To identify the patient profile for Actifuse and for other grafting products used to achieve bone fusion.
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A patient profile for Actifuse and for other grafting products used to achieve
bone fusion.
Secondary outcome
Overall successrate of the individual effectiveness endpoints, including
improvement in outcomescales, neurologic improvement and radiographic fusion
success.
Background summary
This observational study will assess the use of commercially available bone
graft substitutes in spine fusion, as well as autograft according to the
investigators local practice.
Study objective
To identify the patient profile for Actifuse and for other grafting products
used to achieve bone fusion.
Study design
A prospective patient registry
Study burden and risks
Two extra visits to the outpatient department (12 and 24 months) and an extra
CT scan and 2 extra X-rays during those visits.
370 Centennial Avenue
WD6 3TJ Hertfordshire
GB
370 Centennial Avenue
WD6 3TJ Hertfordshire
GB
Listed location countries
Age
Inclusion criteria
requiring spinal fusion surgery
failed conservative treatment
>18 year
Exclusion criteria
Systemic infection or infection op the surgical site
Poor general health
Substance abuse
Pregnancy
participation in another trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34651.075.10 |