CompletedNot Applicable

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

United States81 participantsStarted 2014-01-01

Plain-language summary

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)

Who can participate

Age range20 Years – 75 Years

SexALL

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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.

What they're measuring

Device survivorship at 10-years post-operatively

Timeframe: 10-years post-operatively

Trial details

NCT IDNCT02096198

SponsorDePuy Orthopaedics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-08-20

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