Trial Outcomes & Findings for Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions (NCT NCT03015142)

NCT ID: NCT03015142

Last Updated: 2022-03-08

Results Overview

Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification. Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach \< 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach \> 4 mm. Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers.

• Recruitment status: COMPLETED
• Target enrollment: 21 participants
• Primary outcome timeframe: During surgery, mean 6.71 hours
• Results posted on: 2022-03-08

Participant Flow

Participant milestones

Measure	New Image-guidance Software Patients who had spine surgery with new image-guidance software.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions

Baseline characteristics by cohort

Measure	New Image-guidance Software n=21 Participants Patients who had spine surgery with new image-guidance software
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants
Region of Enrollment Sweden	21 participants n=5 Participants

PRIMARY outcome

Timeframe: During surgery, mean 6.71 hours

Population: 20 subjects were treated with the new image-guidance software. One was treated in the conventional method placing screws by free-hand method. Total of 253 screws (163 in thoracic, 77 in lumbar and 13 in sacral regions) were placed with new image-guidance software.

Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification.

Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach < 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach > 4 mm.

Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers.

Outcome measures

Measure	New Image-guidance Software n=253 Screw placements Patients who had spine surgery with new image-guidance software
Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software	94.1 Percentage of screw placements Interval 90.4 to 96.6

SECONDARY outcome

Timeframe: During surgery, mean 6.71 hours

Time from skin incision to skin closure

Outcome measures

Measure	New Image-guidance Software n=20 Participants Patients who had spine surgery with new image-guidance software
Procedure Time	6.71 Hours Standard Deviation 1.69

SECONDARY outcome

Timeframe: Intraoperative, mean 5.18 hours

Outcome measures

Measure	New Image-guidance Software n=20 Participants Patients who had spine surgery with new image-guidance software
Time to Insert Pedicle Screw	5.18 Minutes Standard Deviation 4.03

SECONDARY outcome

Timeframe: From start of the interventional procedure until hospital discharge, approximately 5.3 days

Outcome measures

Measure	New Image-guidance Software n=20 Participants Patients who had spine surgery with new image-guidance software
Length of Hospitalization	5.3 Days Standard Deviation 1.71

SECONDARY outcome

Timeframe: End of all surgeries

Population: Four independent physicians provided feedback via a validated system usability score (SUS)

The SUS is a validated standard questionnaire to evaluate the system usability. Score varies between 0 and 100 (0 meaning the lowest usability score, 100 meaning highest usability score).

Outcome measures

Measure	New Image-guidance Software n=4 Participants Patients who had spine surgery with new image-guidance software
System Usability Score (SUS Score)	75.6 Scores on a scale Standard Deviation 13.9

SECONDARY outcome

Timeframe: During surgery, mean 6.71 hours

Radiation dose measured in Air Kerma (AK)

Outcome measures

Measure	New Image-guidance Software n=20 Participants Patients who had spine surgery with new image-guidance software
Patient Radiation Dose	158.60 mGy (AK) Standard Deviation 71.014

SECONDARY outcome

Timeframe: During surgery, mean 6.71 hours

Radiation dose measured in Dose Area Product (DAP)

Outcome measures

Measure	New Image-guidance Software n=20 Participants Patients who had spine surgery with new image-guidance software
Patient Radiation Dose	31.26 Gy.cm^2 (DAP) Standard Deviation 12.604

SECONDARY outcome

Timeframe: During surgery, mean 6.71 hours

Population: There were 2 cases out of the 20 patients were the dosage information was missing.

Outcome measures

Measure	New Image-guidance Software n=18 Participants Patients who had spine surgery with new image-guidance software
Radiation Dose (Effective Dose) Received by Operator	0.21 μSv Standard Deviation 0.261

SECONDARY outcome

Timeframe: During surgery, mean 6.71 hours

Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).

Outcome measures

Measure	New Image-guidance Software n=20 Participants Patients who had spine surgery with new image-guidance software
Procedure Related Complications	3 Procedure related complications

SECONDARY outcome

Timeframe: From start of enrollment until hospital discharge, approximately 51 days

Population: 21 patients enrolled, 20 patients treated with new image-guidance software

Outcome measures

Measure	New Image-guidance Software n=21 Participants Patients who had spine surgery with new image-guidance software
Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event Adverse Events (serious and non-serious)	5 Events
Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event Adverse Device Effects	0 Events
Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event Device deficiencies that could have led to SAE	0 Events

Adverse Events

New Image-guidance Software

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	New Image-guidance Software n=20 participants at risk Patients who had spine surgery with new image-guidance software
Surgical and medical procedures Pain right leg due to foramina stenosis by L5 screw. Screw was placed by free-hand.	5.0% 1/20 • Number of events 1 • From start of enrollment until hospital discharge, approximately 51 days

Other adverse events

Measure	New Image-guidance Software n=20 participants at risk Patients who had spine surgery with new image-guidance software
Surgical and medical procedures Horner's syndrome	5.0% 1/20 • Number of events 1 • From start of enrollment until hospital discharge, approximately 51 days
Surgical and medical procedures Postoperative pain	5.0% 1/20 • Number of events 1 • From start of enrollment until hospital discharge, approximately 51 days
Surgical and medical procedures Repeated Xper-CT	5.0% 1/20 • Number of events 1 • From start of enrollment until hospital discharge, approximately 51 days
Surgical and medical procedures Urticaria	5.0% 1/20 • Number of events 1 • From start of enrollment until hospital discharge, approximately 51 days

Additional Information

Rami Nachabe

Philips

Phone: +1-513-926-1486

Email: rami.nachabe@philips.com

Results disclosure agreements

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