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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgical navigation | Experimental | standard surgical method except for navigated instrumentation of pedicle screws and rod implants |
|
| standard surgical method | Active Comparator | standard surgical method established at the institution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical navigation | Device | surgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | 3-dimensional deviation (3D angle) of preoperative planning in postoperative imaging | within 7 days of surgery |
| Accuracy | 3-dimensional deviation (3D translation vector) of preoperative planning in postoperative imaging | within 7 days of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of rod bending attempts | bending attempts are counted during surgery | during surgery |
| Number of length corrections of rod implant | required length corrections are counted during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazda Farshad, Prof. | Balgrist University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balgrist University Hospital | Zurich | Canton of Zurich | 8008 | Switzerland |
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| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| standard surgical method | Other | standard surgical method established at the institution |
|
| during surgery |
| time needed for pedicle screw implantation | time is measured during surgery | during surgery |
| surgery duration | total Duration of surgery | during surgery |
| Radiation dose during surgery | total radiation dose applied during surgery | during surgery |
| Usability | measuring of surgeon satisfaction using visual analogue scale from a minimum of 0 to a maximum of 10 | within 7 days of surgery |
| 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 |
| 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 |