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The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
Based on the literature review of similar devices and on the pre-clinical tests performed with the AQrate System on bench and cadavers, the study is build around the following hypothesis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: AQrate Robotic Assistance System | Experimental | Precise positioning of surgical instruments and spinal implants during general spinal surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQrate Robotic Assistance System | Device | Robotic guidance during spinal fusion surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical acceptance of the performance of the AQrate Robotic Assistance System. | The acceptance of the performance of the AQrate System will be measured by scale given to total of 8 questions. | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative exposure to radiation | Exposure of radiation in seconds from O-arm or other imaging system used during surgery | Day of surgery |
| Accuracy of spinal screws placed | The assessment of the accuracy of pedicle screw will be evaluated post operatively on the CT scan, at discharge with the Gertzbein grading scale and copared to a freehand technique |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Denis Patet, MD | Clinic Genolier, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic Genolier | Genolier | Canton of Vaud | 1272 | Switzerland | ||
| Hôpital du Valais |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22190547 | Background | Kostrzewski S, Duff JM, Baur C, Olszewski M. Robotic system for cervical spine surgery. Int J Med Robot. 2012 Jun;8(2):184-90. doi: 10.1002/rcs.446. Epub 2011 Dec 21. |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| Within one month of surgery |
| Sion |
| Valais |
| 1951 |
| Switzerland |