Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
Key facts
- Where
- Olsztyn, PolandSee the site
Where in Poland
- Wojewodzki Specjalistyczny Szpital DzieciecyOlsztyn, PolandContact: Krzysztof Dowgierd, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AO Innovation Translation Center
- Trial code
- NCT03991728
- Record updated
- 16 September 2026
- Original description
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).Read full original descriptionShow less
International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
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.
Inclusion: 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: Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study; 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.