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

AO Clinical Investigation and Publishing Documentation

Status and phase: Completed; Phase 4

Conditions: Condylar Neck Fractures

Treatments: Procedure: Endoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00206011

06-CMF-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

1

Experimental group

Treatment:

Procedure: Endoscopic surgery

2

Other group

Treatment:

Procedure: Endoscopic surgery