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| Descriptive Information Fields | |||||
| Brief Title † | Micron Tracker: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System | ||||
| Official Title † | 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). |
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| 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 Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Other, Non-Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | spatial coordinates of the target (3 translations and 3 rotations) [ Time Frame: during surgery ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Computer-Assisted Surgery Maxillofacial Surgery |
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| Intervention † | Device: MicronTracker | ||||
| MEDLINE PMIDs | 11757002, 8632238 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Suspended | ||||
| Enrollment † | 20 | ||||
| Start Date † | February 2006 | ||||
| Completion Date | January 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | France | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00225446 | ||||
| Organization ID | DCIC 04 14 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University Hospital, Grenoble | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | University Hospital, Grenoble | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | September 22, 2005 | ||||
| Last Updated Date | June 3, 2008 | ||||
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