- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01457326
Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures
Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures: Clinical and Radiographic Outcomes
Обзор исследования
Статус
Подробное описание
Fractures of the lower extremity are common injuries that can lead to temporary or permanent disability.13 Fracture healing, regardless of treatment, is a multifactorial process that is influenced by time, biomechanics, and host biology (among other variables). The degree, timing, progression, and type of weight bearing after fractures involving the pelvis and lower extremities is an area of debate in the clinical management of a broad spectrum of orthopedic injuries.1,2,4-9,11,15 Periarticular fractures of weight bearing joints are an area of particular interest with regard to post-operative weight bearing due to the prolonged periods that patients must be non-weight bearing after surgery.
Some degree of impairment is inevitable with any traumatic injury. The majority of authors writing about post-fracture weight bearing have determined that timing and extent of weight bearing has an effect on fracture healing, while a small number of authors have published results demonstrating the opposite.14,16,19,21 In addition to potential impacts on healing rates, limited or non-weight bearing carries the added insult of loss of bone density and muscle mass.3,10,12,17,20,22
Traditionally, patients with periarticular fractures have been required to be non-weight bearing on their effected extremity for up to 12 weeks. At this institution, most patients have been required to remain non-weight bearing for 10 weeks, followed by progressively increased levels of weight bearing according to patient tolerance. One of the orthopaedic traumatologists at this institution uses immersion therapy to allow patients with periarticular fractures to begin weight bearing prior to the ten-week mark.
Immersion therapy requires that patients perform their physical therapy, with a trained therapist, in a swimming pool. The use of the pool in post-fracture care may be able to provide a structured and standardized partial weight-bearing environment that could allow for early mobilization. It also has the potential to improve clinical outcomes by mitigating at least some of the loss in bone and muscle mass during the post-operative period; thereby, potentially speeding functional recovery. Immersion therapy is currently utilized on-site at the University of Utah Orthopedic Center for a variety of diagnoses, including in post-fracture care.
There is essentially no orthopedic literature regarding immersion therapy in the management of post-fracture rehabilitation with regard to early weight bearing. Specifically, the investigators are aware of no clinical outcome studies that investigate standardized early weight bearing protocols following periarticular fractures of the lower extremity.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84108
- University Of Utah Orthopedics Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
This study is a prospective cohort study with a retrospective chart review. Patients who are treated by the PI, Dr. Erik Kubiak, will participate in an immersion therapy post-operative protocol. Immersion therapy post-operative protocols have been and are currently used routinely by Dr. Kubiak.
Patients who are treated by Dr. Dan Horwitz and Dr. Thomas Higgins will undergo a traditional 10 week non-weight bearing post-operative care per their standard of procedure. In addition, patients of Dr. Kubiak who are unable to participate in immersion therapy for logistical reasons will be asked to participate in the traditional 10- week non-weight bearing post-operative care protocol. These patients will make up the control cohort.
Описание
Inclusion Criteria:
- Inclusion criteria for the patient population under study consists of both male and female adults, at least 18 years old, who are treated for periarticular fractures of the lower extremity. The periarticular fractures included in this study will be: acetabular, tibial plateau, tibial plafond fractures.
Exclusion Criteria:
- Age <18 years
- Wound complications deemed to be unsafe for immersion.
- Multiple extremity articular fractures
- Other injuries that preclude their safe participation in physical therapy.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Кейс-контроль
- Временные перспективы: Перспективный
Когорты и вмешательства
Группа / когорта |
|---|
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Immersion Therapy- Study
1. Patients who participate in the immersion therapy post-operative protocol and begin progressive weight bearing at 4 weeks (study)
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Control Group
2. Patients who undergo the traditional 10-week non-weight bearing post-operative care protocol (control)
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Immersion Therapy
Временное ограничение: 10 weeks
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10 weeks
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Traditional non-weightbearing
Временное ограничение: 10 weeks
|
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10 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Short Musculoskeletal Function Assessment
Временное ограничение: 1 year
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1 year
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Erik Kubiak, MD, University of Utah Orthopedics
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 34409
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .