Pedicle Screw Placement With XVS

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

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

Study Overview

• Status: Completed
• Conditions: Spine Fusion
• Intervention / Treatment: Device: xvision Spine sytem

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • HaEmek MC
  • Tel HaShomer, Israel, 52621
    • Sheeba Medical Center
  • Tzrifin, Israel, 70300
    • Asaf Harofeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: xvision Spine	Device: xvision Spine sytem; pedicle screw placement will be performed using the XVS navigation system; Other Names: XVS

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Augmedics

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2018
• Primary Completion (Actual): March 16, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DHF-VAP-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No