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Набор по приглашению NCT07286513

Persona SoluTion PPS Femur PMCF

— Наблюдательное Rhematoid Arthritis Osteo Arthritis of the Knee Traumatic Arthritis of Knee (Diagnosis) Polyarthritis

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: Total knee arthroplasty.
Кому может быть актуально
Состояния в реестре: Rhematoid Arthritis, Osteo Arthritis of the Knee, Traumatic Arthritis of Knee (Diagnosis), Polyarthritis. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective, Multi-Center Post-Market Clinical Study Evaluating the Safety, Performance, and Clinical Benefits of the Persona® SoluTion® PPS Femur

Обзор

The goal of this study is to generate clinical evidence and evaluate the safety and performance of the Persona® SoluTion® PPS Femurs in the US market, with data supporting global regulatory submissions, including CE marking under EU MDR. The target population consists of adults undergoing knee arthroplasty with the Persona SoluTion femoral component paired with a Medial Congruent (MC) or Posterior Stabilized (PS) articulating surface in line with its current cleared Instructions for Use (IFU). The primary endpoint is the assessment of clinical performance and benefits by evaluating the average change in the KOOS JR score between pre-operative and 2-year post-operative follow-up.

Вмешательства

  • Устройство Total knee arthroplasty
    The screening population will consist of patients for whom clinical decision has been made to use the Persona® SoluTion® PPS femoral implant in total knee arthroplasty prior to enrollment in the research.

Первичные конечные точки

  • Change in KOOS JR Score between pre-op and 2 years post-op [Срок оценки: 2 years]
Вторичные конечные точки (7)
  • KOOS JR Score [Срок оценки: 5 years]
  • Oxford Knee Score (OKS) [Срок оценки: 5 years]
  • EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire [Срок оценки: 5 years]
  • Numeric Rating Scale (Pain) [Срок оценки: 5 years]
  • Survival Rate of Implant [Срок оценки: 10 years]
  • Frequency and types of Adverse Events [Срок оценки: 10 years]
  • Assessment of the prevalence of metal hypersensitivities using a metal Lymphocyte Transformation Test (LTT) [Срок оценки: 10 years]

Критерии участия

Критерии включения

  • Patient is of legal age of consent and skeletally mature
  • Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document
  • Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
  • Patient qualifies for total knee arthroplasty based upon physical exam and medical history and meets the approved indications for use of the Persona® SoluTion® PPS femoral implant and appropriate compatible components, within a pre-specified variant configuration (cohort).
  • A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research

Критерии исключения

  • Patient is currently participating in any other surgical intervention or pain management study
  • Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
  • Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
  • Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
  • Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
  • Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
  • Insufficient bone stock on femoral or tibial surfaces
  • Skeletal immaturity
  • Neuropathic arthropathy
  • Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
  • A stable, painless arthrodesis in a satisfactory functional position
  • Severe instability secondary to the absence of collateral ligament integrity
  • Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
  • Study device not implanted during surgery, or surgery did not occur
  • KOOS JR score not collected pre-operatively
  • Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition

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 · 2 центра
  • Denver Hip and Knee, Inc. — Denver
  • Medstar Health Research Institute — Baltimore

Идентификаторы

NCT: NCT07286513 · CMU2025-04K

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗