EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol

Официальное название

Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert

Обзор

MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.

Подробное описание

The primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up.

The secondary objectives include:

* Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up; * Characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-5L Scores, out to 10 years follow-up; * To assess subject satisfaction with their TKA procedure using the Forgotten Joint Score and a Satisfaction Survey; * To assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up; * To assess safety and characterize protocol defined adverse events and adverse device effects.

Вмешательства

• Устройство EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
  Primary knee arthroplasty or a revision knee that requires a revision procedure.

Первичные конечные точки

• The proportion of EVOLUTION® Revision Tibial Base components survivorship out to 10 years. [Срок оценки: up to 10 years]
• The proportion of EVOLUTION® STEMMED CS Femoral components survivorship out to 10 years. [Срок оценки: up to 10 years]
• The proportion of EVOLUTION® MP CS tibial inserts survivorship out to 10 years. [Срок оценки: up to 10 years]

Вторичные конечные точки (7)

• Functional Scores [Срок оценки: Year 1,Year 3, Year 5, Year 7, and Year 10]
• Functional Scores [Срок оценки: Year 1,Year 3, Year 5, Year 7, and Year 10]
• Functional Scores [Срок оценки: Year 1,Year 3, Year 5, Year 7, and Year 10]
• Subject Satisfaction [Срок оценки: Year 1,Year 3, Year 5, Year 7, and Year 10]
• Radiolucencies [Срок оценки: Year 1,Year 3, Year 5, Year 7, and Year 10]
• To assess subject safety: Adverse Events o Adverse Events related to study device or the index surgical procedure [Срок оценки: Year 1,Year 3, Year 5, Year 7, and Year 10]
• Incidence of component revision [Срок оценки: Year 1,Year 3, Year 5, Year 7, and Year 10]

Критерии участия

Критерии включения

• Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (EVOLUTION® Revision Tibial System and EVOLUTION® STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert)
• Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
• Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
• 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.

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 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 or had documented substance abuse issues
• Has or had 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

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Gaetano Pini Orthopedic Institute — Milan

Идентификаторы

NCT: NCT06142669 · 18K001CS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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