Clinical trial NCT03968965: Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation
Official title: A Single-Center, Prospective Cohort Study of the Machine-vision Image Guided Surgery (MvIGS) Spine Navigation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis, Lumbar Region
Spondylolisthesis
Keywords: Image guided surgery
Computer-assisted surgery
Machine vision
Navigation
Image guidance
Spine
Lumbar spine
Lead sponsor: 7D Surgical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hospital for Special Surgery, New York
First posted: 2019-05-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single center, prospective, randomized cohort study.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Total Length of Operative Time
timeFrame: Data captured up to four hours after end of surgery
Secondary outcomes:
measure: Length of Stay
timeFrame: Data captured upon patient discharge.
measure: Estimated Blood Loss (EBL)
timeFrame: During surgery
measure: Number of Misaligned Screws
timeFrame: During hospital admission after surgery, an average of approximately 14 days
measure: Complications
timeFrame: During hospital admission after surgery, an average of approximately 14 days
measure: Measurement of Radiation Exposure
timeFrame: During surgery
measure: Radiation Exposure Time
timeFrame: During surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Frank P Cammisa, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.