The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
150
After randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants.
Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
Grenoble, France
Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM
Time frame: two years
measure radiation of the surgeon and the patient in the two groups
delivered dose and irradiation time during the duration of the intervention for the sacro-iliac screw connections, or for the establishment of two pedicle screws in spinal surgery over a 2-D amplifier
Time frame: two years
Show that the operative time is not increased significantly taking into account the learning curve and the benefit provided from a conventional 2-D amplifier
comparison of operating times of interventions between "3D-navigation" and conventional methods
Time frame: two years
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