Pedicle Screw Placement With XVS

Study Overview
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Brief Summary
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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

Official Title
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Feasibility Study of Pedicle Screw Placement in the Spine With the XVISION SPINE System

Conditions
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Spine Fusion

Intervention / Treatment
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* Device: xvision Spine sytem


Participation Criteria
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Eligibility Criteria
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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.) 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 Paraplegia. Pedicle fracture documented before or during surgery. Women pregnant or lactating Subjects requiring anterior release or instrumentation. Subjects who are unwilling to sign written informed consent and assent to participate in the study. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: xvision Spine<br> | Device: xvision Spine sytem<br>* pedicle screw placement will be performed using the XVS navigation system<br>* Other names: XVS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accurate placement of pedicle screws | accurate placement will be evaluated using Gertzbein and Robbins | through study completion , an average of 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| usability and ease of use of the system: questionnaire | usability will be evaluated by questionnaire | The surgeon fills a questionnaire after the surgery, within 7 days. |