Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361797
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-08
Brief Title:
Varying Bone Marrow-Derived Mesenchymal Stem Cells Concentrations Impact on Rotator Cuff Repair Outcomes
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Varying Bone Marrow-Derived Mesenchymal Stem Cell Concentrations Impact on Rotator Cuff Repair Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None