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

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.

Study Overview

• Status: Terminated
• Conditions: Mandibular Fractures
• Intervention / Treatment: Procedure: Surgery; Other: Non-Surgical fracture 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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
• Germany
  • Freiburg, Germany
    • University Hospital Freiburg
  • Hamburg, Germany
    • Medical Center Hamburg Eppendorf
  • Marburg, Germany
    • Universitätsklinikum Marburg
  • München, Germany
    • LMU - Klinikum der Universität München
  • Ulm, Germany
    • Bundeswehrkrankenhauses Ulm
• Malaysia
  • Sungai Buloh, Malaysia
    • Hospital Sungai Buloh
• Mexico
  • Campeche, Mexico
    • Hospital General de Especialidades
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus MC
• Romania
  • Constanţa, Romania
    • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
• Serbia
  • Belgrade, Serbia
    • Clinic for Maxillofacial Surgery, University of Belgrade
• Slovenia
  • Lubiana, Slovenia
    • University Medical Centre Ljubljana
• South Africa
  • Durban, South Africa
    • King Edward VIII Hospital
• Spain
  • Barcelona, Spain
    • Hospital Vall d' Hebron
  • Madrid, Spain
    • Hospital Ramón y Cajal
  • Madrid, Spain
    • Hospital Puerta de Hierro
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital
  • Uppsala, Sweden
    • Uppsala University Hospital
• Switzerland
  • Basel, Switzerland
    • Universitaetsspital Basel
• Taiwan
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Health System
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • R Adams Cowley Shock Trauma Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
• Uruguay
  • Montevideo, Uruguay
    • Hospital Maciel de Montevideo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients older than 60 years old with a mandibular fracture that requires treatment (either surgically or non-surgically)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: Surgery; Surgical fracture treatment; Other Names: Operative; Other: Non-Surgical fracture treatment; Non-Surgical fracture treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusal Status	Occlusion will be assessed without the use of dentures and classified follows: Normal for the patient; Abnormal for the patient (multiple options possible)Anterior open biteCrossbiteLateral open bite in the premolar areaLateral open bite in the molar areaDeep bite: missing molar and/or pre-molar to support occlusionOther; Not assessable (in case of edentulous patients or who use prosthesis)	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: Impaired range of movement (0 normal, 1 slight, 5 severely); Impaired temporomandibular joint function (0 smooth movement without joint sounds, 1 joint sounds in one or both joints, 5 locking and/or luxation of joint); Muscle pain (0 no tenderness, 1 tenderness to palpation in 1-3 palpation sites, 5 tenderness in 4 or more palpation sites); Temporomandibular joint pain (0 no tenderness, 1 tenderness to palpation laterally, 5 tenderness to palpation posteriority); Pain on movement (0 no pain, 1 pain one movement, 5 pain on two or more movements) Patients will be classified according to their score as follow: 0 points, clinically symptom free; 1 - 4 points: mild dysfunction; 5 - 9 points: moderate dysfunction; 10 - 13 points: severe dysfunction; 15 - 17 points: severe dysfunction; 20 - 25 points: severe dysfunction	2 weeks / 6 weeks / 3 months / 6 months
Mandibular Movements (mobility index)	Interincisal opening/maximal opening is defined as distance in millimeters between the edges of the incisors of the mandibular and the maxillary bone.; Lateral movements: With the mandible slightly open, it is defined as the distance in millimeters from the labioincisal embrasure between the central incisors to the labioincisal embrasure of the mandibular incisors; Protrusive movement: With the mandible slightly open, it is defined as the distance in millimeters between the incisal edges of the maxillary central incisor to the mandibular central incisor. Depending on the score, the mobility index will be calculated as follow: 0 points: normal mandibular mobility; 1 - 4 points: slightly impaired mobility; 5 - 20 points: severely impaired mobility	2 weeks / 6 weeks / 3 months / 6 months

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Risto Kontio, Prof., Department of Oral and Maxillofacial Surgery, Helsinki University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Surgical treatment; Fracture fixation; Non-Surgical treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures
• Other Study ID Numbers: MFx 60+_RP_v.1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No