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

Sponsor:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00225446

Purpose

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).

Condition	Intervention	Phase
Computer-Assisted Surgery Maxillofacial Surgery	Device: MicronTracker	Phase I Phase II

Study Type:	Interventional
Study Design:	Non-Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
Official Title:	Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

spatial coordinates of the target (3 translations and 3 rotations) [ Time Frame: during surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time to install the eyebrow mark with each technique. [ Time Frame: during surgery ] [ Designated as safety issue: No ]
adverse events due to the transcutaneous pins. [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]
number of handling realized by the nurse for each technique. [ Time Frame: during surgery ] [ Designated as safety issue: No ]
evaluation of cost: number of cable versus number of marker. [ Time Frame: during surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mandibular orthognathic surgery

Exclusion Criteria:

Age <18 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225446

Locations

France
Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble
Grenoble, France, 38043

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator:

Georges BETTEGA, M.D., Ph.D.

Institut National de la Santé Et de la Recherche Médicale, France

More Information

Publications:

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.

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.

Responsible Party:	University Hospital Grenoble ( Eric Svahn )
Study ID Numbers:	DCIC 04 14
Study First Received:	September 22, 2005
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00225446 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

Orthognathic surgery.
optic repositioning system.

ClinicalTrials.gov processed this record on November 09, 2009