New Robotic Assistance System for Spinal Fusion Surgery (AQrate)

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

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

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Spondylosis; Spondylolisthesis
• Intervention / Treatment: Device: AQrate Robotic Assistance System

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • VD
    • Genolier, VD, Switzerland, 1272
      • Clinic Genolier
  • VS
    • Sion, VS, Switzerland, 1951
      • Hôpital du Valais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Within one month of surgery

Collaborators and Investigators

• Sponsor: KB Medical SA
• Investigators: Principal Investigator: Jean-Denis Patet, MD, Clinic Genolier, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (Estimate): September 24, 2015

Study Record Updates

• Last Update Posted (Estimate): May 10, 2016
• Last Update Submitted That Met QC Criteria: May 9, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Robotic Spinal Fusion Surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: AQrate01/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED