Набор по приглашению NCT06623149

Conservative Management vs. Arthroplasty in Knee Osteoarthritis

— Наблюдательное Knee Osteoarthrosis

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: Non-Surgical Intervention, Current practice.
Кому может быть актуально: Состояния в реестре: Knee Osteoarthrosis. 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: Дания
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

Policy-Induced Conservative Management Prioritization Over Arthroplasty On Knee Osteoarthritis Outcomes

Обзор

The goal of this observational study is to learn about the long-term effects of a non-surgical management programme in people with osteoarthritis that are eligible for a knee joint replacement surgery to treat their knee osteoarthritis (KOA). The main question it aims to answer is: \- Does the non-surgical management programme reduce the proportion of referred patients who are treated with a knee arthroplasty without reducing the health-related quality of life over a two-year perspective?

Подробное описание

Knee arthroplasty (joint replacement surgery) is a well-established and effective treatment for knee osteoarthritis (KOA). The incidence of knee arthroplasty has increased in Denmark from 8,000 procedures in 2017 to over 15,000 in 2023, partly due to demographic changes, demands, and the procedures effectiveness. However, concerns remain that some patients undergo surgery without having fully explored non-surgical options.

A growing body of research and public declarations suggest that individuals with KOA may benefit from conservative treatment regimens encompassing physical training, weight loss, and pain management strategies. It is implicitly suggested that surgical procedures may be circumvented or deferred well beyond the span of these conservative measures, without adversely impacting patients' quality of life. Such contentions have garnered the attention of decision-makers in the policy realm.

Consequently, a task force under the Capital Region of Denmark has recently mandated a policy shift requiring public hospitals to establish pathways for conservative, non-operative treatment with a duration of three months that patients must complete prior to considering knee arthroplasty. The aim of this policy alteration is to further prioritize conservative management and curtail the frequency of knee arthroplasty procedures while preserving patients' quality of life. Although the number of surgical procedures could be ostensibly minimized by constraining healthcare service provisions and impeding patient access, the patients' quality of life remains the paramount political objective. Consequently, the task force has decided to assess the impact of the policy change by endorsing and initiating a study to monitor quality, as summarized in the current protocol synopsis.

The new policy is introduced in a step-wise manner at the major hospitals in the Capital Region of Denmark (Copenhagen) from October 1st 2024 to January 1st 2025) and this observational study enrols patients at the hospitals before and after implementation of the new policy to facilitate a comparison of the two policies (new vs old). The enrolled patients are followed for 2 years with regular collection of patient-reported outcomes and medical record reviews.

Вмешательства

Поведенческое Non-Surgical Intervention
After referral from the general practitioner to the orthopedic department, the patient is offered a 3-month non-operative treatment program. The conservative program consists of several elements that are offered on an individual basis. The program consists of 3 main elements: * Patient education/information * Specialized exercise supervised by a physiotherapist * Weight loss counseling with a dietician
Процедура Current practice
After referral from the general practitioner to the orthopedic department, the patient is assessed by an orthopedic surgeon in the out-patient clinic according to standard practice with a focus on symptoms, history, physical examination, radiography, and an appraisal of the patient's expectations. If an indication for knee arthroplasty is found, the patient is offered knee arthroplasty, and if the patient accepts the offer, he/she is scheduled according to usual practice. If a patient declines t

Первичные конечные точки

Proportion of patients undergoing knee arthroplasty surgery [Срок оценки: 2 years]
Euroqol 5 dimensions questionnaire (EQ5D) [Срок оценки: Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)]

Вторичные конечные точки (9)

Oxford Knee Score questionnaire [Срок оценки: Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)]
Oxford Knee Score questionnaire [Срок оценки: After 2 years (month 24)]
Euroqol 5 dimensions questionnaire (EQ5D) [Срок оценки: After 2 years (month 24)]
Satisfaction questionnaire [Срок оценки: After 1 year (month 12)]
Satisfaction questionnaire [Срок оценки: After 2 years (month 24)]
UCLA Physical Activity Scale [Срок оценки: Change from baseline after 2 years (month 24)]
UCLA Physical Activity Scale [Срок оценки: Change from baseline after 1 year (month 12)]
Copenhagen Knee Range of Motion Scale [Срок оценки: After 1 year (month 12)]
Copenhagen Knee Range of Motion Scale [Срок оценки: After 2 years (month 24)]

Критерии участия

Критерии включения

A diagnosis of knee osteoarthritis.
Referral from primary care to an orthopedic department at a hospital in The Capital Region of Denmark for treatment of knee osteoarthritis