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Набор скоро начнётся NCT06868472

Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery

Без фазы С лечением Rotator Cuff

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: Prehabilitation, Control.
Кому может быть актуально
Состояния в реестре: Rotator Cuff. 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 →

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Обзор

The aim of this randomized controlled trial is to investigate whether the intervention can improve the clinical outcome and patient satisfaction in elective reconstructive shoulder surgeries. The study participants are adults with a diagnosed rotator cuff tear for which surgical treatment is planned. This main question is to be answered by the study: • Does prehabilitation before elective shoulder surgeries lead to an improvement in postoperative outcomes and patient satisfaction compared to the control group? The control group receives standard information about the hospital stay, while the intervention group undergoes the prehabilitation program in the approximately 6 weeks prior to surgery. This program includes: * Information on the condition and pain management * Recommendations for behavior modification * A home exercise program Primary endpoint is the Western Ontario Rotator Cuff Index (WORC). The assessments are conducted at four time points: at study enrollment, immediately before surgery, and at 6, 12, and 24 months after surgery.

Вмешательства

  • Процедура Prehabilitation
    The waiting time until the operation is about 6 weeks. The intervention is carried out during this time: The intervention group receives a brochure with an evidence-based exercise program for the shoulder and shoulder girdle. The brochure contains pages in which the patient documents how the exercises are carried out. The exercise program is supplemented by information in the form of a video/Power Point presentation on: Anatomy/function, pain management, hospitalization and subsequent rehabilit
  • Процедура Control
    The control group receives a leaflet with general information for the period up to the operation (e.g. buy water-resistant plasters, arrange post-op physiotherapy appointments).

Первичные конечные точки

  • Western Ontario Rotator Cuff Index (WORC) [Срок оценки: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
Вторичные конечные точки (8)
  • Patient survey on Treatment satisfaction and willingness to recommend [Срок оценки: before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
  • EQ-5D quality of life questionnaire [Срок оценки: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
  • Constant Murely score for self-evaluation [Срок оценки: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
  • Subjective shoulder value [Срок оценки: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
  • Survey on the use of painkillers [Срок оценки: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
  • Survey on return to pre-operative sport [Срок оценки: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
  • Survey on return to preoperative occupation or daily responsibilities [Срок оценки: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
  • Examination for the presence of a re-rupture [Срок оценки: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]

Критерии участия

Критерии включения

  • Patients with a traumatic or degenerative rupture of the rotator cuff with whom surgical treatment has been discussed in the shoulder clinic.

Критерии исключения

  • Pre-existing fracture of the upper arm or shoulder girdle, rheumatic arthritis/fibromyalgia, additional findings in the shoulder joint (instability, frozen shoulder), neurological disease, cognitive or speech impairment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Германия · 1 центр
  • Kliniken der Stadt Köln gGmbH — Cologne

Идентификаторы

NCT: NCT06868472 · Ethics number: 150/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗