Набор по приглашению NCT04816773

Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

— Наблюдательное Joint Diseases Osteoarthritis Arthritis Knee Avascular Necrosis

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: EVOLUTION® NitrX™.
Кому может быть актуально: Состояния в реестре: Joint Diseases, Osteoarthritis, Arthritis Knee, Avascular Necrosis. Базовые параметры: от 21 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, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available.

Вмешательства

Устройство EVOLUTION® NitrX™
EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

Первичные конечные точки

Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia [Срок оценки: 10 years post-operative]
Component Survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur [Срок оценки: 10 years post-operative]
Component Survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts [Срок оценки: 10 years post-operative]

Вторичные конечные точки (7)

Functional Scores [Срок оценки: 10 years post-operative]
Functional Scores [Срок оценки: 10 years post-operative]
Functional Scores [Срок оценки: 10 years post-operative]
Subject Satisfaction [Срок оценки: 10 years post-operative]
Radiolucencies [Срок оценки: 10 years post-operative]
To assess subject safety: Adverse Events [Срок оценки: 1, 3, 5, 7, 10 years]
To assess device tolerability within subject: Adverse Events [Срок оценки: 10 years post-operative]

Критерии участия

Критерии включения

Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert
Has previously undergone or currently has determined to undergo a primary TKA for any of the following:

non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
inflammatory degenerative joint disease including rheumatoid arthritis;
correction of functional deformity;
Willing to voluntarily sign the informed consent form
Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.
Previously implanted subjects must be enrolled within 14 months of their primary TKA implantation.

Prospective enrollment of a previously unimplanted contralateral knee is permitted in this study provided:

the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) are used,
all other aspects of the Inclusion/Exclusion Criteria are satisfied,
enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
the subject agrees to a second Informed Consent document and data collection specific to the second TKA.

Bilateral subjects can have both TKAs enrolled in the study provided:

the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) were implanted in both,
all other aspects of the Inclusion/Exclusion Criteria are satisfied,
enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
the subject agrees to a second Informed Consent document and data collection specific to the second TKA.

Bilateral implantation can occur at different time periods for the same subject.

Критерии исключения

Skeletally immature (less than 21 years of age) at time of implantation
Has or had an overt infection at the time of implantation
Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
Has documented substance abuse issues
Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
Currently incarcerated or has impending incarceration
Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет