Skip to main content
OpenTrials
Completed

NCT Number: NCT01335841

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France

Grenoble, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navigation station coupled with a 3D fluoroscopy

Device

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.

Primary outcomes

  1. Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM

    Time frame: two years

Secondary outcomes

  1. measure radiation of the surgeon and the patient in the two groups

    Time frame: two years

    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

  2. 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

    Time frame: two years

    comparison of operating times of interventions between "3D-navigation" and conventional methods

Sponsors and collaborators

Lead sponsor

AdministrateurCIC

Other

Collaborators

  • PRAXIM company

Registry information

Acronym: FLUORONAV

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 14, 2011
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.