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

Philips

Status: Completed

Conditions: Spinal Diseases

Treatments: Device: New image-guidance software

Study type: Observational

Funder types: Industry

Identifiers

NCT03015142

XCY607-130099

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

21 participants in 1 patient group

New image-guidance software

Description:

Patients in this group had spine surgery with new image-guidance software application.

Treatment:

Device: New image-guidance software