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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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).
Total length of operative time
The aim is to reduce operative time. Operative time will be determined by the official recorded operative notes.
Time frame: Visit 1 Day 1
Length of time to register images
Aim: To reduce time for registration of reference images Measured: Seconds
Time frame: Visit 1 Day 1
Length of time to place all screws
Aim: To reduce the time for screw placement Measured: Minutes
Time frame: Visit 1 Day 1
Estimated blood loss (EBL)
Aim: To reduce the EBL of each case Measured: Millilitres (mL)
Time frame: Visit 1 Day 1
Dose of intraoperative ionizing radiation
Aim: To reduce intraoperative ionizing radiation Measured: Total amount of the radiation dose in millisievert (mSv)
Time frame: Visit 1 Day 1
Screw placement accuracy
Aim: To improve screw placement accuracy Measured: Graded using radiographic classification and clinical revision rate
Time frame: Visit 1 Day 1
incidence of intraoperative complications
Aim: To decrease the incidence of intraoperative complications Measured: Number of reported complications
Time frame: Visit 1 Day 1
Time to ambulation
Aim: To reduce time to ambulation Measured: Days
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Time frame: Post operative hospital visit (Day 1-10)
Time to hospital discharge after surgery
Aim: To reduce hospital length of stay Measured: Days
Time frame: Post operative hospital visit (Day 1-10)