Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
Recruiting now
Conditions studied: Temporomandibular Joint Disorders
In brief
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.
Key facts
- Study ID
- NCT03991728
- Run by
- AO Innovation Translation Center
- People needed
- 200
- Starts
- 2019-10-15
- Expected to finish
- 2033-12-01
- Last updated by the study team
- 2026-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Hospital BP - A Beneficência Portuguesa de São Paulo — São Paulo, Brazil (enrolling)
- 12 de Octubre University Hospital — Madrid, Spain (enrolling)
- Falu Hospital — Falun, Sweden (enrolling)
- Skåne University Hospital — Lund, Sweden (enrolling)
- Karolinska University Hospital — Stockholm, Sweden (enrolling)
- Uppsala University Hospital — Uppsala, Sweden (enrolling)
- Universitätsspital Basel — Basel, Switzerland (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Hannover Medical School — Hanover, Germany (enrolling)
- University Hospital Leipzig — Leipzig, Germany (enrolling)
- Klinikum der LMU München — Munich, Germany (enrolling)
- Sri Shankara Cancer Hospital and Research Center — Bangalore, India (enrolling)
- Erasmus Medisch Centrum — Rotterdam, Netherlands (enrolling)
- Wojewódzki Specjalistyczny Szpital Dziecięcy — Olsztyn, Poland (enrolling)
- National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation — Moscow, Russia (enrolling)
- Clinic for Maxillofacial Surgery, University of Belgrade — Belgrade, Serbia (enrolling)
- King Edward VIII Hospital — Durban, South Africa (enrolling)
- Estetica Maxilofacial — Bogotá, Colombia
- Hutt Hospital — Lower Hutt, New Zealand
- All India Institute of Medical Sciences (AIIMS) — New Delhi, India
- Mayo Hospital — Lahore, Pakistan
- Klinikum der Johannes Gutenberg Universität Mainz — Mainz, Germany
- Waikato DHB — Christchurch, New Zealand
Full record on ClinicalTrials.gov
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