Surgical Procedure, Unspecified Clinical Trial
Official title:
Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study ScanRach Study
Investigators team propose to evaluate the impact of the use of intraoperative scanning coupled with Stryker navigation, compared to the conventional fluoroscopy technique, on the accuracy of pedicle screws, in instrumented spinal surgery, by a randomised prospective study, in terms of pedicular screw accuracy. We will also evaluate the radiation exposure of the neurosurgical team and the patient in these two techniques.
The use of pedicle screws in spinal surgery has seen a major advance in recent decades,
allowing for greater biomechanical stability and higher fusion rates. In order to avoid any
malposition that could cause neurological, vascular and visceral injuries and compromise this
mechanical stability, imaging-guided surgical techniques have been developed. These are aimed
at improving the positioning accuracy of pedicle screws to reduce these risks and improve
mechanical stability and intervertebral fusion. Fluoroscopic examinations had long been the
mainstay of intraoperative control imaging until the development of computer-assisted
techniques. However, despite intraoperative examination, pedicle screw misalignment remains
very common and even experienced surgeons can deviate screws in 5 to 20% of cases when using
a standard fluoroscopic examination image. Thus, navigation techniques coupled with an
intraoperative scanner, involving the acquisition of 2D images of the surgical field, have
been developed. These techniques allow the neurosurgeon to navigate the spine and thus allow
an improvement in the positioning accuracy of the pedicle screws. The correlate is an
improvement of the safety of the procedure (reduction of complications) but also an
optimisation of the biomechanical efficiency of the osteosynthesis.
With respect to the radiation emitted during navigated spinal surgery coupled with an
intraoperative scan, some comparative studies have shown that the radiation rates received by
the neurosurgical team and the patient were lower than the radiation rates received in
conventional surgery. To date, few studies combining the analysis of the pedicular screw
accuracy rate and the radiation rate transmitted to the neurosurgical team and patients have
been published.
Therefore the team propose to evaluate the impact of the use of intraoperative scanning
(BODYTom, Samsung) coupled with Stryker navigation, compared to the conventional fluoroscopy
technique, on the accuracy of pedicle screws, in instrumented spinal surgery, by a randomised
prospective study, in terms of pedicular screw accuracy. The investigator team will also
evaluate the radiation exposure of the neurosurgical team and the patient in these two
techniques.
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