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Идёт набор NCT05067543

Perform Humeral System Study

— Наблюдательное Osteoarthritis Shoulder Avascular Necrosis Post-traumatic Arthrosis of Other Joints, Shoulder Region Rotator Cuff Tear Arthropathy

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: Tornier Perform Humeral - Stem.
Кому может быть актуально
Состояния в реестре: Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Tear Arthropathy. 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, Канада, Франция, Швейцария, Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

Подробное описание

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be collected for the commercially available PERFORM™ Humeral System. The objective of this study is to demonstrate the safety and performance of the PERFORM™ Humeral System devices after implantation over a standard follow-up period using Patient Reported Outcome Measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. Safety and performance measures will be evaluated throughout the patient's participation in the study.

Вмешательства

  • Устройство Tornier Perform Humeral - Stem
    The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.

Первичные конечные точки

  • Change from Baseline to last follow-up visit in ASES scores [Срок оценки: Baseline through Follow-Up visits through 24 months Post-Op]
Вторичные конечные точки (7)
  • Change from Baseline to last follow-up visit in Constant Murley scores [Срок оценки: Baseline through Follow-Up visits through 10 years Post-Op]
  • Change from Baseline to last follow-up visit in SANE scores [Срок оценки: Baseline through Follow-Up visits through 10 years Post-Op]
  • Change from Baseline to last follow-up visit in Subject Satisfaction scores [Срок оценки: Baseline through Follow-Up visits through 10 years Post-Op]
  • Change from Baseline to last follow-up visit in EQ-5D scores [Срок оценки: Baseline through Follow-Up visits through 10 years Post-Op]
  • Number of device associated and procedure associated adverse events. [Срок оценки: Baseline through Follow-Up visits through 10 years Post-Op]
  • Rates of revision surgeries. [Срок оценки: Baseline through Follow-Up visits through 10 years Post-Op]
  • Evaluation of radiological imaging of the affected shoulder [Срок оценки: Baseline through Follow-Up visits through 10 years Post-Op]

Критерии участия

Критерии включения

  • 18 years or older at the time of the informed consent or non-opposition (when applicable).
  • Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
  • Willing and able to comply with the requirements of the study protocol.
  • Considered a candidate for shoulder arthroplasty using a study device.
  • Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements

Критерии исключения

  • Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
  • Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
  • Active local or systemic infection, sepsis, or osteomyelitis
  • Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
  • Significant injury to the brachial plexus
  • Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
  • Neuromuscular disease (e.g., joint neuropathy)
  • Patient with known allergy to one of the product materials
  • Metabolic disorders which may impair bone formation
  • Patient pregnancy
  • Planned for two-stage surgery

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 6 центров
  • Baptist Healthcare — Lexington
  • Summit Orthopedics — Eagan
  • Mayo Clinic — Rochester
  • Washington University — St Louis
  • Orthopedic Institute — Sioux Falls
  • University of Utah — Salt Lake City
Канада · 1 центр
  • Roth McFarlane Hand and Upper Limb Centre — London
Франция · 1 центр
  • Orthopedic Center Santy — Lyon
Швейцария · 1 центр
  • Schulthess Klinik — Zurich
Великобритания · 1 центр
  • Wrightington Hospital — Wigan

Идентификаторы

NCT: NCT05067543 · 20D-W-PHS-RM

Первоисточники (государственные реестры)

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