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.
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Latissimus dorsi tendon transfer
Procedure/SurgeryLatissimus 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.
Superior capsular reconstruction
Procedure/SurgerySuperior 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 are improved.
Constant-Murley score
Functionality will be measured based on the Constant-Murley score. This questionaire includes 4 sections, regarding pain, activities of daily living (ADL), range of motion (ROM) and muscle strength. The questions regarding pain and ADL are filled by the patients, whereas the assessment of ROM and muscle strength require physical examination by a member of the research team. For the assessment of strength a handheld dynamometer will be used. The minimum score is 0 and the maximum 100.
American Shoulder and Elbow Surgeons (ASES) score
American Shoulder and Elbow Surgeons (ASES) score, measures functionality of the shoulder. It includes 17 multiple-choice questions which are filled by the patients and is divided in two sections: one section about pain assessment and one about activities of daily living (ADL). The minimum score is 0 and the maximum 100.
Visual Analog Scale (VAS) for pain
The Visual Analog Scale for pain is a scale from 0 to 10, that measures the intensity of pain and is a patient-reported score. 0 means "no pain at all" and 10 "pain as bad as it can be". The scale is included in the Pain Questionaire of the American Shoulder and Elbow Surgeons (ASES) score.
Active Range of Motion (ROM)
The active Range of Motion (ROM) will be measured before and after surgery and compared between the two arms. The participants will be examined clinically by an investigator who will be blinded to the type of surgery. The active ROM in forward flexion, abduction, internal and external roation of the shoulder will be examined. For this purpose, a typical goniometer will be used. During the examination the patients should be standing and the scapula should be stabilised in the vertical plane.
Treatment of Pseudoparalysis
Pseudoparalysis is defined as inability of forward flexion at 90°, with absence of neurological deficit, and maintained passive range of motion (ROM). Patients will be examined clinically for the progression or treatment of pseudoparalysis and the results will be compared between the two arms.
Progression of Rotator Cuff Arthropathy
The progression of rotator cuff arthropathy will be assessed. by a radiologist who will be blinded to the type of treatment. Radiographs will be taken at 2, 12 and 24 months after surgery and the progression of osteoarthritis will be examined based on the Hamada classification (grade I to V). The acromiohumeral distance will also be measured in each radiograph. The results will be compared between the two arms.
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