Pedicle Screw Placement With XVS

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04682418

Enrollment

Registered

2020-12-23

Start date

2018-05-20

Completion date

2021-07-07

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine Fusion

Brief 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

Interventions

DEVICExvision Spine sytem

pedicle screw placement will be performed using the XVS navigation system

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Subjects aged 18 - 80 yrs. 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

1. Subjects with severe Osteoporosis (T score \<-3.5) 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. \-

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026