Computer-Assisted SurgeryPhase 1/2NCT00225446
Micron Tracker: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System
A Phase 1/2 study testing MicronTracker in people with Computer-Assisted Surgery and Maxillofacial Surgery, run by University Hospital, Grenoble at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Computer-Assisted Surgery, Maxillofacial Surgery
- What is being tested?
- MicronTracker
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to Jan 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mandibular orthognathic surgery
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
France1 site
Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble
Grenoble, 38043
About this study
Official title: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.
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).
Read the 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.
- Conditions
- Computer-Assisted Surgery, Maxillofacial Surgery
- Being tested
- MicronTracker
- Keywords
- Orthognathic surgery., optic repositioning system.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicronTrackerDevice
MicronTracker is a Third Generation Optic Repositioning System in orthognatic surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
spatial coordinates of the target (3 translations and 3 rotations)
Measured: during surgery
Secondary outcomes (4)
time to install the eyebrow mark with each technique.
Measured: during surgery
adverse events due to the transcutaneous pins.
Measured: during surgery
number of handling realized by the nurse for each technique.
Measured: during surgery
evaluation of cost: number of cable versus number of marker.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startFeb 2006
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Computer-Assisted SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- Georges BETTEGA, M.D., Ph.D., Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225446
- Sponsor's protocol ID
- DCIC 04 14
- Status last verified
- Jun 2008
- First submitted
- 22 Sep 2005
- Last updated
- 4 Jun 2008
- Results posted
- No
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. doi: 10.1053/joms.2002.29069.
PubMed 11757002Bettega 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. doi: 10.1016/s0278-2391(96)90630-8.
PubMed 8632238Dessenne 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.
- ClinicalTrials.gov ID
- NCT00225446
- Acronym / sponsor ID
- DCIC 04 14
- Conditions
- Computer-Assisted Surgery, Maxillofacial Surgery
- Keywords
- Orthognathic surgery., optic repositioning system.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mandibular orthognathic surgery
Key exclusion criteria (1 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicronTrackerMicronTracker is a Third Generation Optic Repositioning System in orthognatic surgery. | Device | – |
Primary outcome
spatial coordinates of the target (3 translations and 3 rotations)
Time frame: during surgery
4 secondary outcomes
time to install the eyebrow mark with each technique.
Time frame: during surgery
adverse events due to the transcutaneous pins.
Time frame: during surgery
number of handling realized by the nurse for each technique.
Time frame: during surgery
evaluation of cost: number of cable versus number of marker.
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
- Background: PubMed 11757002Bettega 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. doi: 10.1053/joms.2002.29069.
- Background: PubMed 8632238Bettega 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. doi: 10.1016/s0278-2391(96)90630-8.
- BackgroundDessenne 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
- BackgroundBettega 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges BETTEGA, M.D., Ph.D. principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MicronTracker in people with Computer-Assisted Surgery and Maxillofacial Surgery, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spatial coordinates of the target (3 translations and 3 rotations) (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00225446, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2008.