Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Diseases
- Sponsor
- Philips Clinical & Medical Affairs Global
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Procedure Time(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)(End of all surgeries)
- Patient Radiation Dose(During surgery, mean 6.71 hours)
- Radiation Dose (Effective Dose) Received by Operator(During surgery, mean 6.71 hours)
- Procedure Related Complications(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)