Идёт набор NCT05302934

Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty

— Наблюдательное Degenerative Osteoarthritis Rheumatoid Arthritis Posttraumatic Arthropathy Chronic Instability of Knee

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: В протоколе указаны: Pheno4U.
Кому может быть актуально: Состояния в реестре: Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy, Chronic Instability of Knee. 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: Германия, Великобритания
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

Prospective, Multinational Pilot Study for Evaluation of the PHENO4U Data Platform in Total Knee Arthroplasty Patients

Обзор

Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients

Подробное описание

The study will collect data for each patient receiving an Aesculap Total Knee Arthroplasty (TKA) implant. The data set will be analyzed for critical risk factors among implant and patient data in order to optimize patient-centered therapies.

The products under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). Data obtained in routine clinical use will be collected in the Pheno4U data platform. In addition, patients are expected to answer questionnaires about their health status. Furthermore, patients are asked to use the so called "BPMpathway" sensor and application in order to measure the active Range of Motion (ROM). The sensor can also be used for pre- and postoperative training .

Вмешательства

Устройство Pheno4U
Total Knee Arthroplasty represents a well-established, reliable and successful treatment option for end-stage bicompartmental osteoarthritis or other indications resulting in joint destruction. In general, Implantation of a total knee prosthesis improves the quality of life through pain alleviation, deformity correction, joint stabilization, and/or functional range of motion (ROM) through restoration of normal knee kinematics and functionality

Первичные конечные точки

Identification of any unknown risks or side effects in Total Knee Arthroplasty by using sensors and patient apps [Срок оценки: up to 12 months postoperatively]

Вторичные конечные точки (7)

Change of Knee Injury and Osteoarthritis Outcome score [Срок оценки: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery]
Change of Hospital for Special Surgery (HSS) Knee Surgery Expectations Survey [Срок оценки: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery]
Change of Pain [Срок оценки: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery]
Patient satisfaction [Срок оценки: approximately 9 months after surgery]
Net Promoter Score [Срок оценки: approximately 12 months after surgery]
Change of Depression, Anxiety and Stress Scale - 21 Items [Срок оценки: 1 week prior to surgery and 2 weeks postoperatively]
Development of Active Range of Motion [Срок оценки: up to 3 months after surgery]

Критерии участия

Критерии включения

Patient undergoing a total knee arthroplasty with a B. Braun knee implant system
Signed written informed consent
Patient's willingness \& ability to use the "BPMpathway"sensor
Patient's willingness \& ability to use the "4Patient" application

Критерии исключения

Patient age < 18 years
Patient not willing to participate at the further follow-up
Pregnancy
If intraoperatively an implant from a different manufacturer is used, the study patient has to be excluded from the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет