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

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

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).

Study Overview

• Status: Suspended
• Conditions: Maxillofacial Surgery; Computer-Assisted Surgery
• Intervention / Treatment: Device: MicronTracker

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Mandibular orthognathic surgery

Exclusion Criteria:

• Age <18 years

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
spatial coordinates of the target (3 translations and 3 rotations)	during surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
time to install the eyebrow mark with each technique.	during surgery
adverse events due to the transcutaneous pins.	during surgery
number of handling realized by the nurse for each technique.	during surgery
evaluation of cost: number of cable versus number of marker.	during surgery

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Georges BETTEGA, M.D., Ph.D., Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General Publications

• Bettega G, Cinquin P, Lebeau J, Raphael B. Computer-assisted orthognathic surgery: clinical evaluation of a mandibular condyle repositioning system. J Oral Maxillofac Surg. 2002 Jan;60(1):27-34; discussion 34-5. doi: 10.1053/joms.2002.29069.
• Bettega G, Dessenne V, Raphael B, Cinquin P. Computer-assisted mandibular condyle positioning in orthognathic surgery. J Oral Maxillofac Surg. 1996 May;54(5):553-8. doi: 10.1016/s0278-2391(96)90630-8.
• Dessenne V. Gestes médico-chirurgicaux assistés par ordinateur: applications à la ligamentoplastie du genou et à la chirurgie orthognatique. Thèse de Génie biologique et médical, Grenoble 1996
• Bettega G. La chirurgie orthognatique assistée par ordinateur: de la planification à la réalisation. Thèse de Génie biologique et médical, Grenoble 1997

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Anticipated): January 1, 2009
• Study Completion (Anticipated): January 1, 2009

Study Registration Dates

• First Submitted: September 22, 2005
• First Submitted That Met QC Criteria: September 22, 2005
• First Posted (Estimate): September 23, 2005

Study Record Updates

• Last Update Posted (Estimate): June 4, 2008
• Last Update Submitted That Met QC Criteria: June 3, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Orthognathic surgery.; optic repositioning system.
• Other Study ID Numbers: DCIC 04 14