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Varying Bone Marrow-Derived Mesenchymal Stem Cells Concentrations' Impact on Rotator Cuff Repair Outcomes

Rotator Cuff Tears Clinical Trial

Official title:
Varying Bone Marrow-Derived Mesenchymal Stem Cell Concentrations' Impact on Rotator Cuff Repair Outcomes

Clinical Trial Summary

Randomized controlled trial comparing benefits of varying amounts of proximal humerus-derived bone marrow aspirate and bone marrow concentrate in rotator cuff repair.

Clinical Trial Description

Randomized controlled trial comparing benefits of proximal humerus-derived bone marrow aspirate and bone marrow concentrate in rotator cuff repair. The participants will be randomized intraoperatively after confirmation of inclusion criteria. The participants will be followed-up at 2 weeks, 1 month, 3 months, 6 months, 12 months and 24 months post-operatively. Primary outcome is re-tear of the rotator cuff demonstrated by 6-month post-operative MRI. Additional outcomes include American Shoulder and Elbow Surgeons questionnaire (ASES), Visual Analogue Scale (VAS), Subjective Shoulder Value (SSV), and Comprehensive Shoulder Assessment (CSA). The investigators will also assess the rate of revision surgery and required oral and intra-articular corticosteroids in each study arm. A sample of bone marrow obtained intraoperatively will be analyzed to identify osteogenic progenitor cells. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06361797
Study type Interventional
Source Johns Hopkins University
Contact Uma Srikumaran, MD, MBA, MPH
Phone 443-546-1550
Email us@jhmi.edu
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date December 2027
View Details
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