Degenerative Disc Disease Clinical Trial
Official title:
Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
Based on the literature review of similar devices and on the pre-clinical tests performed
with the AQrate System on bench and cadavers, the study is build around the following
hypothesis:
1. The design and principle of operation of the AQrate System permits a correct
integration in the surgical procedure flow thus enabling the surgeon to benefit from
its advantages while not generating any additional operational difficulties
2. The stability and ease of use of the device will permit the surgeon to achieve any
planned spinal fusion without requiring additional assistance from the medical staff
compared to a conventional spinal fusion surgery.
3. A spinal fusion surgery procedure that is performed with the use of the AQrate System
is similar to conventional spinal fusion surgery. If correctly used, no additional
adverse event should be observed.
4. The exposure to x-ray should decrease as the need of intraoperative recheck of pedicle
screws placed should be reduced
5. The precision of placement of pedicle screw should not be adversely affected by the use
of the system compared to conventional spinal surgery.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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