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

Primary Purpose

Condylar Neck Fractures

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Endoscopic surgery
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Condylar Neck Fractures focused on measuring Condylar neck, fractures, endoscopic, Helkimo Dysfunction index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Functional outcome based on the Helkimo dysfunction index

Secondary Outcome Measures

Complication rate
Cost effectiveness

Full Information

First Posted
September 14, 2005
Last Updated
August 12, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
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1. Study Identification

Unique Protocol Identification Number
NCT00206011
Brief Title
Open Versus Endoscopic Surgery of Craniomaxillofacial (CMF) Condylar Neck Fractures
Official Title
Open Versus Endoscopic Surgery of Condylar Neck Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The primary outcome measure is functional outcome based on the Helkimo dysfunction index.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Condylar Neck Fractures
Keywords
Condylar neck, fractures, endoscopic, Helkimo Dysfunction index

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Endoscopic surgery
Intervention Description
Open surgical intervention compared to endoscopic intervention
Primary Outcome Measure Information:
Title
Functional outcome based on the Helkimo dysfunction index
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complication rate
Time Frame
24 months
Title
Cost effectiveness
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Schmlezeisen, Prof. Dr.
Organizational Affiliation
Universitaet Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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