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Summary
This is an Observational Device Registry Study of CERAMENT\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2023-08-17
Completion Date
2028-09-22
Last Updated
2025-09-26
Healthy Volunteers
No
Interventions
CERAMENT G
* Primary mode of action is to be a resorbable ceramic bone graft substitute intended to fill gaps and voids in the skeleton system to promote bone healing. CERAMENT ™\|G provides a void/gap filler that during the surgical procedure can augment hardware and bone alignments. * Secondary mode of action is to prevent colonization of Gentamicin sensitive microorganisms in order to protect bone healing.
Locations (3)
North Park Podiatry
San Diego, California, United States
OrthoCarolina
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States