Rotator Cuff Tear Clinical Trial
Official title:
Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study
Verified date | October 2022 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Suspended |
Enrollment | 44 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade de São Paulo | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI integrity | Sugaya classification | 6 months | |
Secondary | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) | minimum 0 points, maximum 100 points. Higher values are considered best outcomes. | 6, 12 and 24-months | |
Secondary | University at California at Los Angeles Shouder Rating Scale (UCLA) | minimum 3 points, maximum 35 points. Higher values are considered best outcomes. | 6, 12 and 24-months | |
Secondary | Visual Analog Scale for Pain (VAS) | miminum 0 points, maximum 10 points. Higher values are considered worst outcomes. | 6, 12 and 24-months |
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