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

NCT ID: NCT03968965

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-09
• Study Completion Date: 2019-11-01

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.

Conditions

Spinal Stenosis, Lumbar Region; Spondylolisthesis

Keywords

Image guided surgery; Computer-assisted surgery; Machine vision; Navigation; Image guidance; Spine; Lumbar spine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D MvIGS

One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance.

Group Type: EXPERIMENTAL

3D MvIGS Spine Navigation

Intervention Type: DEVICE

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.

2D Fluoroscopy

One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.

Group Type: OTHER

2D Fluoroscopy

Intervention Type: OTHER

Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.

Interventions

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.

Intervention Type: DEVICE

2D Fluoroscopy

Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: collaborator

7D Surgical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank P Cammisa, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30743024 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30291261 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-0328

Identifier Type: -

Identifier Source: org_study_id