Robotic-assisted Pedicule Screw Placement

Not Applicable

Completed

• Conditions: Lumbar Degenerative Spinal Disease
• Interventions: Device: The ROSA™ robot

• Registration Number: NCT01944553
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-17
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• pregnant patient
• patient nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prospective	The ROSA™ robot	Single Arm

Primary Outcome Measures

Name	Time	Method
accurancy of pedicle screw placement	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

Name	Time	Method
operative time / irradiation doses	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.

Trial Locations

Locations (1)

Montpellier Hospital; 🇫🇷 Montpellier, France