Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAO Innovation Translation Center

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 years and or older

Patients requiring alloplastic total TMJ replacement

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

200 Participants
are grouped into 1 trial group

Locations

23
Brazil
Hospital BP - A Beneficência Portuguesa de São Paulo São Paulo Brazil
Colombia
Estetica Maxilofacial Bogotá Colombia
Denmark
Rigshospitalet2100, Copenhagen Denmark
Germany
Hannover Medical School30625, Hanover Germany

Sponsors and collaborators

AO Innovation Translation Center

Lead sponsor