Lumbar Degenerative Spinal Disease Clinical Trial
Official title:
A Prospective Study on the Feasibility of Pedicle Screw Placement in the Lumbar Level With a New Robotic-assisted System
The main objective of the study is to evaluate the feasibility of using the robotic assisted device ROSA™ for pedicle screws placement. This device is currently used in cranial neurosurgery but its applications can be extended to other fields, such as spinal surgery. In the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and safety of surgery for the patient.
The medical device subject of this research is the surgical robot ROSA™ designed for cranial
surgery, and used here in another application, spinal surgery - more specifically for the
placement of pedicle screws.
It is intended for spine surgeons to treat diseases requiring the placement of pedicle
screws through posterior open surgery approach or minimally invasive surgery.
The system allows the precise guidance of instruments as defined by the surgeon on patient
radiological images. The expected performance is a good rate of pedicle screws placement,
increasing the performance observed with the conventional method. This system can be
transported from one operating room to another, and stored in a storage room.
It interfaces with the most common intra -operative surgical imaging systems (mobile C-arms
available at Montpellier University Hospital). Further versions of the device will enable
the use of 3D intra-operative imaging systems such as the O-arm from Medtronic.
The main objective of the study is to evaluate the feasibility of using the robot ROSA™ for
pedicle screws placement. In this study, the robot will be used with an open surgery
approach, which is a first step in demonstrating the potential of the robot.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment