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

Phase 1

Suspended

• Conditions: Computer-Assisted Surgery; Maxillofacial Surgery

• Registration Number: NCT00225446
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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).

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 Timeline

• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-23
• Study Start: 2006-02
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-03
• Last Update Posted: 2008-06-04
• Primary Completion: 2009-01
• Study Completion: 2009-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Mandibular orthognathic surgery

Exclusion Criteria

• Age <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
spatial coordinates of the target (3 translations and 3 rotations)	during surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble; 🇫🇷 Grenoble, France