TerminatedNot Applicable

Patients 60 Years and Older Suffering From Mandibular Fractures Registry

Stopped: Low recruitment

United States, Finland, Germany25 participantsStarted 2019-10-14

Plain-language 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.

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient-reported outcome

Timeframe: Baseline (preinjury)/ 2 weeks / 6 weeks / 3 months / 6 months

Trial details

NCT IDNCT03849898

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03-29

View on ClinicalTrials.gov More Mandibular Fractures trials