Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03015142|
Recruitment Status : Completed
First Posted : January 9, 2017
Results First Posted : September 30, 2019
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment|
|Spinal Diseases||Device: New image-guidance software|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions|
|Actual Study Start Date :||November 9, 2016|
|Actual Primary Completion Date :||October 8, 2017|
|Actual Study Completion Date :||October 8, 2017|
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
- Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software [ Time Frame: 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.
- Procedure Time [ Time Frame: During surgery, mean 6.71 hours ]Time from skin incision to skin closure
- Time to Insert Pedicle Screw [ Time Frame: Intraoperative, mean 5.18 hours ]
- Length of Hospitalization [ Time Frame: From start of the interventional procedure until hospital discharge, approximately 5.3 days ]
- System Usability Score (SUS Score) [ Time Frame: 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 [ Time Frame: During surgery, mean 6.71 hours ]Radiation dose measured in Air Kerma (AK)
- Patient Radiation Dose [ Time Frame: During surgery, mean 6.71 hours ]Radiation dose measured in Dose Area Product (DAP)
- Radiation Dose (Effective Dose) Received by Operator [ Time Frame: During surgery, mean 6.71 hours ]
- Procedure Related Complications [ Time Frame: 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 [ Time Frame: From start of enrollment until hospital discharge, approximately 51 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015142
|Karolinska University Hospital|
|Principal Investigator:||Adrian Elmi-Terander, MD||Karolinska University Hospital|