Summary:
Nearly 1 in 40 of the population seeks medical advice related to a shoulder problem every year, with a majority of these visits for rotator cuff pathology. The rotator cuff muscles provide stability to the shoulder glenohumeral joint and can be torn by trauma or can tear through age related degeneration. Surgical repair is often used for these tears, but recent research has suggested less than complete efficacy, especially in larger tears. Despite historical wide spread use of surgery to repair partial thickness rotator cuff tears, the status of the evidence supporting this practice is poor and there is no widespread consensus on when surgical intervention is the best option. As a result, some practitioners have begun to wonder if injection therapy using biologics may be a robust non-surgical option to aid healing.
Animal studies have shown promise for the augmentation of tendon healing via biologics such as platelet rich plasma (PRP). Bone marrow derived mesenchymal stem cells (MSCs) also show promise to augment tendon repair based on the results from animal studies. To date, there has been sparse clinical data on the use of MSCs to augment tendon healing in patients.
This is a prospective, randomized, controlled study to include 25 subjects treated with Regenexx SD and 25 subjects treated with Exercise Therapy alone. The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx SD vs. Exercise Therapy treatment of non-retracted supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months.
Injection Procedures: 60 cc of autologous bone marrow aspirate from 6 sites at the PSIS are drawn using sterile technique into heparinized syringes. The patient also provides two-100 cc whole blood samples which are processed to produce platelet rich plasma (PRP) and platelet lysate (PL). The whole marrow is centrifuged to isolate the buffy coat (the fraction that contains the mesenchymal stem cells), which is extracted and placed in a syringe. The buffy coat is mixed with the PRP and PL and activated using human thrombin and calcium until a gel is observed. This is then injected under imaging guidance (using ultrasound) into the area of the supraspinatus tendon tear.
Study subjects will be evaluated post-operatively at the clinical site at 1 month and 3, 6, 12, & 24 months. The evaluation will include a clinic visit and the completion of subject-reported outcomes surveys. Patients randomized to the Exercise Therapy alone group will undergo a home exercise therapy regimen consisting of rotator cuff strengthening and shoulder range of motion exercises. Patients in the control, exercise therapy arm, will have the opportunity to cross-over to the study treatment arm at the 3 month visit and then continue to be followed through 24 months.
Inclusion Criteria: - Candidates must meet ALL of the following:
- Voluntary signature of the IRB approved Informed Consent
- Skeletally mature Male or Female ages 18 to 65
- Unremitting pain in the affected shoulder having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy or a corticosteroid injection) for at least 3 months
- Significant functional disability related to pain, lack of strength, or other shoulder symptoms
- Physical examination consistent with Rotator Cuff tear
- Positive diagnostic imaging, which may include arthrogram, ultrasound and/or MR, on the affected shoulder indicating a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes
- Reasonable movement of the non-treated arm, defined as a shoulder elevation of equal or more than 90°, and able to perform (post-injection) exercises
- Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Exclusion Criteria:- Candidates will be excluded if they meet ANY of the following:
- A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
- Previous surgery to the affected shoulder
- Prior rotator cuff prolotherapy, PRP or other RC injection-based therapies within the past three months
- Concomitant tears of multiple rotator cuff or biceps tendons
- Grade 2 or greater SLAP tear
- Type 3 acromion
- Significant bone spur in subacromial space
- Inflammatory or auto-immune based joint diseases or other upper extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
- Quinolone or Statin induced myopathy/ tendinopathy
- Kellgren-Lawrence grade 2 or greater glenohumeral osteoarthritis
- Adhesive capsulitis (mild or severe)
- Symptomatic cervical spine pathology (e.g. radicular cervical pain)
- Severe neurogenic inflammation of the cutaneous nerves about the shoulder
- Shoulder instability requiring surgical stabilization
- Contraindications for MRI
- Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
- Condition represents a worker's compensation case
- Currently involved in a health-related litigation procedure
- Is pregnant
- Bleeding disorders
- Currently taking anticoagulant or immunosuppressive medication
- Allergy or intolerance to study medication
- Use of chronic opioid
- Documented history of drug abuse within six months of treatment
- Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment.