Patients 60 Years and Older Suffering From Mandibular Fractures Registry

Terminated

• Conditions: Mandibular Fractures
• Interventions: Procedure: Surgery; Other: Non-Surgical fracture treatment

• Registration Number: NCT03849898
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Study Start: 2019-10-14
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Age > 60 years at the time of the injury

• Diagnosis of any kind of mandibular fracture

• Informed consent obtained, i.e.:

  • Ability to understand the content of the patient information/ informed consent form (ICF)
  • Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
  • Signed and dated EC/IRB approved written informed consent OR For patients who are not able to provide independent written informed consent: Written consent provided according to defined and IRB/EC approved procedures

Exclusion Criteria

• Patients with previous history of mandibular fractures or mandibular defects treated surgically
• Participation in any other medical device or medicinal product study within the previous months that could influence bone healing and the results of the present study in the opinion of the treating physician

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mandibular Fracture	Non-Surgical fracture treatment	Elderly patients of \> 60 years who present a mandibular fracture Surgery or Non-surgical fracture treatment will be applied according to routine clinical practice
Mandibular Fracture	Surgery	Elderly patients of \> 60 years who present a mandibular fracture Surgery or Non-surgical fracture treatment will be applied according to routine clinical practice

Primary Outcome Measures

Name	Time	Method
Patient-reported outcome	Baseline (preinjury)/ 2 weeks / 6 weeks / 3 months / 6 months	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.

Trial Locations

Locations (24)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Clinic for Maxillofacial Surgery, University of Belgrade; 🇷🇸 Belgrade, Serbia

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Hospital General de Especialidades; 🇲🇽 Campeche, Mexico

R Adams Cowley Shock Trauma Center; 🇺🇸 Baltimore, Maryland, United States

UC Davis Health System; 🇺🇸 Sacramento, California, United States

LMU - Klinikum der Universität München; 🇩🇪 München, Germany

Hospital Sungai Buloh; 🇲🇾 Sungai Buloh, Malaysia

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Universitaetsspital Basel; 🇨🇭 Basel, Switzerland

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Universitatsklinikum Marburg; 🇩🇪 Marburg, Germany

Medical Center Hamburg Eppendorf; 🇩🇪 Hamburg, Germany

Bundeswehrkrankenhauses Ulm; 🇩🇪 Ulm, Germany

University Hospital Freiburg; 🇩🇪 Freiburg, Germany

King Edward VIII Hospital; 🇿🇦 Durban, South Africa

Hospital Vall d' Hebron; 🇪🇸 Barcelona, Spain

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Puerta de Hierro; 🇪🇸 Madrid, Spain

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Hospital Maciel de Montevideo; 🇺🇾 Montevideo, Uruguay

Spitalul Clinic Judeţean de Urgenţă "Sf. Apostol Andrei" Constanţa; 🇷🇴 Constanţa, Romania

University Medical Centre Ljubljana; 🇸🇮 Lubiana, Slovenia