New Robotic Assistance System for Spinal Fusion Surgery

NCT ID: NCT02558621

Last Updated: 2016-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-05-31

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.

Conditions

Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis; Spondylosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device: AQrate Robotic Assistance System

Precise positioning of surgical instruments and spinal implants during general spinal surgery.

Group Type: EXPERIMENTAL

AQrate Robotic Assistance System

Intervention Type: DEVICE

Robotic guidance during spinal fusion surgery

Interventions

AQrate Robotic Assistance System

Robotic guidance during spinal fusion surgery

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KB Medical SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Denis Patet, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic Genolier, Switzerland

Locations

Clinic Genolier

Genolier, Canton of Vaud, Switzerland

Hôpital du Valais

Sion, Valais, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 22190547 (View on PubMed)

Other Identifiers

AQrate01/2015

Identifier Type: -

Identifier Source: org_study_id