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Идёт набор NCT06371833

PRIMA EU Retrospective & Prospective

— Наблюдательное Arthroplasty Replacement 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: Shoulder Arthroplasy with PRIMA humeral stem.
Кому может быть актуально
Состояния в реестре: Arthroplasty, Replacement, Shoulder. 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
Италия
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

A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty

Обзор

This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications.

Вмешательства

  • Устройство Shoulder Arthroplasy with PRIMA humeral stem
    Data collection of population that underwent a total shoulder arthroplasty with PRIMA humeral stem (anatomic configuration or reverse configuration)

Первичные конечные точки

  • Changes of Costant Murley Score (CS) [Срок оценки: From preoperative (baseline) to 24-month follow-up.]
Вторичные конечные точки (5)
  • Changes in the American Shoudler and Elbow Surgeons (ASES) score [Срок оценки: From preoperative (baseline) to 24-month follow-up.]
  • Changes in Range of Motion measures [Срок оценки: From preoperative (baseline) to 24-month follow-up.]
  • Radiographic stability of the humeral component [Срок оценки: From immediate postoperative (baseline) to 24-months follow-up]
  • Survival rate (Kaplan-Meier estimate) [Срок оценки: From immediate post-operative to 24-months follow-up.]
  • Incidence, type and severity of Adverse Events and Adverse Device Effects [Срок оценки: From surgery to 24-months follow-up.]

Критерии участия

Критерии включения

  • Age ≥ 18 years old;
  • Full skeletal maturity;
  • Life expectancy over 24 months;
  • Patient's joint anatomically and structurally suited to receive the selected implants and functional deltoid muscle;
  • Patient meets at least one of the following indications:

For Anatomic configuration:

  • non-inflammatory degenerative joint disease (i.e., osteoarthritis);
  • inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
  • avascular necrosis of the humeral head;
  • cuff tear arthropathy (CTA Heads only);

For Reverse configuration:

  • rotator cuff tear arthropathy;
  • osteoarthritiswith rotator cuff tear;
  • rheumatoid arthritis with rotator cuff tear;
  • massive irreparable rotator cuff tear;
  • Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;
  • Patient has signed the Informed Consent form previously approved by the Ethics Committee before study activities.

Критерии исключения

  • Patients who lack capacity to be able to provide informed consent to participate in the study.
  • Local or systemic general infection;
  • Septicaemia;
  • Persistent acute or chronic local or systemic osteomyelitis;
  • Confirmed neurologic lesion compromising shoulder joint function;
  • Deltoid muscle insufficiency;
  • Poor meta-epiphyseal bone stock compromising stability of the implant (severe fracture of the proximal humerus, meta-epiphyseal pseudoarthrosis, osteoporosis, osteomalacia, extended bone loss after previous prosthetic or non-prosthetic surgery);
  • Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course;
  • Serious muscular, neurological, or arterial vascular diseases compromising stability of the implant;
  • Proximal humerus fracture sequelae with inadequate bone stock;
  • Vascular or nerve diseases affecting the concerned limb;
  • Metabolic disorders which may impair fixation and stability of the implant;
  • Any concomitant disease that might affect the implanted prosthesis;
  • Metal hypersensitivity to implant materials (CoCrMo);
  • Patient with significant renal impairment;
  • Lower mobility issues that may affect the study evaluation;
  • Unwillingness or inability (due to physical or mental issues) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;
  • Women of childbearing potential who are pregnant, nursing, or planning to become pregnant;
  • Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy — Cattolica

Идентификаторы

NCT: NCT06371833 · S-52

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗