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Completed

NCT Number: NCT04682418

Pedicle Screw Placement With XVS

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

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Key information

Conditions

Spine Fusion

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haemek MC, Afula, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

xvision Spine sytem

Device

pedicle screw placement will be performed using the XVS navigation system

Other names: XVS

Primary outcomes

  1. accurate placement of pedicle screws

    Time frame: through study completion , an average of 6 months.

    accurate placement will be evaluated using Gertzbein and Robbins

Secondary outcomes

  1. usability and ease of use of the system: questionnaire

    Time frame: The surgeon fills a questionnaire after the surgery, within 7 days.

    usability will be evaluated by questionnaire

Sponsors and collaborators

Lead sponsor

Augmedics

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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