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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014