CERAMENT G Device Registry
Part of paid clinical trials in San Diego, California.
- Sponsor
- BONESUPPORT AB
- Study ID
- NCT06010433
- Status
- Recruiting
Conditions
- Chronic Osteomyelitis
- Diabetic Foot Osteomyelitis
- Fracture Related Infection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CERAMENT G — DEVICE* 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.
Study Details
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.
Key Dates
- Start date
- Aug 17, 2023
- Status verified
- Sep 2025
- Primary completion
- Sep 22, 2028
- Completion
- Sep 22, 2028
Study Design
- Enrollment
- 100 participants (estimated)
Primary Outcome Measure
Primary Outcomes [ Time Frame: 12 months ]
Central Contacts
- Brian M Bartholdi16178923927
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Park Podiatry | San Diego | California | 92104 | Trent Brookshier, DPM (PRINCIPAL_INVESTIGATOR) |
| OrthoCarolina | Charlotte | North Carolina | 28207 | Samuel Ford, MD (PRINCIPAL_INVESTIGATOR) |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Alexander Nighswander, MPH George Ochenjele, MD (PRINCIPAL_INVESTIGATOR) |