Latissimus Dorsi Tendon Transfer vs. Superior Capsular Reconstruction in Massive Rotator Cuff Tears

Официальное название

Comparison Between Latissimus Dorsi Tendon Transfer and Superior Capsular Reconstruction in Massive Rotator Cuff Tears: A Randomised Controlled Trial.

Обзор

The goal of this clinical trial is to compare the results of two surgical operations for the treatment of massive rotator cuff tears: latissimus dorsi tendon transfer (LDT) and superior capsular reconstruction (SCR). The main question it wants to answer is which of the two operations provides better functional results, as measured by two patient-reported questionaires: the American Shoulder and Elbow Surgeons (ASES) score and the Constant-Murley score. The patients will be randomly assigned to one of two groups according to the surgery they will undergo (LDT or SCR). They will be examined clinically and asked to fill the questionaires before the surgery, at 6 weeks and at 3, 6, 12 and 24 months after surgery.

Подробное описание

The participants will be included in the research protocol by Mai 2025. The sample size is determined through a power analysis based on the postoperative Constant scores of a similar trial after 31 months of follow-up (see References). Τhe mean difference between preoperative and postoperative Constant scores was used to calculate sample size with a power of 80% and a=0.05. A two-tailed test was used for two independent mean values with effect size d=0.8841. According to the power analysis, 22 patients are required for each cohort (44 patients in total) to achieve a statistically significant difference between mean preoperative and postoperative Constant scores. The critical t value was 2.018 for 42 degrees of freedom. The authors used the Shapiro-Wilk test to confirm the normal distribution of the data. The power analysis was conducted using the G\*power 3.1 software. Enrolled patients will be randomized into two treatment cohorts by a member of the research team who will be blinded to the preoperative patient data, with randomization software. 22 patients will undergo latissimus dorsi tendon transfer (LDT) and 22 patients will undergo superior capsular reconstruction (SCR).

Primary outcomes include the Constant score, the American Shoulder and Elbow Surgeons (ASES) score, and the Visual Analog Scale (VAS) for pain assessment. Secondary outcomes include the progression to osteoarthritis, the measurement of the acromiohumeral distance (AHD) and the treatment of pseudoparalysis.

The patients will be physically examined before surgery, at 6 weeks and at 3 months, 6 months, 12 months and 24 months after surgery. During follow-ups in 3, 6, 12 and 24 months postoperatively, patients will be physically examined by a member of the research team who will be blinded to the type of surgery.

To assess active range of motion (ROM) in forward flexion, abduction, internal and external rotation, a typical goniometer will be used. Patients should be upright with the scapula stabilised in the vertical plane. Additionally, muscle strength will be assessed using a handheld dynamometer. Patients will fill in the Constant, ASES and VAS questionnaires in each follow-up. Moreover, in 2, 12 and 24 months after surgery anterior-posterior radiographs will be performed. Radiographs will be assessed for the progression of rotator cuff arthropathy (based on the Hamada classification) and the AHD will be measured by a radiologist who will be blinded to the type of surgery.

Вмешательства

• Процедура Latissimus dorsi tendon transfer
  Latissimus dorsi tendon transfer is a surgical procedure that aims to restore active range of motion and stability of the shoulder in patients with massive rotator cuff tears. The tendon of the latissimus dorsi muscle is dettached from its insertion in the midbicipital groove of the humerus and reattached to the greater tubetosity. Therefore, the muscle acts as an external rotator, while the forces created pull the humeral head down and stabilize it in the glenoid.
• Процедура Superior capsular reconstruction
  Superior capsular reconstruction is a surgical procedure that aims to restore shoulder stability in patients with massive rotator cuff tears. The superior capsule of the shoulder joint is attached to the greater tuberosity and is therefore often torn in cases of supraspinatus or infraspinatus tears. A fascia lata autograft is used to reconstruct the torn capsule, between the greater tuberosity and the glenoid. Thus, superior migration of the humeral head is prevented, and pain and functionality

Первичные конечные точки

• Constant-Murley score [Срок оценки: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.]
• American Shoulder and Elbow Surgeons (ASES) score [Срок оценки: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.]
• Visual Analog Scale (VAS) for pain [Срок оценки: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.]
• Active Range of Motion (ROM) [Срок оценки: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.]
• Muscle strength [Срок оценки: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.]

Вторичные конечные точки (2)

• Treatment of Pseudoparalysis [Срок оценки: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.]
• Progression of Rotator Cuff Arthropathy [Срок оценки: Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.]

Критерии участия

Критерии включения

Adult patients (over 18 years old). Massive rotator cuff tear diagnosis based on shoulder MRI. -

Критерии исключения

Advanced glenohumeral arthritis (Hamada ≥3). Deltoid dysfunction. Irrepearable subscapularis tear. Infection. Prior shoulder surgery. Shoulder stiffness.

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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

Двойное слепое

Основная цель

Лечение

Центры проведения

Греция · 1 центр

• Konstantopouleio-Patision General Hospital of Nea Ionia — Athens

Публикации

• Ozturk BY, Ak S, Gultekin O, Baykus A, Kulduk A. Prospective, randomized evaluation of latissimus dorsi transfer and superior capsular reconstruction in massive, irreparable rotator cuff tears. J Shoulder Elbow Surg. 2021 Jul;30(7):1561-1571. doi: 10.1016/j.jse.2021.01.036. Epub 2021 Mar 4. PMID 33675971

Идентификаторы

NCT: NCT07154641 · 102/13-3-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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