Chronic Osteomyelitis, Diabetic Foot Osteomyelitis, Fracture Related Infection
Conditions
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.
Interventions
DEVICECERAMENT 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.
Sponsors
BONESUPPORT AB
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcomes | 12 months | • Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome | 12 months | Bone healing at final follow-up |
Countries
United States
Contacts
Primary ContactBrian M Bartholdi
Outcome results
None listed