CERAMENT G Device Registry

Recruiting

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

• Registration Number: NCT06010433
• Lead Sponsor: BONESUPPORT AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-25
• Study Start: 2023-08-17
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2028-09-22
• Study Completion: 2028-09-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcomes	12 months	• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	12 months	(Recurrence of) infection/revision surgery

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States