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Набор скоро начнётся NCT05314387

S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem

— Наблюдательное Shoulder Arthritis Shoulder Osteoarthritis Arthrosis Osteoarthritis

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: SMR TT Hybrid Glenoid without Cementless Finned Short Stem, SMR TT Hybrid Glenoid with Cementless Finned Short Stem.
Кому может быть актуально
Состояния в реестре: Shoulder Arthritis, Shoulder Osteoarthritis, Arthrosis, Osteoarthritis. 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
Список центров уточняется — проверьте первичный протокол.
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 Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem

Обзор

Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem

Вмешательства

  • Устройство SMR TT Hybrid Glenoid without Cementless Finned Short Stem
    The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation.
  • Устройство SMR TT Hybrid Glenoid with Cementless Finned Short Stem
    The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation. The fins are intended to enhance press-fit fixation. The same proximal morse taper is used for coupling to the same humeral bodies in the SMR Shoulder System. The SMR finned short stem is intended for cementless fixation.

Первичные конечные точки

  • Proportion of patients reaching a clinical progression from baseline to 24-month follow-up [Срок оценки: 24 Months]
Вторичные конечные точки (11)
  • Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES) [Срок оценки: Baseline to 24 and 60 Months]
  • Measure Oxford shoulder score [Срок оценки: Baseline to 24 and 60 Months]
  • Measure Constant Score [Срок оценки: Baseline to 24 and 60 Months]
  • Measure Simple Shoulder Test [Срок оценки: Baseline to 24 and 60 Months]
  • Measure Patient Satisfaction [Срок оценки: Baseline to 24 and 60 Months]
  • Stability of the SMR TT hybrid glenoid component with or without SMR cementless finned short stem [Срок оценки: Immediately postoperative to 24 Months]
  • System conversion rate, intended as a conversion within the SMR system from anatomic to reverse [Срок оценки: 24 Months]
  • Failure rate, intended as removal of the SMR TT hybrid glenoid component [Срок оценки: Immediately postoperative to 24 Months]
  • Failure rate, intended as removal of the SMR cementless finned short stem [Срок оценки: Immediately postoperative to 24 Months]
  • Incidence of device-related AE/SAE (ADE/SADE) [Срок оценки: Immediately postoperative to 24 and 60 Months]
  • Survival rate (Kaplan-Meier) [Срок оценки: 60 Months]

Критерии участия

Inclusion Criteria:(Key)

  • Both genders;
  • Age ≥ 18 years old;
  • Full skeletal maturity;
  • Life expectancy over 5 years;
  • Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;
  • Good bone quality evaluated by the Investigator and the intraoperative evaluation;
  • A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:
  • Primary osteoarthritis;
  • Secondary osteoarthritis;
  • Post-traumatic arthritis;
  • Rheumatoid arthritis;
  • Avascular necrosis
  • acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
  • cuff tear arthropathy (only in combination with CTA Heads);
  • Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.

Exclusion Criteria (Key):

  • Patient requiring revision shoulder arthroplasty;
  • Osteoporosis with a history of non-traumatic fractures;
  • Steroid injections within the previous 3 months;
  • Contralateral shoulder replacement within the previous 3 months;
  • Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;
  • Significant neurological or musculoskeletal disorders that may compromise functional recovery;
  • Not recovered axillary nerve palsy;
  • Non functioning deltoid muscle;
  • Known or suspicious hypersensitivity to the metal or other components and materials of the implant;
  • Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;
  • Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.

These are key eligibility criteria, other eligibility criteria apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05314387 · S-11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗