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

This study has been completed.
Sponsor:
Collaborator:
PRAXIM company
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01335841
First received: January 31, 2011
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Surgical Procedure, Unspecified
Device: Navigation station coupled with a 3D fluoroscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • measure radiation of the surgeon and the patient in the two groups [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    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

  • 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 ] [ Designated as safety issue: Yes ]
    comparison of operating times of interventions between "3D-navigation" and conventional methods


Enrollment: 150
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335841

Locations
France
Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
Grenoble, France
Sponsors and Collaborators
AdministrateurCIC
PRAXIM company
Investigators
Principal Investigator: Philippe Merloz, Pr University Hospital, Grenoble
  More Information

Additional Information:
No publications provided

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01335841     History of Changes
Other Study ID Numbers: DCIC-10 25
Study First Received: January 31, 2011
Last Updated: January 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on October 23, 2014