CERAMENT G Device Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Primary Outcomes — 12 months
  • Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.

Trial sites (3)

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