New Robotic Assistance System for Spinal Fusion Surgery

Not Applicable

Completed

• Conditions: Spondylolisthesis; Degenerative Disc Disease; Spinal Stenosis; Spondylosis
• Interventions: Device: AQrate Robotic Assistance System

• Registration Number: NCT02558621
• Lead Sponsor: KB Medical SA

Brief 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adult patients (age from 18 years to 85 years) scheduled for spinal fusion surgery,
• Primary spinal surgery (It is the first surgery on this patient's spine)
• Patient is capable of complying with study requirements, and
• Patient is willing to provide a signed informed consent.

Exclusion Criteria

• Pregnancy and lactation
• Simultaneous participation in other clinical studies
• Infection or malignancy
• Previous spondylodesis
• Previous spinal surgical procedures
• Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, neurofibroma)
• Spinal cord abnormalities with any neurologic symptoms or signs
• Paraplegia
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
• Patient cannot follow study protocol, for any reason
• Patient cannot or will not sign informed consent
• Patients in emergency situation, are not legally competent, cannot understand the situation,
• Pediatric patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device: AQrate Robotic Assistance System	AQrate Robotic Assistance System	Precise positioning of surgical instruments and spinal implants during general spinal surgery.

Primary Outcome Measures

Name	Time	Method
clinical acceptance of the performance of the AQrate Robotic Assistance System.	Day of surgery	The acceptance of the performance of the AQrate System will be measured by scale given to total of 8 questions.

Secondary Outcome Measures

Name	Time	Method
Accuracy of spinal screws placed	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
Intraoperative exposure to radiation	Day of surgery	Exposure of radiation in seconds from O-arm or other imaging system used during surgery

Trial Locations

Locations (2)

Clinic Genolier; 🇨🇭 Genolier, VD, Switzerland

Hôpital du Valais; 🇨🇭 Sion, VS, Switzerland