Recruiting

CERAMENT G

Sponsor:

BONESUPPORT AB

Code:

NCT06010433

Conditions

Chronic Osteomyelitis

Fracture Related Infection

Diabetic Foot Osteomyelitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CERAMENT G

Study Details

Brief 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.

Conditions

Chronic Osteomyelitis

Fracture Related Infection

Diabetic Foot Osteomyelitis

Study ID

NCT06010433

Start date

Aug 17, 2023

Status verified date

Sep, 2025

Completion date

Sep 22, 2028

Anticipated

Primary completion date

Sep 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Primary Outcomes [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Brian M Bartholdi

16178923927brian.bartholdi@bonesupport.com

Locations

North Park Podiatry

Recruiting

San Diego, California, United States, 92104

Contacts

Trent Brookshier, DPM

6172832097trentbrookshier@gmail.com

Principal Investigator:

Trent Brookshier, DPM

OrthoCarolina

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Zach Hutchko, MS

704 323 2556Zachery.Hutchko@orthocarolina.com

Principal Investigator:

Samuel Ford, MD

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Alexander Nighswander, MPH

alexander.nighswander@uhhospitals.org

Principal Investigator:

George Ochenjele, MD

More Information

Sponsor

BONESUPPORT AB

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BONESUPPORT AB on 2025-09-26.