Pedicle Screw Placement With XVS | NCT04682418

Studies
Pedicle Screw Placement With XVS

NCT04682418

Sponsor

Augmedics

Status

Completed

Last Update Posted

Aug 24, 2021Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Spine Fusion

Interventions

xvision Spine sytem

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2018Actual

Primary Completion Date

Mar 16, 2021Actual

Completion Date

Jul 7, 2021Actual

First Submitted Date

Apr 5, 2019

First Submission Date that Met QC Criteria

Dec 22, 2020

First Posted Date

Dec 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2021

Last Update Posted Date

Aug 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Label	Type	Description	Intervention Names
xvision Spine	Experimental		Device: xvision Spine sytem

Name	Type	Description	Arm Group Labels	Other Names
xvision Spine sytem	Device	pedicle screw placement will be performed using the XVS navigation system	xvision Spine

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Haemek MC		Afula			Israel
Sheeba Medical Center