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

Computer-Assisted Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00225446
• Other study ID #: DCIC 04 14
• Status: Suspended
• Phase: Phase 1/Phase 2
• First received: September 22, 2005
• Last updated: June 3, 2008
• Start date: February 2006
• Est. completion date: January 2009

Study information

• Verified date: June 2008
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mandibular orthognathic surgery

Exclusion Criteria:

• Age <18 years

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Computer-Assisted Surgery
• Maxillofacial Surgery

Intervention

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

Locations

Country	Name	City	State
France	Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

Bettega G, Cinquin P, Lebeau J, Raphaël 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. — View Citation

Bettega G, Dessenne V, Raphaël B, Cinquin P. Computer-assisted mandibular condyle positioning in orthognathic surgery. J Oral Maxillofac Surg. 1996 May;54(5):553-8. — View Citation

Bettega G. La chirurgie orthognatique assistée par ordinateur: de la planification à la réalisation. Thèse de Génie biologique et médical, Grenoble 1997

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spatial coordinates of the target (3 translations and 3 rotations)		during surgery	No
Secondary	time to install the eyebrow mark with each technique.		during surgery	No
Secondary	adverse events due to the transcutaneous pins.		during surgery	Yes
Secondary	number of handling realized by the nurse for each technique.		during surgery	No
Secondary	evaluation of cost: number of cable versus number of marker.		during surgery	No