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

This study has been completed.

First Received: September 14, 2005 Last Updated: January 29, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Fractures Surgery

U.S. FDA Resources

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 ]

Enrollment:	134
Study Start Date:	April 2003
Study Completion Date:	January 2009
Primary Completion Date:	October 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

Locations

Germany
Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie
Freiburg, Germany, 79106

Sponsors and Collaborators

AO Clinical Investigation and Documentation

Investigators

Principal Investigator:

Rainer Schmlezeisen, Prof. Dr.

Universitaet Freiburg

More Information

No publications provided

Responsible Party:	AO Clinical Investigation of NA ( Judy He )
Study ID Numbers:	06-CMF-01
Study First Received:	September 14, 2005
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00206011 History of Changes
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

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on November 30, 2009