Spinal Stenosis, Lumbar RegionNCT03968965
Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation
A study testing 3D MvIGS Spine Navigation and 2D Fluoroscopy in people with Spinal Stenosis, Lumbar Region and Spondylolisthesis, run by 7D Surgical Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal Stenosis, Lumbar Region, Spondylolisthesis
- What is being tested?
- 3D MvIGS Spine Navigation and 2D Fluoroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Single-Center, Prospective Cohort Study of the Machine-vision Image Guided Surgery (MvIGS) Spine Navigation System
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.
Read the 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
- Being tested
- 3D MvIGS Spine Navigation, 2D Fluoroscopy
- Keywords
- Image guided surgery, Computer-assisted surgery, Machine vision, Navigation, Image guidance, Spine, Lumbar spine
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D MvIGS Spine NavigationDevice
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 FluoroscopyOther
Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.
| Study group | Role | What they receive |
|---|---|---|
| 3D MvIGS | Experimental | One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance. Receives: 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. Receives: Other: 2D Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Total Length of Operative Time
Operative time determined by the official recorded operative notes
Measured: Data captured up to four hours after end of surgery
Secondary outcomes (6)
Length of Stay
Length of hospital stay
Measured: Data captured upon patient discharge.
Estimated Blood Loss (EBL)
Blood loss during surgery
Measured: 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.
Measured: During hospital admission after surgery, an average of approximately 14 days
Complications
Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized
Measured: During hospital admission after surgery, an average of approximately 14 days
Measurement of Radiation Exposure
Exposure measured by Dose Area Product (DAP)
Measured: During surgery
Radiation Exposure Time
Radiation exposure time
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start9 May 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Stenosis, Lumbar RegionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, prospective, randomized cohort study.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- 7D Surgical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital for Special Surgery, New York
- Responsible party
- Sponsor
- Investigators
- Frank P Cammisa, Jr., MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968965
- Sponsor's protocol ID
- 2018-0328
- Status last verified
- Mar 2021
- First submitted
- 24 May 2019
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 30743024Jakubovic 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.
PubMed 30291261
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective Cohort Study of the Machine-vision Image Guided Surgery (MvIGS) Spine Navigation System
- ClinicalTrials.gov ID
- NCT03968965
- Acronym / sponsor ID
- 2018-0328
- Conditions
- Spinal Stenosis, Lumbar Region, Spondylolisthesis
- Keywords
- Image guided surgery, Computer-assisted surgery, Machine vision, Navigation, Image guidance, Spine, Lumbar spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- 7D Surgical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hospital for Special Surgery, New York
- Study start
- 9 May 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Posted 27 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single center, prospective, randomized cohort study.
| Arm | Type | Receives |
|---|---|---|
| 3D MvIGS | Experimental | Device: 3D MvIGS Spine NavigationOne, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance. |
| 2D Fluoroscopy | Other | Other: 2D FluoroscopyOne, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D MvIGS Spine NavigationThe 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. | Device | 3D MvIGS |
| 2D FluoroscopyPedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality. | Other | 2D Fluoroscopy |
Primary outcome
Mean Total Length of Operative Time
Time frame: Data captured up to four hours after end of surgery
Operative time determined by the official recorded operative notes
6 secondary outcomes
Length of Stay
Time frame: Data captured upon patient discharge.
Estimated Blood Loss (EBL)
Time frame: During surgery
Number of Misaligned Screws
Time frame: During hospital admission after surgery, an average of approximately 14 days
Complications
Time frame: During hospital admission after surgery, an average of approximately 14 days
Measurement of Radiation Exposure
Time frame: During surgery
Radiation Exposure Time
Time frame: During surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30743024Guha 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.
- Background: PubMed 30291261Jakubovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank P Cammisa, Jr., MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D MvIGS Spine Navigation and 2D Fluoroscopy in people with Spinal Stenosis, Lumbar Region and Spondylolisthesis, run by 7D Surgical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Total Length of Operative Time (time frame: Data captured up to four hours after end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968965, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.