Micron Tracker: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System
This study is currently recruiting patients
Verified by University Hospital of Grenoble July 2006
| Sponsored by: |
University Hospital of Grenoble |
| Information provided by: |
University Hospital of 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: Educational/Counseling/Training, Non-Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.
Further study details as provided by University Hospital of Grenoble:
Primary Outcomes: spatial coordinates of the target (3 translations and 3 rotations)
Secondary Outcomes: time to install the eyebrow mark with each technique.; adverse events due to the transcutaneous pins.; number of handling realized by the nurse for each technique.; evaluation of cost: number of cable versus number of marker.
Expected Total Enrollment:
20
Study start: March 2005;
Expected completion: March 2007
Last follow-up: October 2006;
Data entry closure: October 2006
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 above,
Genders Eligible for Study:
Both
Criteria
Inclusion Criteria:
- Mandibular orthognathic surgery
Exclusion Criteria:
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00225446
FranceMaxillofacial and Plastic Surgery Department - University Hospital of Grenoble, Grenoble,
38043,
France; Recruiting
Study chairs or principal investigators
Georges BETTEGA, M.D., Ph.D., Principal Investigator, Institut National de la Santé Et de la Recherche Médicale, France
More Information
Study ID Numbers:
DCIC 04 14
Last Updated:
July 5, 2006
Record first received:
September 22, 2005
ClinicalTrials.gov Identifier:
NCT00225446Health Authority: France: Afssaps - French Health Products Safety Agency ClinicalTrials.gov processed this record on 2006-09-29 |
