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Идёт набор NCT06869343

Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture

Без фазы С лечением Orthopedic Disorder Humerus Fracture Shoulder Arthroplasty Reverse Shoulder Replacement

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: Physical Therapy.
Кому может быть актуально
Состояния в реестре: Orthopedic Disorder, Humerus Fracture, Shoulder Arthroplasty, Reverse Shoulder Replacement. Базовые параметры: 50 лет — 85 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
США
Следующий шаг
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Официальное название

A Randomized Controlled Trial of Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture

Обзор

Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion. Evidence has shown that reverse total shoulder arthroplasty (rTSA) is an effective option to improve pain and function for patients with acute displaced proximal humerus fractures. Given that patients undergoing rTSA for proximal humerus fractures typically experience worse functional outcomes, worse patient-reported outcomes, and higher rates of complication compared to those with elective indications for surgical intervention, it is critical to determine a secure path to recovery for these patients after surgery. Early rehabilitation has been proposed to be safe and effective for patients who undergo rTSA for elective indications; however, there is a paucity of research evaluating safety and effectiveness of timing of rehabilitation for rTSA patients in the trauma setting. Currently, there exists a great variability in postoperative rehabilitation protocols across orthopaedic practices. This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of patients undergoing rTSA for proximal humerus fractures in order to provide more specific recommendations for this patient population.

Подробное описание

The overarching goal is to better understand the impact of timing of initiation of rehabilitation on functional and patient reported outcomes on patients undergoing rTSA in the trauma setting.

Specifically, the investigators will conduct a pilot study in the form of a randomized controlled trial to evaluate whether, in patients undergoing rTSA for proximal humerus fracture, early rehabilitation yields a significant difference in range of motion, patient-reported outcomes, or postoperative complications compared to those who undergo delayed rehabilitation. The specific aims are:

Aim 1: To compare the range of motion and patient reported outcomes between early and delayed rehabilitation in patients undergoing rTSA for proximal humerus fracture by conducting a randomized trial. The investigators will enroll patients in a randomized controlled trial postoperatively that will allocate patients to begin physical rehabilitation early (two weeks after operation) or delayed (six weeks after operation). In-person clinic visits and radiographs will occur at multiple time points (six weeks, three months, and six months) postoperatively. The investigators hypothesize that patients undergoing rTSA for proximal humerus fracture participating in early rehabilitation will have no difference in range of motion (forward flexion, abduction) or patient reported outcomes American Shoulder Elbow Surgeons Shoulder Score Constant score.

Aim 2: To compare the rates of postoperative complications between early and delayed rehabilitation in patients undergoing rTSA for proximal humerus fracture. Investigators will conduct chart reviews as well as in-person clinic visits and radiographs at multiple time points postoperatively. Investigators hypothesize that there will be no difference in rates of postoperative complications between early and delayed rehabilitation groups.

The expected outcome of this study is an enhanced understanding of the impact of rehabilitation after proximal humerus fracture, and the degree to which timing of initiation of therapy impacts patient outcomes. This will have a positive impact because it creates a foundation for developing rehabilitation protocols in this population.

Вмешательства

  • Другое Physical Therapy
    Subjects will begin physical therapy at either 2 or 6 weeks s/p a rTSA.

Первичные конечные точки

  • Measurement of Range of motion of shoulder Forward Flexion using a goniometer [Срок оценки: 2 week, 6 week, 3 month, and 6 month]

Критерии участия

Критерии включения

  • aged 50-85 undergo reverse Total Shoulder Arthroplasty by a single surgeon for proximal humerus fractures

Критерии исключения

  • previous rTSA to ipsilateral shoulder
  • undergoing elective rTSA
  • Prisoners
  • unwilling to be randomized
  • unwilling or unable to attend follow up visits

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
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Virginia Medical Center — Charlottesville

Идентификаторы

NCT: NCT06869343 · HSR301914 · FOT Grant ID 9024-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗