Набор скоро начнётся NCT04724811

Weight-bearing of Surgically Treated Acetabular Fractures.

Без фазы С лечением Acetabular Fracture

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: Open reduction and internal fixation (ORIF).
Кому может быть актуально: Состояния в реестре: Acetabular Fracture. Базовые параметры: от 60 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: Финляндия
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

Weight-bearing of Surgically Treated Acetabular Fractures. A Randomised Controlled Trial

Обзор

The purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively. Both study groups are stratified according to * Type of fracture (anterior approach vs anterior + additional posterior approach) * Dislocated dome vs non-dislocated/ non existing separate dome fragment Patients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. This is to examine a potential participation bias in the RCT groups. These patients will not be counted into the target amount of 50 RCT patients.

Подробное описание

For the past 20 years, the established treatment of dislocated acetabular fractures has been surgical reduction and stable osteosynthesis. Good long-term results have been reported in these patients. At present, the mobilisation of these patients after surgery is generally restricted for several weeks ranging from 6-12 weeks touch-down- or non-weight-bearing with no uniform protocol. However there is no scientific evidence for limiting post operative weight-bearing. Accordingly the need of studies on weight-bearing surrounding periarticular fractures has been advocated.

Acetabular fractures in the elderly population are becoming more common and pose significant challenges for treatment including postoperative rehabilitation. Our aim is to investigate if patients benefit of a more liberal weight-bearing regime postoperatively. The primary outcome is measured at 1 year, secondary outcomes are followed up to 10 years postoperatively

Вмешательства

Процедура Open reduction and internal fixation (ORIF)
Approaches used: * Intrapelvic approach +/- iliac window * Kocher-Langenbeck approach

Первичные конечные точки

mHHS [Срок оценки: 1 year]
NRS [Срок оценки: 1 year]

Вторичные конечные точки (4)

mHHS [Срок оценки: 0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years]
NRS [Срок оценки: 0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years]
WOMAC [Срок оценки: 0 weeks, 1 year, 2 years, 5 years, 10 years]
RAND36 [Срок оценки: 0 weeks, 1 Year, 2 years, 5 years, 10 years]

Критерии участия

Критерии включения

Unilateral dislocated acetabulum fracture (displacement of over 2mm in preoperative CT scan)
The osteosynthesis is performed during 21 days after initial trauma
The patient is willing to participate in the follow-up