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Robotic-assisted Pedicule Screw Placement (ARASS)

Primary Purpose

Lumbar Degenerative Spinal Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The ROSA™ robot
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Degenerative Spinal Disease focused on measuring Spine, Accurancy, Robotic, Screw placement, Degenerative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant patient
  • patient nursing

Sites / Locations

  • Montpellier Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prospective

Arm Description

Single Arm

Outcomes

Primary Outcome Measures

accurancy of pedicle screw placement
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
The secondary outcome of the study is to evaluate the operative time and the irradiation doses during the surgery with this medical device.

Full Information

First Posted
September 12, 2013
Last Updated
February 26, 2014
Sponsor
University Hospital, Montpellier
Collaborators
Medtech S.A.S
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1. Study Identification

Unique Protocol Identification Number
NCT01944553
Brief Title
Robotic-assisted Pedicule Screw Placement
Acronym
ARASS
Official Title
A Prospective Study on the Feasibility of Pedicle Screw Placement in the Lumbar Level With a New Robotic-assisted System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Medtech S.A.S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Degenerative Spinal Disease
Keywords
Spine, Accurancy, Robotic, Screw placement, Degenerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prospective
Arm Type
Experimental
Arm Description
Single Arm
Intervention Type
Device
Intervention Name(s)
The ROSA™ robot
Intervention Description
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
Primary Outcome Measure Information:
Title
accurancy of pedicle screw placement
Description
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.
Time Frame
during the surgery
Secondary Outcome Measure Information:
Title
operative time / irradiation doses
Description
The secondary outcome of the study is to evaluate the operative time and the irradiation doses during the surgery with this medical device.
Time Frame
During the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from lumbar back pain for more than 3 months Consent signed Exclusion Criteria: pregnant patient patient nursing
Facility Information:
Facility Name
Montpellier Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

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Robotic-assisted Pedicule Screw Placement

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