Pedicle Screw Placement With XVS (NCT04682418) | Clinical Trial Compass
CompletedNot Applicable
Pedicle Screw Placement With XVS
Israel19 participantsStarted 2018-05-20
Plain-language summary
Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system.
Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score.
Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration.
Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score.
Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subjects aged 18 - 80 yrs.
✓. Subjects with Spondylosis scheduled to undergo an elective short (6 or less consecutive vertebrae) S1-L1 open spinal fixation surgery using pedicle screws.
✓. Subjects requiring a posterior approach surgical procedure.
✓. Subjects with normal global spinal alignment (coronal, sagittal view) and/ or patients with degenerative spine disorders.
Exclusion criteria
✕. Subjects with severe Osteoporosis (T score \<-3.5)
✕. Subjects with kyphosis at the operated area (≥ stage 3)
✕. Subjects with Spondylolisthesis Grade III and above.
✕. Subjects scheduled for revision fusion surgery (prior laminectomy or discectomy is not excluded).
✕. Subjects with significant abnormalities of bones (e.g. osteogenesis imperfecta, tumors, infection or malignancy, etc.)
What they're measuring
1
accurate placement of pedicle screws
Timeframe: through study completion , an average of 6 months.
. Subjects with neurologic diseases or damage (e.g. due to trauma, tumor, Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)
✕. Subjects with spinal cord abnormalities with any neurologic symptoms or signs