Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Last updated: February 17, 2026
Sponsor: AO Innovation Translation Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Treatment

N/A

Clinical Study ID

NCT03991728
TMJ Replacement
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 consentform (ICF)

  • Willingness and ability to participate in the registry according to theRegistry Plan (RP)

  • Signed and dated ethics committee (EC) / Institutional review board (IRB)approved written informed consent

Exclusion

Exclusion Criteria:

  • Recent history of substance abuse (i.e. recreational drugs, alcohol) that wouldpreclude reliable assessment

  • Pregnancy or women planning to conceive within the study period

  • Participation in any other medical device or medicinal product study within theprevious month that could influence the results of the present study

Study Design

Total Participants: 200
Study Start date:
October 15, 2019
Estimated Completion Date:
December 31, 2033

Study 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

Connect with a study center

  • Hospital BP - A Beneficência Portuguesa de São Paulo

    São Paulo,
    Brazil

    Site Not Available

  • Hospital BP - A Beneficência Portuguesa de São Paulo

    São Paulo 3448439,
    Brazil

    Active - Recruiting

  • Estetica Maxilofacial

    Bogotá,
    Colombia

    Site Not Available

  • Estetica Maxilofacial

    Bogotá 3688689,
    Colombia

    Suspended

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen 2618425, 2100
    Denmark

    Active - Recruiting

  • Helsinki University Hospital

    Helsinki,
    Finland

    Site Not Available

  • Universitätsklinikum Düsseldorf (UKD)

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Hannover Medical School

    Hannover, 30625
    Germany

    Site Not Available

  • Hannover Medical School

    Hanover 2910831, 30625
    Germany

    Active - Recruiting

  • University Hospital Leipzig

    Leipzig,
    Germany

    Site Not Available

  • University Hospital Leipzig

    Leipzig 2879139,
    Germany

    Active - Recruiting

  • Klinikum der Johannes Gutenberg Universität Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Klinikum der Johannes Gutenberg Universität Mainz

    Mainz 2874225, 55131
    Germany

    Site Not Available

  • Klinikum der LMU München

    Munich, 80337
    Germany

    Site Not Available

  • Klinikum der LMU München

    Munich 2867714, 80337
    Germany

    Active - Recruiting

  • Sri Shankara Cancer Hospital and Research Center

    Bangalore,
    India

    Site Not Available

  • Sri Shankara Cancer Hospital and Research Center

    Bangalore 1277333,
    India

    Active - Recruiting

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, 110029
    India

    Site Not Available

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi 1261481, 110029
    India

    Terminated

  • Erasmus Medisch Centrum

    Rotterdam, 3075
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam 2747891, 3075
    Netherlands

    Active - Recruiting

  • Waikato DHB

    Christchurch,
    New Zealand

    Site Not Available

  • Waikato DHB

    Christchurch 2192362,
    New Zealand

    Terminated

  • Hutt Hospital

    Lower Hutt,
    New Zealand

    Site Not Available

  • Hutt Hospital

    Lower Hutt 2188164,
    New Zealand

    Suspended

  • Mayo Hospital

    Lahore,
    Pakistan

    Site Not Available

  • Mayo Hospital

    Lahore 1172451,
    Pakistan

    Terminated

  • Wojewódzki Specjalistyczny Szpital Dziecięcy

    Olsztyn,
    Poland

    Site Not Available

  • Wojewódzki Specjalistyczny Szpital Dziecięcy

    Olsztyn 763166,
    Poland

    Active - Recruiting

  • National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation

    Moscow 524901,
    Russia

    Active - Recruiting

  • National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation

    Moscow,
    Russian Federation

    Site Not Available

  • Clinic for Maxillofacial Surgery, University of Belgrade

    Belgrade,
    Serbia

    Site Not Available

  • Clinic for Maxillofacial Surgery, University of Belgrade

    Belgrade 792680,
    Serbia

    Active - Recruiting

  • King Edward VIII Hospital

    Durban, 4030
    South Africa

    Site Not Available

  • King Edward VIII Hospital

    Durban 1007311, 4030
    South Africa

    Active - Recruiting

  • 12 de Octubre University Hospital

    Madrid, 28041
    Spain

    Site Not Available

  • 12 de Octubre University Hospital

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Falu Hospital

    Falun, 79182
    Sweden

    Site Not Available

  • Falu Hospital

    Falun 2715459, 79182
    Sweden

    Active - Recruiting

  • Skåne University Hospital

    Lund,
    Sweden

    Site Not Available

  • Skåne University Hospital

    Lund 2693678,
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm 2673730,
    Sweden

    Active - Recruiting

  • Uppsala University Hospital

    Uppsala, SE-75185
    Sweden

    Site Not Available

  • Uppsala University Hospital

    Uppsala 2666199, SE-75185
    Sweden

    Active - Recruiting

  • Universitätsspital Basel

    Basel,
    Switzerland

    Site Not Available

  • Universitätsspital Basel

    Basel 2661604,
    Switzerland

    Active - Recruiting

  • University of Texas Health

    San Antonio, Texas 78229
    United States

    Site Not Available

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