RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
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: Shoulder arthroplasty.
- Кому может быть актуально
- Состояния в реестре: Humeral Fracture, Proximal, Glenohumeral Osteoarthritis, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear. 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
- Франция, Monaco
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS. The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term. Secondary objectives are * Revision rate at each post op visit * Range of motion at each post op visit * Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit * Radiological assessment of implant positioning through geometrical parameters at each post op visit * Incidence of complications at each post op visit * Qualitative feedback from surgeons on the instrumentation
Подробное описание
1004 cases are planned to be included in 11 groups of implants (range, indication and constructs).
Recruitment of patients can be retrospective or prospective, preferrably prospective.
Prospective follow-up of the patients after inclusion at 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years , 7 years and 10 years postoperatively.
Вмешательства
- Процедура Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Первичные конечные точки
- Revision rate (KM) at 10 years postoperative [Срок оценки: at the end of the postoperative follow-up period of 10 years]
Вторичные конечные точки (10)
- Revision rate (KM) at each post-operative visits [Срок оценки: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)]
- Range of Motions at each postoperative visit [Срок оценки: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- QuickDASH score at each follow-up visit [Срок оценки: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- Constant-Murley score at each follow-up visit [Срок оценки: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- ASES score at each postoperative visit [Срок оценки: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- VAS pain at each postoperative visit [Срок оценки: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- SSV score at each postoperative visit [Срок оценки: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- Radiological assessment of implant positioning at each postoperative visit [Срок оценки: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- Incidence of complications at each postoperative visit [Срок оценки: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- Qualitative feedback on the instrumentation [Срок оценки: at surgery reporting]
Критерии участия
Критерии включения
- Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.
- Patient aged 18 years and above
- Patient insured with a social security system
- Has been informed and did consent to participate to the study.
Критерии исключения
- Neurological pathologies compromising the shoulder stability
- Morbid obesity
- Muscular deficiencies impairing the shoulder joint
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 21 центр
- CHU Amiens Picardie — Amiens
- CHU d' Angers — Angers
- Hôpital Jean Minjoz — Besançon
- Clinique Aguiléra — Biarritz
- Hôpital privé Saint-Martin — Caen
- Infirmerie Protestante — Caluire-et-Cuire
- CHMS Chambéry — Chambéry
- HÔPITAUX CIVILS de Colmar — Colmar
- … и ещё 13 центров
Monaco · 1 центр
- Centre Hospitalier Princesse Grace — Monaco
Идентификаторы
NCT: NCT07558590 · FX_PROTOC_CL_19-03 · 2019-A01279-48