Status:
COMPLETED
Open Versus Endoscopic Surgery of Craniomaxillofacial (CMF) Condylar Neck Fractures
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Condylar Neck Fractures
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is a comparison of open surgery versus an endoscopic approach in condylar neck fractures; it will look at functional outcome, cosmetic outcome and patient satisfaction.
Detailed Description
The primary outcome measure is functional outcome based on the Helkimo dysfunction index.
Eligibility Criteria
Inclusion
- Adult patient \> 18 years
- Unilateral or bilateral fracture of the condylar neck
- Inclination of the condyle \> 30%
- Severe dislocation
- Severe pain upon palpation/movement
- Eligible for open reduction and internal fixation of the fracture
- Amenable to endoscopic as well as open surgery
Exclusion
- High or intracapsular condylar neck fracture
- Very low fractures that can be reduced intraorally
- CMF malfunctioning
- Drug or alcohol abuse
- General or local conditions that adversely affect bone physiology
- Physical or mental incapacity to sign informed consent
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00206011
Start Date
April 1 2003
End Date
January 1 2009
Last Update
August 14 2020
Active Locations (1)
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1
Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie
Freiburg im Breisgau, Germany, 79106