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Набор по приглашению NCT05199870

MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads

— Наблюдательное Hip Arthritis Hip Disease Hip Fractures Hip Injuries

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: RingLoc Bipolar Acetabular Cup, Endo II Femoral Head.
Кому может быть актуально
Состояния в реестре: Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries. 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

Post-Market Clinical Follow-Up Study to Provide Safety, Performance and Clinical Benefits Data of the RingLoc Bipolar Acetabular Cup or Endo II Heads (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study

Обзор

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).

Подробное описание

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).

The primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to implant, instrumentation and/or procedure should be specified.

The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).

Вмешательства

  • Устройство RingLoc Bipolar Acetabular Cup
    Patients that have been implanted with a RingLoc Bipolar acetabular cup.
  • Устройство Endo II Femoral Head
    Subjects that have been implanted with an Endo II Femoral Head

Первичные конечные точки

  • Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events. [Срок оценки: Greater than or equal to 8 years.]
Вторичные конечные точки (1)
  • Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment. [Срок оценки: Greater than or equal to 8 years.]

Критерии участия

Критерии включения

  • Patient must be 18 years of age or older and skeletally mature
  • Patient must have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following:
  • Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • Correction of functional deformity
  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Критерии исключения

  • Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability
  • Off-label use or not according to the approved instructions for use (IFU) of study devices
  • Revision procedures where other treatment or devices have failed
  • Uncooperative patient or patient with neurologic disorders who is incapable of following directions
  • Patient has a psychiatric illness or

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
  • Inova Fairfax Hospital — Falls Church

Идентификаторы

NCT: NCT05199870 · MDRG2017-89MS-43H

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗