NCT06361797

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
OTHER	Rotator cuff repair augmented with whole bone marrow	Bone marrow derived from the proximal humerus will be aspirated during the rotator cuff repair. At the end of the procedure, the aspirate will be injected back into the joint space.
OTHER	Rotator cuff repair augmented with concentrated bone marrow	Bone marrow derived from the proximal humerus will be aspirated during the rotator cuff repair. This volume will be concentrated and, at the end of the procedure, the concentrate will be injected back into the joint space.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-07-01
• Completion: 2027-12-01
• First posted: 2024-04-12
• Last updated: 2024-11-29

Locations

2 sites across 1 country: United States