Evaluation of the Accuracy of Surgical Navigation in Spine Instrumentation Using Augmented Reality
- Conditions
- Surgery
- Interventions
- Device: surgical navigationOther: standard surgical method
- Registration Number
- NCT04610411
- Lead Sponsor
- Balgrist University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description surgical navigation surgical navigation standard surgical method except for navigated instrumentation of pedicle screws and rod implants standard surgical method standard surgical method standard surgical method established at the institution
- Primary Outcome Measures
Name Time Method Accuracy within 7 days of surgery 3-dimensional deviation (3D translation vector) of preoperative planning in postoperative imaging
- Secondary Outcome Measures
Name Time Method Clinical Outcome Disability 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
time needed for pedicle screw implantation during surgery time is measured during surgery
Number of rod bending attempts during surgery bending attempts are counted during surgery
Radiation dose during surgery during surgery total radiation dose applied during surgery
Usability within 7 days of surgery measuring of surgeon satisfaction using visual analogue scale from a minimum of 0 to a maximum of 10
Number of length corrections of rod implant during surgery required length corrections are counted during surgery
surgery duration during surgery total Duration of surgery
Clinical Outcome Pain 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
Trial Locations
- Locations (1)
Balgrist University Hospital
🇨ðŸ‡Zürich, Zurich, Switzerland