NCT02558621

New Robotic Assistance System for Spinal Fusion Surgery

Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: KB Medical SA · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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: 1. 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 2. 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. 3. 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. 4. The exposure to x-ray should decrease as the need of intraoperative recheck of pedicle screws placed should be reduced 5. The precision of placement of pedicle screw should not be adversely affected by the use of the system compared to conventional spinal surgery.

Conditions

• Degenerative Disc Disease
• Spinal Stenosis
• Spondylolisthesis
• Spondylosis

Interventions

Type	Name	Description
DEVICE	AQrate Robotic Assistance System	Robotic guidance during spinal fusion surgery

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-09-24
• Last updated: 2016-05-10

Locations

2 sites across 1 country: Switzerland