Osteoarthritis Clinical Trial
Official title:
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.
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