28mm Ceramic-on-Ceramic Total Hip Replacement Study

Stopped early

Conditions studied: Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis

In brief

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.

Key facts

Study ID

NCT01657435

Run by

DePuy Orthopaedics

People needed

185

Starts

2012-05-01

Expected to finish

2019-09-24

Last updated by the study team

2019-11-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• In the opinion of the Investigator, the individual does not qualify based upon approved labeling requirements.

Where it is running

• Joint Surgeons of Sacremento — Sacramento, California, United States
• Colorado Joint Replacement — Denver, Colorado, United States
• Study site — Fort Collins, Colorado, United States
• Florida University — Gainesville, Florida, United States
• FOI Florida Orthopaedic Institute — Tampa, Florida, United States
• New England Baptist Hospital — Boston, Massachusetts, United States
• Tufts - New England Medical Center — Boston, Massachusetts, United States
• Duke University — Durham, North Carolina, United States
• OrthoCarolina — Winston-Salem, North Carolina, United States
• Cardinal Orthopaedic Institute — Columbus, Ohio, United States
• UPenn — Philadelphia, Pennsylvania, United States
• Anderson Orthopaedic Research Institute — Alexandria, Virginia, United States
• McGill University - Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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