Prospective observational study.
The aim of this study was to evaluate the accuracy of pedicle screw placement using augmented reality surgical navigation in a clinical trial.
Recent cadaveric studies have shown improved accuracy for pedicle screw placement in the thoracic spine using augmented reality surgical navigation with intraoperative 3D imaging, without the need for peri-procedural X-ray. In this clinical study, we used the same system to place pedicle screws in the thoracic and lumbosacral spine of 20 patients.
The study was performed in a hybrid operating room with an integrated augmented reality surgical navigation system encompassing a surgical table, a motorized flat detector C-arm with intraoperative 2D/3D capabilities, integrated optical cameras for augmented reality navigation, and noninvasive patient motion tracking. Three independent reviewers assessed screw placement accuracy using the Gertzbein grading on 3D scans obtained prior to wound closure. In addition, the navigation time per screw placement was measured.
One orthopedic spinal surgeon placed 253 lumbosacral and thoracic pedicle screws on 20 consenting patients scheduled for spinal fixation surgery. An overall accuracy of 94.1% of primarily thoracic pedicle screws was achieved. No screws were deemed severely misplaced (Gertzbein grade 3). Fifteen (5.9%) screws had 2–4 mm breach (Gertzbein grade 2), occurring in scoliosis patients only. Thirteen of those fifteen screws were larger than the pedicle in which they were placed. Two medial breaches were observed and thirteen were lateral. Thirteen of the grade 2 breaches were in the thoracic spine. The average screw placement time was 5.2 ± 4.1 min. During the study, no device-related adverse event occurred.
Augmented reality surgical navigation can be clinically used to place thoracic and lumbosacral pedicle screws with high accuracy and with acceptable navigation time. Consequently, the risk for revision surgery and complications could be minimized.
Level of Evidence: 3.
*Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
†Department of Neurosurgery, Karolinska University Hospital, Stockholm, Sweden
‡Department of Image Guided Therapy Systems, Philips Healthcare, Best, the Netherlands
§Department of Neurosurgery, Landspítali University Hospital, Reykjavík, Iceland
¶Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden
||Department of Clinical Sciences, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden; Department of Reconstructive Orthopaedics, Karolinska University Hospital, Stockholm, Sweden.
Address correspondence and reprint requests to Rami Nachabe, PhD, Department of Image Guided Therapy Systems, Philips Healthcare, Veenpluis 6, 5684 PC Best, the Netherlands; E-mail: email@example.com
Received 5 July, 2018
Revised 13 August, 2018
Accepted 22 August, 2018
Adrian Elmi Terander and Gustav Burström contributed equally to this work
The device that is the subject of this manuscript is not FDA-approved and is not commercially available in the United States.
Philips Healthcare/the Netherlands funds were received in support of this work.
Relevant financial activities outside the submitted work: consultancy, patents, grants, employment, travel/accommodations/meeting expenses.