Rotator Cuff Tear, Muscle Atrophy, Tendon Tear
Conditions
Brief summary
Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.
Interventions
DEVICERinger's solution
Ringer's solution
DEVICEAutologous Stomal Vascular Fraction Material
Autologous Stomal Vascular Fraction Material Prepared from the Tissue Genesis® Icellator Cell Isolation System™
Sponsors
Orthopedic Research and Education Foundation
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and females * Age 45-65 years old at the time of enrollment * Full-thickness supraspinatus tendon tear with endon retraction ≤ 3 cm * Magnetic resonance imaging Goutallier score ≤ grade 2 * Completed at least 6 weeks of standard physical therapy but continue to have pain and limited function (failed physical therapy) * Sufficient subcutaneous abdominal adipose tissue to allow the recovery of 60-120cc of lipoaspirate * Must pass standard of care blood work screening
Exclusion criteria
* Any tears of any cuff tendon other than the supraspinatus * Magnetic resonance imaging Goutallier scores ≥ 3 * Frank signs of glenohumeral osteoarthritis on magnetic resonance imaging * A history of previous rotator cuff repair * A history of upper extremity fracture or other moderate to severe upper extremity trauma * A BMI \< 20 or \> 35 * Pregnant or breast feeding * Premenopausal women who are not using contraception * Previous abdominal liposuction or any major open abdominal surgery * Type I or type II diabetes, or glycated hemoglobin (hemoglobin A1C) values \> 6.5 or other metabolic disorders * Hypercholesterolemia (total cholesterol ≥240mg/dL) * History of cancer * Autoimmune disorder or HIV+ status * Use of nicotine products * Have any other history of major medical illness, disease or other relevant orthopaedic disability * Who do not speak English * Liodcaine allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in scapular plane abduction strength from baseline, and additional isometric, isokinetic strength measurements to assess supraspinatus function. | 2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Change in Penn Shoulder score, ASES score and Short Form Global Health scale (PROMIS-SF) from baseline (range 0 minimum to 30 maximum) | 2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery |
| Change in supraspinatus muscle stiffness from baseline, measured by ultrasound shear wave elastrography | 1 month prior to surgery, 6 months after surgery, 24 months after surgery |
| Change in fatty infiltration from baseline, measured by magnetic resonance imaging | 1 month prior to surgery, 6 months after surgery, 24 months after surgery |
Countries
United States
Outcome results
None listed