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

Completed

• Conditions: Spinal Diseases
• Interventions: Device: New image-guidance software

• Registration Number: NCT03015142
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief Summary

There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries). The objective of the study was to investigate the accuracy of screw placement during spine surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-09
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-09
• Primary Completion: 2017-10-08
• Study Completion: 2017-10-08
• Results First Submitted: 2019-07-22
• Results First Submitted QC: 2019-09-03
• Results First Posted: 2019-09-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Subject undergoing a spine surgery with pedicle screw placement
• Subject 16 years of age or older
• Subject able to give informed consent

Exclusion Criteria

• Subject participating in a potentially confounding device or drug trial during the course of the study.
• Subject meeting an exclusion criteria according to national law (e.g. pregnant woman, breast feeding woman)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
New image-guidance software	New image-guidance software	Patients in this group had spine surgery with new image-guidance software application.

Primary Outcome Measures

Name	Time	Method
Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software	During surgery, mean 6.71 hours	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.

Secondary Outcome Measures

Name	Time	Method
Procedure Time	During surgery, mean 6.71 hours	Time from skin incision to skin closure
Time to Insert Pedicle Screw	Intraoperative, mean 5.18 hours
Length of Hospitalization	From start of the interventional procedure until hospital discharge, approximately 5.3 days
System Usability Score (SUS Score)	End of all surgeries	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).
Patient Radiation Dose	During surgery, mean 6.71 hours	Radiation dose measured in Dose Area Product (DAP)
Radiation Dose (Effective Dose) Received by Operator	During surgery, mean 6.71 hours
Procedure Related Complications	During surgery, mean 6.71 hours	Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).
Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event	From start of enrollment until hospital discharge, approximately 51 days

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden