Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears (NCT01788683) | Clinical Trial Compass
CompletedNot Applicable
Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears
United States51 participantsStarted 2013-02
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 p…