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

Phase 4CompletedNCT00206011

AO Clinical Investigation and Publishing Documentation134 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Condylar Neck Fractures

Interventions

Endoscopic surgeryPROCEDURE

Open surgical intervention compared to endoscopic intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie

Freiburg im Breisgau, Germany

Outcomes

Primary Outcomes

Functional outcome based on the Helkimo dysfunction index

Time frame: 3 months

Secondary Outcomes

Complication rate

Time frame: 24 months

Cost effectiveness

Time frame: 24 months

Data from ClinicalTrials.gov

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