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Идёт набор NCT06754150

Shoulder Innovations Clinical Data Registry

— Наблюдательное Shoulder Arthroplasty

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Shoulder Arthroplasty. 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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Обзор

The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).

Подробное описание

The study is a non-randomized, multi-center prospective registry that will collect standard-of-care data for patients who plan to receive or have received shoulder arthroplasty (anatomic or reverse) with a Shoulder Innovations (SI) Total Shoulder System device and consent to participate in the study. The study will evaluate short and long term clinical and radiographic outcomes associated with real-world use of the arthroplasty system from the implant procedure through 10 years post-operatively.

Первичные конечные точки

  • Durability of the device component implant [Срок оценки: From the implant procedure until 10 years post-operatively]
Вторичные конечные точки (6)
  • Change in range of motion (ROM) post-operatively at specified timepoints as compared to baseline [Срок оценки: From baseline (pre-operatively) until 10 years post-operatively]
  • Change in ASES score post-operatively at specified timepoints as compared to baseline [Срок оценки: From baseline (pre-operatively) until 10 years post-operatively]
  • Change in SANE score post-operatively at specified timepoints as compared to baseline [Срок оценки: From baseline (pre-operatively) until 10 years post-operatively]
  • Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline [Срок оценки: From baseline (per-operatively) until 10 years post-operatively]
  • Evaluation of radiographic images for radiolucent lines, implant stability and loosening [Срок оценки: From baseline (pre-operatively) until 10 years post-operatively]
  • Rate of intra-operative and post-operative adverse device effects (ADEs)/complications [Срок оценки: From the implant procedure until 10 years post-operatively]

Критерии участия

Критерии включения

  • At least 18 years of age.
  • Plan to receive or has received a shoulder arthroplasty surgical procedure, with a minimum of one implanted Shoulder Innovations (SI) device component and be willing and able to complete post-operative visits as long as at least one SI device component remains implanted.
  • Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained).
  • Agree to and be able to consistently answer the specified Patient Reported Outcome Measures (PROM) pre-operatively and at each of the post-operative visits without the use of a translator.
  • Willing and able to comply with the requirements of the study protocol

Критерии исключения

  • Participation in a clinical trial of an investigational drug or device that would confound the results of this trial. Participation in another observational registry is allowed provided there are no conflicting requirements to this trial.
  • Incarceration.
  • Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study 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

США · 8 центров
  • St. Vincent's Orthopedics — Birmingham
  • St. Vincent's Orthopedics — Birmingham
  • California Pacific Orthopaedics — San Francisco
  • Western Orthopaedics — Denver
  • Connolly Orthopedics — Bradenton
  • Georgia Bone and Joint — Newnan
  • North Shore Physicians Group — Peabody
  • University Medical Center of Southern Nevada — Las Vegas

Идентификаторы

NCT: NCT06754150 · SICDR 31.0.1.1.1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗