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

NCT03968965 | Completed Results FDA Device

• 1 other identifier: 2018-0328
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis, Lumbar Region; Spondylolisthesis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Length of Stay

  Data captured upon patient discharge.

• Estimated Blood Loss (EBL)

  During surgery

• Number of Misaligned Screws

  During hospital admission after surgery, an average of approximately 14 days

• Complications

  During hospital admission after surgery, an average of approximately 14 days

• Measurement of Radiation Exposure

  During surgery

Study Arms (2)

3D MvIGS

EXPERIMENTAL

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

2D Fluoroscopy

OTHER

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

Other: 2D Fluoroscopy

Interventions

3D MvIGS Spine Navigation 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.

3D MvIGS

2D Fluoroscopy OTHER

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

2D Fluoroscopy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 7D Surgical Inc.: lead
• Hospital for Special Surgery, New York: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (2)

• 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.

  PMID: 30743024 BACKGROUND

• 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.

  PMID: 30291261 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Results Point of Contact

• Title: Celeste Abjornson
• Organization: Hospital for Special Surgery

AbjornsonC@HSS.edu

2127742126

Study Officials

• Frank P Cammisa, Jr., MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single center, prospective, randomized cohort study.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 30, 2019
• Study Start: May 9, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 1, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-03

Locations

US (1)