Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2018-05-20
2021-07-07
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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xvision Spine
xvision Spine sytem
pedicle screw placement will be performed using the XVS navigation system
Interventions
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xvision Spine sytem
pedicle screw placement will be performed using the XVS navigation system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects with Spondylosis scheduled to undergo an elective short (6 or less consecutive vertebrae) S1-L1 open spinal fixation surgery using pedicle screws.
3. Subjects requiring a posterior approach surgical procedure.
4. Subjects with normal global spinal alignment (coronal, sagittal view) and/ or patients with degenerative spine disorders.
Exclusion Criteria
2. Subjects with kyphosis at the operated area (≥ stage 3)
3. Subjects with Spondylolisthesis Grade III and above.
4. Subjects scheduled for revision fusion surgery (prior laminectomy or discectomy is not excluded).
5. Subjects with significant abnormalities of bones (e.g. osteogenesis imperfecta, tumors, infection or malignancy, etc.)
6. Subjects with neurologic diseases or damage (e.g. due to trauma, tumor, Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)
7. Subjects with spinal cord abnormalities with any neurologic symptoms or signs
8. Paraplegia.
9. Pedicle fracture documented before or during surgery.
10. Women pregnant or lactating
11. Subjects requiring anterior release or instrumentation.
12. Subjects who are unwilling to sign written informed consent and assent to participate in the study.
\-
18 Years
80 Years
ALL
No
Sponsors
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Augmedics
INDUSTRY
Responsible Party
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Locations
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Haemek MC
Afula, , Israel
Sheeba Medical Center
Tel Litwinsky, , Israel
Asaf Harofeh
Tzrifin, , Israel
Countries
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Other Identifiers
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DHF-VAP-002
Identifier Type: -
Identifier Source: org_study_id
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