Идёт набор NCT06025448

Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?

Без фазы С лечением Arthroplasty Complications Shoulder Osteoarthritis

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: BIO-RSA, MIO-RSA.
Кому может быть актуально: Состояния в реестре: Arthroplasty Complications, Shoulder Osteoarthritis. Базовые параметры: 45 лет — 80 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: Норвегия
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

From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (CARS 2: Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability Measured With CT-based Motion Analysis (CTMA)?).

Обзор

This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).

Подробное описание

Lateralization of reverse shoulder arthroplasties may reduce the risk for complications such as limited range of motion (ROM), and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. There's several ways to lateralize the glenoid component, a bone transplant placed underneath the glenoid component (Bony Increased Offset Reversed Shoulder Arthroplasty: BIO-RSA) has been used for some time. Recently glenoid components with metallic lateralization of the joint centre (Metal-Increased Offset Reversed Shoulder Arthroplasty: MIO-RSA) have been introduced, but there is not much comparative literature on metal vs. bony lateralization.

Patients with osteoarthritis and medialization of the glenoid articular surface, who willing to participate in a study will be randomized to receive either MIO-RSA or a BIO-RSA. CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation.

Вмешательства

Процедура BIO-RSA
Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using bony lateralization (BIO-RSA).
Процедура MIO-RSA
Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using metallic lateralization (MIO-RSA).

Первичные конечные точки

Migration of glenoid component from baseline until 24 months [Срок оценки: At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.]

Вторичные конечные точки (7)

Change in WOOS Index [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
Change in Constant-Murley Score [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
Change in EuroQol-5 [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
Change in range of motion [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
Change in Subjective Shoulder Value [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
Anchor Question 1 [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
Anchor Question 2 [Срок оценки: 3, 12 and 24 months postoperatively]

Критерии участия

Критерии включения

Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
massive glenoid medialization
Able to read or write Norwegian