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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Diseases
• Intervention / Treatment: Device: New image-guidance software

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients > 16 years.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
New image-guidance software; Patients in this group had spine surgery with new image-guidance software application.	Device: New image-guidance software; Patients in this group had spine surgery with new image-guidance software application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Accuracy of Pedicle Screw Placement Using 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.	During surgery, mean 6.71 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	Time from skin incision to skin closure	During surgery, mean 6.71 hours
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)	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).	End of all surgeries
Patient Radiation Dose	Radiation dose measured in Air Kerma (AK)	During surgery, mean 6.71 hours
Patient Radiation Dose	Radiation dose measured in Dose Area Product (DAP)	During surgery, mean 6.71 hours
Radiation Dose (Effective Dose) Received by Operator		During surgery, mean 6.71 hours
Procedure Related Complications	Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).	During surgery, mean 6.71 hours
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

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Adrian Elmi-Terander, MD, Karolinska University Hospital

Publications and helpful links

Helpful Links

• Pedicle Screw Placement Using Augmented Reality Surgical Navigation with Intraoperative 3D Imaging. A First In-Human Prospective Cohort Study.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2016
• Primary Completion (Actual): October 8, 2017
• Study Completion (Actual): October 8, 2017

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: XCY607-130099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No