Trial Outcomes & Findings for Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation (NCT NCT03968965)

NCT ID: NCT03968965

Last Updated: 2021-11-01

Results Overview

Operative time determined by the official recorded operative notes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: Data captured up to four hours after end of surgery
• Results posted on: 2021-11-01

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	32	32
Overall Study COMPLETED	32	30
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	3D MvIGS n=32 Participants 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.	2D Fluoroscopy n=30 Participants 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.	Total n=62 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 12.5 • n=32 Participants	63.9 years STANDARD_DEVIATION 9.2 • n=30 Participants	62.3 years STANDARD_DEVIATION 11.1 • n=62 Participants
Sex: Female, Male Female	17 Participants n=32 Participants	20 Participants n=30 Participants	37 Participants n=62 Participants
Sex: Female, Male Male	15 Participants n=32 Participants	10 Participants n=30 Participants	25 Participants n=62 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	32 participants n=32 Participants	30 participants n=30 Participants	62 participants n=62 Participants

PRIMARY outcome

Timeframe: Data captured up to four hours after end of surgery

Operative time determined by the official recorded operative notes

Outcome measures

Measure	3D MvIGS n=32 Participants 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.	2D Fluoroscopy n=30 Participants 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.
Mean Total Length of Operative Time	218 minutes Standard Deviation 37	218.5 minutes Standard Deviation 49

SECONDARY outcome

Timeframe: Data captured upon patient discharge.

Length of hospital stay

Outcome measures

Measure	3D MvIGS n=32 Participants 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.	2D Fluoroscopy n=30 Participants 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.
Length of Stay	95.3 Hours Standard Deviation 34.7	98.4 Hours Standard Deviation 42.9

SECONDARY outcome

Timeframe: During surgery

Blood loss during surgery

Outcome measures

Measure	3D MvIGS n=32 Participants 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.	2D Fluoroscopy n=30 Participants 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.
Estimated Blood Loss (EBL)	408.6 mL Standard Deviation 361.1	424.8 mL Standard Deviation 211.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	3D MvIGS n=69 Pedicle Screws 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.	2D Fluoroscopy n=88 Pedicle Screws 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.
Number of Misaligned Screws	2 screws	3 screws

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	3D MvIGS n=32 Participants 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.	2D Fluoroscopy n=30 Participants 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.
Complications	0 complications	0 complications

SECONDARY outcome

Timeframe: During surgery

Exposure measured by Dose Area Product (DAP)

Outcome measures

Measure	3D MvIGS n=32 Participants 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.	2D Fluoroscopy n=30 Participants 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.
Measurement of Radiation Exposure	10.3 mGy Standard Deviation 7.75	12.6 mGy Standard Deviation 7.30

SECONDARY outcome

Timeframe: During surgery

Radiation exposure time

Outcome measures

Measure	3D MvIGS n=32 Participants 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.	2D Fluoroscopy n=30 Participants 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.
Radiation Exposure Time	17.7 seconds Standard Deviation 11.23	18.7 seconds Standard Deviation 8.19

Adverse Events

3D MvIGS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2D Fluoroscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Celeste Abjornson

Hospital for Special Surgery

Phone: 2127742126

Email: AbjornsonC@HSS.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place