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Идёт набор NCT05807854

RSA Vs RCR for Massive RCTs

Без фазы С лечением Rotator Cuff Tears

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: Arthroscopy, Reverse Shoulder Arthroplasty.
Кому может быть актуально
Состояния в реестре: Rotator Cuff Tears. Базовые параметры: 60 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
США, Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial

Обзор

Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).

Подробное описание

The majority of degenerative rotator cuff tears occur in individuals over 60 years of age. Therefore, as our population increases in size and advances in age, the incidence of rotator cuff tears is also increasing. A growing number of people are remaining active at this age, and continue to place substantial physical demands on their shoulders notably into their seventh and eighth decades of life. At the same time, the rotator cuff undergoes intrinsic degeneration and the prevalence of osteoporosis increases. Consequently, a significant and growing number of arthroscopic rotator cuff repairs are performed in individuals with poor soft tissue or bone quality. Moreover, whereas most rotator cuff tears occur at the tendon-bone insertion, fixation quality can be challenged by a tear that occurs more medially, leaving only a small amount of tendon for fixation by suture.

Different treatment options are available for massive or irreparable rotator cuff tears, including debridement and subacromial decompression, repair (partial or complete), transfer of the subscapularis tendon, transfer of the teres major muscle, deltoid flap reconstruction, transfer of the latissimus dorsi or the pectoralis major, superior capsule reconstruction, augmented cuff repair, subacromial balloon and reverse total shoulder replacements. None of these treatments has proved superiority on other ones, particularly when the rotator cuff is massively torn.

Massive degenerative rotator ruff tears are a challenge. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. Recently, Liu et al. demonstrated that both rotator cuff repair (RCR) and reverse shoulder arthroplasty (RSA) are effective and reliable options for massive rotator cuff tears (RCT), but revealed a better shoulder function for patients in the rotator cuff repair (RCR) group. While these results are interesting, this study remains retrospective and call for new studies with a higher level of evidence.

The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).

Вмешательства

  • Процедура Arthroscopy
    The surgeon reattaches the torn tendon to the bone with anchors and sutures.
  • Устройство Reverse Shoulder Arthroplasty
    It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).

Первичные конечные точки

  • American Shoulder and Elbow Surgeon (ASES) score [Срок оценки: At 24 post-operative months]
Вторичные конечные точки (12)
  • Pain on Visual Analogue Scale (pVAS) [Срок оценки: At 24 post-operative months]
  • Constant score [Срок оценки: At 24 post-operative months]
  • Single Assessment Numeric Evaluation (SANE) [Срок оценки: At 24 post-operative months]
  • Complication [Срок оценки: Within the 24 post-operative months]
  • Location of the defect [Срок оценки: At 24 post-operative months]
  • Signs of anchor displacement and location [Срок оценки: At 24 post-operative months]
  • Signs of suture cut-through [Срок оценки: At 24 post-operative months]
  • Patient satisfaction [Срок оценки: At 24 post-operative months]
  • Range of motion [Срок оценки: At 24 post-operative months]
  • Tendon defect [Срок оценки: At 24 post-operative months]
  • Signs of stem or glenoid loosening [Срок оценки: At 24 post-operative months]
  • Scapular notching [Срок оценки: At 24 post-operative months]

Критерии участия

Критерии включения

  • 1 Patient voluntarily consents to participate
  • 2 Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment
  • 3 Patients with the following pre-operative images: Three standardized X-rays series and Magnetic Resonance Imaging (MRI) or arthro Magnetic Resonance Imaging without sign of traumatic lesions

Критерии исключения

  • 1 Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study
  • 2 Revision rotator cuff repair
  • 3 Patient consent withdrawal
  • 4 Glenohumeral arthritis defined as stage > 3 Hamada classification
  • 5 Infection and neuropathic joints
  • 6 Known or suspected non-compliance, drug or alcohol abuse
  • 7 Patients incapable of judgement or under tutelage
  • 8 Inability to follow the procedures of the study
  • 9 Enrolment of the investigator, his/her family members, employees and other dependent persons

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

США · 1 центр
  • Oregon Health & Science University — Portland
Швейцария · 1 центр
  • La Tour hospital — Meyrin

Публикации

  • Ladermann A, Pernoud A, Cochard B, Bothorel H. Treatment of degenerative massive rotator cuff tears: a study protocol for a randomized non-inferiority comparative surgical trial. Trials. 2025 Aug 4;26(1):270. doi: 10.1186/s13063-025-08990-9. PMID 40759980

Идентификаторы

NCT: NCT05807854 · 2023-00111

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗