The ATtune Knee Outcome Study
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: Total Knee Arthroplasty (uncemented rotating platform ATTUNE).
- Кому может быть актуально
- Состояния в реестре: Osteoarthritis, Knee, Knee Osteoarthritis, Knee Rheumatism, Rheumatoid Arthritis. Базовые параметры: 21 лет — 90 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
- 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
The ATtune Knee Outcome Study: Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty
Обзор
To accomodate dissatisfied patients with a total knee arthroplasty (TKA) and improve outcomes, several knee systems have been developed. The cemented ATTUNE TKA shows superiority over other established knee systems at short-term, abating with longer follow-up. There have been no studies reporting on the results of the uncemented version of the ATTUNE. Therefore, the main objective of the current study was to report patient reported outcome measures (PROMs), survivorship and complications associated with the uncemented ATTUNE TKA.
Подробное описание
Every year, 1.5 million total knee arthroplasties (TKA) are performed worldwide in patients whose joints have been severely affected by osteoarthritis, rheumatoid arthritis, or trauma, causing intense pain and loss of function. Due to the ageing society, these numbers are expected to have increased six-fold to 3.48 million cases annually by 2030. Even though joint replacement provides satisfactory and durable results for most patients, 20% is thought to still not be satisfied with their artificial joint. To accommodate this dissatisfied population and improve durability of implants even more, several knee systems have been developed over the years. One of the newest models is the ATTUNE knee system (DePuy, Warsaw, Indiana, USA). One of the landmark features is a gradually reducing radius in the geometry of the femoral component, more closely mimicking the anatomical patellofemoral joint and facilitating more natural femoral rollback during flexion. Comparisons of the cemented ATTUNE with previous knee systems show promising results in terms of patellofemoral outcomes, but fail to demonstrate definitive superiority in terms of all patient reported outcomes. Clinical superiority of the ATTUNE tends to abate with longer follow-up, implicating a possible superiority in the short-term recovery and return to activities. There is no follow-up study reporting the results of the uncemented ATTUNE. Moreover, all previously cited studies report better patellofemoral outcomes with patellar resurfacing, making it still unclear whether the implicated superior design changes of the femoral component hold ground without patellar resurfacing.
The primary objective is to report survivorship, complications and patient reported outcome measures associated with the uncemented ATTUNE rotating platform knee system. Secondary objectives are (1) evaluate patient reported (patellofemoral) outcomes (2) assess return to work and sport after TKA (3) translate and validate the Dutch version of the University of California, Los Angeles (UCLA) activity scale and (4) analyse psychologic factors (such as pain catastrophising and coping) and the impact on dissatisfaction following TKA.
Вмешательства
- Устройство Total Knee Arthroplasty (uncemented rotating platform ATTUNE)
All patients receive an uncemented ATTUNE rotating platform knee system.
Первичные конечные точки
- Survivorship [Срок оценки: 10 year]
- Complication rate [Срок оценки: 10 year]
- Forgotten Joint Score 12 (FJS-12) [Срок оценки: 10 year]
- Kujala Anterior Knee Pain Scale (AKPS) [Срок оценки: 10 year]
- Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form [Срок оценки: 10 year]
- Numeric Rating Scale (NRS) [Срок оценки: 10 year]
- EuroQol 5 Dimensions, 3 Levels (EQ5D-3L) [Срок оценки: 10 year]
Вторичные конечные точки (10)
- 30 second chair stand test (30sCST) [Срок оценки: 1 year]
- 40m Fast paced walk test (40m-FPWT) [Срок оценки: 1 year]
- Stair climb test (SCT) [Срок оценки: 1 year]
- Tegner activity rating scale [Срок оценки: 1 year]
- University of California, Los Angeles (UCLA) activity rating scale [Срок оценки: 1 year]
- Return to work [Срок оценки: 1 year]
- Alignment [Срок оценки: 1 year]
- Patient Health Questionnaire (PHQ-2) [Срок оценки: 10 year]
- Pain Self Efficacy Questionnaire (PSEQ) [Срок оценки: 10 year]
- Pain Catastrophizing Scale (PCS) [Срок оценки: 10 year]
Критерии участия
Критерии включения
- End-stage osteoarthritis of the knee warranting joint replacement therapy.
- Indicated for an ATTUNE total knee system as part of regular clinical practice.
- Capability and willingness to sign informed consent and comply with follow-up procedures.
- Capable enough in Dutch or English to be able to understand study procedures
Критерии исключения
- Unable or unwilling to sign informed consent and comply with follow-up
- Indication for primary revision arthroplasty
- Absolute indication for cemented fixation (decreased bone stock/quality of spongiosa)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 1 центр
- Spaarne Gasthuis — Hoofddorp
Публикации
- Rassir R, Sierevelt IN, Schager M, Nolte PA; ATKOS group. Design and rationale of the ATtune Knee Outcome Study (ATKOS): multicenter prospective evaluation of a novel uncemented rotating platform knee system. BMC Musculoskelet Disord. 2021 Jul 15;22(1):622. doi: 10.1186/s12891-021-04493-1. PMID 34266444
Идентификаторы
NCT: NCT04247672 · 2019.0084