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

Not Applicable

Completed

Conditions: Spinal Stenosis, Lumbar Region
Spondylolisthesis

Interventions: Other: 2D Fluoroscopy
Device: 3D MvIGS Spine Navigation

Registration Number: NCT03968965

Lead Sponsor: 7D Surgical Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 64

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2D Fluoroscopy	2D Fluoroscopy	One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.
3D MvIGS	3D MvIGS Spine Navigation	One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance.

Primary Outcome Measures

Name	Time	Method
Mean Total Length of Operative Time	Data captured up to four hours after end of surgery	Operative time determined by the official recorded operative notes

Secondary Outcome Measures

Name	Time	Method
Estimated Blood Loss (EBL)	During surgery	Blood loss during surgery
Length of Stay	Data captured upon patient discharge.	Length of hospital stay
Number of Misaligned Screws	During hospital admission after surgery, an average of approximately 14 days	Number of screws that were misaligned as defined by discrepancies between the pilot hole and preoperative plan and final screw trajectory.
Complications	During hospital admission after surgery, an average of approximately 14 days	Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized
Measurement of Radiation Exposure	During surgery	Exposure measured by Dose Area Product (DAP)
Radiation Exposure Time	During surgery	Radiation exposure time