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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225446
Recruitment Status : Suspended
First Posted : September 23, 2005
Last Update Posted : June 4, 2008
Sponsor:
Information provided by:
University Hospital, Grenoble

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).

Condition or disease Intervention/treatment Phase
Computer-Assisted Surgery Maxillofacial Surgery Device: MicronTracker Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.
Study Start Date : February 2006
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : January 2009

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


Primary Outcome Measures :
  1. spatial coordinates of the target (3 translations and 3 rotations) [ Time Frame: during surgery ]

Secondary Outcome Measures :
  1. time to install the eyebrow mark with each technique. [ Time Frame: during surgery ]
  2. adverse events due to the transcutaneous pins. [ Time Frame: during surgery ]
  3. number of handling realized by the nurse for each technique. [ Time Frame: during surgery ]
  4. evaluation of cost: number of cable versus number of marker. [ Time Frame: during surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mandibular orthognathic surgery

Exclusion Criteria:

  • Age <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225446


Locations
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France
Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Georges BETTEGA, M.D., Ph.D. Institut National de la Santé Et de la Recherche Médicale, France

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

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Responsible Party: Eric Svahn, University Hospital Grenoble
ClinicalTrials.gov Identifier: NCT00225446    
Other Study ID Numbers: DCIC 04 14
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008
Keywords provided by University Hospital, Grenoble:
Orthognathic surgery.
optic repositioning system.