Back to resultsNew Robotic Assistance System for Spinal Fusion Surgery (AQrate)
Primary Purpose
Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
AQrate Robotic Assistance System
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Robotic Spinal Fusion Surgery
Eligibility Criteria
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
Sites / Locations
- Clinic Genolier
- Hôpital du Valais
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device: AQrate Robotic Assistance System
Arm Description
Precise positioning of surgical instruments and spinal implants during general spinal surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Intraoperative exposure to radiation
Exposure of radiation in seconds from O-arm or other imaging system used during 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02558621
Brief Title
New Robotic Assistance System for Spinal Fusion Surgery
Acronym
AQrate
Official Title
Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KB Medical SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
Keywords
Robotic Spinal Fusion Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device: AQrate Robotic Assistance System
Arm Type
Experimental
Arm Description
Precise positioning of surgical instruments and spinal implants during general spinal surgery.
Intervention Type
Device
Intervention Name(s)
AQrate Robotic Assistance System
Intervention Description
Robotic guidance during spinal fusion surgery
Primary Outcome Measure Information:
Title
clinical acceptance of the performance of the AQrate Robotic Assistance System.
Description
The acceptance of the performance of the AQrate System will be measured by scale given to total of 8 questions.
Time Frame
Day of surgery
Secondary Outcome Measure Information:
Title
Intraoperative exposure to radiation
Description
Exposure of radiation in seconds from O-arm or other imaging system used during surgery
Time Frame
Day of surgery
Title
Accuracy of spinal screws placed
Description
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
Time Frame
Within one month of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Denis Patet, MD
Organizational Affiliation
Clinic Genolier, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic Genolier
City
Genolier
State/Province
VD
ZIP/Postal Code
1272
Country
Switzerland
Facility Name
Hôpital du Valais
City
Sion
State/Province
VS
ZIP/Postal Code
1951
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22190547
Citation
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.
Results Reference
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New Robotic Assistance System for Spinal Fusion Surgery
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