Orthofix is committed to the development of evidence supporting improvements to scientific advancements and clinical knowledge in patient outcomes around the world.
A 49-year-old man presented with a traumatic sagittal split fracture of C4 and a left lateral mass fracture of C5 with anterior depression and 50% height loss, strain of the interspinous/supraspinous ligaments, fluid within the left C4-C5 facet joint, Klippel-Feil syndrome with autofusion of the…
This operative technique describes a novel application of 7D navigation system in a minimally invasive approach for posterior lumbar interbody fusion with percutaneous screw placement. This technique was found to be efficient, reliable and requires a systematic study to further evaluate long-term…
MvIGS reduced the operative time by 63.6 minutes and reduced intraoperative radiation exposure by 66%, which may play an important role in reducing the risks to the surgeon and operating room staff associated with radiation in spinal surgery procedures.
MvIGS for screw insertion in PSF contributed to a significant reduction in intraoperative radiation exposure and fluoroscopy time, as well as blood loss and length of stay. The real-time feedback and ability to visualize the pedicle in 3D with MvIGS enabled greater curve correction without increa…
“Ultra-low dose” CT scans without sedation were feasible in paediatric patients with neuromuscular scoliosis. The effective dose was similar between the standard preoperative spinal XR and “ultra-low dose” CT scans. The “ultra-low dose” CT scan allowed accurate assessment of the anatomy, aided in…
The use of optic technology in skull base surgeries has the potential to revolutionize the field of medicine, particularly neurosurgery and neurology. In this review, the present the past, present, and future of skull-base surgery is explored, with an emphasis on the applications of optical topog…
Spinal instability and shifting anatomy due to unstable spinal fratures can make spinal fixation challenging. FLASH Navigation resulted in accurate registration, easy and efficient workflow and limited radiation in a T7-L1 posterolateral fusion for a traumatic unstable thoracolumbar fracture.
Image-guided neuronavigation was used to improve the accuracy and the safety of subaxial cervical pedicle screw placement, given their increased difficulty of cannulation relative to the larger pedicles in the thoracolumbar spine.
This operative technique outlines an efficient technique with placement of navigated percutaneous pedicle screws using an optical topographic navigation approach combined with open placement of interbody cage using a midline open incision, without extensive dissection and intraoperative radiation ex
This study is a retrospective cohort investigation of 150 consecutive patients who underwent spinal instrumentation placement utilizing visible light navigation. The objective was to determine the utility of the navigation system and its strengths and weaknesses as well as to assess patient safety
Randomized study comparing 7D to 3D Nav. 7D & 3D Nav demonstrate high accuracy for screw placement. 7D showed significant reduction in intraop radiation time (94.3%) & dose (97.8%). 7D does not require 3D-fluoro or radiolucent operating tables; reduced registration time & equip may reduce costs.
CTA-guided navigation creates 3d reconstruction of cervical spine anatomy to assist surgeons. Machine-Vision system registers in seconds, minimizing operative time with no additional radiation exposure. Surgeons can better adjust for abnormal vertebral artery anatomy and increase procedure safety
Image-guided navigation has become an accepted & proven technology for improving accuracy of spine fixation screws. Machine-Vision is the most recent iteration, providing same level of accuracy as other nav systems but with greater intraop workflow efficiency & without the need for intraop radiation
Clinical study of 118 patients undergoing a craniotomy or spinal procedure using navigation. The 7D System provided automatic registration in <3 seconds, with average time from optical imaging to navigation being 46 seconds.
Optical technology can be used for intraoperative image guidance and instrument tracking in spine surgery. The 7D System is the first navigation system to use structured light for patient-to-image registration, which is significantly faster than other techniques and has equivalent accuracy.
The 7D System uses an all-optical nonionizing structured light and advanced machine vision algorithms to quickly achieve image registration, reducing the steps required to set up and operate an image guided surgery system, leading to a fast workflow with a short learning curve
Cadaveric and clinical study quantifying geometric symmetry in posterior spine exposures and identifying potential predictors of navigation error. Geometric congruence is greatest at C1 and subaxial cervical spine. Including the base of the spinous process in registration improves accuracy.
Retrospective review of 6 patients with posterior cervical instrumentation using the 7D System. Accuracy of the system shows it is comparable to other navigation systems, but with a more efficient registration process that doesn’t interrupt surgeon workflow.
Identified a technique to use the 7D System to reduce the incidence of wrong level spine surgery. 4 detectors were tested with 310 measurements from 46 cases; each detector determined if the level was correct with 94% accuracy.
Prospective clinical and cadaveric study investigating accuracy of the 7D System when navigating distant to the spine reference frame and registered vertebral body. Results showed that navigating instruments within 2 levels of the reference frame minimizes risk of navigation error.
Prospective clinical study of 162 pedicle screws comparing 7D System to two legacy navigation systems indicates significant workflow improvement with a decrease of registration time and setup (41s vs. 258s vs. 794s respectively) without compromising accuracy (no difference in breach rate or error).
Prospective clinical and cadaveric study testing the accuracy of the 7D System in the cervical spine with an open posterior approach showed comparable accuracy in the cervical spine as with open thoracolumbar procedures, and comparable accuracy to other spinal navigation systems.
Prospective clinical and cadaveric study investigating the accuracy of the 7D System with mini-open exposures of 25-40mm showed comparable accuracy of mini open to open exposures, and demonstrated successful registration is dependent on number of surface point registrations and not exposure size.
Registration with the 7D System allows for segmental registration and accuracy of each vertebrae and quick re-registration if reference frame is displaced. It uses visible bone for structured light imaging, capturing >250,000 data points. It is highly recommended for open posterior spine procedures.
Phantom and clinical study to develop augmented reality feature for the 7D System to maintain precision and accuracy of surgical navigation by superimposing pedicle safe zones as see-through lines on live video feed to help visualize target trajectories relative to patient anatomy.
Randomized, prospective study of 26 patients with spine surgery using 2D fluoroscopy or 3D navigation (7D). The 7D System reduced total radiation exposure time and dose (27.4s vs 28.8s and 14.3mGy vs. 16.1mGy). Mean operative time was 236 min vs. 251 min, indicating 7D did not disturb workflow.
