Study Stopped
Low recruitment
Patients 60 Years and Older Suffering From Mandibular Fractures Registry
International, Multicenter, Prospective Registry to Collect Data in Patients 60 Years and Older Suffering From Mandibular Fractures
1 other identifier
observational
25
14 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2019
Typical duration for all trials
23 active sites
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
First Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
October 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2023
CompletedJuly 16, 2024
July 1, 2024
3.5 years
February 15, 2019
July 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (4)
Occlusal Status
2 weeks / 6 weeks / 3 months / 6 months
Degree of malocclusion (if present)
2 weeks / 6 weeks / 3 months / 6 months
Mandibular dysfunction (Helkimo index)
2 weeks / 6 weeks / 3 months / 6 months
- +1 more other outcomes
Study Arms (1)
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
Interventions
Eligibility Criteria
Patients older than 60 years old with a mandibular fracture that requires treatment (either surgically or non-surgically)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
UC Davis Health System
Sacramento, California, 95817, United States
R Adams Cowley Shock Trauma Center
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Risto Kontio, Prof.
Department of Oral and Maxillofacial Surgery, Helsinki University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 21, 2019
Study Start
October 14, 2019
Primary Completion
March 29, 2023
Study Completion
March 29, 2023
Last Updated
July 16, 2024
Record last verified: 2024-07