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

Balgrist University Hospital

Status: Completed

Conditions: Surgery

Treatments: Other: standard surgical method; Device: surgical navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04610411

HoloNavigation

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for surgical instrumentation of the spine (Os Sacrum, L1-L5, Th1-Th12) without or with correction of a malposition.
• Anatomical adaptation of the rod implant necessary.
• The trial participant is able to give his/her consent.
• Signed written declaration of consent after oral and written explanation.
• Male and female patients aged 18 years and older.
• Indication for a preoperative CT scan of the lumbar spine
• Existence of a preoperative planning, which was created on the basis of 3D CT imaging

Exclusion criteria

• Pregnant or breastfeeding women
• Emergency situations
• Other known clinically significant concomitant diseases (e.g. infections, tumors, co-existing arthrosis).
• Known or suspected incompliance with the protocol, such as drug or alcohol abuse.
• Inability of the patient to follow the study procedures, e.g., due to language problems, mental illness, dementia, etc.
• There is no conventional surgical treatment that can be used if the MP cannot be used intraoperatively.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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4 participants in 2 patient groups

surgical navigation

Experimental group

Description:

standard surgical method except for navigated instrumentation of pedicle screws and rod implants

Treatment:

Device: surgical navigation

standard surgical method

Active Comparator group

Description:

standard surgical method established at the institution

Treatment:

Other: standard surgical method