CERAMENT G Device Registry

Diabetic Foot Osteomyelitis Clinical Trial

Official title:

CERAMENT G Device Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06010433
• Other study ID #: S050/2018
• Status: Not yet recruiting
• Start date: September 22, 2023
• Est. completion date: September 22, 2028

Study information

• Verified date: August 2023
• Source: BONESUPPORT AB
• Contact: Brian M Bartholdi
• Phone: 16178923927
• Email: brian.bartholdi[@]bonesupport.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 22, 2028
• Est. primary completion date: September 22, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Osteomyelitis
• Diabetic Foot
• Diabetic Foot Osteomyelitis
• Osteomyelitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BONESUPPORT AB

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcomes	• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.	12 months
Secondary	Secondary Outcome	Bone healing at final follow-up	12 months
Secondary	Secondary Outcome	Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 & 12 months, if normally conducted	6 and 12 months
Secondary	Secondary Outcome	(Recurrence of) infection/revision surgery	12 months