Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement
Completed
Conditions studied: Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
In brief
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)
Key facts
- Study ID
- NCT02096198
- Run by
- DePuy Orthopaedics
- People needed
- 81
- Starts
- 2014-01-01
- Expected to finish
- 2018-08-20
- Last updated by the study team
- 2019-01-29
Who can join
Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Sacramento, California, United States
- Study site — Denver, Colorado, United States
- Study site — Winston-Salem, North Carolina, United States
- Orthopedic One — Columbus, Ohio, United States
- Study site — Alexandria, Virginia, United States
Full record on ClinicalTrials.gov
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