Pedicle Screw Placement With XVS

Spine Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682418
• Other study ID #: DHF-VAP-002
• Status: Completed
• Phase: N/A
• Start date: May 20, 2018
• Est. completion date: July 7, 2021

Study information

• Verified date: December 2020
• Source: Augmedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 7, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Spine Fusion

Intervention

Device:
• xvision Spine sytem
pedicle screw placement will be performed using the XVS navigation system

Locations

Country	Name	City	State
Israel	Haemek MC	Afula
Israel	Sheeba Medical Center	Tel HaShomer
Israel	Asaf Harofeh	Tzrifin

Sponsors (1)

Lead Sponsor	Collaborator
Augmedics

Country where clinical trial is conducted

Israel, 

Outcome

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