NCT00225446

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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

Enrollment Period

2.9 years

First QC Date

September 22, 2005

Last Update Submit

June 3, 2008

Conditions

Computer-Assisted SurgeryMaxillofacial Surgery

Keywords

Orthognathic surgery.optic repositioning system.

Outcome Measures

Primary Outcomes (1)

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

    during surgery

Secondary Outcomes (4)

  • time to install the eyebrow mark with each technique.

    during surgery

  • adverse events due to the transcutaneous pins.

    during surgery

  • number of handling realized by the nurse for each technique.

    during surgery

  • evaluation of cost: number of cable versus number of marker.

    during surgery

Interventions

MicronTrackerDEVICE

MicronTracker is a Third Generation Optic Repositioning System in orthognatic surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mandibular orthognathic surgery

You may not qualify if:

  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble

Grenoble, 38043, France

Location

Related Publications (4)

  • 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.

    PMID: 11757002BACKGROUND

  • Bettega 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.

    PMID: 8632238BACKGROUND

  • 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

    BACKGROUND

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

    BACKGROUND

Study Officials

  • Georges BETTEGA, M.D., Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 23, 2005

Study Start

February 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 4, 2008

Record last verified: 2008-06

Locations

FR(1)