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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03015142
Other study ID # XCY607-130099
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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