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Набор по приглашению NCT07410650

Subscapularis-Sparing Total Shoulder Arthroplasty

— Наблюдательное Total Shoulder Arthroplasty

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: Subscapularis-Sparing Total Shoulder Arthroplasty.
Кому может быть актуально
Состояния в реестре: Total Shoulder Arthroplasty. Базовые параметры: 18 лет — 90 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
Следующий шаг
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Официальное название

Subscapularis-Sparing Total Shoulder Arthroplasty: A Prospective Study

Обзор

The investigators purpose of this study are to perform a prospective clinical study to determine the following after subscapularis-sparing anatomic total shoulder arthroplasty performed for glenohumeral osteoarthritis: 1. patient-reported outcomes 2. shoulder motion and strength 3. rotator cuff integrity 4. the accuracy of component placement and the completeness of osteophyte removal

Подробное описание

Anatomic total shoulder arthroplasty (TSA) provides excellent pain relief and restoration of shoulder function in the setting of glenohumeral osteoarthritis. However, the surgical approach requires the subscapularis to be cut and repaired, via either a lesser tuberosity osteotomy, a subscapularis tenotomy, or a subscapularis peel.This repair must be protected post-operatively, even with a lesser tuberosity osteotomy, or it can displace or fail to heal, which complicates rehabilitation. Failure of the subscapularis repair occurs in 10-25% of patients. Failure of the subscapularis repair is often devastating for shoulder function and often requires revision to a reverse total shoulder arthroplasty. Even when muscle-tendon-bone healing does occur there is post-operative atrophy of the subscapularis that may compromise function and strength. Atrophy of the subscapularis may lead to imbalance of the rotator cuff musculature, leading to subluxation and glenoid loosening. While there have been attempts to develop approaches that do not involve cutting the subscapularis, they have been plagued by osteophyte retention, component malposition, damage to the deltoid, or damage to the supraspinatus.

The principal investigator has spent four years developing a technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons and has been through the learning curve with this technique by completing \>20 cases and at least as many cadaver surgeries during that time period. This technique has been designed to avoid the potential issues with prior attempts and utilizes purpose designed instrumentation and retractors.

Вмешательства

  • Процедура Subscapularis-Sparing Total Shoulder Arthroplasty
    A surgical technique for anatomic total shoulder arthroplasty that does not involve cutting any muscles or tendons.

Первичные конечные точки

  • Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score [Срок оценки: Pre-operative]
  • Patient-reported outcome (Simple Shoulder Test (SST)) [Срок оценки: Pre-operative]
  • Patient-reported outcome (Visual Analogue Score (VAS)) [Срок оценки: Pre-operative]
  • Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score [Срок оценки: 6-weeks post-operative]
  • Patient-reported outcome (Simple Shoulder Test (SST)) [Срок оценки: 6-weeks post-operative]
  • Patient-reported outcome (Visual Analogue Score (VAS)) [Срок оценки: 6-weeks post-operative]
  • Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score [Срок оценки: 3-months post-operative]
  • Patient-reported outcome (Simple Shoulder Test (SST)) [Срок оценки: 3-months post-operative]
  • Patient-reported outcome (Visual Analogue Score (VAS)) [Срок оценки: 3-months post-operative]
  • Patient-reported outcome (American Shoulder and Elbow Surgeons (ASES) Score [Срок оценки: 1-year post-operative]

Критерии участия

Критерии включения

  • Patients undergoing subscapularis-sparing anatomic total shoulder arthroplasty by the principal investigator at the University of Utah.

Критерии исключения

  • Patients unwilling to consent and comply with study procedures (i.e. follow up visits).
  • Patients under the age of 18.
  • Patients with contraindications to an anatomic total shoulder arthroplasty such as active infection, insufficient glenoid bone, damage to the rotator cuff, or a history of instability.
  • Patients with known prior shoulder arthroplasty.
  • Patients unable to undergo a magnetic resonance imaging study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Utah Orthopedics — Salt Lake City

Идентификаторы

NCT: NCT07410650 · 137991

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗