Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon

Официальное название

Use of Long Head of bíceps Brachii Tendon as an Augmentation for Supraspinatus Tears: a Comparative Clinical Trial.

Обзор

The goal of this clinical trial is to reduce the risk for re-tear in rotator cuff surgeries and improve clinical results in a working age population. The main questions it aims to answer are: If we can improve surgical results using the long head of the biceps tendon as a graft. If we can reduce the risk of re-tear using the long head of the biceps tendon as a graft. Researchers will compare participants with rotator cuff tears with two different surgical techniques to see if their clinical results improve using the long head of the biceps tendon as a graft compared with not using a graft. Participants will be asked to get enrolled in the study not knowing in which group they will be assigned to by signing a Informed Consent Form and both groups would have the same follow up conditions and treatment.

Вмешательства

• Процедура Augmented supraspinatus repair
  After conventional arthroscopic repair of the supraspinsatus with a double row technique, an autologous graft obtained from the long head of the biceps will be used as a Graf to improve biological properties of the supraspinatus tear; aiming to reduce re-tears and to improve Clinical results.
• Процедура Convencional Supraspinatus tear repair
  A double row technique will be performed arthroscopically.

Первичные конечные точки

• Constant Murley Score [Срок оценки: From enrollment to the end of follow up at 1 year after surgery]

Вторичные конечные точки (6)

• ASES score [Срок оценки: From enrollment to 1 year after surgery]
• VAS [Срок оценки: From enrollment to 1 year after surgery]
• Range of Motion [Срок оценки: From enrollment to 1 year after surgery]
• Strenght in abduction [Срок оценки: From enrollment to 1 year after surgery]
• Re-tear rate [Срок оценки: From enrollment to 1 year after surgery]
• Satisfaction index [Срок оценки: From enrollment to 1 year after surgery]

Критерии участия

Критерии включения

• Active workers.
• A supraspinatus tear diagnosed in MRI.
• Modified Rohi equal or over 5 points.
• Failed conservative treatment (at least 3 months of phisiotherapy) or surgical indication secondary to acute traumatic tear with severe functional limitation.
• Age between 18 and 65.
• Long head of the biceps tendon pathology.
• Able to understand and sign the Informed Consent Form.

Критерии исключения

• Tear of the subscapularis or infraspinatus tendon.
• Supraspinatus tears <1cm.
• Lack of long head of the biceps tendon.
• Rotator Cuff Arthropathy (Hamada >3).
• Glenohumeral osteoarthritis.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07657689 · 23/654-E_Tesis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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