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

NCT01335841 | Completed Phase 3 DMC

• 1 other identifier: DCIC-10 25
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

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

  two years

Secondary Outcomes (2)

• measure radiation of the surgeon and the patient in the two groups

  two years

• 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

Study Arms (2)

3D fluoroscopy and navigation station

EXPERIMENTAL

Device: Navigation station coupled with a 3D fluoroscopy

2D and anatomical landmarks

ACTIVE COMPARATOR

Device: Navigation station coupled with a 3D fluoroscopy

Interventions

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.

2D and anatomical landmarks; 3D fluoroscopy and navigation station

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AdministrateurCIC: lead
• PRAXIM company: collaborator

Study Sites (1)

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

Grenoble, France

Location

Study Officials

• Philippe Merloz, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: April 14, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

FR (1)