Идёт набор NCT05146986

RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

— Наблюдательное Rib; 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: Non surgical and Surgical.
Кому может быть актуально: Состояния в реестре: Rib; Fracture. 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: Австралия, South Korea
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

Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

Обзор

This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.

Подробное описание

The objective of this study is to evaluate the benefits of surgical stabilization of rib fractures (SSRF) in patients with non-flail chest rib fractures using RibFix Blu Thoracic Fixation System when compared to non-surgical (analgesia and symptomatic management) treatment. The study will include up to 167 cases of non-flail chest rib fractures with 95 cases in non-surgical treatment group and 72 cases in the surgical group. Each center may enroll up to maximum 30 cases to permit the assessment of outcome across a variety investigators and clinical settings. Enrolment will be competitive among sites and closed as soon as a total of 167 cases are recruited.

Вмешательства

Устройство Non surgical and Surgical
For non-surgical group, patients will receive non-surgical treatment (analgesia and symptomatic management treatment). For surgical group, patients will receive surgical treatment using RibFix Blu Thoracic Fixation System.

Первичные конечные точки

Thoracic pain as assessed by numeric Rating Scale (NRS) [Срок оценки: 2 weeks]

Вторичные конечные точки (6)

Rate of Analgesic use [Срок оценки: 12 weeks]
Length of Hospital stay [Срок оценки: 12 weeks]
Quality of life using EuroQoL-5L [Срок оценки: 2 weeks, 6 weeks and 12 weeks]
Pulmonary function [Срок оценки: 12 weeks]
Pulmonary function [Срок оценки: 2 weeks, 6 weeks and 12 weeks]
Number of Participants with respiratory complications [Срок оценки: 2 weeks, 6 weeks and 12 weeks]

Критерии участия

Критерии включения

Age 18 and above (inclusive)
Simple rib fracture with ≥ 3 consecutive ribs, and the broken ends showed clear displacements
Indicated for surgical repair of rib fractures using RibFix Blu Thoracic Fixation System or non-surgical treatment (analgesia and symptomatic management treatment)
Willing and able to complete scheduled follow-up evaluations as described in the study protocol
Has participated in the Informed Consent process and is willing and able to sign an Institutional Review Board or Ethics Committee (IRB/EC) approved Patient Information/ Informed consent Form (PICF)

Критерии исключения

Flail chest rib fractures based on radiological or clinical findings
Previous rib fractures or pulmonary problems, requiring continuous oxygen use at home pre-trauma
Presence of any serious medical issues that placed patient in generally poor conditions such that he or she could not tolerate the surgery
Chest trauma associated with severe craniocerebral injury, abdominal organ injury, severe spinal injury, limb fracture, or pelvic fracture requiring long-term bed rest
Has serious medical disease that is a contraindication for general anesthesia, such as cerebral infarction, myocardial infarction and hemorrhagic syndrome
Any contraindications listed in the manufacturer's Instruction to use for RibFix Blu Thoracic Fixation System as per below:

Spanning a midline sternotomy
Active Infection
Foreign body sensitivity
Is known to be pregnant
Is a prisoner, known alcohol or drug user or mentally incompetent or unable to understand what participation in this study entails.
Participation in another surgical intervention that may influence any of the outcome parameters.

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

Здоровые добровольцы: Да