Robotic-assisted Pedicule Screw Placement (ARASS)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Study on the Feasibility of Pedicle Screw Placement in the Lumbar Level With a New Robotic-assisted System|
- accurancy of pedicle screw placement [ Time Frame: during the surgery ] [ Designated as safety issue: Yes ]The main objective of the study is to evaluate the feasibility of the robot ROSA in the pedicle screw placement anf for obtaining a CE mark for this application.The expected performance are a "good rate positioning" of pedicle screws better than the performance observed in conventional surgery.
- operative time / irradiation doses [ Time Frame: During the surgery ] [ Designated as safety issue: Yes ]The secondary outcome of the study is to evaluate the operative time and the irradiation doses during the surgery with this medical device.
|Study Start Date:||September 2013|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Device: The ROSA™ robot
The ROSA™ robot can assist in identifying the pedicle entry point and in controlling the screw trajectory through a system of continuous monitoring of patient motion. This process strengthens the accuracy of pedicle screws implantation.
Stabilisation in treatment for spine degenerative disease
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01944553
|Montpellier, France, 34000|