New Robotic Assistance System for Spinal Fusion Surgery

Degenerative Disc Disease Clinical Trial

— AQrate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558621
• Other study ID #: AQrate01/2015
• Status: Completed
• Phase: N/A
• First received: September 23, 2015
• Last updated: May 9, 2016
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: KB Medical SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Stenosis
• Spondylolisthesis
• Spondylosis

Intervention

Device:
• AQrate Robotic Assistance System
Robotic guidance during spinal fusion surgery

Locations

Country	Name	City	State
Switzerland	Clinic Genolier	Genolier	VD
Switzerland	Hôpital du Valais	Sion	VS

Sponsors (1)

Lead Sponsor	Collaborator
KB Medical SA

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Intraoperative exposure to radiation	Exposure of radiation in seconds from O-arm or other imaging system used during surgery	Day of surgery	No
Secondary	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	Within one month of surgery	Yes