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Идёт набор NCT06631638

EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))

Без фазы С лечением Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis Congential Hip Dysplasia

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: EMPHASYS Cup with VHN.
Кому может быть актуально
Состояния в реестре: Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congential Hip Dysplasia. 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
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

Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation

Обзор

The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software. Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.

Вмешательства

  • Устройство EMPHASYS Cup with VHN
    Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation

Первичные конечные точки

  • Composite endpoint: Acetabular Cup Position Success at 6 Weeks [Срок оценки: 6 Weeks]
Вторичные конечные точки (12)
  • Inclination Success [Срок оценки: 6 weeks]
  • Version Success [Срок оценки: 6 weeks]
  • Final Intraoperative Inclination [Срок оценки: 12 weeks]
  • Final Intraoperative Version [Срок оценки: 12 weeks]
  • Harris Hip Score [Срок оценки: 12 weeks]
  • Radiographic Outcomes [Срок оценки: 12 weeks]
  • EQ-5D-5L [Срок оценки: 12 weeks]
  • Forgotten Joint Score [Срок оценки: 6 weeks]
  • Operating Room Times [Срок оценки: Immediately after the Surgical Procedure]
  • Leg Length Discrepancy [Срок оценки: Immediately after the Surgical Procedure]
  • Complication Rates [Срок оценки: 30 days]
  • Complication Rates [Срок оценки: 90 days]

Критерии участия

Критерии включения

  • All hip replacement component devices are to be used according to the approved indications.
  • The subject is undergoing a standard of care primary uncemented hip replacement with the EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral, anterolateral, or direct lateral approach with the subject in the lateral decubitus position.
  • The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced
  • Individuals who are able to speak, read, and comprehend the Informed Participant Consent Document and willing and able to provide consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
  • Individuals who are willing and able to complete follow-up as specified by the study protocol.
  • Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.
  • Individuals who are not bedridden per the discretion of the investigator.
  • Individuals who are a minimum age of 21 years at the time of consent

Критерии исключения

  • Active local or systemic infection.
  • Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
  • Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
  • Charcot's or Paget's disease.
  • The Subject is a woman who is pregnant or lactating.
  • Subject had a contralateral amputation.
  • Previous partial hip replacement in affected hip.
  • Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
  • Contralateral hip was replaced less than 6 months prior to surgery date.
  • Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
  • Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
  • Subject has a medical condition with less than 2 years of life expectancy.
  • Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete subject reported questionnaires or be compliant with follow-up requirements.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 5 центров
  • UC Davis Health System — Sacramento
  • Florida Orthopaedic Institute — Gainesville
  • Northwell Health — Lake Success
  • Montefiore Medical Center — The Bronx
  • Carolina Orthopaedic and Sports Medicine Center — Gastonia

Идентификаторы

NCT: NCT06631638 · DSJ202006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗