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

Tracking Information

First Received Date ^ICMJE

September 22, 2005

Last Updated Date

June 3, 2008

Start Date ^ICMJE

February 2006

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

spatial coordinates of the target (3 translations and 3 rotations)

Change History

Complete list of historical versions of study NCT00225446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

time to install the eyebrow mark with each technique.
adverse events due to the transcutaneous pins.
number of handling realized by thenurse for each technique.
evaluation of cost: number of cable versus number of marker.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Computer-Assisted Surgery
Maxillofacial Surgery

Intervention ^ICMJE

Device: MicronTracker

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Mandibular orthognathic surgery

Exclusion Criteria:

Age <18 years

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00225446

Responsible Party

Eric Svahn, University Hospital Grenoble

Study ID Numbers ^ICMJE

DCIC 04 14

Study Sponsor ^ICMJE

University Hospital, Grenoble

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

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

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

Information Provided By

University Hospital, Grenoble

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP