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

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

January 29, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Functional outcome based on the Helkimo dysfunction index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Functional outcome based on the Helkimo dysfunction index

Change History

Complete list of historical versions of study NCT00206011 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Complication rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Cost effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Complication rate
Cosmetic outcome
Cost effectiveness

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Open Versus Endoscopic Surgery of Condylar Neck Fractures

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Condylar Neck Fractures

Intervention ^ICMJE

Procedure: Endoscopic surgery

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

134

Completion Date

January 2009

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00206011

Responsible Party

Judy He, AO Clinical Investigation of NA

Study ID Numbers ^ICMJE

06-CMF-01

Study Sponsor ^ICMJE

AO Clinical Investigation and Documentation

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Rainer Schmlezeisen, Prof. Dr.

Universitaet Freiburg

Information Provided By

AO Clinical Investigation and Documentation

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP