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Robotic-assisted Pedicule Screw Placement (ARASS)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Lumbar Degenerative Spinal Disease

Treatments

Device: The ROSA™ robot

Study type

Interventional

Funder types

Other

Identifiers

NCT01944553
UF 9180
2013-A00749-36 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • pregnant patient
  • patient nursing

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

prospective
Experimental group
Description:
Single Arm
Treatment:
Device: The ROSA™ robot

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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