Status:
COMPLETED
Pedicle Screw Placement With XVS
Lead Sponsor:
Augmedics
Conditions:
Spine Fusion
Eligibility:
All Genders
18-80 years
Phase:
NA
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, us...
Eligibility Criteria
Inclusion
- 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
- 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.
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Key Trial Info
Start Date :
May 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04682418
Start Date
May 20 2018
End Date
July 7 2021
Last Update
August 24 2021
Active Locations (3)
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1
Haemek MC
Afula, Israel
2
Sheeba Medical Center
Tel Litwinsky, Israel, 52621
3
Asaf Harofeh
Tzrifin, Israel, 70300