N/A Completed N=21

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

Spinal Diseases

Source: ClinicalTrials.gov NCT03015142 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Sep 2019

Primary outcomePrimary: Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software — 94.1 Percentage of screw placements

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.

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 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	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.