Status:
RECRUITING
Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Rotator Cuff
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 f...
Detailed Description
Muscle fiber fragment (MFF) therapy has shown pre-clinical and clinical promise in the treatment of bladder neck insufficiency/incompetent outlet. Fragmentation of muscle fibers derived from autologou...
Eligibility Criteria
Inclusion
- Males and females, ages 40 to 80 years
- Unilateral Disease
- \< 1.5cm tear
Exclusion
- Diabetes
- Peripheral Neuropathy
- Previous Shoulder Surgery
- Pain Syndrome; cuff arthroplasty
- Major co-morbidities including, but not limited to, uncontrolled diabetes, cardiovascular, pulmonary, GI, coagulopathies
- Arthritis of Shoulder
- Unwilling or unable to comply with post-operative instructions or follow-up visits
- Auto Immune Disease
- Complete Subscapularis Tear
- Teres Minor involvement
- History of testing positive for HIV, Hep B, Hep C, HTLV-1, HTLV-2
- Pregnancy
- Implanted devices containing ferromagnetic material
- Any implanted electrical stimulation devices (i.e. cochlear implant, defibrillator)
- Any other condition which the PI feels would be not in the best interest for the patient or the study
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03752034
Start Date
November 4 2019
End Date
December 1 2026
Last Update
December 22 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157