Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis (FLUORONAV)

The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Device: Navigation station coupled with a 3D fluoroscopy

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient aged over 18 years old
• Patient affiliated to social security or similarly regime
• Patient with a disease of the pelvic ring, with an indication of establishment of a screw sacro-iliac
• Patient with a disease of the spine, with an indication of establishment of pedicle implant

Exclusion Criteria:

• Intubated patient resuscitation
• Pregnant women and lactating mothers
• Adult unable to express their consent
• Ward of court or under guardianship
• Person under legal protection
• Person deprived of freedom by judicial or administrative decision
• Person hospitalized without their consent

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D fluoroscopy and navigation station	Device: Navigation station coupled with a 3D fluoroscopy; After randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants.
Active Comparator: 2D and anatomical landmarks	Device: Navigation station coupled with a 3D fluoroscopy; After randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure radiation of the surgeon and the patient in the two groups	delivered dose and irradiation time during the duration of the intervention for the sacro-iliac screw connections, or for the establishment of two pedicle screws in spinal surgery over a 2-D amplifier	two years
Show that the operative time is not increased significantly taking into account the learning curve and the benefit provided from a conventional 2-D amplifier	comparison of operating times of interventions between "3D-navigation" and conventional methods	two years

Collaborators and Investigators

• Sponsor: AdministrateurCIC
• Collaborators: PRAXIM company
• Investigators: Principal Investigator: Philippe Merloz, Pr, University Hospital, Grenoble

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Estimate): January 25, 2013
• Last Update Submitted That Met QC Criteria: January 24, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: DCIC-10 25