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Recruiting NCT03991728

Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Conditions: Temporomandibular Joint Disorders

Sponsor: AO Innovation Translation Center

trial.available_in: БГ
Overview
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.
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
Who can participate
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
Locations 13
Brazil (1)
Hospital BP - A Beneficência Portuguesa de São Paulo
São Paulo
Colombia (1)
Estetica Maxilofacial
Bogotá
SUSPENDED
Denmark (1)
Rigshospitalet
Copenhagen
India (1)
Sri Shankara Cancer Hospital and Research Center
Bangalore
Netherlands (1)
Erasmus Medisch Centrum
Rotterdam
New Zealand (1)
Waikato DHB
Christchurch
TERMINATED
Pakistan (1)
Mayo Hospital
Lahore
TERMINATED
Poland (1)
Wojewódzki Specjalistyczny Szpital Dziecięcy
Olsztyn
Russia (1)
National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation
Moscow
Serbia (1)
Clinic for Maxillofacial Surgery, University of Belgrade
Belgrade
South Africa (1)
King Edward VIII Hospital
Durban
Spain (1)
12 de Octubre University Hospital
Madrid
Sweden (1)
Falu Hospital
Falun
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.10.2019
Completion date
01.12.2033
Registry ID
NCT03991728
Source
anzctr
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