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Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Recruitingn/aAges 18 Years - anyAllAO Innovation Translation Center
NCT03991728 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications). This registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years and or older * Patients requiring alloplastic total TMJ replacement * 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 registry according to the Registry Plan (RP) * Signed and dated ethics committee (EC) / Institutional review board (IRB) approved written informed consent Exclusion Criteria: * Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment * Pregnancy or women planning to conceive within the study period * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
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What it tests

  • Not listed
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Where

23 sites
Hospital BP - A Beneficência Portuguesa de São Paulo
São Paulo, Brazil
Estetica Maxilofacial
Bogotá, Colombia
Rigshospitalet
Copenhagen, Denmark
Hannover Medical School
Hanover, Germany
University Hospital Leipzig
Leipzig, Germany
Klinikum der Johannes Gutenberg Universität Mainz
Mainz, Germany
Klinikum der LMU München
Munich, Germany
Sri Shankara Cancer Hospital and Research Center
Bangalore, India

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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