Pedicle Screw Placement With XVS

NCT04682418 | Completed

• 1 other identifier: DHF-VAP-002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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

Conditions

Spine Fusion

Outcome Measures

Primary Outcomes (1)

• accurate placement of pedicle screws

  accurate placement will be evaluated using Gertzbein and Robbins

  through study completion , an average of 6 months.

Secondary Outcomes (1)

• usability and ease of use of the system: questionnaire

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

Study Arms (1)

xvision Spine

EXPERIMENTAL

Device: xvision Spine sytem

Interventions

xvision Spine sytem DEVICE

pedicle screw placement will be performed using the XVS navigation system

Also known as: XVS

xvision Spine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augmedics: lead

Study Sites (3)

Haemek MC

Afula, Israel

Location

Sheeba Medical Center

Tel Litwinsky, 52621, Israel

Location

Asaf Harofeh

Tzrifin, 70300, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: December 23, 2020
• Study Start: May 20, 2018
• Primary Completion: March 16, 2021
• Study Completion: July 7, 2021
• Last Updated: August 24, 2021

Record last verified: 2020-12

Locations

IL (3)