Spinal Stenosis, Lumbar Region, Spondylolisthesis
Conditions
Keywords
Image guided surgery, Computer-assisted surgery, Machine vision, Navigation, Image guidance, Spine, Lumbar spine
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.
Interventions
DEVICE3D 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.
OTHER2D Fluoroscopy
Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.
Sponsors
Hospital for Special Surgery, New York
7D Surgical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single center, prospective, randomized cohort study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss (EBL) | During surgery | Blood loss during surgery |
| 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. |
| Length of Stay | Data captured upon patient discharge. | Length of hospital stay |
| Measurement of Radiation Exposure | During surgery | Exposure measured by Dose Area Product (DAP) |
| Radiation Exposure Time | During surgery | Radiation exposure time |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3D MvIGS One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 3D MvIGS intraoperative navigation guidance.
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. | 32 |
| 2D Fluoroscopy One, two and three-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under 2D fluoroscopy.
2D Fluoroscopy: Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality. | 30 |
| Total | 62 |
Baseline characteristics
| Characteristic | 2D Fluoroscopy | Total | 3D MvIGS |
|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 9.2 | 62.3 years STANDARD_DEVIATION 11.1 | 60.7 years STANDARD_DEVIATION 12.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 participants | 62 participants | 32 participants |
| Sex: Female, Male Female | 20 Participants | 37 Participants | 17 Participants |
| Sex: Female, Male Male | 10 Participants | 25 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 30 |
| other Total, other adverse events | 0 / 32 | 0 / 30 |
| serious Total, serious adverse events | 0 / 32 | 0 / 30 |
Outcome results
Primary
Mean Total Length of Operative Time
Operative time determined by the official recorded operative notes
Time frame: Data captured up to four hours after end of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3D MvIGS | Mean Total Length of Operative Time | 218 minutes | Standard Deviation 37 |
| 2D Fluoroscopy | Mean Total Length of Operative Time | 218.5 minutes | Standard Deviation 49 |
Secondary
Complications
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3D MvIGS | Complications | 0 complications |
| 2D Fluoroscopy | Complications | 0 complications |
Secondary
Estimated Blood Loss (EBL)
Blood loss during surgery
Time frame: During surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3D MvIGS | Estimated Blood Loss (EBL) | 408.6 mL | Standard Deviation 361.1 |
| 2D Fluoroscopy | Estimated Blood Loss (EBL) | 424.8 mL | Standard Deviation 211.8 |
Secondary
Length of Stay
Length of hospital stay
Time frame: Data captured upon patient discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3D MvIGS | Length of Stay | 95.3 Hours | Standard Deviation 34.7 |
| 2D Fluoroscopy | Length of Stay | 98.4 Hours | Standard Deviation 42.9 |
Secondary
Measurement of Radiation Exposure
Exposure measured by Dose Area Product (DAP)
Time frame: During surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3D MvIGS | Measurement of Radiation Exposure | 10.3 mGy | Standard Deviation 7.75 |
| 2D Fluoroscopy | Measurement of Radiation Exposure | 12.6 mGy | Standard Deviation 7.3 |
Secondary
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.
Time frame: During hospital admission after surgery, an average of approximately 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3D MvIGS | Number of Misaligned Screws | 2 screws |
| 2D Fluoroscopy | Number of Misaligned Screws | 3 screws |
Secondary
Radiation Exposure Time
Radiation exposure time
Time frame: During surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3D MvIGS | Radiation Exposure Time | 17.7 seconds | Standard Deviation 11.23 |
| 2D Fluoroscopy | Radiation Exposure Time | 18.7 seconds | Standard Deviation 8.19 |