Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Temporomandibular Joint Disorders. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бразилия, Колумбия, Дания, Германия, Индия +10
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
Обзор
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.
Подробное 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
Первичные конечные точки
- The registry has no primary but several objectives. [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
Вторичные конечные точки (12)
- Demographics [Срок оценки: pre-operative]
- Comorbidities [Срок оценки: pre-operative]
- Refusal of alloplastic total TMJ replacement surgery [Срок оценки: pre-operative]
- Clinical and functional outcomes - Mandibular movements [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Clinical and functional outcomes - Occlusal status [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Clinical and functional outcomes - Dentition [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Clinical and functional outcomes - Helkimo Clinical dysfunction index [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Patient Reported Outcomes - Pain numeric rating scale (NRS) [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Patient Reported Outcomes - Jaw function NRS [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Patient Reported Outcomes - Diet limitation NRS [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Patient Reported Outcomes - EuroQoL five dimension (EQ-5D-5L) [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months]
- Patient Reported Outcomes - Oral Health Impact Profile (OHIP) - 14 [Срок оценки: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 4 центра
- Hannover Medical School — Hanover
- University Hospital Leipzig — Leipzig
- Klinikum der Johannes Gutenberg Universität Mainz — Mainz
- Klinikum der LMU München — Munich
Швеция · 4 центра
- Falu Hospital — Falun
- Skåne University Hospital — Lund
- Karolinska University Hospital — Stockholm
- Uppsala University Hospital — Uppsala
Индия · 2 центра
- Sri Shankara Cancer Hospital and Research Center — Bangalore
- All India Institute of Medical Sciences (AIIMS) — New Delhi
Новая Зеландия · 2 центра
- Waikato DHB — Christchurch
- Hutt Hospital — Lower Hutt
Бразилия · 1 центр
- Hospital BP - A Beneficência Portuguesa de São Paulo — São Paulo
Колумбия · 1 центр
- Estetica Maxilofacial — Bogotá
Дания · 1 центр
- Rigshospitalet — Copenhagen
Нидерланды · 1 центр
- Erasmus Medisch Centrum — Rotterdam
Пакистан · 1 центр
- Mayo Hospital — Lahore
Польша · 1 центр
- Wojewódzki Specjalistyczny Szpital Dziecięcy — Olsztyn
Россия · 1 центр
- National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthca — Moscow
Сербия · 1 центр
- Clinic for Maxillofacial Surgery, University of Belgrade — Belgrade
ЮАР · 1 центр
- King Edward VIII Hospital — Durban
Испания · 1 центр
- 12 de Octubre University Hospital — Madrid
Швейцария · 1 центр
- Universitätsspital Basel — Basel
Публикации
- Thor A, Bengtsson M, Dowgierd K, Epifanov S, Fichter AM, Jelovac D, Korn PN, Nilsson JL, Pastore G, Rughubar V, Smolka W, Talvilahti J, Thiem D, Thieringer F, Ulmner M, Wolvius EB, Zubillaga Rodriguez I, Kumar VV. Alloplastic total temporomandibular joint (TMJ) replacement registry: a protocol for a prospective global multicentre observational cohort study. BMJ Open. 2026 Mar 9;16(3):e113558. doi: PMID 41802784
Идентификаторы
NCT: NCT03991728 · TMJ Replacement