Actively Recruiting
Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
Led by Wake Forest University Health Sciences · Updated on 2026-03-27
20
Participants Needed
1
Research Sites
421 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, a chest muscle sample (biopsy) will be taken and the muscle fibers will be removed from the sample and made into smaller strands or fragments. During this same procedure, those muscle fiber fragments (MFFs) will then be injected directly into the supraspinatus muscle. Once injected, the MFFs will remain in the supraspinatus where Investigators believe the MFF will become part of the participants' existing muscle and provide increased muscle size and strength, improving function (rotator cuff strength and stability).
CONDITIONS
Official Title
Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females, ages 40 to 80 years
- Unilateral disease
- Tear size less than 1.5 cm
You will not qualify if you...
- Diabetes
- Peripheral neuropathy
- Previous shoulder surgery
- Pain syndrome or cuff arthroplasty
- Major co-morbidities including uncontrolled diabetes, cardiovascular, pulmonary, gastrointestinal, or blood clotting disorders
- Arthritis of the shoulder
- Unwilling or unable to follow post-operative instructions or attend follow-up visits
- Autoimmune disease
- Complete subscapularis tear
- Teres minor involvement
- History of positive tests for HIV, Hepatitis B, Hepatitis C, HTLV-1, or HTLV-2
- Pregnancy
- Implanted devices containing ferromagnetic material
- Implanted electrical stimulation devices such as cochlear implants or defibrillators
- Any other condition deemed unsuitable by the principal investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
M
Mary-Clare Day, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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