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Micron Tracker: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System

This study is currently recruiting patients

Verified by University Hospital of Grenoble July 2006

Sponsored by: University Hospital of Grenoble
Information provided by: University Hospital of Grenoble
ClinicalTrials.gov Identifier: NCT00225446


Purpose

The main objective of this study is to validate a simplified platform of a repositioning system in orthognathic surgery (a third generation optic repositioning system called MicronTracker) compared with the actual clinically validated one (Orthopilot system).


Condition Intervention Phase
Computer-Assisted Surgery
Maxillofacial Surgery
Device: MicronTracker Phase I
Phase II

Study Type: Interventional
Study Design: Educational/Counseling/Training, Non-Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study

Official Title: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.

Further study details as provided by University Hospital of Grenoble:
Primary Outcomes: spatial coordinates of the target (3 translations and 3 rotations)
Secondary Outcomes: time to install the eyebrow mark with each technique.; adverse events due to the transcutaneous pins.; number of handling realized by the nurse for each technique.; evaluation of cost: number of cable versus number of marker.
Expected Total Enrollment:  20

Study start: March 2005;  Expected completion: March 2007
Last follow-up: October 2006;  Data entry closure: October 2006

For the past 10 years, the use of computer-assisted surgery has expanded and is now widely spread in the orthopaedic domain, but not in maxillary-facial surgery. The main disadvantages of this technique are the necessity to fix a mark on the eyebrow with two transcutaneous pins, which is a long and invasive act, and to connect the infrared transmitter which is in contact with the patient with the computer in a limited surgery area. In this study, we want to show that the new repositioning optic systems are performing similarly to the actual validated one, that they permit to suppress the transcutaneous pins and the computer connection, and that it reduces the financial cost of this surgery. Neither the surgery technique, nor the pre-operative check-up will be modified in the study. The two repositioning systems will be used simultaneously during the mandibular osteotomy.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Mandibular orthognathic surgery

Exclusion Criteria:

  • Age <18 years

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00225446

Jean-Luc Cracowski, M.D., Ph.D.       JLCracowski@chu-grenoble.fr

France
Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble, Grenoble,  38043,  France; Recruiting
Georges Bettega   GBettega@chu-grenoble.fr 
Georges Bettega,  Principal Investigator

Study chairs or principal investigators

Georges BETTEGA, M.D., Ph.D.,  Principal Investigator,  Institut National de la Santé Et de la Recherche Médicale, France   

More Information

Study ID Numbers:  DCIC 04 14
Last Updated:  July 5, 2006
Record first received:  September 22, 2005
ClinicalTrials.gov Identifier:  NCT00225446
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2006-09-29





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