Clinical Trials Directory

Trials / Completed

CompletedNCT04610411

Evaluation of the Accuracy of Surgical Navigation in Spine Instrumentation Using Augmented Reality

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Balgrist University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study will investigate the accuracy of implant navigation for spinal instrumentation. The tested technique is based on commercially available AR-glasses and a specially developed software component

Detailed description

The experimental intervention consists of using the AR-glasses and a specially developed software as a navigation aid in surgery. The surgical technique for the intervention group corresponds to the established standard method. It is identical to the control intervention except for the step where pedicle screws or rod implants are instrumented. The surgeon wears the hardware component during the entire surgery. He proceeds conventionally up to the point where navigation of pedicle screws and rod implants with is required.

Conditions

Interventions

TypeNameDescription
DEVICEsurgical navigationsurgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software
OTHERstandard surgical methodstandard surgical method established at the institution

Timeline

Start date
2020-11-01
Primary completion
2024-04-11
Completion
2024-04-12
First posted
2020-10-30
Last updated
2024-05-31

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04610411. Inclusion in this directory is not an endorsement.