Open Versus Endoscopic Surgery of Craniomaxillofacial (CM... | NCT00206011

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

NCT00206011

Sponsor

AO Clinical Investigation and Publishing Documentation

Status

Completed

Last Update Posted

Aug 14, 2020Actual

Enrollment

134Actual

Phase

Phase 4

Conditions

Condylar Neck Fractures

Interventions

Endoscopic surgery

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Oct 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2020

Last Update Posted Date

Aug 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Procedure: Endoscopic surgery
2	Other		Procedure: Endoscopic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic surgery	Procedure	Open surgical intervention compared to endoscopic intervention	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional outcome based on the Helkimo dysfunction index		3 months

Secondary Outcomes

Measure	Description	Time Frame
Complication rate		24 months
Cost effectiveness		24 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rainer Schmlezeisen, Prof. Dr.	Universitaet Freiburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie		Freiburg im Breisgau		79106	Germany

ID	Term
D050723	Fractures, Bone

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D004724	Endoscopy

Ancestor Terms

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided