Clinical trial NCT02558621: New Robotic Assistance System for Spinal Fusion Surgery
Official title: Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis
Spondylosis
Keywords: Robotic Spinal Fusion Surgery
Lead sponsor: KB Medical SA
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: clinical acceptance of the performance of the AQrate Robotic Assistance System.
timeFrame: Day of surgery
Secondary outcomes:
measure: Intraoperative exposure to radiation
timeFrame: Day of surgery
measure: Accuracy of spinal screws placed
timeFrame: Within one month of surgery
Other outcomes:
Locations:
city: Genolier
country: Switzerland
facility: Clinic Genolier
state: VD
city: Sion
country: Switzerland
facility: Hôpital du Valais
state: VS
Study officials:
affiliation: Clinic Genolier, Switzerland
name: Jean-Denis Patet, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.