Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?
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, RSA.
- Кому может быть актуально
- Состояния в реестре: Arthroplasty, Replacement, Shoulder, 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 (Study 1: Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?).
Обзор
The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.
Подробное описание
Many studies have showed pain relief and improvement in shoulder function following reverse shoulder arthroplasty (RSA), but medialization of the centre of rotation (COR) in RSA may cause complications like limited range of motion (ROM), luxation of the prosthesis, and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. Joint centre lateralization with a bone transplant placed underneath the glenoid component (BIO-RSA) was introduced to maximize ROM in the prosthetic joint, increase stability and to prevent scapular notching. In recent years it has been claimed that lateralization of the COR with BIO-RSA decreases the risk of the aforementioned complication, but no consensus on when or how to lateralize the COR exists as of today. This knowledge will also be of critical importance when it comes to decision making on how these patients are best treated. Results from this research project is expected to have a significant impact on how these patients are treated in the future, both nationally and internationally.
The purpose of this study is to compare functional results between patients with bony increased offset-reversed shoulder arthroplasty (BIO-RSA) and conventional reverse shoulder arthroplasty (RSA) to investigate if lateralization of the glenosphere yields superior outcomes and fewer complications after 2 years.
This multicenter study will include 130 patients in 4 hospitals scheduled for RSA. Patients will be asked to participate in a blinded RCT, where they are randomly assigned to either BIO-RSA or conventional RSA. Functional results will be measured primarily by the patient-reported outcome measure Western Ontario Osteoarthritis Shoulder (WOOS), but they will also be examined by a physiotherapist and CT imagery will be assessed by a radiologist.
Вмешательства
- Процедура BIO-RSA
Bony increased offset-reversed shoulder arthroplasty(BIO-RSA) will be performed. - Процедура RSA
Conventional reversed shoulder arthroplasty(RSA) will be performed.
Первичные конечные точки
- Change in WOOS index from baseline to 24 months postoperatively. [Срок оценки: Before randomization, 24 months postoperatively. Also measured 3 and 12 months postoperatively. Change after 24 months will be the primary outcome.]
Вторичные конечные точки (7)
- Change in EuroQol-5 from baseline to 24 months postoperatively. [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
- CT scan [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
- Change in Constant-Murley Score from baseline to 24 months postoperatively. [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
- Change in range of motion from baseline to 24 months postoperatively. [Срок оценки: Before randomization, 3, 12 and 24 months postoperatively.]
- Change in Subjective Shoulder Value from baseline to 24 months postoperatively. [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
- Able to read or write Norwegian
Критерии исключения
- Severe osteoporosis
- Osteonecrosis of the humeral head
- Dementia
- Poor deltoid function
- Revision surgery
- ASA IV
- Suspected chronic infection
- Acute fracture
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Норвегия · 2 центра
- Sykehuset Telemark HF — Skien
- Lovisenberg Diaconal Hospital — Oslo
Идентификаторы
NCT: NCT06025331 · CARS-1