Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

Официальное название

Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette

Обзор

Randomized clinical trial, parallel 1:1, comparing Latarjet to Modified Eden-Hybinette (iliac bone crest + capsular repair) for recurrent traumatic anterior glenohumeral dislocation.

Подробное описание

The Latarjet technique has proven reliable for the treatment of dislocations, with lower recurrence rates (5%) even in the presence of bone lesions. This technique allows a stable fixation of the graft, with 2 screws, and the dynamic effect of the conjoint tendon, the sling effect. However, several complications are described, such as neurological injuries, nonunion and graft resorption. Hamel et al, showed that vascularization of the coracoid graft is impaired during the course of Latarjet procedure. Together with the small thickness of the coracoid, it may justify its high rate of resorption.

The Eden-Hybinette surgery does not have the potential advantages of the sling effect. However, it allows a better restoration of the area of the glenoid, without the risks related to the coracoid osteotomy. All clinical studies about the different bone grafting techniques have a low quality. Furthermore, there is no comparative study of the techniques of Latarjet and Eden-Hybinette.

Вмешательства

• Процедура Latarjet procedure
  Open anterior glenoid bone graft from coracoid process
• Процедура Modified Eden-Hybinette
  Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation

Первичные конечные точки

• Western Ontario Shoulder Instability Index (WOSI) [Срок оценки: 2 years]

Вторичные конечные точки (12)

• ROWE score [Срок оценки: 2 years]
• Visual analog scale (VAS) for shoulder pain [Срок оценки: 2 years]
• VAS for iliac pain [Срок оценки: 6 weeks]
• VAS for iliac pain [Срок оценки: 3 months]
• VAS for iliac pain [Срок оценки: 2 years]
• Single Assessment Numeric Evaluation (SANE) [Срок оценки: 2 years]
• Dislocation recurrence rate [Срок оценки: 2 years]
• Rate of complications and reoperations [Срок оценки: 2 years]
• Kible scale for Scapular movement [Срок оценки: 2 years]
• Categoric evaluation for scapular movement [Срок оценки: 2 years]
• Tomographic evaluation [Срок оценки: 2 years]
• Radiographic evaluation [Срок оценки: 2 years]

Критерии участия

Критерии включения

• History of one or more previous episodes of traumatic glenohumeral dislocation;
• Anterior glenoid bone loss superior to 20% of its diameter, regardless of the ISIS score;
• Recurrence of glenohumeral dislocation in cases previously treated with arthroscopic Bankart repair, regardless of the ISIS score and severity of bone lesion of the glenoid;
• Borderline bipolar bone lesions:
• Instability Severity Index Score of (ISIS) greater than or equal to 4 points, with anterior glenoid bone loss (bone Bankart lesion) greater than 13.5% of their diameter, measured by the method described by Sugaya et al.;
• Hill-Sachs lesion and glenoid considered "off-track".

Критерии исключения

• Hill-Sachs lesion greater than 40% of the humeral head diameter (measured by the preoperative CT);
• Untreated seizures;
• Previously diagnosed rotator cuff complete tear;
• Fractures of the proximal humerus (except for Hill-Sachs lesions);
• Multidirectional instability;
• Advanced glenohumeral osteoarthritis (grade 3 Samilson and Pietro)

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

Лечение

Центры проведения

Бразилия · 1 центр

• Instituto de Ortopedia e Traumatologia — São Paulo

Идентификаторы

NCT: NCT02913352 · Latarjet vs Eden

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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