Evaluation of the Accuracy of Surgical Navigation in Spine Instrumentation Using Augmented Reality
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Accuracy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Accuracy
Time Frame: within 7 days of surgery
3-dimensional deviation (3D angle) of preoperative planning in postoperative imaging
Secondary Outcomes
- Clinical Outcome Disability(up to 1 year of surgery)
- Number of rod bending attempts(during surgery)
- Radiation dose during surgery(during surgery)
- time needed for pedicle screw implantation(during surgery)
- Usability(within 7 days of surgery)
- Number of length corrections of rod implant(during surgery)
- surgery duration(during surgery)
- Clinical Outcome Pain(up to 1 year of surgery)