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Robotic-assisted Pedicule Screw Placement (ARASS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01944553
First Posted: September 17, 2013
Last Update Posted: February 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtech S.A.S
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose
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.

Condition Intervention
Lumbar Degenerative Spinal Disease Device: The ROSA™ robot

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study on the Feasibility of Pedicle Screw Placement in the Lumbar Level With a New Robotic-assisted System

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: September 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant patient
  • patient nursing
  Contacts and Locations
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): NCT01944553


Locations
France
Montpellier Hospital
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
Medtech S.A.S
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01944553     History of Changes
Other Study ID Numbers: UF 9180
2013-A00749-36 ( Other Identifier: ID-RCB )
First Submitted: September 12, 2013
First Posted: September 17, 2013
Last Update Posted: February 27, 2014
Last Verified: February 2014

Keywords provided by University Hospital, Montpellier:
Spine
Accurancy
Robotic
Screw placement
Degenerative

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases