Surgery
Conditions
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.
Interventions
DEVICEsurgical navigation
surgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software
OTHERstandard surgical method
standard surgical method established at the institution
Sponsors
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy | within 7 days of surgery | 3-dimensional deviation (3D angle) of preoperative planning in postoperative imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of length corrections of rod implant | during surgery | required length corrections are counted during surgery |
| time needed for pedicle screw implantation | during surgery | time is measured during surgery |
| surgery duration | during surgery | total Duration of surgery |
| Number of rod bending attempts | during surgery | bending attempts are counted 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 |
| 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 |
| 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 |
| Radiation dose during surgery | during surgery | total radiation dose applied during surgery |
Countries
Switzerland
Outcome results
None listed