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

Primary Purpose

Spinal Stenosis, Lumbar Region, Spondylolisthesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D MvIGS Spine Navigation
2D Fluoroscopy
Sponsored by
7D Surgical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis, Lumbar Region focused on measuring Image guided surgery, Computer-assisted surgery, Machine vision, Navigation, Image guidance, Spine, Lumbar spine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

3D MvIGS

2D Fluoroscopy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Total Length of Operative Time
Operative time determined by the official recorded operative notes

Secondary Outcome Measures

Length of Stay
Length of hospital stay
Estimated Blood Loss (EBL)
Blood loss 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.
Complications
Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized
Measurement of Radiation Exposure
Exposure measured by Dose Area Product (DAP)
Radiation Exposure Time
Radiation exposure time

Full Information

First Posted
May 24, 2019
Last Updated
October 20, 2021
Sponsor
7D Surgical Inc.
Collaborators
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT03968965
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
7D Surgical Inc.
Collaborators
Hospital for Special Surgery, New York

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis, Lumbar Region, Spondylolisthesis
Keywords
Image guided surgery, Computer-assisted surgery, Machine vision, Navigation, Image guidance, Spine, Lumbar spine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single center, prospective, randomized cohort study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D MvIGS
Arm Type
Experimental
Arm Description
One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance.
Arm Title
2D Fluoroscopy
Arm Type
Other
Arm Description
One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.
Intervention Type
Device
Intervention Name(s)
3D MvIGS Spine Navigation
Intervention Description
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
Other
Intervention Name(s)
2D Fluoroscopy
Intervention Description
Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.
Primary Outcome Measure Information:
Title
Mean Total Length of Operative Time
Description
Operative time determined by the official recorded operative notes
Time Frame
Data captured up to four hours after end of surgery
Secondary Outcome Measure Information:
Title
Length of Stay
Description
Length of hospital stay
Time Frame
Data captured upon patient discharge.
Title
Estimated Blood Loss (EBL)
Description
Blood loss during surgery
Time Frame
During surgery
Title
Number of Misaligned Screws
Description
Number of screws that were misaligned as defined by discrepancies between the pilot hole and preoperative plan and final screw trajectory.
Time Frame
During hospital admission after surgery, an average of approximately 14 days
Title
Complications
Description
Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized
Time Frame
During hospital admission after surgery, an average of approximately 14 days
Title
Measurement of Radiation Exposure
Description
Exposure measured by Dose Area Product (DAP)
Time Frame
During surgery
Title
Radiation Exposure Time
Description
Radiation exposure time
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank P Cammisa, Jr., MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30743024
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.
Results Reference
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PubMed Identifier
30291261
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.
Results Reference
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Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation

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