Orthopedic Disorder
Conditions
Brief summary
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
Detailed description
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
Interventions
DEVICECERAMENT BVF
CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.
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 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
Exclusion criteria
* Any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAEs 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 | 12 months | SAEs 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 | 12 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 |
| Adverse events 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 | 12 and 18 months | Adverse events 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 |
| adverse device events 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 | 18 months | Adverse device events 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 | 12 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain VAS score | 6, 12, and 18 Months | Pain assessment at 6,12, and 18 months |
| EQ-5D-3L | 6, 12, and 18 months | Functional assessment at 6, 12, and 18 months |
| Radiological assessment at 6 and 12 months. Objective assessment of regeneration | 6 Months | Bone healing |
Countries
United States
Contacts
Primary ContactBrian M Bartholdi
Outcome results
None listed