Status:
SUSPENDED
Mesenchymal Stem Cells in Rotator Cuff Repair
Lead Sponsor:
University of Sao Paulo
Conditions:
Rotator Cuff Tear
Tendon Injuries
Eligibility:
All Genders
35+ years
Phase:
PHASE2
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 outcom...
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03362424
Start Date
November 1 2020
End Date
December 1 2023
Last Update
October 19 2022
Active Locations (1)
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1
Universidade de São Paulo
São Paulo, São Paulo, Brazil, 05403-010