Clinical trial NCT00225446: Micron Tracker: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System
Official title: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Computer-Assisted Surgery
Maxillofacial Surgery
Keywords: Orthognathic surgery.
optic repositioning system.
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: Inclusion Criteria:

* Mandibular orthognathic surgery

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: spatial coordinates of the target (3 translations and 3 rotations)
timeFrame: during surgery
Secondary outcomes:
measure: time to install the eyebrow mark with each technique.
timeFrame: during surgery
measure: adverse events due to the transcutaneous pins.
timeFrame: during surgery
measure: number of handling realized by the nurse for each technique.
timeFrame: during surgery
measure: evaluation of cost: number of cable versus number of marker.
timeFrame: during surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Georges BETTEGA, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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
citation: Bettega G. La chirurgie orthognatique assistée par ordinateur: de la planification à la réalisation. Thèse de Génie biologique et médical, Grenoble 1997