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Идёт набор NCT07520669

Does Capsuloplasty Reduce External Rotation After Coracoid Impingement?

Без фазы С лечением Shoulder Anterior Latarjet Instability

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: Open coracoid impingement repair without capsuloplasty, Open coracoid impingement repair with capsuloplasty.
Кому может быть актуально
Состояния в реестре: Shoulder Anterior Latarjet Instability. Базовые параметры: 18 лет — 50 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Does Capsuloplasty Reduce External Rotation After Coracoid Impingement? A Randomized Controlled Trial

Обзор

The coracoid anchor (Latarjet procedure) is the gold standard technique for treating recurrent anterior shoulder instability. Despite excellent postoperative stability, a reduction in external rotation has been reported, which can affect function, glenohumeral kinematics, and return to sports, particularly among athletes in combat and contact sports. The combination of an anterior capsuloplasty with the coracoid buttress is performed inconsistently among surgeons, with no consensus; the capsular repair techniques associated with the Latarjet procedure vary widely among teams. Some teams routinely perform capsular repair to enhance stability and reposition the capsule on the glenoid rim, while others consider it non-essential and potentially responsible for further limiting external rotation. To date, there are few studies specifically evaluating the impact of capsuloplasty on joint range of motion beyond the end-stop, and the available results remain contradictory. In 2023, the team of Kim et al. suggested that the Latarjet technique without capsular repair resulted in good restoration of laxity and good clinical outcomes, with less early postoperative limitation of external rotation than that observed with the same technique combined with capsular repair. Nevertheless, at 1 year, there was no significant deficit in external rotation between the two groups. A prospective randomized comparative analysis will determine whether the addition of capsuloplasty significantly alters ranges of motion, given identical surgical and rehabilitation protocols. The results could clarify the indications for this procedure, optimize surgical practices, and improve recommendations for the management of shoulder instability.

Вмешательства

  • Процедура Open coracoid impingement repair without capsuloplasty
    All patients undergo an open coracoid osteotomy performed using the center's standard technique. The procedure is performed under general anesthesia combined with an interscalene block. The patient is positioned in a semi-sitting position. The approach is delto-pectoral; an osteotomy of the coracoid process is performed after detachment of the acromiocoracoid ligament and the pectoralis minor tendon. A tunnel is created through the subscapularis muscle, followed by a horizontal capsulotomy with
  • Процедура Open coracoid impingement repair with capsuloplasty
    All patients undergo an open coracoid osteotomy performed using the center's standard technique. The procedure is performed under general anesthesia combined with an interscalene block. The patient is positioned in a semi-sitting position. The approach is delto-pectoral; an osteotomy of the coracoid process is performed after detachment of the acromiocoracoid ligament and the pectoralis minor tendon. A tunnel is created through the subscapularis muscle, followed by a horizontal capsulotomy with

Первичные конечные точки

  • Range of external rotation [Срок оценки: 12 months after surgery]
Вторичные конечные точки (2)
  • Recurrence of instability [Срок оценки: 12 months after surgery]
  • Rowe score [Срок оценки: 12 months after surgery]

Критерии участия

Критерии включения

  • Standard indications for surgery (glenoid bone loss, advanced Hill-Sachs lesion, failed Bankart repair, contact sports, etc.).
  • Shoulder not previously operated on

Критерии исключения

  • Significant associated rotator cuff pathology, associated SLAP lesion
  • Advanced glenohumeral osteoarthritis.
  • Recurrent impingement, history of shoulder surgery
  • Presence of severe external rotation deficit of the shoulder prior to surgery

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

Франция · 1 центр
  • Clinique du Sport — Mérignac

Идентификаторы

NCT: NCT07520669 · 2025-65-SBM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗