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.
Study Type
OBSERVATIONAL
Enrollment
100
* 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.
North Park Podiatry
San Diego, California, United States
RECRUITINGOrthoCarolina
Charlotte, North Carolina, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGPrimary Outcomes
• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.
Time frame: 12 months
Secondary Outcome
Bone healing at final follow-up
Time frame: 12 months
Secondary Outcome
Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 \& 12 months, if normally conducted
Time frame: 6 and 12 months
Secondary Outcome
(Recurrence of) infection/revision surgery
Time frame: 12 months
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