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

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

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.

Study Overview

• Status: Completed
• Conditions: Spondylolisthesis; Spinal Stenosis, Lumbar Region
• Intervention / Treatment: Device: 3D MvIGS Spine Navigation; Other: 2D Fluoroscopy

Detailed Description

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
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3D MvIGS; 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; 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.
OTHER: 2D Fluoroscopy; One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.	Other: 2D Fluoroscopy; Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 7D Surgical Inc.
• Collaborators: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Frank P Cammisa, Jr., MD, Hospital for Special Surgery, New York

Publications and helpful links

General Publications

• Guha D, Jakubovic R, Alotaibi NM, Klostranec JM, Saini S, Deorajh R, Gupta S, Fehlings MG, Mainprize TG, Yee A, Yang VXD. Optical Topographic Imaging for Spinal Intraoperative Three-Dimensional Navigation in Mini-Open Approaches: A Prospective Cohort Study of Initial Preclinical and Clinical Feasibility. World Neurosurg. 2019 May;125:e863-e872. doi: 10.1016/j.wneu.2019.01.201. Epub 2019 Feb 8.
• Jakubovic R, Guha D, Gupta S, Lu M, Jivraj J, Standish BA, Leung MK, Mariampillai A, Lee K, Siegler P, Skowron P, Farooq H, Nguyen N, Alarcon J, Deorajh R, Ramjist J, Ford M, Howard P, Phan N, Costa LD, Heyn C, Tan G, George R, Cadotte DW, Mainprize T, Yee A, Yang VXD. High Speed, High Density Intraoperative 3D Optical Topographical Imaging with Efficient Registration to MRI and CT for Craniospinal Surgical Navigation. Sci Rep. 2018 Oct 5;8(1):14894. doi: 10.1038/s41598-018-32424-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2018
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (ACTUAL): May 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Image guidance; Navigation; Image guided surgery; Lumbar spine; Spine; Computer-assisted surgery; Machine vision
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: 2018-0328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No