Mandibular FracturesNCT03849898
Patients 60 Years and Older Suffering From Mandibular Fractures Registry
An observational study of Mandibular Fractures, run by AO Clinical Investigation and Publishing Documentation at 24 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Surgery and Non-Surgical fracture treatment
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 24 sitesin 15 countries
- Study dates
- 14 Oct 2019to 29 Mar 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Study population: Patients older than 60 years old with a mandibular fracture that requires treatment (either surgically or non-surgically)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
24 sites in 15 countries.
24 sites in 15 countries
Germany5 sites
University Hospital Freiburg
Freiburg im Breisgau
Medical Center Hamburg Eppendorf
Hamburg
Universitatsklinikum Marburg
Marburg
LMU - Klinikum der Universität München
München
Bundeswehrkrankenhauses Ulm
Ulm
United States3 sites
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
UC Davis Health System
Sacramento, California, 95817
Harborview Medical Center
Seattle, Washington, 98104
Spain3 sites
Hospital Vall d' Hebron
Barcelona
Hospital Puerta de Hierro
Madrid
Hospital Ramon y Cajal
Madrid
Sweden2 sites
Karolinska University Hospital
Stockholm
Uppsala University Hospital
Uppsala
Romania1 site
Spitalul Clinic Judeţean de Urgenţă "Sf. Apostol Andrei" Constanţa
Constanța
About this study
Official title: International, Multicenter, Prospective Registry to Collect Data in Patients 60 Years and Older Suffering From Mandibular Fractures
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.
Read the 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.
- Conditions
- Mandibular Fractures
- Being tested
- Surgery, Non-Surgical fracture treatment
- Keywords
- Fracture fixation, Surgical treatment, Non-Surgical treatment
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Operative
Surgical fracture treatment
Non-Surgical fracture treatmentOther
Non-Surgical fracture treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Surgery; Other: Non-Surgical fracture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preinjury)/ 2 weeks / 6 weeks / 3 months / 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start14 Oct 2019
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Risto Kontio, Prof., Principal investigator, Department of Oral and Maxillofacial Surgery, Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849898
- Sponsor's protocol ID
- MFx 60+_RP_v.1.0
- Status last verified
- Jul 2024
- First submitted
- 15 Feb 2019
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Prospective Registry to Collect Data in Patients 60 Years and Older Suffering From Mandibular Fractures
- ClinicalTrials.gov ID
- NCT03849898
- Acronym / sponsor ID
- MFx 60+_RP_v.1.0
- Conditions
- Mandibular Fractures
- Keywords
- Fracture fixation, Surgical treatment, Non-Surgical treatment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mandibular Fracture | – | Procedure: Surgery, Other: Non-Surgical fracture treatmentElderly patients of > 60 years who present a mandibular fracture Surgery or Non-surgical fracture treatment will be applied according to routine clinical practice |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 60 years old with a mandibular fracture that requires treatment (either surgically or non-surgically)
Key inclusion criteria (6 listed)
- Age > 60 years at the time of the injury
- Diagnosis of any kind of mandibular fracture
- Informed consent obtained, i.e.:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAlso: OperativeSurgical fracture treatment | Procedure or surgery | Mandibular Fracture |
| Non-Surgical fracture treatmentNon-Surgical fracture treatment | Other | Mandibular Fracture |
Primary outcome
Patient-reported outcome
Time frame: 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.
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Mandibular Fractures
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Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
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Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risto Kontio, Prof. principal investigator
Department of Oral and Maxillofacial Surgery, Helsinki University Hospital
24 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Fractures, run by AO Clinical Investigation and Publishing Documentation at 24 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, United States, Spain, Sweden, Finland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcome (time frame: Baseline (preinjury)/ 2 weeks / 6 weeks / 3 months / 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.