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).
Males and females, ages 40 to 80 years
Unilateral Disease
< 1.5cm tear
Diabetes
Peripheral Neuropathy
Previous Shoulder Surgery
Pain Syndrome; cuff arthroplasty
Single group
Muscle Fiber Fragments (MFFs)
Other interventionDuring the rotator cuff repair procedure, a biopsy of muscle will be taken from the pectoralis major and processed under sterile conditions in the operating room to obtain MFFs. The final product, composed of autologous MFFs in suspension, will be delivered via targeted injection into the muscle belly of the supraspinatus through the Naviaser Portal with visual guidance after rotator cuff repair is complete.
Incidence of Adverse Events
The incidence of adverse events will be documented in the areas of product related, biopsy procedure-related, and injection-related reporting for each group.
Incidence of Adverse Events
The incidence of adverse events will be documented in the areas of product related, biopsy procedure-related, and injection-related reporting for each group.
Fat Free Muscle Volume
Fat-free muscle volume (total muscle volume minus % of fatty infiltration).
Goutallier Score via MRI 1.5+ image analysis
Measured by MRI T1 Sagittal image at the Y position. Total score values 0- 4 (Grade 0 =normal muscle; Grade 1 =Muscle that contain some fatty streaks; Grade 2 = Fatty infiltration but more muscle than fat; Grade 3 = Equal amounts of fat and muscle; Grade 4 = More fat than muscle.) Lower values denotes better outcomes.
Constant Score
The constant score, a 0-100 point scale with 100 being Normal and Abnormal Side \>30 Poor, 21-30 Fair, 11-20 Good and \<11 Excellent will measure muscle recovery including strength and level of atrophy. Higher scores denote worse outcome measures.
ASES Shoulder Score
The ASES Shoulder Score (scale with a max of 100 which is normal function with no pain to minimum of 0 which is extreme pain) will measure muscle recovery. Higher scores denote better outcomes.
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