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

This study is currently recruiting participants.

Verified by AO Clinical Investigation and Documentation, May 2008

Sponsored by:	AO Clinical Investigation and Documentation
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT00206011

Purpose

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.

Condition	Intervention	Phase
Condylar Neck Fractures	Procedure: Endoscopic surgery	Phase IV

MedlinePlus related topics: Endoscopy Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Open Versus Endoscopic Surgery of Condylar Neck Fractures

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	160
Study Start Date:	April 2003
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: Endoscopic surgery Open surgical intervention compared to endoscopic intervention
2	Procedure: Endoscopic surgery Open surgical intervention compared to endoscopic intervention

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206011

Contacts

Contact: Judy He, MSc

609-375-2317

judy.he@aofoundation.org

Locations

Germany
Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie	Recruiting
Freiburg, Germany, 79106
Contact: Rainer Schmelzeisen, Prof. Dr. 49-761-270-4940 schmelz@zmk2.ukl.uni-freiburg.de

Sponsors and Collaborators

AO Clinical Investigation and Documentation

Investigators

Principal Investigator:

Rainer Schmlezeisen, Prof. Dr.

Universitaet Freiburg

More Information

Responsible Party:	AO Clinical Investigation of NA ( Judy He )
Study ID Numbers:	06-CMF-01
Study First Received:	September 14, 2005
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00206011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AO Clinical Investigation and Documentation:

Condylar neck
fractures
endoscopic
Helkimo Dysfunction index

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 16, 2009