CERAMENT G Device Registry

Recruiting now

Conditions studied: Chronic Osteomyelitis, Fracture Related Infection, Diabetic Foot Osteomyelitis

In brief

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 facts

Study ID

NCT06010433

Run by

BONESUPPORT AB

People needed

100

Starts

2023-08-17

Expected to finish

2028-09-22

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Any exclusion criteria as per IFU for CERAMENT\|G
• Any off-label use

Where it is running

• North Park Podiatry — San Diego, California, United States (enrolling)
• OrthoCarolina — Charlotte, North Carolina, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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