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

Surgical Procedure, Unspecified Clinical Trial

— FLUORONAV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335841
• Other study ID #: DCIC-10 25
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2011
• Last updated: January 24, 2013
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

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.

Locations

Country	Name	City	State
France	Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
AdministrateurCIC	PRAXIM company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM		two years	Yes
Secondary	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	Yes
Secondary	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	Yes

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