CERAMENT G Device Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBONESUPPORT AB
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Any exclusion criteria as per IFU for CERAMENT|G
Any off-label use
Trial population
The racial, gender and ethnic characteristics of the individuals approached for participation in this Observational Registry Study shall reflect the demographics of patients that would ordinarily receive CERAMENT\|G for the treatment of their condition at the designated investigative centres. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender, or sexuality
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary Outcomes
• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.
Time frame
12 monthsSecondary outcomes
1
Secondary Outcome
Bone healing at final follow-up
Time frame
12 months2
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
Time frame
6 and 12 months3
Secondary Outcome
(Recurrence of) infection/revision surgery
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov