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

Phase 3

Completed

• Conditions: Surgical Procedure, Unspecified
• Interventions: Device: Navigation station coupled with a 3D fluoroscopy

• Registration Number: NCT01335841
• Lead Sponsor: AdministrateurCIC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-31
• Study Start: 2011-03
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D fluoroscopy and navigation station	Navigation station coupled with a 3D fluoroscopy	-
2D and anatomical landmarks	Navigation station coupled with a 3D fluoroscopy	-

Primary Outcome Measures

Name	Time	Method
Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM	two years

Secondary Outcome Measures

Name	Time	Method
measure radiation of the surgeon and the patient in the two groups	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
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	two years	comparison of operating times of interventions between "3D-navigation" and conventional methods

Trial Locations

Locations (1)

Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France; 🇫🇷 Grenoble, France