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

NCT ID: NCT00206011

Last Updated: 2020-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Condylar Neck Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Endoscopic surgery

Intervention Type PROCEDURE

Open surgical intervention compared to endoscopic intervention

2

Group Type OTHER

Endoscopic surgery

Intervention Type PROCEDURE

Open surgical intervention compared to endoscopic intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic surgery

Open surgical intervention compared to endoscopic intervention

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rainer Schmlezeisen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitaet Freiburg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitaestklinik Freiburg, Klinik für Mund- Gesichts- und Kieferchirurgie

Freiburg im Breisgau, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06-CMF-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non Randomized Humerusshaft Fracture
NCT00205972 COMPLETED PHASE4