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

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ClinicalTrials.gov Identifier: NCT04610411
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Surgery Device: surgical navigation Other: standard surgical method Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Accuracy of Surgical Navigation in Spine Instrumentation Using Augmented Reality
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy [ Time Frame: within 7 days of surgery ]
    3-dimensional deviation (3D angle) of preoperative planning in postoperative imaging

  2. Accuracy [ Time Frame: within 7 days of surgery ]
    3-dimensional deviation (3D translation vector) of preoperative planning in postoperative imaging


Secondary Outcome Measures :
  1. Number of rod bending attempts [ Time Frame: during surgery ]
    bending attempts are counted during surgery

  2. Number of length corrections of rod implant [ Time Frame: during surgery ]
    required length corrections are counted during surgery

  3. time needed for pedicle screw implantation [ Time Frame: during surgery ]
    time is measured during surgery

  4. surgery duration [ Time Frame: during surgery ]
    total Duration of surgery

  5. Radiation dose during surgery [ Time Frame: during surgery ]
    total radiation dose applied during surgery

  6. Usability [ Time Frame: within 7 days of surgery ]
    measuring of surgeon satisfaction using visual analogue scale from a minimum of 0 to a maximum of 10

  7. Clinical Outcome Pain [ Time Frame: up to 1 year of surgery ]
    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

  8. Clinical Outcome Disability [ Time Frame: up to 1 year of surgery ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610411


Contacts
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Contact: Mazda Farshad, Prof. +41 44 386 1111 mazda.farshad@balgrist.ch
Contact: Philipp Fuernstahl, Prof. +41 44 510 7366 philipp.fuernstahl@balgrist.ch

Locations
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Switzerland
Balgrist University Hospital Recruiting
Zürich, Zurich, Switzerland, 8008
Contact: Mazda Farshad, PD Dr.med.    +41 44 386 1270    mazda.farshad@balgrist.ch   
Contact: José Spirig, Dr.med.    +41 44 386 5761    jose.spirig@balgrist.ch   
Sponsors and Collaborators
Balgrist University Hospital
Investigators
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Principal Investigator: Mazda Farshad, Prof. Balgrist University Hospital
More Information
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Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT04610411    
Other Study ID Numbers: HoloNavigation
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No