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

Surgery Clinical Trial

— HoloNavi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610411
• Other study ID #: HoloNavigation
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: April 12, 2024

Study information

• Verified date: February 2023
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 12, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

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

Other:
• standard surgical method
standard surgical method established at the institution

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	3-dimensional deviation (3D angle) of preoperative planning in postoperative imaging	within 7 days of surgery
Primary	Accuracy	3-dimensional deviation (3D translation vector) of preoperative planning in postoperative imaging	within 7 days of surgery
Secondary	Number of rod bending attempts	bending attempts are counted during surgery	during surgery
Secondary	Number of length corrections of rod implant	required length corrections are counted during surgery	during surgery
Secondary	time needed for pedicle screw implantation	time is measured during surgery	during surgery
Secondary	surgery duration	total Duration of surgery	during surgery
Secondary	Radiation dose during surgery	total radiation dose applied during surgery	during surgery
Secondary	Usability	measuring of surgeon satisfaction using visual analogue scale from a minimum of 0 to a maximum of 10	within 7 days of surgery
Secondary	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
Secondary	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