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RECRUITING
NCT06010433

CERAMENT G Device Registry

Sponsor: BONESUPPORT AB

View on ClinicalTrials.gov

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

DEVICE

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