Osteoarthritis Clinical Trial
Official title:
36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects
This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to 10-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component that articulates with a ceramic femoral head in the COC total hip replacement system)
Up to five (5) sites will participate. These sites participated in the IDE study and will
continue subject follow-up.
Subjects from the original IDE study (COC 36mm investigational subjects only) will be seen
for a clinic visit at the time of consent (First visit at approximately 5 to 7 years post-op
or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years
(3650-4015 days). Harris Hip evaluation, radiographic evaluation, subject hip-outcomes, and
adverse event information will be collected at each visit.
If a subject is not willing or able to return for a clinical and radiographic follow-up for
either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone
interview may be utilized for the purpose of determining device survivorship.
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