TerminatedNot Applicable

28mm Ceramic-on-Ceramic Total Hip Replacement Study

Stopped: Adequate data to satisfy PAS as agreed to with FDA 02OCT2019

United States185 participantsStarted 2012-05-01

Plain-language summary

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.

Who can participate

SexALL

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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.

What they're measuring

Survivorship

Timeframe: 10 years

Trial details

NCT IDNCT01657435

SponsorDePuy Orthopaedics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-09-24

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