Scoliosis, Spinal Stenosis, Spondylolisthesis
Conditions
Brief summary
The goal of this study is to prospectively collect information about the operative time and intraoperative radiation experienced by patients undergoing posterior spinal fusion procedures guided by the MvIGS spine navigation system.
Detailed description
This is a single-center, prospective case series to assess the use of the Machine-vision Image Guided Surgery (MvIGS) spine navigation system for treatment of spinal stenosis, scoliosis, and spondylolisthesis that requires fusion. This is a single-arm, open-label study. All participants will undergo their single and multi-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under MvIGS intraoperative navigation guidance.
Interventions
DEVICEMachine-vision Image Guided Surgery (MvIGS) spine navigation system.
The intended use of the MvIGS navigation system is to provide high quality intraoperative imaging with no radiation exposure. Use of the proprietary integrated surgical light with embedded tracking technology and Flash™ registration allows for continuous and direct visualization of the surgical field. The MvIGS system is exempt from IDE regulations as the device cleared Premarket Notification FDA-510(k) (K162375). The device includes: * A single mobile cart with a boom arm and an integrated surgical light with embedded tracking technology (P/N 10-0001); * Proprietary imaging software (P/N 60-0007); and, * Kit of tacked surgical instruments including a spine reference clamp, awl tip, pedicle probe (P/N 11-0006).
Sponsors
7D Surgical Inc.
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis, all grades, and planning to undergo surgical fusion; * Skeletally mature adults between the ages of 18-85 years at the time of surgery; * Has completed at least 6 months of conservative therapy for degenerative diagnosis, if appropriate; and, * Personally signed and dated an 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
* History of malignancy, craniocervical junction pathology, cervical and thoracic locations, and/or previous lumbar operation; * Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis; * Significant peripheral vascular disease (defined as diminished dorsalis pedis or tibial pulses); * Morbid obesity, defined as BMI \> 40 kg/m2; * Active systemic or local infection; * Active hepatitis (defined as receiving medical treatment within two years); * Immunocompromised, such as but not limited to being diagnosed with Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, or 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; * 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; * Non-English speaking; * Patients who are incarcerated; * Worker's compensation cases; or, * Patients involved in active litigation relating to his/her spinal condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total length of operative time | Visit 1 Day 1 | The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of time to place all screws | Visit 1 Day 1 | Aim: To reduce the time for screw placement Measured: Minutes |
| Estimated blood loss (EBL) | Visit 1 Day 1 | Aim: To reduce the EBL of each case Measured: Millilitres (mL) |
| Dose of intraoperative ionizing radiation | Visit 1 Day 1 | Aim: To reduce intraoperative ionizing radiation Measured: Total amount of the radiation dose in millisievert (mSv) |
| Length of time to register images | Visit 1 Day 1 | Aim: To reduce time for registration of reference images Measured: Seconds |
| incidence of intraoperative complications | Visit 1 Day 1 | Aim: To decrease the incidence of intraoperative complications Measured: Number of reported complications |
| Time to ambulation | Post operative hospital visit (Day 1-10) | Aim: To reduce time to ambulation Measured: Days |
| Time to hospital discharge after surgery | Post operative hospital visit (Day 1-10) | Aim: To reduce hospital length of stay Measured: Days |
| Screw placement accuracy | Visit 1 Day 1 | Aim: To improve screw placement accuracy Measured: Graded using radiographic classification and clinical revision rate |
Outcome results
None listed