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Идёт набор NCT04468178

Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder

Без фазы С лечением Osteoarthritis of the Shoulder

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: Total joint arthroplasty of the glenohumeral joint.
Кому может быть актуально
Состояния в реестре: Osteoarthritis of the Shoulder. Базовые параметры: 18 лет — 80 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
Германия
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 primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).

Подробное описание

The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).

As secondary endpoints, the migration behavior of the humeral components over time will be determined by radiostereometric analysis (RSA), the further clinical-functional results and the satisfaction of the patients treated will be investigated. Clinical outcomes are measured using standardized and reproducible clinical scores (Oxford Shoulder Score -OSS and Short Form Health 36-SF-36 v1.0 ) at each time of examination.

Other endpoints include revision rate within the follow-up period, surgical time (incision to suture), and delays in surgical procedures due to instrumentation.

The times of data acquisition are the admission day before the operation to determine the preoperative status, the discharge day and the follow-up appointments after 3 months, 6 months, 12 months and 24 months to determine the postoperative status and course.

Вмешательства

  • Устройство Total joint arthroplasty of the glenohumeral joint
    The arthroplasty of the glenohumeral joint will be performed as an anatomical reconstruction after primary or post-traumatic osteoarthritis.

Первичные конечные точки

  • Constant-Murley Score (CMS) [Срок оценки: 3 months postoperative]
  • Constant-Murley Score (CMS) [Срок оценки: 12 months postoperative]
  • Constant-Murley Score (CMS) [Срок оценки: 24 months postoperative]
Вторичные конечные точки (6)
  • Oxford Shoulder Score (OSS) [Срок оценки: 3 months postoperative]
  • Oxford Shoulder Score (OSS) [Срок оценки: 12 months postoperative]
  • Oxford Shoulder Score (OSS) [Срок оценки: 24 months postoperative]
  • Short Form Health 36 (SF-36) [Срок оценки: 3 months postoperative]
  • Short Form Health 36 (SF-36) [Срок оценки: 12 months postoperative]
  • Short Form Health 36 (SF-36) [Срок оценки: 24 months postoperative]

Критерии участия

Критерии включения

  • Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
  • Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
  • Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.
  • Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed.
  • Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).

Критерии исключения

  • Previous operation on the rotator cuff of the affected shoulder
  • Dysfunctional rotator cuff
  • Infection of the affected shoulder joint or systemic infection
  • Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Германия · 1 центр
  • Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift — Hanover

Идентификаторы

NCT: NCT04468178 · IIT-RSA-Global-Icon-2020

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗