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Идёт набор NCT04028687

MDR - PMCF Study for Taperloc Complete Stems

— 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: Taperloc Complete Stem.
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 Taperloc Complete Stems

Обзор

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

Подробное описание

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.

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

\*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point

Вмешательства

  • Устройство Taperloc Complete Stem
    Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.

Первичные конечные точки

  • Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events. [Срок оценки: Out to 10 Years]
Вторичные конечные точки (2)
  • Device Performance and Benefits evaluated through the Harris Hip Score [Срок оценки: Out to 10 Years]
  • Device Performance and Benefits evaluated through the Oxford Hip Score [Срок оценки: Out to 10 Years]

Критерии участия

Критерии включения

  • Patient must be 18 years of age or older and skeletally mature
  • Patient must be willing and able to sign IRB approved informed consent
  • Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following:
  • Non-inflammatory 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 by other techniques

Критерии исключения

  • Off-label use
  • Infection
  • Sepsis
  • Osteomyelitis
  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions
  • Osteoporosis
  • Metabolic disorders which may impair bone formation
  • Osteomalacia
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy, or neuromuscular disease
  • Patient is known to be pregnant or nursing
  • Patient is a prisoner
  • Patient is a known alcohol or drug abuser
  • Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent

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 · 3 центра
  • Orthopaedic Institute of Henderson — Henderson
  • Texas Health Physicians Group — Plano
  • Proliance Orthopaedics and Sports Medicine — Bellevue

Идентификаторы

NCT: NCT04028687 · MDRG2017-89MS-39H

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗