Balgrist University Hospital
Zurich, Canton of Zurich, 8008, Switzerland
NCT Number: NCT04610411
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Zurich, Canton of Zurich, 8008, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
surgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software
standard surgical method established at the institution
Time frame: within 7 days of surgery
3-dimensional deviation (3D angle) of preoperative planning in postoperative imaging
Time frame: within 7 days of surgery
3-dimensional deviation (3D translation vector) of preoperative planning in postoperative imaging
Time frame: during surgery
bending attempts are counted during surgery
Time frame: during surgery
required length corrections are counted during surgery
Time frame: during surgery
time is measured during surgery
Time frame: during surgery
total Duration of surgery
Time frame: during surgery
total radiation dose applied during surgery
Time frame: within 7 days of surgery
measuring of surgeon satisfaction using visual analogue scale from a minimum of 0 to a maximum of 10
Time frame: 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
Time frame: 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
Balgrist University Hospital
Other
Acronym: HoloNavi
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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