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Набира участници NCT03991728

Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Заболявания: Temporomandibular Joint Disorders

Спонсор: AO Innovation Translation Center

Налично на: БГ
Обобщение
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.
Описание
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
Кой може да участва
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
Места на провеждане 13
Бразилия (1)
Hospital BP - A Beneficência Portuguesa de São Paulo
São Paulo
Colombia (1)
Estetica Maxilofacial
Bogotá
SUSPENDED
Дания (1)
Rigshospitalet
Copenhagen
Индия (1)
Sri Shankara Cancer Hospital and Research Center
Bangalore
Нидерландия (1)
Erasmus Medisch Centrum
Rotterdam
New Zealand (1)
Waikato DHB
Christchurch
TERMINATED
Pakistan (1)
Mayo Hospital
Lahore
TERMINATED
Полша (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
Сърбия (1)
Clinic for Maxillofacial Surgery, University of Belgrade
Belgrade
South Africa (1)
King Edward VIII Hospital
Durban
Испания (1)
12 de Octubre University Hospital
Madrid
Швеция (1)
Falu Hospital
Falun
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
15.10.2019
Крайна дата
01.12.2033
Регистрационен номер
NCT03991728
Източник
anzctr
Запитване за медицински туризъм

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