Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears
Completed · Not applicable
Conditions studied: Rotator Cuff Tear
In brief
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months. Secondary objectives include evaluation of US evidence of tendon repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
Key facts
- Study ID
- NCT01788683
- Run by
- Regenexx, LLC
- People needed
- 51
- Starts
- 2013-02-01
- Expected to finish
- 2022-07-28
- Last updated by the study team
- 2022-12-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Physical examination consistent with Rotator Cuff tear
- Unremitting pain in the affected shoulder for at least 3 months
- Significant functional disability related to pain, lack of strength, or other shoulder symptoms
- 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
You may not qualify if…
- 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
- Concomitant tears of 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
- Use of chronic opioid
Where it is running
- Centeno-Schultz Clinic — Broomfield, Colorado, United States
Full record on ClinicalTrials.gov
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