CERAMENT G Device Registry

BONESUPPORT

Status: Enrolling

Conditions: Fracture Related Infection; Chronic Osteomyelitis; Diabetic Foot Osteomyelitis

Treatments: Device: CERAMENT G

Study type: Observational

Funder types: Industry

Identifiers

NCT06010433

S050/2018

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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