A Phase 3 interventional study of Navigation station coupled with a 3D fluoroscopy in Surgical Procedure, Unspecified, sponsored by AdministrateurCIC. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-25.
Sponsored by AdministrateurCIC · Phase 3 and Interventional
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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.
AdministrateurCIC is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Device: Navigation station coupled with a 3D fluoroscopy
Device: Navigation station coupled with a 3D fluoroscopy
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.
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
The record gives a start of Mar 2011, a primary completion of Jul 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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AdministrateurCIC