Pedicle Screw Placement With XVS

Augmedics

Status: Completed

Conditions: Spine Fusion

Treatments: Device: xvision Spine sytem

Study type: Interventional

Funder types: Industry

Identifiers

NCT04682418

DHF-VAP-002

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

xvision Spine

Experimental group

Treatment:

Device: xvision Spine sytem