRA
Email:TODell2@its.jnj.com
Phone:574-372-7104

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Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System

This study is intended to gather medium (0-5 years) and long-term (6-10 years) information
regarding the performance and safety of the commercially available Ceramax™ Ceramic on
Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase
and a clinical outcomes phase.

In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered
for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective
evaluations and radiographs will be completed annually.

In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey
will be mailed to subjects annually.

This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This
study will follow each subject through 10 years postoperatively and will consist of:

1. a clinical follow-up phase and

2. a clinical outcomes phase.

Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then
annually through year 5 for each subject. For years 6 - 10, a communication will be sent to
each subject in order to collect survivorship and general health information. This
communication will ask whether the COC device is still in vivo and, if not, when the revision
surgery took place, why, and which components were removed, if applicable. In addition,
subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up
interval. A self-addressed, stamped envelope will be provided to facilitate information
return and privacy.

Inclusion Criteria:

- Subjects who were previously enrolled in the COC28 IDE study, or

- Newly recruited individuals who are qualified based on the approved labeling of the
device, and;

- Individuals who are willing and able to provide informed patient consent for
participation in the study;

- Individuals who are willing and able to return for follow-up as specified by the study
protocol; and

- Individuals who are willing and able to complete the Hip Outcomes questionnaire and
SF-12 Health Survey as specified by the study protocol

Exclusion Criteria:

- In the opinion of the Investigator, the individual does not qualify based upon
approved labeling requirements.
We found this trial at
14
sites
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Columbus, OH
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Alexandria, VA
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Boston, MA
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from
Boston, MA
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Denver, Colorado 80210
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Denver, CO
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Durham, NC
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Fort Collins, CO
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from
Gainesville, FL
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from
Montreal,
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from
Philadelphia, PA
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from
Philadelphia, PA
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from
Sacramento, CA
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from
Tampa, FL
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from
Winston-Salem, NC
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