CERAMENT G Device Registry
BONESUPPORT AB
100 participants
Aug 17, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria1
- Any off-label use
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Interventions
* 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06010433