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Completed

NCT Number: NCT04610411

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

surgical navigation

Device

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

standard surgical method

Other

standard surgical method established at the institution

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Acronym: HoloNavi

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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