NCT06010433Recruiting
CERAMENT G Device Registry
BONESUPPORT AB
Start Date
8/17/2023
Completion Date
9/22/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 18 years and over (on the day of surgery)
* receive CERAMENT\|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product
* In receipt of patient information leaflet and have signed appropriately designed informed consent form.
Exclusion Criteria:
* Any exclusion criteria as per IFU for CERAMENT\|G
* Any off-label use
Interventions
DEVICE
CERAMENT G
Conditions
Chronic OsteomyelitisFracture Related InfectionDiabetic Foot Osteomyelitis
Locations
North Park Podiatry
San Diego, California 92104
United States
OrthoCarolina
Charlotte, North Carolina 28207
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States