Partial Thickness Rotator Cuff Tears (PTRCT) are a commonly seen injury in aging and active adult populations. In many instances, PTRCT are treated with orthopedic surgery, which is associated with prolonged recovery timelines, risk of re-injury, surgical failure, and significant out of pocket medical costs. Some projections estimate a 400+ million-dollar cost of rotator cuff reconstructions per year. Other interventions, such as corticosteroid injections administered to the injured tendon, are used to manage pain when surgery is not appropriate. However, this procedure is known to greatly increase the chance of a larger injury and the need for surgical intervention.
ORI exists within the growing field of non-surgical orthopedics, with ORI working to research and provide alternative solutions for patients in pain. We use orthopedic biology (orthobiologics) based injections to repair injured tissues via minimally invasive procedures. Examples of orthobiologics are Platelet Rich Plasma (PRP), bone marrow stem cells, or other cell-based procedures. Our patients go home the same day, have minimal requirements for rest and recovery, and return to activity. As an organization, we design and conduct clinical trials and publish research using orthobiologic procedures to push the field of regenerative medicine forward and advance non-surgical options for patients.
ORI has designed a single-blind randomized controlled trial using Micro-fragmented adipose transfer (MFAT) for repair of rotator cuff tears (PTRCT). MFAT is fat cells taken from a patient’s body, then minimally washed and reshaped for orthopedic use. Our trial is the first to apply MFAT into rotator cuff tears but is supported by hundreds of research publications showing MFAT to have use in an orthopedic setting. The Food and Drug Administration (FDA) has approved this procedure as safe for patients but experimental.
60 patients will be enrolled into the trial over a 24-month period. Each patient will remain active in the trial for 12- months. Patients will undergo a thorough, review board approved questionnaire to determine eligibility. If accepted, a patient will undergo a minimally invasive procedure to harvest fat cells. These cells will be washed, reshaped, and prepared for injection. 40 patients in the trial will receive the experimental MFAT procedure. 20 patients will receive a placebo injection of corticosteroids. All injections will be conducted under ultrasonographic guidance. Patients will be blinded and not know if they received the MFAT or placebo injection until the end of the trial.
All patients in the trial will work with ORI for 12 months (one year). During their participation, a patient will have an MRI taken of their shoulder before they receive their procedure, and then have a repeat MRI conducted 12 months later to determine changes in the rotator cuff tissue. In the 12-month long trial, each patient will complete outcome forms measuring levels of pain and functional limitations from a secure data collection system. Once the 12-month timeline is completed, the patient will finish their enrollment in the trial and will be discharged.
Patients will receive this procedure at no cost to them. MRI studies, the procedure, and visits will be covered by ORI’s funding. Special care will be taken to ensure that underinsured and underserved communities are provided access to the trial including inclusion of vulnerable demographic groups and women. While we do not have requirements for demographic groups, we acknowledge the vital importance of conducting equitable research.
Patients included in the trial will undergo a robust screening process to ensure eligibility. Please contact our research team for a full assessment of all screening components. The basic inclusion criteria includes but is not limited to age of 18 >, diagnosis of rotator cuff tear, acceptable pain and function score ranges, prior history of failed conservative care and therapy, ability to speak and understand English. The basic exclusion criteria includes but is not limited to having a complete rotator cuff rupture, autoimmune disease, severe obesity, undergoing injection or surgical procedure within the past three months, infection, having poor pain and functional score ranges, allergy to procedure materials, history of cancer or chemotherapy in the shoulder, pregnancy or breast-feeding, incarceration status, or other medical conditions which the physician may determine as a contraindication.
Patients included in the trial will undergo a robust screening process to ensure eligibility. Please contact our research team for a full assessment of all screening components. The basic inclusion criteria includes but is not limited to age of 18 >, diagnosis of rotator cuff tear, acceptable pain and function score ranges, prior history of failed conservative care and therapy, ability to speak and understand English. The basic exclusion criteria includes but is not limited to having a complete rotator cuff rupture, autoimmune disease, severe obesity, undergoing injection or surgical procedure within the past three months, infection, having poor pain and functional score ranges, allergy to procedure materials, history of cancer or chemotherapy in the shoulder, pregnancy or breast-feeding, incarceration status, or other medical conditions which the physician may determine as a contraindication.
Inclusion Criteria
1. Age ≥ 18 years old at the date of screening.
2. Have both clinical and radiographic (MRI) findings consistent with partial thickness rotator cuff tear
a. Participant has clinical findings including (but not limited to) tenderness to palpation, swelling/effusion, stiffness, loss of strength based on functional assessment, chronic limited range of motion.
3. Participant has a diagnosis of grade 2-3 rotator cuff tear, per discretion of radiologist and/or Principal Investigator, defined using the Neer grading system.
4. Ability speak, read, and understand English language.
5. Index Shoulder Visual Analog Scale (VAS) pain score greater than 2 and/or a Quick Disabilities of the Arm, Hand, & Shoulder (DASH) score of less than or 80.
6. Prior history of failed physical therapy (30 days or longer) for the affected shoulder. 7. Prior history of failed oral pain medications for the affected shoulder (30 days or longer).
Exclusion Criteria
1. Diagnosis of retracted rupture of rotator cuff tendon tear per the evaluation and report produced by the independent radiologist.
2. BMI greater than 35 kg/m2.
3. Diagnosis of rheumatoid arthritis, psoriatic arthritis, or any other disorder which attributes to the primary source of their shoulder/arm pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tumor, cancer.
4. Presence of any clinically observed active infection including in the index shoulder joint, infection at the site of adipose tissue harvest, and/or any active systemic or local infection. 5. Undergone injection in target shoulder within 3 months prior to screening visit, including but not limited to corticosteroids, hyaluronic acid (HA), bone marrow concentrate (BMAC) platelet rich plasma (PRP), human cellular exosomes, amniotic fluid, or any human birth tissue. 6. Undergone surgical procedures of index shoulder within 6 months prior to the screening visit. 7. Index Shoulder Visual Analog Scale (VAS) pain score less than or equal to 2 and/or a Quick Disabilities of the Arm, Hand, & Shoulder (DASH) score of greater than or equal to 80. 8. Index shoulder consisting of a Type III acromion.
9. Shoulder pain associated with osteochondritis dissecans, ligament damage or displaced Grade 2 or greater Superior Labrum Anterior to Posterior (SLAP) tear.
10. Current or historical autoimmune disease that requires immunosuppressive medication. 11. Any disorder affecting musculoskeletal pain and/or function, including symptomatic OA of the neck or cervical spondylosis that would interfere with the evaluation of the treated shoulder. 12. Planned or expected surgery within the next 12 months.
13. Allergy to lidocaine, epinephrine, or valium.
14. Diagnosis of HIV or viral hepatitis.
15. Use of oral systemic corticosteroids within the last 90 days and for the duration of the study. 16. History of any chemotherapy or radiation therapy of the targeted/treatment shoulder or adipose harvest site.
17. Active worker’s compensation case.
18. Diagnosis of coagulation disorders (e.g., Von Willebrand’s disease) and/or currently on anti coagulant therapy.
19. Occurrence of shoulder trauma to the index shoulder within six months prior to screening.
Protocol Number: MSC-MFA-001 Approval Date: December 4, 2024 Approval Number: IRCM-2024-420 Continuing Review Date: December 10, 2025
20. Unwilling or unable to stop usage of over-the-counter pain medication (e.g., Acetaminophen or NSAID), “Rescue Analgesics”, for 7 days prior to any follow-up visit, with the exception of one “baby aspirin” per day for cardiovascular therapy or prophylaxis.
21. Unwilling or unable to stop taking prescription pain or prescription anti-inflammatory medication for the duration of the study, with the exception of Tramadol during the immediate post-procedure period noted below.
22. Unwilling or unable to abstain from NSAIDS for 7 days pre-injection and 2 weeks post-injection. Tramadol is allowed during the 72 hours immediately post-injection, with diary documentation of usage.
23. Currently taking prescription pain medication for a condition other than the index shoulder. 24. Currently in prison.
25. Untreated symptomatic injury of the index shoulder (e.g, Grade 2 or greater SLAP tear, loose body, or Osteochondral defect of the glenoid cavity characterized by mechanical issue such as locking or catching).
26. Impossibility to harvest enough adipose tissue.
27. Any medical issue that the clinician feels would be a contraindication to the study treatment including, but not limited to: a. Uncontrolled diabetes defined as HbA1c >7%, b. History of uncontrolled hypertension defined by average systolic BP >140 mmHg or diastolic BP > 90 mmHg on ≥ 3 blood pressure medications, c. History of cardiovascular disease, d. History of cerebrovascular disease, e. Uncontrolled asthma, defined as symptomatic (i.e., shortness of breath and/or wheezing) despite therapy, f. History of solid organ or hematologic transplantation, g. Diagnosis of non-basal cell malignancy within preceding 5 years h. Change in prescription medication within 1 month prior to enrollment, i. Clinically significant abnormalities in vital signs at the time of screening defined by Systolic BP >140 or 90 or 99 °F 28. History of septic arthritis of the glenohumeral joint in the affected shoulder within 6 months prior to screening, infection requiring antibiotic treatment within the preceding 3 months or history of bacteremia.
29. Women who are breastfeeding.
30. Unwilling or unable to use hormonal contraception for 3 months post procedure unless postmenopausal (for at least 2 years) or are medically unable to conceive (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) to avoid potential teratogenicity.
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