Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

AO Innovation Translation Center

Status: Enrolling

Conditions: Temporomandibular Joint Disorders

Study type: Observational

Funder types: Other

Identifiers

NCT03991728

TMJ Replacement

Details and patient eligibility

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.

Full description

More in detail this registry has the following objectives:

• To describe clinical indications for TMJ replacement, and treatment patterns (including differences among regions if feasible)
• To describe the clinical evolution and outcomes of patients treated with a TMJ replacement
• To explore the relationship(s) between treatment, outcome(s) and quality of life (QoL).
• To identify predictive factors for favorable outcomes (pain reduction, range of motion (ROM), occlusal status, QoL) in patients treated with TMJ replacement.
• To describe the reasons of patients who refused TMJ replacements

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Alloplastic total TMJ replacement

Description:

All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. The registry does not dictate any specific treatment.