Open Versus Endoscopic Surgery of Craniomaxillofacial (CMF) Condylar Neck Fractures

Condylar Neck Fractures Clinical Trial

Official title:

Open Versus Endoscopic Surgery of Condylar Neck Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206011
• Other study ID #: 06-CMF-01
• Status: Completed
• Phase: Phase 4
• Start date: April 2003
• Est. completion date: January 2009

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The primary outcome measure is functional outcome based on the Helkimo dysfunction index.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Condylar Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Endoscopic surgery
Open surgical intervention compared to endoscopic intervention

Locations

Country	Name	City	State
Germany	Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome based on the Helkimo dysfunction index		3 months
Secondary	Complication rate		24 months
Secondary	Cost effectiveness		24 months