Идёт набор NCT06077942

FX Shoulder Solutions Retrospective / Prospective Clinical Study

— Наблюдательное Rotator Cuff Syndrome of Shoulder and Allied Disorders Osteoarthritis Shoulder Fracture, Shoulder

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: FX Artificial Shoulder Prosthesis.
Кому может быть актуально: Состояния в реестре: Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder, Fracture, Shoulder. Базовые параметры: Без ограничений · 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.

Подробное описание

To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.

To provide data and analysis for presentations, abstracts, publications and other public release of results.

Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study.

Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.

Вмешательства

Устройство FX Artificial Shoulder Prosthesis
Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, PRCT II Fracture Plate, V-135

Первичные конечные точки

Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments. [Срок оценки: 10 years]

Вторичные конечные точки (10)

Adjusted Constant Score [Срок оценки: 3, 6, 12, 24 months, 5 and 10 years.]
QuickDASH [Срок оценки: 3, 6, 12, 24 months, 5 and 10 years.]
American Shoulder and Elbow Surgeon (ASES) [Срок оценки: 3, 6, 12, 24 months, 5 and 10 years.]
Visual Analog Scale (VAS). A validated measurement of pain in a patient where 0 indicates no pain and 100 indicates severe pain. The VAS is a straight horizontal line of fixed length. [Срок оценки: 3, 6, 12, 24 months, 5 and 10 years]
Range of Motion [Срок оценки: 3, 6, 12, 24 months, 5 and 10 years.]
Number of Participants Who Have a Secondary Surgical Intervention (SSI) [Срок оценки: 24 months and at 5 and 10 years]
Device Related Adverse Events. [Срок оценки: 24 months and at 5 and 10 years postoperative]
Serious Adverse Event [Срок оценки: 24 months and at 5 and 10 years postoperative]
Serious Adverse Device Effects (SADE) [Срок оценки: 24 months and at 5 and 10 years postoperative.]
Number of Participants with Radiographic Reviews and Assessments. [Срок оценки: 24 months, at 5 years and 10 years postoperative]

Критерии участия

Критерии включения

Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023.