Open Versus Endoscopic Surgery of Craniomaxillofacial (CMF) Condylar Neck Fractures
Phase 4
Completed
- Conditions
- Condylar Neck Fractures
- Interventions
- Procedure: Endoscopic surgery
- Registration Number
- NCT00206011
- Lead Sponsor
- AO Clinical Investigation and Publishing Documentation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Endoscopic surgery - 1 Endoscopic surgery -
- Primary Outcome Measures
Name Time Method Functional outcome based on the Helkimo dysfunction index 3 months
- Secondary Outcome Measures
Name Time Method Cost effectiveness 24 months Complication rate 24 months
Trial Locations
- Locations (1)
Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie
🇩🇪Freiburg, Germany