N/A
N=21
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
Spinal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03015142 ↗Enrolled (actual)
21
Serious AEs
5.0%
Results posted
Sep 2019
Primary outcome: Primary: Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software — 94.1 Percentage of screw placements
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- New image-guidance software (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Philips Clinical & Medical Affairs Global
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software |
94.1 | — |
| SECONDARY Procedure Time |
6.71 | — |
| SECONDARY Time to Insert Pedicle Screw |
5.18 | — |
| SECONDARY Length of Hospitalization |
5.3 | — |
| SECONDARY System Usability Score (SUS Score) |
75.6 | — |
| SECONDARY Patient Radiation Dose |
31.26 | — |
| SECONDARY Patient Radiation Dose |
31.26 | — |
| SECONDARY Radiation Dose (Effective Dose) Received by Operator |
0.21 | — |
| SECONDARY Procedure Related Complications |
3 | — |
| SECONDARY Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event |
5; 0; 0 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03015142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.