Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
NCT ID: NCT03991728
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2019-10-15
2033-12-31
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Alloplastic total TMJ replacement
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AO Innovation Translation Center
OTHER
Responsible Party
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Principal Investigators
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Andreas Thor, MD
Role: PRINCIPAL_INVESTIGATOR
Oral and Maxillofacial surgery Uppsala University Hospital
Vinay V Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Oral and Maxillofacial surgery Uppsala University Hospital
Locations
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Hospital BP - A Beneficência Portuguesa de São Paulo
São Paulo, , Brazil
Estetica Maxilofacial
Bogotá, , Colombia
Rigshospitalet
Copenhagen, , Denmark
Hannover Medical School
Hanover, , Germany
University Hospital Leipzig
Leipzig, , Germany
Klinikum der Johannes Gutenberg Universität Mainz
Mainz, , Germany
Klinikum der LMU München
Munich, , Germany
Sri Shankara Cancer Hospital and Research Center
Bangalore, , India
All India Institute of Medical Sciences (AIIMS)
New Delhi, , India
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Waikato DHB
Christchurch, , New Zealand
Hutt Hospital
Lower Hutt, , New Zealand
Mayo Hospital
Lahore, , Pakistan
Wojewódzki Specjalistyczny Szpital Dziecięcy
Olsztyn, , Poland
National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation
Moscow, , Russia
Clinic for Maxillofacial Surgery, University of Belgrade
Belgrade, , Serbia
King Edward VIII Hospital
Durban, , South Africa
12 de Octubre University Hospital
Madrid, , Spain
Falu Hospital
Falun, , Sweden
Skåne University Hospital
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Universitätsspital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Gabriel Pastore, MD
Role: primary
Daniel Thiem
Role: primary
Wenko Smolka, MD
Role: primary
Vinay V Kumar, MD
Role: primary
Eppo Wolvius, MD
Role: primary
Sergey Epifanov, MD
Role: primary
Vivesh Rughubar, MD
Role: primary
Ignacio Zubillaga, MD
Role: primary
Jani Talvilahti, MD
Role: primary
Martin Bengtsson, MD
Role: primary
Mattias Ulmner, MD
Role: primary
Florian Thieringer, MD
Role: primary
Other Identifiers
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TMJ Replacement
Identifier Type: -
Identifier Source: org_study_id
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