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Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair

RecruitingNAAges 40 Years - 80 YearsAllWake Forest University Health Sciences
NCT03752034 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Males and females, ages 40 to 80 years * Unilateral Disease * \< 1.5cm tear Exclusion Criteria: * 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
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What it tests

  • Muscle Fiber Fragments (MFFs)
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Where

1 site
Wake Forest University Health Sciences
Winston-Salem, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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