Pedicle Screw Placement With XVS

Not Applicable

Completed

• Conditions: Spine Fusion
• Interventions: Device: xvision Spine sytem

• Registration Number: NCT04682418
• Lead Sponsor: Augmedics

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 available

Study Timeline

• Study Start: 2018-05-20
• Study First Submitted: 2019-04-05
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Primary Completion: 2021-03-16
• Study Completion: 2021-07-07
• Last Update Submitted: 2021-08-22
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
xvision Spine	xvision Spine sytem	-

Primary Outcome Measures

Name	Time	Method
accurate placement of pedicle screws	through study completion , an average of 6 months.	accurate placement will be evaluated using Gertzbein and Robbins

Secondary Outcome Measures

Name	Time	Method
usability and ease of use of the system: questionnaire	The surgeon fills a questionnaire after the surgery, within 7 days.	usability will be evaluated by questionnaire

Trial Locations

Locations (3)

Haemek MC; 🇮🇱 Afula, Israel

Sheeba Medical Center; 🇮🇱 Tel HaShomer, Israel

Asaf Harofeh; 🇮🇱 Tzrifin, Israel