NCT00206011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

5.5 years

First QC Date

September 14, 2005

Last Update Submit

August 12, 2020

Conditions

Condylar Neck Fractures

Keywords

Condylar neckfracturesendoscopicHelkimo Dysfunction index

Outcome Measures

Primary Outcomes (1)

  • Functional outcome based on the Helkimo dysfunction index

    3 months

Secondary Outcomes (2)

  • Complication rate

    24 months

  • Cost effectiveness

    24 months

Study Arms (2)

1

EXPERIMENTAL
Procedure: Endoscopic surgery

2

OTHER
Procedure: Endoscopic surgery

Interventions

Endoscopic surgeryPROCEDURE

Open surgical intervention compared to endoscopic intervention

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie

Freiburg im Breisgau, 79106, Germany

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Rainer Schmlezeisen, Prof. Dr.

    Universitaet Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

April 1, 2003

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

DE(1)