Clinical trial NCT04610411: Evaluation of the Accuracy of Surgical Navigation in Spine Instrumentation Using Augmented Reality
Official title: Evaluation of the Accuracy of Surgical Navigation in Spine Instrumentation Using Augmented Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Accuracy
timeFrame: within 7 days of surgery
measure: Accuracy
timeFrame: within 7 days of surgery
Secondary outcomes:
measure: Number of rod bending attempts
timeFrame: during surgery
measure: Number of length corrections of rod implant
timeFrame: during surgery
measure: time needed for pedicle screw implantation
timeFrame: during surgery
measure: surgery duration
timeFrame: during surgery
measure: Radiation dose during surgery
timeFrame: during surgery
measure: Usability
timeFrame: within 7 days of surgery
measure: Clinical Outcome Pain
timeFrame: up to 1 year of surgery
measure: Clinical Outcome Disability
timeFrame: up to 1 year of surgery
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital
state: Zurich
Study officials:
affiliation: Balgrist University Hospital
name: Mazda Farshad, Prof.
role: PRINCIPAL_INVESTIGATOR
References: