Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
Recruiting · NCT03991728 · Observational (researchers observe without assigning treatment) · Lead sponsor: AO Innovation Translation Center
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
23 locations listed.
- Sri Shankara Cancer Hospital and Research Center - Bangalore, India
- Universitätsspital Basel - Basel, Switzerland
- Clinic for Maxillofacial Surgery, University of Belgrade - Belgrade, Serbia
- Estetica Maxilofacial - Bogotá, Colombia
- Waikato DHB - Christchurch, New Zealand
- Rigshospitalet - Copenhagen, Denmark
- King Edward VIII Hospital - Durban, South Africa
- Falu Hospital - Falun, Sweden
- Hannover Medical School - Hanover, Germany
- Mayo Hospital - Lahore, Pakistan
- University Hospital Leipzig - Leipzig, Germany
- Hutt Hospital - Lower Hutt, New Zealand
- Skåne University Hospital - Lund, Sweden
- 12 de Octubre University Hospital - Madrid, Spain
- Klinikum der Johannes Gutenberg Universität Mainz - Mainz, Germany
- National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation - Moscow, Russia
- Klinikum der LMU München - Munich, Germany
- All India Institute of Medical Sciences (AIIMS) - New Delhi, India
- Wojewódzki Specjalistyczny Szpital Dziecięcy - Olsztyn, Poland
- Erasmus Medisch Centrum - Rotterdam, Netherlands
- Karolinska University Hospital - Stockholm, Sweden
- Hospital BP - A Beneficência Portuguesa de São Paulo - São Paulo, Brazil
- Uppsala University Hospital - Uppsala, Sweden