Rotator Cuff Injuries
Conditions
Interventions
This is a randomized, controlled, two-arm clinical trial, triple-blind (blinding applied to the research assistant collecting data, to the physicians examining the patients and imaging studies and to
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Instituto Jundiaiense de Ortopedia e Traumatologia
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 70 years at the time of surgery. Both genders. MRI finding of a rotator cuff injury involving at least the tendons of the supraspinatus and infraspinatus muscles. MRI finding of fatty infiltration of the supraspinatus and infraspinatus muscles at stage III according to the Goutallier classification modified by Fuchs et al. Unsuccessful non-operative treatment, defined as subjective patient dissatisfaction, even after four months of continuous physical therapy
Exclusion criteria
Exclusion criteria: Intraoperative finding of reparability of the posterosuperior rotator cuff tear. Intraoperative finding of irreparability of any subscapularis tendon injury. Patient who does not return for at least one medical consultation after surgery. Patient who does not follow all stages of post-operative physiotherapy rehabilitation for at least six months after surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome: a minimum increase of 15 points is expected on the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, translated and adapted into Portuguese, when comparing preoperative and postoperative measurements (at 24 months after surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: A minimum increase of 15 points is expected in the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form translated and adapted into Portuguese, between pre- and postoperative measurements (at 6 and 12 months after surgery). Expected outcome 2: A minimum increase of 3 points is expected in the Modified University of California at Los Angeles shoulder rating scale translated and adapted into Portuguese (at 6, 12, and 24 months after surgery). Expected outcome 3: A minimum increase of 8 points is expected in the Constant-Murley score between pre- and postoperative measurements (at 6, 12, and 24 months after surgery). Expected outcome 4: A statistically significant increase is expected in the Activities of Daily Living that Require External Rotation scale between pre- and postoperative measurements (at 6, 12, and 24 months after surgery). Expected outcome 5: A minimum increase of 8 points is expected in the Subjective Shoulder Value scale between pre- and postoperative measurements (at 6, 12, and 24 months after surgery). Expected outcome 6: A minimum increase of 11 degrees is expected in goniometric measurements of active shoulder range of motion, according to the American Academy of Orthopaedic Surgeons standardization. Expected outcome 7: A minimum decrease of 2.4 points is expected in the Visual Analog Scale between pre- and postoperative measurements (at 6, 12, and 24 months after surgery). Expected outcome 8: A statistically significant increase is expected in the acromiohumeral distance: the distance (in millimeters) between the inferior surface of the acromion and the most superior point of the humerus, measured on an anteroposterior corrected standing radiograph, between pre- and postoperative measurements (at 6, 12, and 24 months after surgery). Expected outcome 9: Maintenance of the Hamada scale, determined on an anteroposterior corrected standing shoulder radiograph, between pre- and postoperative measurements (at 6, | — |
Countries
Brazil
Contacts
Public ContactEduardo Malavolta
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed