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OpenTrials
Completed

NCT Number: NCT00206011

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

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.

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Key information

Conditions

Condylar Neck Fractures Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie

Freiburg im Breisgau, 79106, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic surgery

Procedure

Open surgical intervention compared to endoscopic intervention

Primary outcomes

  1. Functional outcome based on the Helkimo dysfunction index

    Time frame: 3 months

Secondary outcomes

  1. Complication rate

    Time frame: 24 months

  2. Cost effectiveness

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

Open Versus Endoscopic Surgery of Condylar Neck Fractures

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Sep 21, 2005
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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