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New Robotic Assistance System for Spinal Fusion Surgery (AQrate)

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ClinicalTrials.gov Identifier: NCT02558621
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spinal Stenosis Spondylolisthesis Spondylosis Device: AQrate Robotic Assistance System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery
Study Start Date : September 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. clinical acceptance of the performance of the AQrate Robotic Assistance System. [ Time Frame: 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 :
  1. Intraoperative exposure to radiation [ Time Frame: Day of surgery ]
    Exposure of radiation in seconds from O-arm or other imaging system used during surgery

  2. Accuracy of spinal screws placed [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558621


Locations
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Switzerland
Clinic Genolier
Genolier, VD, Switzerland, 1272
Hôpital du Valais
Sion, VS, Switzerland, 1951
Sponsors and Collaborators
KB Medical SA
Investigators
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Principal Investigator: Jean-Denis Patet, MD Clinic Genolier, Switzerland

Publications:
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Responsible Party: KB Medical SA
ClinicalTrials.gov Identifier: NCT02558621     History of Changes
Other Study ID Numbers: AQrate01/2015
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by KB Medical SA:
Robotic Spinal Fusion Surgery

Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis