CERAMENT G Device Registry

Description

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.

Conditions

Chronic Osteomyelitis, Fracture Related Infection, Diabetic Foot Osteomyelitis

Study Overview

Study Details

Study overview

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.

CERAMENT G Device Registry

CERAMENT G Device Registry

Condition
Chronic Osteomyelitis
Intervention / Treatment

-

Contacts and Locations

Cleveland

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BONESUPPORT AB,

Study Record Dates

2028-09-22