Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
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: Spartan Stem, World Acetabular Cup and World Liner.
- Кому может быть актуально
- Состояния в реестре: Hip Replacement. Базовые параметры: 18 лет — 75 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
- 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
The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.
Подробное описание
The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up.
The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered.
The revision rate of the components will be monitored as the primary objective, along with pre and post operative measurement of the Oxford Hip Score (OHS), patient-reported outcome measure (PROM) to quantify patient satisfaction.
Radiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.
Вмешательства
- Устройство Spartan Stem, World Acetabular Cup and World Liner
The Spartan Stem is a wedge-shaped fit and fill design stem with Titanium Plasma Spray(TPS) and Hydroxyapatite (HA) coating. The World Acetabular cup is Porous coated and mated with cross-linked polyethylene World Liner
Первичные конечные точки
- Spartan Stem, World Acetabular Cup and World Liner Survival Rate [Срок оценки: up to 2 years]
Вторичные конечные точки (1)
- Oxford Hip Score (OHS) [Срок оценки: up to 2 years]
Критерии участия
Критерии включения
- patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g., osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
- patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient.
- male and non-pregnant female patients aged 18-75
- patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up.
Критерии исключения
- patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
- patient is a female of child-bearing age and not taking and not taking contraceptive pills
- patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
- patient has a known or suspected metal sensitivity
- patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
- patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
- patient is severely overweight with a BMI>40.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Cleveland Clinic — Cleveland
Идентификаторы
NCT: NCT06172569 · 111-440-100