Mesenchymal Stem Cell, Rotator Cuff Tear, Tendon Injuries
Conditions
Brief summary
Randomized clinical study involving 44 patients, evaluating the effect of mesenchymal cells on rotator cuff repair. The primary outcome will be post-operative MRI tendon integrity and secondary outcomes clinical assessment by the UCLA and American Shoulder and Elbow Surgeons (ASES) scales and pain by visual analog scale (VAS).
Detailed description
Rotator cuff tendinopathy is the main cause of shoulder pain and tear of these tendons affects 20% of the population. Although arthroscopic repair leads to satisfactory clinical results, the retear rates varies from 4 to 94%. The main cause of failure after rotator cuff repair is not related to the material used, but to the tissue deficiency and the healing process between the tendon and the bone. After the intervention, the rotator cuff does not restore its original histological characteristics and its fixation occurs through scar tissue with lower biomechanical resistance. There are few clinical studies on the use of mesenchymal cells in rotator cuff repair,, with good results. The investigators will perform a randomized clinical study involving 44 patients, evaluating the effect of mesenchymal cells on rotator cuff repair. The primary outcome will be post-operative MRI tendon integrity and secondary outcomes clinical assessment by the UCLA and American Shoulder and Elbow Surgeons (ASES) scales and pain by visual analog scale (VAS).
Interventions
BIOLOGICALMesenchymal stem cell
Mesenchymal stem cells applies at the end of rotator cuff repair in de active group
PROCEDURERotator cuff repair
Rotator cuff repair
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Surgeon and patients not blinded
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Full thickness posterosuperior rotator cuff tear, of small or medium size, fully repairable at the time of surgery, regardless of size; * Pain and / or decreased shoulder function for at least 3 months, with no improvement with non-surgical treatment; * Absence of the following changes in MRI: * Fat degeneration of the rotator cuff musculature of grade 3 according to the classification of Fuchs (presence of equal or superior amount of fat compared to muscle fibers); * Absence of the following changes in radiographs * Advanced glenohumeral arthrosis (grades 2, 3 and 4 of Samilson and Prieto * Signs of rotator cuff arthropathy, according to Seebauer classification; * Skeletal maturity; * Absence of surgeries or previous fractures in the shoulder in question; * Absence of psychiatric illnesses, fibromyalgia or painful pathologies of the cervical spine; * Absence of rheumatic diseases or chronic use of corticosteroids; * Absence of active or recent infection; * Absence of thrombocytopenia, coagulopathies or chronic use of anticoagulants; * Absence of vascular or neurological lesions affecting the upper limb; * Absence of pregnancy; * Clinical non-compensated comorbidities; * Chronic use of corticosteroids; * Consent to free and informed consent; * Live in Brazil.
Exclusion criteria
* Visualization during the operative event of one or more of the findings: * Irreparable rupture of rotator cuff; * Subsecapularis tear involving two thirds or more of its extension; * Need to open surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI integrity | 6 months | Sugaya classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) | 6, 12 and 24-months | minimum 0 points, maximum 100 points. Higher values are considered best outcomes. |
| University at California at Los Angeles Shouder Rating Scale (UCLA) | 6, 12 and 24-months | minimum 3 points, maximum 35 points. Higher values are considered best outcomes. |
| Visual Analog Scale for Pain (VAS) | 6, 12 and 24-months | miminum 0 points, maximum 10 points. Higher values are considered worst outcomes. |
Countries
Brazil
Outcome results
None listed