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

AdministrateurCIC

Status and phase: Completed; Phase 3

Conditions: Surgical Procedure, Unspecified

Treatments: Device: Navigation station coupled with a 3D fluoroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01335841

DCIC-10 25

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

3D fluoroscopy and navigation station

Experimental group

Treatment:

Device: Navigation station coupled with a 3D fluoroscopy

2D and anatomical landmarks

Active Comparator group

Treatment:

Device: Navigation station coupled with a 3D fluoroscopy