Registry for patients undergoing TMJ replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry collects prospective data from approximately 200 patients who are treated with alloplastic total temporomandibular joint (TMJ) replacement. Participants will be followed for up to 5 years to assess clinical indications, treatment patterns, and patient-reported outcomes. The study aims to explore the relationship between treatment and quality of life, identify predictive factors for favorable outcomes, and document reasons for patients refusing the procedure. Data will also include complications and adverse events related to the treatment.

Why it matters

Who can join: the full rules

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's running

• Hospital BP - A Beneficência Portuguesa de São Paulo
  São Paulo, Brazil Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Hannover Medical School
  Hanover, Germany Recruiting
• University Hospital Leipzig
  Leipzig, Germany Recruiting
• Klinikum der LMU München
  Munich, Germany Recruiting
• Sri Shankara Cancer Hospital and Research Center
  Bangalore, India Recruiting

Study contacts

• Principal investigator: Andreas Thor, MD — Oral and Maxillofacial surgery Uppsala University Hospital
• Study coordinator: Viola Grünenfelder
• Email: viola.gruenenfelder@aofoundation.org
• Phone: +41 79 696 33 97

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.