Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement

Launched by DEPUY ORTHOPAEDICS · Mar 21, 2014

Keywords

ClinConnect Summary

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 clinic...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects who were previously enrolled in the COC 36 IDE study;
• • 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 Subject Hip Outcomes questionnaire as specified by the study protocol.
• Exclusion Criteria:
• • In the opinion of the Investigator, the individual does not qualify if there are any concerns with the ability to follow the protocol specified evaluations.
• • Any component of the primary total hip was previously revised.