Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
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: reversed glenoid prothesis.
- Кому может быть актуально
- Состояния в реестре: Arthroplasty, Replacement, Shoulder, Glenoid Cavity, Osteoarthritis of the Shoulder. 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
- Бельгия, Нидерланды
- 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
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study
Обзор
This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system
Подробное описание
The Glenius glenoid implant is a solution for patients who need a reversed glenoid reconstruction (primary or revision) because of a severely damaged glenoid associated with severe bone loss. In these cases, standard reconstruction of the glenoid is not possible because of the lack of body support of the glenoid rim or columns.
The Glenius implant is custom-made prothesis: during pre-operative planning, the implant is designed based on a detailed 3D CT analysis of the defect with special reference to bone quality and the anatomy of the bone deficient glenoid. Optimized screw fixation trajectories are defined for each individual patient, which accommodate screws that are positioned and angled towards the best bone stock available in the glenoid/coracoid/scapula with each specific patient. The surgeon provides feedback on the the design and orientation of the implant needed to achieve the optimal inclination of the head and the position \& offset of the joint's centre of rotation.
Because Glenius is a relatively new product and only for use in specific and complex cases of severy glenoid erosion, follow-up data on the clinical and radiological outcome are scarce. With this study we aim to collect long-term clinical and radiological follow-up data for patients treated with Glenius in a uniform, standardized way.
Вмешательства
- Устройство reversed glenoid prothesis
All patients will undergo a primary or revision arthroplasty with Glenius according to the routine practice at the investigation site and will be followed at specified visiting moments, during which radiological and clinical data will be gathered.
Первичные конечные точки
- Change in baseline Constant-Murley Score after surgery [Срок оценки: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery]
Вторичные конечные точки (12)
- Change in baseline Simple Shoulder Test (SST) after surgery [Срок оценки: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery]
- Change in baseline Oxford Shoulder Score (OSS) after surgery [Срок оценки: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery]
- change in general health EQ5D score after surgery [Срок оценки: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery]
- change in baseline pain score using Visual Analogue Scales (VAS) after surgery [Срок оценки: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery]
- Translational deviation from planned implant position [Срок оценки: 6 weeks after surgery]
- Rotational deviation from planned implant position [Срок оценки: 6 weeks after surgery]
- Translational deviation from initial implant position [Срок оценки: 1 year after surgery]
- Rotational deviation from initial implant position [Срок оценки: 1 year after surgery]
- Scapular notching [Срок оценки: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery]
- Radiolucensies [Срок оценки: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery]
- Heterotopic ossifications [Срок оценки: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery]
- rate of implant revision surgeries up to 5 years after surgery [Срок оценки: up to 5 years after surgery]
Критерии участия
Критерии включения
- patients having primary or revision shoulder joint replacement with severe glenoid bone defects
- Patient is 18 years of age or older
- Patient can follow the Glenius system procedure that is standard of care
- Patient is willing to cooperate in the required post-operative therapy
- Patient has participated in the informed consent process and has signed the EC approved informed consent form
Критерии исключения
- Pregnant patients
- Skeletally immature patients
- Prisoners
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 3 центра
- AZ St-Elisabeth — Herentals
- University Hospital Leuven - Traumatology — Leuven
- University Hospital Leuven - Orthopedics — Leuven
Нидерланды · 1 центр
- Sint-Maartenskliniek — Nijmegen
Идентификаторы
NCT: NCT03806881 · SMAT009