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

NCT04610411 | Completed DMC

• 1 other identifier: HoloNavigation
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Number of rod bending attempts

  during surgery

• Number of length corrections of rod implant

  during surgery

• time needed for pedicle screw implantation

  during surgery

• surgery duration

  during surgery

• Radiation dose during surgery

  during surgery

Study Arms (2)

surgical navigation

EXPERIMENTAL

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

Device: surgical navigation

standard surgical method

ACTIVE COMPARATOR

standard surgical method established at the institution

Other: standard surgical method

Interventions

surgical navigation DEVICE

surgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software

surgical navigation

standard surgical method OTHER

standard surgical method established at the institution

standard surgical method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Surgery, Computer-Assisted

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Mazda Farshad, Prof.

  Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: October 30, 2020
• Study Start: November 1, 2020
• Primary Completion: April 11, 2024
• Study Completion: April 12, 2024
• Last Updated: May 31, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)