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| Name | Class |
|---|---|
| PRAXIM company | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D fluoroscopy and navigation station | Experimental |
| |
| 2D and anatomical landmarks | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation station coupled with a 3D fluoroscopy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM | two years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Merloz, Pr | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France | Grenoble | France |
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|
comparison of operating times of interventions between "3D-navigation" and conventional methods |
| two years |