CERAMENT G Device Registry

• Sponsor: BONESUPPORT AB (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06010433
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 60

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Osteomyelitis; Fracture Related Infection; Diabetic Foot Osteomyelitis	Device: CERAMENT G

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: CERAMENT G Device Registry
• Anticipated Study Start Date: Sep 22, 2023
• Anticipated Primary Completion Date: Sep 22, 2028
• Anticipated Study Completion Date: Sep 22, 2028

Outcome Measures

Primary Outcome Measures

1. Primary Outcomes [12 months]

   • Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.

Secondary Outcome Measures

1. Secondary Outcome [12 months]

   Bone healing at final follow-up

2. Secondary Outcome [6 and 12 months]

   Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 & 12 months, if normally conducted

3. Secondary Outcome [12 months]

   (Recurrence of) infection/revision surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• BONESUPPORT AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BONESUPPORT AB
• ClinicalTrials.gov Identifier: NCT06010433
• Other Study ID Numbers: S050/2018
• First Posted: Aug 24, 2023
• Last Update Posted: Aug 24, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Osteomyelitis; Diabetic Foot

Study Results

No Results Posted as of Aug 24, 2023