Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT03752034

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

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females, ages 40 to 80 years
  • Unilateral disease
  • Tear size less than 1.5 cm
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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