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

Spinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015142
• Other study ID #: XCY607-130099
• Status: Completed
• Start date: November 9, 2016
• Est. completion date: October 8, 2017

Study information

• Verified date: March 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 8, 2017
• Est. primary completion date: October 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Diseases

Intervention

Device:
• New image-guidance software
Patients in this group had spine surgery with new image-guidance software application

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedure Time	Time from skin incision to skin closure	During surgery, mean 6.71 hours
Secondary	Time to Insert Pedicle Screw		Intraoperative, mean 5.18 hours
Secondary	Length of Hospitalization		From start of the interventional procedure until hospital discharge, approximately 5.3 days
Secondary	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
Secondary	Patient Radiation Dose	Radiation dose measured in Air Kerma (AK)	During surgery, mean 6.71 hours
Secondary	Patient Radiation Dose	Radiation dose measured in Dose Area Product (DAP)	During surgery, mean 6.71 hours
Secondary	Radiation Dose (Effective Dose) Received by Operator		During surgery, mean 6.71 hours
Secondary	Procedure Related Complications	Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).	During surgery, mean 6.71 hours
Secondary	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

External Links

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