The aim of the study is to determine the accuracy of pedicle screw placement when using the iNav navigation tool compared with the established computertomography based navigation.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the accuracy of the pedicle screw position according to
the classification of Gertzbein and Robbins in which Grade A and B are defined
as *good position*, based on the computertomography imaging at the end of each
surgical procedure.
Secondary outcome
Other study parameters are duration of surgery, complications, and length of
hospital stay.
Background summary
Spinal instrumentation is more frequently performed with the aid of navigation
resulting in good outcome and less complications. Since the established
computer tomography-based navigation system is costly and associated with
radiation exposure, there is a need for alternative less complex navigation
systems with similar accuracy. Recently, a novel iOS (operating system on which
Apple personal devices run) based spinal navigation system has been developed;
iNav system (Circinus Medical Technology).
Study objective
The aim of the study is to determine the accuracy of pedicle screw placement
when using the iNav navigation tool compared with the established
computertomography based navigation.
Study design
The research project will start with a pilot study on 20 patients who will be
operated with iNav navigation, which will be compared and checked with the
standard computertomography based navigation during surgery. Whenever at least
90% of the implanted pedicle screws have an acceptable position in the pedicle,
we will continue with the randomized trial, which is designed as a randomized
controlled single-blinded, single center, non-inferiority trial in which iNav
navigation will be compared with computertomography based navigation.
Intervention
Patients undergoing spinal navigated instrumentation will be randomized into
one group in which pedicle screws will be inserted by guidance of the iNav
system, and one group in which pedicle screw will be inserted by guidance of
the computertomography based navigation.
Study burden and risks
The patients will not experience any burden since the study objective concerns
the surgical navigation procedure only, and no additional imaging, blood
sample, nor questionnaires will be asked. In general, pedicle screw fixation
can be associated with a small risk of screw malposition with consequent nerve
root injury. In case of iNav navigation, the risk of pedicle screw deviation
might be higher although all patients will receive intraoperative
computertomography control imaging to check the iNav pedicle trajectory and
reposition the screw if necessary.
Domino Drive 100-7
Concord MA 01742
US
Domino Drive 100-7
Concord MA 01742
US
Listed location countries
Age
Inclusion criteria
- Patients older than 18 years
- informed consent
- single or multilevel fusions (T12 to S1) for the following indications:
degenerative spinal stenosis
spondylolisthesis
degenerative disc disease
failed back surgery syndrome.
Exclusion criteria
- cervical surgery and thoracic surgery above T12.
- trauma, infection, and tumor.
- cortical trajectory screw fixation.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL74268.058.20 |