Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single-Center, Prospective Cohort Study of the Machine-vision Image Guided Surgery (MvIGS) Spine Navigation System

Conditions
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Spinal Stenosis, Lumbar Region, Spondylolisthesis

Intervention / Treatment
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* Device: 3D MvIGS Spine Navigation
* Other: 2D Fluoroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of spinal stenosis of the lumbar spine with ≤ grade 2 degenerative spondylolisthesis Skeletally mature adults between the ages of 18-85 years at the time of surgery Has completed at least 6 months of conservative therapy Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study Exclusion Criteria: Gross instability, defined as > 3 mm translational motion on flexion/extension studies Degenerative spondylolisthesis > grade 2 Degenerative scoliosis > 10° at any level in lumbar spine Congenital lumbar spinal stenosis Endplate changes Visible change in disc height Radiographic confirmation of facet joint disease or degeneration Prior surgery at any lumbar level including the level being treated except for: Lamino/Foraminotomy, Microdiscectomy, IDET, and Percutaneous Discectomy Any evidence of a prior/current fracture, compromised vertebra, current or past trauma, or tumor at affected level or the spinous processes at the adjacent levels Requires destabilizing surgical decompression that adversely affects the functioning of the facets Cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence) Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses) Morbid obesity, defined as BMI > 40 kg/m2 Active systemic or local infection Active Hepatitis (receiving medical treatment within two years) Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia Insulin dependent diabetes mellitus or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months History of Paget's disease, osteomalacia, or any other metabolic bone disease Active malignancy. A patient with a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy >5 years Involved in study of another investigational product that may affect outcome Women who are pregnant, lactating or anticipate becoming pregnant within 24 months post-surgery Patients who are incarcerated Worker's compensation cases Patients involved in active litigation relating to his/her spinal condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single center, prospective, randomized cohort study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D MvIGS<br>One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance. | Device: 3D MvIGS Spine Navigation<br>* 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.<br>|
| Other: 2D Fluoroscopy<br>One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy. | Other: 2D Fluoroscopy<br>* Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Total Length of Operative Time | Operative time determined by the official recorded operative notes | Data captured up to four hours after end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Length of hospital stay | Data captured upon patient discharge. | 
| Estimated Blood Loss (EBL) | Blood loss during surgery | 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. | 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 | During hospital admission after surgery, an average of approximately 14 days | 
| Measurement of Radiation Exposure | Exposure measured by Dose Area Product (DAP) | During surgery | 
| Radiation Exposure Time | Radiation exposure time | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Image guided surgery, Computer-assisted surgery, Machine vision, Navigation, Image guidance, Spine, Lumbar spine