nilateral condylar mandibular fractures:Conservative treatment vs. open reduction and internal fixation. A multi-centre prospective study
Recruiting
- Conditions
- mandibular condylar fracture treatment
- Registration Number
- NL-OMON23974
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
none
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
18 years or older.
-Unilateral condylar mandibular fracture (neck and/or base), with or without other fractures of the mandible, with or without injury of the front teeth, caused by trauma.
Exclusion Criteria
-No informed consent.
-Not able to undergo surgery because of comorbidity.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional parameters: <br /><br>1.Pain registration with the VAS-score in millimetres <br /><br>2.Masticatory performance, measured with Mixing Ability Test in pixels<br /><br>3.Clinical examination of the mandible (laterotrusion, protrusion, maximal opening of the mouth –interincisal distance-, deviation of the chin when opening) in millimetres<br /><br>4.RAND36 questionnaire<br /><br>5.MFIQ questionnaire<br>
- Secondary Outcome Measures
Name Time Method 1.Anatomic parameters:<br /><br>-Anatomic position of the fracture on radiologic imaging<br /><br>-Occlusion disorder<br /><br /><br><br>2.Patient characteristics:<br /><br>-Age<br /><br>-Sex<br /><br>-Trauma mechanism<br /><br>-Other mandibular fractures<br /><br>-Unilateral zygoma fracture<br /><br>-Other injuries<br /><br>-Injury of the teeth<br /><br>-Pain medication<br /><br>3.Alteration of treatment (escape treatment) required?<br /><br>4.Co-intervention required? <br /><br>5.(Post)operative complications<br /><br>6.Timing of intervention<br /><br>7.Duration of surgery/conservative treatment<br /><br>8.Cost of treatment<br /><br>9.Length of hospitalization <br>