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

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

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Device: surgical navigation; Other: standard surgical method

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mazda Farshad, Prof.; Phone Number: +41 44 386 1111; Email: mazda.farshad@balgrist.ch
• Study Contact Backup: Name: Philipp Fuernstahl, Prof.; Phone Number: +41 44 510 7366; Email: philipp.fuernstahl@balgrist.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8008
      • Recruiting
      • Balgrist University Hospital
      • Contact: Mazda Farshad, PD Dr.med.; Phone Number: +41 44 386 1270; Email: mazda.farshad@balgrist.ch
      • Contact: José Spirig, Dr.med.; Phone Number: +41 44 386 5761; Email: jose.spirig@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: surgical navigation; standard surgical method except for navigated instrumentation of pedicle screws and rod implants	Device: surgical navigation; surgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software
ACTIVE_COMPARATOR: standard surgical method; standard surgical method established at the institution	Other: standard surgical method; standard surgical method established at the institution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	3-dimensional deviation (3D angle) of preoperative planning in postoperative imaging	within 7 days of surgery
Accuracy	3-dimensional deviation (3D translation vector) of preoperative planning in postoperative imaging	within 7 days of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of rod bending attempts	bending attempts are counted during surgery	during surgery
Number of length corrections of rod implant	required length corrections are counted during surgery	during surgery
time needed for pedicle screw implantation	time is measured during surgery	during surgery
surgery duration	total Duration of surgery	during surgery
Radiation dose during surgery	total radiation dose applied during surgery	during surgery
Usability	measuring of surgeon satisfaction using visual analogue scale from a minimum of 0 to a maximum of 10	within 7 days of surgery
Clinical Outcome Pain	Standardized clinical pain score (visual analogue scale for pain with 0=no pain and 10=unbearable pain) is routinely evaluated before surgery and in the follow up	up to 1 year of surgery
Clinical Outcome Disability	Standardized clinical disability score (Oswestry Low Back Pain Questionnaire with 0%=minimal disability and 100%=maximal disability ) is routinely evaluated before surgery and in the follow up	up to 1 year of surgery

Collaborators and Investigators

• Sponsor: Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (ACTUAL): October 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HoloNavigation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No