NCT06010433

CERAMENT G Device Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: BONESUPPORT AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-17
• Primary completion: 2028-09-22
• Completion: 2028-09-22
• First posted: 2023-08-24
• Last updated: 2025-09-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study