Using muscle fiber fragments to enhance rotator cuff recovery
Safety of Autologous Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
NA · Wake Forest University Health Sciences · NCT03752034
This study is testing whether injecting muscle fiber fragments from the chest into the shoulder can help people recover better and regain strength after rotator cuff surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT03752034 on ClinicalTrials.gov |
What this trial studies
This study involves taking a biopsy of chest muscle to extract muscle fiber fragments, which are then injected into the supraspinatus muscle following rotator cuff repair. The hypothesis is that these fragments will integrate into the existing muscle tissue, potentially increasing muscle size and strength, thereby improving rotator cuff function. The approach aims to provide a less invasive alternative to traditional surgical therapies, with the goal of enhancing recovery and restoring muscle function more effectively.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 40 to 80 with a unilateral rotator cuff tear less than 1.5 cm.
Not a fit: Patients with diabetes, previous shoulder surgery, or major comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients undergoing rotator cuff repair.
How similar studies have performed: While muscle fiber fragment therapy has shown promise in other conditions, this specific application for rotator cuff repair is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Gary G Poehling, MD — Wake Forest University Health Sciences
- Study coordinator: Mary-Clare Day, RN
- Email: mday@wakehealth.edu
- Phone: 336-713-1343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff, Muscle Fiber Fragments, Rotator Cuff Musculature, Rotator Cuff Repair