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

This study has been completed.
Sponsor:
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00206011
First received: September 14, 2005
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Versus Endoscopic Surgery of Condylar Neck Fractures

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Fractures
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
Experimental: 1 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: Judy He, AO Clinical Investigation of NA
ClinicalTrials.gov Identifier: NCT00206011     History of Changes
Other Study ID Numbers: 06-CMF-01
Study First Received: September 14, 2005
Last Updated: January 29, 2009
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

ClinicalTrials.gov processed this record on May 22, 2013