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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Surgery

Intervention / Treatment
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* Device: surgical navigation
* Other: standard surgical method


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgical navigation<br>standard surgical method except for navigated instrumentation of pedicle screws and rod implants | Device: surgical navigation<br>* surgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software<br>|
| Active Comparator: standard surgical method<br>standard surgical method established at the institution | Other: standard surgical method<br>* standard surgical method established at the institution<br>|

What is the study measuring?
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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 |