Идёт набор NCT04364334

Knee Registry (Knieregister)

— Наблюдательное Knee Pathology Osteoarthritis, Knee Osteochondritis Dissecans Chondral Defect

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: Knee Pathology, Osteoarthritis, Knee, Osteochondritis Dissecans, Chondral Defect. Базовые параметры: Без ограничений · 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: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Collecting Diagnostic, Treatment and Follow-up Data on Knee Treatments.

Обзор

Rationale: In view of patient care, patient characteristics and treatment parameters are registered for all patients visiting the Mobility Clinic of the University Medical Center Utrecht for orthopaedic knee treatment. Patients also fill out questionnaires for function, pain and mobility of the knee, before and after treatment. Objective: The main objective of this registry is to collect patient characteristics and treatment parameters together with data from the questionnaires in a database. This knee registry can be used for future research questions. Study design: This is a longitudinal observational registry. Study population: All patients that visit the Mobility Clinic will be asked to participate in the knee registry. Patients that meet one or more of the following criteria will be excluded: are below the age of 16, not able or willing to sign the broad consent form, not being able to read and understand Dutch language, or receiving medical treatment for their knee elsewhere. Main study parameters/endpoints: Data will be collected for future research for which the purpose is not known at this time. When new research will be conducted, study parameters will be set. A study application has to be submitted to the institutional ethical review board of the University Medical Center Utrecht. Patients do not need to be asked permission for the use of their data for each study individually. Only when additional information is needed. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for patients to participate in this registry is minimal and consists of time. Any future results may be beneficial for patients. Participation or refusal to participate in the registry has no consequences for their treatment.

Первичные конечные точки

Patient characteristics and medical data [Срок оценки: Status at baseline.]
Change in EQ5D (EuroQol 5 dimensions) [Срок оценки: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.]
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) [Срок оценки: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.]
Change in IKDC (International Knee Documentation Committee) [Срок оценки: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]
Change in SF-36 [Срок оценки: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]
Change in VAS pain (Visual Analogue Scale) [Срок оценки: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]
Change in NRS pain (Numeric Rating Scale) [Срок оценки: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.]
Change in Tegner [Срок оценки: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]
Anker questions [Срок оценки: After treatment at 3, 6 and 12 months]
Change in OKS (Oxford knee score) [Срок оценки: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]

Критерии участия

Критерии включения

Receives orthopaedic knee surgery or conservative knee treatment (advice, physiotherapy, injections etc) at the UMC Utrecht;
Able to read and understand Dutch language;
Is able and willing to signs the broad consent form.