New Robotic Assistance System for Spinal Fusion Surgery (AQrate)
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|ClinicalTrials.gov Identifier: NCT02558621|
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : May 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease Spinal Stenosis Spondylolisthesis Spondylosis||Device: AQrate Robotic Assistance System||Not Applicable|
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:
- The design and principle of operation of the AQrate System permits a correct integration in the surgical procedure flow thus enabling the surgeon to benefit from its advantages while not generating any additional operational difficulties
- The stability and ease of use of the device will permit the surgeon to achieve any planned spinal fusion without requiring additional assistance from the medical staff compared to a conventional spinal fusion surgery.
- A spinal fusion surgery procedure that is performed with the use of the AQrate System is similar to conventional spinal fusion surgery. If correctly used, no additional adverse event should be observed.
- The exposure to x-ray should decrease as the need of intraoperative recheck of pedicle screws placed should be reduced
- The precision of placement of pedicle screw should not be adversely affected by the use of the system compared to conventional spinal surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Device: AQrate Robotic Assistance System
Precise positioning of surgical instruments and spinal implants during general spinal surgery.
Device: AQrate Robotic Assistance System
Robotic guidance during spinal fusion surgery
- clinical acceptance of the performance of the AQrate Robotic Assistance System. [ Time Frame: Day of surgery ]The acceptance of the performance of the AQrate System will be measured by scale given to total of 8 questions.
- Intraoperative exposure to radiation [ Time Frame: Day of surgery ]Exposure of radiation in seconds from O-arm or other imaging system used during surgery
- Accuracy of spinal screws placed [ Time Frame: Within one month of surgery ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558621
|Genolier, VD, Switzerland, 1272|
|Hôpital du Valais|
|Sion, VS, Switzerland, 1951|
|Principal Investigator:||Jean-Denis Patet, MD||Clinic Genolier, Switzerland|