Zimmer Biomet Shoulder Arthroplasty PMCF

Официальное название

Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study

Обзор

The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.

Подробное описание

The primary endpoint is defined as survival of the implant at 10 years, which is based on removal or intended removal of at least 1-study implant component and will be determined by using the Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Separate analysis will be done for each arm of the study.

The secondary endpoint is represented by the performance and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation after 2 years, which will be assessed by the American Shoulder and Elbow Surgeons (ASES) shoulder score. The secondary endpoint evaluation will also assess the overall pain, functional performance, quality of life and radiographic parameters of all enrolled study subjects.

Вмешательства

• Устройство Alliance Glenoid
  Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty
• Устройство Identity Stem
  Identity Shoulder System is intended to be used in anatomic total shoulder arthroplasty, shoulder hemi-arthroplasty, or total reverse shoulder arthroplasty in both Primary or Revision Total Shoulder Arthroplasty

Первичные конечные точки

• Implant Survivorship at 10 years follow-up (Kaplan Meier) [Срок оценки: 10 years]
• Frequency and Incidence of Adverse Events (Safety) [Срок оценки: 10 years]

Вторичные конечные точки (7)

• Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 2 years follow-up [Срок оценки: 2 years]
• Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L) [Срок оценки: 2 years]
• Radiographic Performance [Radiolucency] at 2 years follow-up [Срок оценки: 2 years]
• Radiographic Performance [Osteolysis] at 2 years follow-up [Срок оценки: 2 years]
• Radiographic Performance [Heterotopic Ossification] at 2 years follow-up [Срок оценки: 2 years]
• Radiographic Performance [Humeral Component Subsidence] at 2 years follow-up [Срок оценки: 2 year]
• Radiographic Performance [Glenoid Component Migration] at 2 years follow-up [Срок оценки: 2 year]

Критерии участия

Критерии включения

• Patient must be 20 years of age or older.
• Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
• Patient is a candidate for shoulder arthroplasty due to one or more of the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.
• Patient must be able and willing to complete the protocol required follow-up.
• Patient must be able and willing to sign the IRB/EC approved informed consent.
• Patient has grossly deficient rotator, (for reverse application)

• With severe arthropathy and/or
• Previously failed shoulder joint replacement
• Patient must have functional deltoid muscle (for reverse application)

Критерии исключения

• Patient is unwilling or unable to give consent or to comply with the follow-up program.
• Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
• Patient is known to be pregnant or breastfeeding.
• Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
• Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
• Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
• Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable.
• Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device.
• Patient has osteomalacia.
• Patient has a metabolic disorder that may impair bone formation.
• Patient has deficient rotator cuff.
• Patient presents with significant injury to the upper brachial plexus.
• Patient has paralysis of the axillary nerve.
• Patient has non-functional deltoid or external rotator muscles.

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 · 12 центров

• Hoag Orthopedic Institute — Irvine
• Panorama Orthopaedic and Spine Center — Golden
• Northwestern University — Chicago
• Norton Healthcare, Inc — Louisville
• William Beaumont Hospital — Royal Oak
• TRIA Orthopaedic Center Research Institute — Bloomington
• Mississippi Sports Medicine and Orthopaedic Center, PLLC — Jackson
• Advance Bone and Joint — City of Saint Peters
• … и ещё 4 центра

Япония · 4 центра

• Fukui General Hospital — Fukui
• Iwaki City Medical Center — Fukushima
• Yuuai Medical Center — Okinawa
• Kichijoji Minami Hospital — Tokyo

Новая Зеландия · 1 центр

• Kensington Private Hospital — Whangarei

Идентификаторы

NCT: NCT04984291 · CMU2019-35E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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