CERAMENT™| Bone Void Filler Device Registry
ConditionOrthopedic Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBONESUPPORT AB
About this trial
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years and over (on the day of surgery)
Receive CERAMENT BVF as a component of their treatment at a participating, contracted center 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
Disqualifiers
Any exclusion criteria as per IFU for CERAMENT BVF
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 received CERAMENT BVF for the treatment of their condition at the designated investigative centers. 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 BVF
DeviceCERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame
12 months2
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame
18 months3
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame
12 months4
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame
18 monthsSecondary outcomes
1
Radiological assessment at 6 and 12 months. Objective assessment of regeneration
Bone healing
Time frame
6 Months2
Radiological assessment at 6 and 12 months. Objective assessment of regeneration
Bone healing
Time frame
12 Months3
Pain VAS score
Pain assessment at 6,12, and 18 months
Time frame
6, 12, and 18 Months4
EQ-5D-3L
Functional assessment at 6, 12, and 18 months
Time frame
6, 12, and 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov