Study Summary
This trial is testing whether adding stem cells to rotator cuff surgery helps the repair better than surgery alone. 100 patients will be followed for at least a year.
Eligible Conditions
- Rotator Cuff Tear
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 1 year
1 year
Magnetic Resonance Imaging (MRI) Scan
Year 1
Functional Outcomes - Shoulder Exam
Patient Centered Outcomes - Shoulder Survey
One year
American Shoulder and Elbow Surgeons (ASES) Score
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Rotator cuff repair with stem cells
1 of 2
Rotator cuff repair without stem cells
1 of 2
Experimental Treatment
Non-Treatment Group
100 Total Participants · 2 Treatment Groups
Primary Treatment: Mesenchymal stem cell augmentation in rotator cuff repair · Has Placebo Group · N/A
Rotator cuff repair with stem cellsExperimental Group · 2 Interventions: Standard arthroscopic rotator cuff repair, Mesenchymal stem cell augmentation in rotator cuff repair · Intervention Types: Procedure, Biological
Rotator cuff repair without stem cells
Procedure
PlaceboComparator Group · 1 Intervention: Standard arthroscopic rotator cuff repair · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
390 Previous Clinical Trials
153,484 Total Patients Enrolled
Nikhil N Verma, MDPrincipal InvestigatorMidwest Orthopaedics at Rush University
2 Previous Clinical Trials
Eligibility Criteria
Age 18 - 70 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- MacDonald, Peter, Sheila McRae, Jeffrey Leiter, Randy Mascarenhas, and Peter Lapner. 2011. “Arthroscopic Rotator Cuff Repair with and Without Acromioplasty in the Treatment of Full-thickness Rotator Cuff Tears”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.k.00488.
- Roy, Jean-Sébastien, Joy C. MacDermid, and Linda J. Woodhouse. 2009. “Measuring Shoulder Function: A Systematic Review of Four Questionnaires”. Arthritis & Rheumatism. Wiley. doi:10.1002/art.24396.
- Tashjian, Robert Z., Julia Deloach, Andrew Green, Christina A. Porucznik, and Amy P. Powell. 2010. “Minimal Clinically Important Differences in ASES and Simple Shoulder Test Scores After Nonoperative Treatment of Rotator Cuff Disease”. The Journal of Bone & Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.h.01296.
- MacDonald, Peter, Sheila McRae, Jeffrey Leiter, Randy Mascarenhas, and Peter Lapner. 2011. “Arthroscopic Rotator Cuff Repair with and Without Acromioplasty in the Treatment of Full-thickness Rotator Cuff Tears”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.k.00488.
- Roy JS, MacDermid JC, Woodhouse LJ. Measuring shoulder function: a systematic review of four questionnaires. Arthritis Rheum. 2009 May 15;61(5):623-32. doi: 10.1002/art.24396.
- 2015. "Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02484950.
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