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Low recruitment
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Approximately 200 of patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. All patients will be treated and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.
Patients of 60 years or older who present a mandibular fracture will be enrolled in this registry. All patients will be treated (surgical or non-surgical) and followed up according to the local standard (routine) of care at around 2 weeks, 6 weeks, 3 months and 6 months after treatment.
Data collection will include patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications). Radiographs and/or other images (e.g. CT scan) taken as per standard of care will be collected within the registry.
Primary objectives are to obtain epidemiological data and describe the most common mandibular fracture patterns in older patients, to explore the relationship(s) between the treatment of mandibular fractures and its outcome in older patients, to identify risk factors and initiating factors of elderly related to mandible fracture events and to describe concomitant fractures associated with mandibular fractures in older patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandibular Fracture | Elderly patients of > 60 years who present a mandibular fracture Surgery or Non-surgical fracture treatment will be applied according to routine clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Surgical fracture treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcome | Change in Geriatric/general Oral Self Assessment Index (GOHAI) over the follow up period: Self-reported measurement to describe three hypothetical dimensions 1) physical function, 2) psychosocial function and 3) pain and/or discomfort. It consisted of 12 items evaluated using a 5-point Likert from "never" to "always" in which higher scores indicated better outcomes. | Baseline (preinjury)/ 2 weeks / 6 weeks / 3 months / 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Occlusal Status | Occlusion will be assessed without the use of dentures and classified follows:
|
Inclusion Criteria:
Age > 60 years at the time of the injury
Diagnosis of any kind of mandibular fracture
Informed consent obtained, i.e.:
Exclusion Criteria:
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Patients older than 60 years old with a mandibular fracture that requires treatment (either surgically or non-surgically)
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| Name | Affiliation | Role |
|---|---|---|
| Risto Kontio, Prof. | Department of Oral and Maxillofacial Surgery, Helsinki University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Health System | Sacramento | California | 95817 | United States | ||
| R Adams Cowley Shock Trauma Center |
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| Non-Surgical fracture treatment | Other | Non-Surgical fracture treatment |
|
| 2 weeks / 6 weeks / 3 months / 6 months |
| Degree of malocclusion (if present) | The thin-paper bite test will be used to evaluate the status of the occlusion. This test will be performed only if malocclusion is detected. Patients will be asked to close the mouth and bring teeth together while biting into a thin paper (<1mm). Deviations between opposite teeth greater than 1mm will be assessed as major, while deviations <1mm will be assessed as minor. | 2 weeks / 6 weeks / 3 months / 6 months |
| Mandibular dysfunction (Helkimo index) | Evaluation by means Helkimo Index:
Patients will be classified according to their score as follow:
| 2 weeks / 6 weeks / 3 months / 6 months |
| Mandibular Movements (mobility index) |
Depending on the score, the mobility index will be calculated as follow:
| 2 weeks / 6 weeks / 3 months / 6 months |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Helsinki University Hospital | Helsinki | Finland |
| University Hospital Freiburg | Freiburg im Breisgau | Germany |
| Medical Center Hamburg Eppendorf | Hamburg | Germany |
| Universitatsklinikum Marburg | Marburg | Germany |
| LMU - Klinikum der Universität München | München | Germany |
| Bundeswehrkrankenhauses Ulm | Ulm | Germany |
| Hospital Sungai Buloh | Sungai Buloh | Malaysia |
| Hospital General de Especialidades | Campeche | Mexico |
| Erasmus MC | Rotterdam | Netherlands |
| Spitalul Clinic Judeţean de Urgenţă "Sf. Apostol Andrei" Constanţa | Constanța | Romania |
| Clinic for Maxillofacial Surgery, University of Belgrade | Belgrade | Serbia |
| University Medical Centre Ljubljana | Ljubljana | Slovenia |
| King Edward VIII Hospital | Durban | South Africa |
| Hospital Vall d' Hebron | Barcelona | Spain |
| Hospital Puerta de Hierro | Madrid | Spain |
| Hospital Ramon y Cajal | Madrid | Spain |
| Karolinska University Hospital | Stockholm | Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| Universitaetsspital Basel | Basel | Switzerland |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| Hospital Maciel de Montevideo | Montevideo | Uruguay |
| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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