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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Suspended
Phase 2
Phase 1

Conditions

Maxillofacial Surgery
Computer-Assisted Surgery

Treatments

Device: MicronTracker

Study type

Interventional

Funder types

Other

Identifiers

NCT00225446
DCIC 04 14

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Mandibular orthognathic surgery

Exclusion criteria

  • Age <18 years

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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