New Robotic Assistance System for Spinal Fusion Surgery

KB Medical SA24 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Degenerative Disc Disease Spinal Stenosis Spondylolisthesis Spondylosis

Interventions

AQrate Robotic Assistance SystemDEVICE

Robotic guidance during spinal fusion surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Clinic Genolier

Genolier, Canton of Vaud, Switzerland

Hôpital du Valais

Sion, Valais, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: Day of surgery

Secondary Outcomes

Intraoperative exposure to radiation

Exposure of radiation in seconds from O-arm or other imaging system used during surgery

Time frame: 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

Time frame: Within one month of surgery

Data from ClinicalTrials.gov

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