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
Locations
23Sponsors and collaborators
AO Innovation Translation Center
Lead sponsor