Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Launched by AO INNOVATION TRANSLATION CENTER · Jun 18, 2019

Keywords

ClinConnect Summary

The Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry is a clinical trial focused on patients dealing with Temporomandibular Joint Disorders, which can cause pain and difficulty with jaw movement. In this study, researchers will collect information from about 200 patients who undergo a total TMJ replacement, a surgical procedure that replaces the damaged joint with an artificial one. Participants will be followed for up to 5 years to understand how well the treatment works, any complications that might arise, and how it affects their daily lives. Importantly, the study will also record cases where patients decide against the surgery, helping to understand patient choices better.

To be eligible for the study, participants must be at least 18 years old and need a total TMJ replacement. They should be able to understand the study details and provide written consent to participate. However, individuals with a recent history of substance abuse, those who are pregnant or planning to become pregnant, or those involved in other studies that may affect the results are not eligible. Participants can expect regular follow-ups and will contribute valuable information that could help improve future treatments for TMJ disorders.

Gender

ALL

Eligibility criteria

• 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