Camilo A Molina 1,2 , Daniel M Sciubba 2 , Jacob K Greenberg 1 , Majid Khan 3 , Timothy Witham 2 Show Affiliations »
Abstract
BACKGROUND: Augmented reality mediated spine surgery is a novel technology for spine navigation. Benchmark cadaveric data have demonstrated high accuracy and precision leading to recent regulatory approval. Absence of respiratory motion in cadaveric studies may positively bias precision and accuracy results and analogous investigations are prudent in live clinical scenarios. OBJECTIVE: To report a technical note, accuracy, precision analysis of the first in-human deployment of this technology. METHODS: A 78-yr-old female underwent an L4-S1 decompression, pedicle screw, and rod fixation for degenerative spine disease. Six pedicle screws were inserted via AR-HMD (xvision; Augmedics, Chicago, Illinois) navigation. Intraoperative computed tomography was used for navigation registration as well as implant accuracy and precision assessment. Clinical accuracy was graded per the Gertzbein-Robbins (GS) scale by an independent neuroradiologist. Technical precision was analyzed by comparing 3-dimensional (3D) (x, y, z) virtual implant vs real implant position coordinates and reported as linear (mm) and angular (°) deviation. Present data were compared to benchmark cadaveric data. RESULTS: Clinical accuracy (per the GS grading scale) was 100%. Technical precision analysis yielded a mean linear deviation of 2.07 mm (95% CI: 1.62-2.52 mm) and angular deviation of 2.41° (95% CI: 1.57-3.25°). In comparison to prior cadaveric data (99.1%, 2.03 ± 0.99 mm, 1.41 ± 0.61°; GS accuracy 3D linear and angular deviation, respectively), the present results were not significantly different (P > .05). CONCLUSION: The first in human deployment of the single Food and Drug Administration approved AR-HMD stereotactic spine navigation platform demonstrated clinical accuracy and technical precision of inserted hardware comparable to previously acquired cadaveric studies. © Congress of Neurological Surgeons 2020.
BACKGROUND: Augmented reality mediated spine surgery is a novel technology for spine navigation. Benchmark cadaveric data have demonstrated high accuracy and precision leading to recent regulatory approval. Absence of respiratory motion in cadaveric studies may positively bias precision and accuracy results and analogous investigations are prudent in live clinical scenarios. OBJECTIVE: To report a technical note, accuracy, precision analysis of the first in-human deployment of this technology. METHODS: A 78-yr-old female underwent an L4-S1 decompression, pedicle screw, and rod fixation for degenerative spine disease . Six pedicle screws were inserted via AR-HMD (xvision; Augmedics, Chicago, Illinois) navigation. Intraoperative computed tomography was used for navigation registration as well as implant accuracy and precision assessment. Clinical accuracy was graded per the Gertzbein-Robbins (GS ) scale by an independent neuroradiologist. Technical precision was analyzed by comparing 3-dimensional (3D) (x, y, z) virtual implant vs real implant position coordinates and reported as linear (mm) and angular (°) deviation. Present data were compared to benchmark cadaveric data. RESULTS: Clinical accuracy (per the GS grading scale) was 100%. Technical precision analysis yielded a mean linear deviation of 2.07 mm (95% CI: 1.62-2.52 mm) and angular deviation of 2.41° (95% CI: 1.57-3.25°). In comparison to prior cadaveric data (99.1%, 2.03 ± 0.99 mm, 1.41 ± 0.61°; GS accuracy 3D linear and angular deviation, respectively), the present results were not significantly different (P > .05). CONCLUSION: The first in human deployment of the single Food and Drug Administration approved AR-HMD stereotactic spine navigation platform demonstrated clinical accuracy and technical precision of inserted hardware comparable to previously acquired cadaveric studies. © Congress of Neurological Surgeons 2020.
Entities: Chemical
Disease
Species
Keywords:
Augmented reality; Computer-assisted spine surgery; Mixed reality; Spine navigation
Mesh： See more »
Year: 2021
PMID： 33377137 DOI： 10.1093/ons/opaa398
Source DB: PubMed Journal: Oper Neurosurg (Hagerstown) ISSN： 2332-4252 Impact factor: 2.703