Trials Sponsors Conditions Drugs Pricing

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 fluoroscopyDevice

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 landmarks3D fluoroscopy and navigation station

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient aged over 18 years old
Patient affiliated to social security or similarly regime

Sponsors & Collaborators

PRAXIM company
Type not reportedcollaborator
AdministrateurCIC
Otherlead

Study Sites (1)

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

Grenoble, France

Study Officials

Philippe Merloz, Pr
University Hospital, Grenoble
PRINCIPAL INVESTIGATOR

Enrollment

150 participants (actual enrollment reported by the registry).

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 2011

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

3D fluoroscopy and navigation station

2D and anatomical landmarks

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

3D fluoroscopy and navigation station

2D and anatomical landmarks

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations