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

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

Status
Suspended
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00225446
Enrollment
20
Registered
2005-09-23
Start date
2006-02-28
Completion date
2009-01-31
Last updated
2008-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Computer-Assisted Surgery, Maxillofacial Surgery

Keywords

Orthognathic surgery., optic repositioning system.

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.

Interventions

DEVICEMicronTracker

MicronTracker is a Third Generation Optic Repositioning System in orthognatic surgery.

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Mandibular orthognathic surgery

Exclusion criteria

* Age \<18 years

Design outcomes

Primary

MeasureTime frame
spatial coordinates of the target (3 translations and 3 rotations)during surgery

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026