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Набор скоро начнётся NCT07464977

EMG and Delta Function in Standard RTSA vs Lateralization

Без фазы С лечением Cuff Tear Arthropathy Omarthrosis Rotator Cuff Tear Arthropathy

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: Lateralization of glenoid component, Standard implantation technique.
Кому может быть актуально
Состояния в реестре: Cuff Tear Arthropathy, Omarthrosis, Rotator Cuff Tear Arthropathy. Базовые параметры: 60 лет — 85 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
Австрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Postoperative Deltoid EMG Activity and Function in Patients After Reverse Total Shoulder Arthroplasty: A Comparison of Standard Implantation Technique and Lateralization

Обзор

Reverse total shoulder arthroplasty (RTSA) is a well-established method to treat patients with irreparable rotator cuff tears and glenohumeral osteoarthritis. The biomechanical principle implies a medialization and distalization of the center of rotation (COR). Deficiencies in internal and external rotation constitute frequently encountered functional problems. Some studies showed reduced activation of the posterior deltoid in EMG measurements, which may explain the inability to compensate these movements. Lateralized prosthetic designs demonstrated increased external rotation through an alteration of the deltoid's lever arm. The aim of the study is to investigate the impact of lateralization on functional outcome and deltoid EMG activity in comparison to a standard implantation technique.

Подробное описание

Introduction Reverse total shoulder arthroplasty (RTSA) is a well-established method to treat patients with irreparable rotator cuff tears and glenohumeral osteoarthritis. The biomechanical principle is a medialization and distalization of the center of rotation (COR) to provide a compensatory role for the insufficient rotator cuff. Deficiencies in internal and external shoulder rotation constitute frequently seen functional problems. Some studies showed reduced activation of the posterior deltoid in EMG measurements, which may explain the inability to compensate these movements. Lateralized prosthetic designs implants demonstrated increased external rotation force through an alteration of the deltoid's lever arm.

Material and Methods This study will be conducted as a monocentric randomized, prospective trial. Approximately 130 patients, scheduled for reversed total shoulder arthroplasty (RSA), will be enrolled. The patients will be divided into two groups depending on receiving RSA or a lateralized implant via randomization. Preoperatively and at 4 follow-up visits, a surface EMG (sEMG) of the deltoid muscle will be conducted and clinical scores (Constant-Murley Score and Quick DASH questionnaire) will be assessed. As patient related outcome measures, p-ASES-S and SVV will be evaluated. Pre- and postoperative x-rays and CT scans will be conducted for preoperative planning and measurement of achieved lateralization. Clinical and radiological complications will be routinely documented. Group comparisons and correlations will be performed to compare both groups pre- and postoperatively. The study's duration is scheduled for 2 years.

Aim of the Study The aim of the study is to evaluate a possible difference in function and EMG activity between the two patient groups. Especially a different increase in external rotation range of motion and strength shall be investigated. Furthermore a possible connection between preoperative deltoid muscle activity and postoperative outcome shall be pointed out. Lastly, the impact of lateralization on functional outcome, shall be evaluated compared to the standard implantation technique.

Вмешательства

  • Устройство Lateralization of glenoid component
    Lateralization of glenoid component in reverse total shoulder arthroplasty via metal augment on the glenoid side with a thickness of at least 4mm
  • Устройство Standard implantation technique
    Implantation of a standard glenoid component without any lateralization via metal back on the glenoid site

Первичные конечные точки

  • Delta Muscle activity (especially posterior Delta part) [Срок оценки: preoperative]
  • Delta Muscle activity (especially posterior Delta part) [Срок оценки: 6 weeks postoperative]
  • Delta Muscle activity (especially posterior Delta part) [Срок оценки: 3 months postoperative]
  • Delta Muscle activity (especially posterior Delta part) [Срок оценки: 6 months postoperative]
  • Delta Muscle activity (especially posterior Delta part) [Срок оценки: 1 year postoperative]
Вторичные конечные точки (11)
  • Range of movement (forward flexion, abduction, external rotation, extension) [Срок оценки: preoperative]
  • Range of movement (forward flexion, abduction, external rotation, extension) [Срок оценки: 6 weeks postoperative]
  • Range of movement (forward flexion, abduction, external rotation, extension) [Срок оценки: 3 months postoperative]
  • Range of movement (forward flexion, abduction, external rotation, extension) [Срок оценки: 6 months postoperative]
  • Range of movement (forward flexion, abduction, external rotation, extension) [Срок оценки: 1 year postoperative]
  • Objective and subjective outcome scores / Quality of life scores [Срок оценки: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]
  • Objective and subjective outcome scores / Quality of life scores [Срок оценки: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]
  • Objective and subjective outcome scores / Quality of life scores [Срок оценки: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]
  • Objective and subjective outcome scores / Quality of life scores [Срок оценки: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]
  • Difference in lateralization between preoperative 3D CT-based planning and postoperative CT-based implant position [Срок оценки: Preoperative and 1 year postoperative]
  • Humeral Length (Millimeters) Measured on Standardized Radiographs [Срок оценки: preoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, 12 months postoperative]

Критерии участия

Критерии включения

  • male/female, 60-85y
  • diagnosis of Cuff tear arthropathy (CTA)
  • irreparable rotator cuff tear
  • severe osteoarthritis (OA)
  • primary RSA
  • verified rotator cuff tear in preoperative MRI
  • absence of severe cognitive impairment

Критерии исключения

  • previous muscle transfer
  • revision surgery
  • highly dysplastic glenoid
  • axillary nerve palsy
  • upper limb radiculopathy
  • cervical myelopathy
  • degenerative muscular disease,
  • previous proximal humeral fracture
  • revision arthroplasty
  • rheumatoid arthritis

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
Простое слепое
Основная цель
Диагностика

Центры проведения

Австрия · 1 центр
  • Klinik Donaustadt — Vienna

Идентификаторы

NCT: NCT07464977 · Protocol EMG RTSA 4.0

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗