Robotic-assisted Pedicule Screw Placement (ARASS)

February 26, 2014 updated by: University Hospital, Montpellier

A Prospective Study on the Feasibility of Pedicle Screw Placement in the Lumbar Level With a New Robotic-assisted System

The main objective of the study is to evaluate the feasibility of using the robotic assisted device ROSA™ for pedicle screws placement. This device is currently used in cranial neurosurgery but its applications can be extended to other fields, such as spinal surgery. In the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and safety of surgery for the patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The medical device subject of this research is the surgical robot ROSA™ designed for cranial surgery, and used here in another application, spinal surgery - more specifically for the placement of pedicle screws.

It is intended for spine surgeons to treat diseases requiring the placement of pedicle screws through posterior open surgery approach or minimally invasive surgery.

The system allows the precise guidance of instruments as defined by the surgeon on patient radiological images. The expected performance is a good rate of pedicle screws placement, increasing the performance observed with the conventional method. This system can be transported from one operating room to another, and stored in a storage room.

It interfaces with the most common intra -operative surgical imaging systems (mobile C-arms available at Montpellier University Hospital). Further versions of the device will enable the use of 3D intra-operative imaging systems such as the O-arm from Medtronic.

The main objective of the study is to evaluate the feasibility of using the robot ROSA™ for pedicle screws placement. In this study, the robot will be used with an open surgery approach, which is a first step in demonstrating the potential of the robot.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34000
        • Montpellier Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suffering from lumbar back pain for more than 3 months
  • Consent signed

Exclusion Criteria:

  • pregnant patient
  • patient nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: prospective
Single Arm
Device: The ROSA™ robot

The ROSA™ robot can assist in identifying the pedicle entry point and in controlling the screw trajectory through a system of continuous monitoring of patient motion. This process strengthens the accuracy of pedicle screws implantation.

Stabilisation in treatment for spine degenerative disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accurancy of pedicle screw placement
Time Frame: during the surgery
The main objective of the study is to evaluate the feasibility of the robot ROSA in the pedicle screw placement anf for obtaining a CE mark for this application.The expected performance are a "good rate positioning" of pedicle screws better than the performance observed in conventional surgery.
during the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time / irradiation doses
Time Frame: During the surgery
The secondary outcome of the study is to evaluate the operative time and the irradiation doses during the surgery with this medical device.
During the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Medtech S.A.S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (ESTIMATE)

September 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 9180
  • 2013-A00749-36 (OTHER: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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