Patients 60 Years and Older Suffering From Mandibular Fractures Registry

Mandibular Fractures Clinical Trial

Official title:

International, Multicenter, Prospective Registry to Collect Data in Patients 60 Years and Older Suffering From Mandibular Fractures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03849898
• Other study ID #: MFx 60+_RP_v.1.0
• Status: Terminated
• Start date: October 14, 2019
• Est. completion date: March 29, 2023

Study information

• Verified date: March 2024
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

Procedure:
• Surgery
Surgical fracture treatment

Other:
• Non-Surgical fracture treatment
Non-Surgical fracture treatment

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

United States,  Uruguay,  Finland,  Germany,  Malaysia,  Mexico,  Netherlands,  Romania,  Serbia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 bite; Crossbite; Lateral open bite in the premolar area; Lateral open bite in the molar area; Deep bite: missing molar and/or pre-molar to support occlusion; Other; Not assessable (in case of edentulous patients or who use prosthesis)	2 weeks / 6 weeks / 3 months / 6 months
Other	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
Other	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
Other	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
Primary	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