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Идёт набор NCT07199751

Comparison of Complication Rate, Functional Outcome and Quality of Life Between Standard Therapy Versus Fast-track Therapy in Patients Following Hip Replacement Surgery

Наблюдательное Coxarthrosis

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: Coxarthrosis. 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
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Vergleich Der Komplikationsrate, Des Funktionellen Outcomes Und Der Lebensqualität Zwischen Standard Therapie Versus Fast Track Therapie Bei Patienten Und Patientinnen Nach Hüft-TEP Operationen

Обзор

The fast track group vs. control group will be compared with regard to hospitalization time and the non-inferiority of the fast track group vs. control group with regard to HOOS will be assessed. The questionnaires will only be collected in the study: Eq-5d-5l, HOOS, self-efficacy, enjoyment of movement, fear of movement, pain catastrophizing.

Подробное описание

Around 400,000 hip and knee endoprostheses are implanted in Germany every year. Due to demographic change, the trend is clearly on the rise, which also results in rising costs in this area for the solidarity community. The Clinic for Orthopaedics and Sports Orthopaedics at the TUM Clinic is about to implement the Fast Track method after total hip arthroplasty (THA, in German: Hüft-TEP). The aim of this method is to shorten the length of stay in hospital and the post-operative recovery time as well as to promote rapid mobilization and independence of patients without worsening the functional outcome or the complication rate. The investigators will therefore investigate the extent to which it is possible to reduce the length of hospital stay without compromising function.

* Primary endpoints: Hospital length of stay, HOOS. * Secondary endpoints: PROMs Quality of life Eq-5d-5l (EuroQol 5 dimensions Lang) Function Mobility (TUG test) in seconds Pain (NRS), ROM (neutral zero method), Strength (Nm/kg body weight, muscle function test) Self-efficacy/ pleasure/ fear of movement/pain catastrophizing Exercise self efficacy scale (ESES), physical activity enjoyment scale (PACES), Kinesiophobia (TSK), Pain catastrophizing scale (PCS).

With an original length of stay of 6 days and a target length of stay of 4 days, the expected reduction is 2 days. A standard deviation of 3 days is assumed in both groups (calculations based on patient data from August to December 2024) and a significance level of 0.05 and power of 80% are assumed. The required number of cases is therefore at least 36 participants per group. With this number of cases, the non-inferiority of the fast-track method compared to the standard method with regard to HOOS can also be demonstrated with a probability of 80%, assuming that the true mean difference between the methods is 0 points and the standard deviation for both methods is 15 points (Δ = 10 points, one-sided 97.5% confidence interval). To compensate for a potential drop-out rate, 45 patients per group should be recruited. With a primary hip TEP (THA) surgery rate of approx. 10 patients per week (cf. 2024) and a 2-month duration per group, the investigators can recruit a maximum of 80 patients per group. The investigators are therefore confident that the required case number of 45 per group will be reached.

Первичные конечные точки

  • Hospital length of stay (days) [Срок оценки: From day of surgery until discharge, up to 4 days post-surgery]
  • Hip Disability and Osteoarthritis Outcome Score (HOOS) [Срок оценки: From baseline (pre-surgery) to 3 months post-surgery]
Вторичные конечные точки (8)
  • Timed Up and Go (TUG) Test [Срок оценки: From baseline (pre-surgery) to 3 months post-surgery]
  • EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels) [Срок оценки: From baseline (pre-surgery) to 3 months post-surgery]
  • Range of Motion (ROM) - Neutral Zero Method (degrees) [Срок оценки: From baseline (pre-surgery) to 3 months post-surgery]
  • Exercise Self-Efficacy Scale (ESES) [Срок оценки: From baseline (pre-surgery) to 3 months post-surgery]
  • Pain Catastrophizing Scale (PCS) [Срок оценки: From baseline (pre-surgery) to 3 months post-surgery]
  • Tampa Scale for Kinesiophobia (TSK) [Срок оценки: From baseline (pre-surgery) to 3 months post-surgery]
  • Muscle Strength (Nm/kg body weight) [Срок оценки: From baseline (pre-surgery) to 3 months post-surgery]
  • Physical Activity Enjoyment Scale (PACES) [Срок оценки: From baseline (pre-surgery) to 3 months post-surgery]

Критерии участия

Критерии включения

  • Age ≥18 years
  • The patient will undergo surgery at Klinikum rechts der Isar, Technical University of Munich (TUM)
  • Written informed consent for participation in the study after detailed explanation of the nature, significance, risks and scope of the clinical trial
  • Written informed consent from the patient for data collection and data processing, with the patient fully informed.
  • Sufficient German language skills of the patient.

Критерии исключения

  • Age < 18 years
  • The patient is under guardianship, legally incapacitated or has limited legal capacity
  • Only partial weight-bearing permitted

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Германия · 1 центр
  • Department Physical Therapy — München

Идентификаторы

NCT: NCT07199751 · 2025-155-S-CB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗