This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults. There will be separate study arms for cases utilizing the three-dimensional (3D) MvIGS spine navigation system and cases that utilize conventional two-dimensional (2D) fluoroscopy.
This is a single center, randomized, prospective cohort study to comparatively evaluate the implementation of the MvIGS spine navigation system to conventional 2D fluoroscopy for pedicle screw fixation for the treatment of spinal stenosis with degenerative spondylolisthesis of the lumbar spine. Fluoroscopy and the MvIGS navigation system are both intraoperative imaging options available to aid spine surgeons. Fluoroscopy uses X-rays to obtain images of patient anatomy. The MvIGS spine navigation system provides patient specific, high quality intraoperative imaging with no radiation exposure. After the spine is exposed, intraoperative images are obtained using visible light then registered to the patient's preoperative computed tomography scan. Use of the proprietary integrated surgical light with embedded tracking technology and Instant Flash™ registration allows for continuous and direct visualization of the surgical field without disturbing surgeon workflow.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
The 7D Surgical MvIGS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. The surgical light containing the machine vision cameras is the sole luminaire during image guided surgery.
Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.
Hospital for Special Surgery
New York, New York, United States
Mean Total Length of Operative Time
Operative time determined by the official recorded operative notes
Time frame: Data captured up to four hours after end of surgery
Length of Stay
Length of hospital stay
Time frame: Data captured upon patient discharge.
Estimated Blood Loss (EBL)
Blood loss during surgery
Time frame: During surgery
Number of Misaligned Screws
Number of screws that were misaligned as defined by discrepancies between the pilot hole and preoperative plan and final screw trajectory.
Time frame: During hospital admission after surgery, an average of approximately 14 days
Complications
Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized
Time frame: During hospital admission after surgery, an average of approximately 14 days
Measurement of Radiation Exposure
Exposure measured by Dose Area Product (DAP)
Time frame: During surgery
Radiation Exposure Time
Radiation exposure time
Time frame: During surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.