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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Diseases

Intervention / Treatment
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* Device: New image-guidance software


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| New image-guidance software<br>Patients in this group had spine surgery with new image-guidance software application. | Device: New image-guidance software<br>* Patients in this group had spine surgery with new image-guidance software application<br>|

What is the study measuring?
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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 |