Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears
NCT ID: NCT01788683
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2013-02-28
2022-07-28
Brief Summary
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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.
Detailed Description
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Subjects will have a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes as evidenced with positive diagnostic imaging such as arthrogram, ultrasound and/or MR.
Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of exercise therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.
The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint. At that point, subjects enrolled in the Exercise Therapy group will be given the option of crossing over to the Regenexx SD treatment groups. Subjects will continue to be followed through the 2 year endpoint with data analysis performed at the 1 year and 2 year time points.
Subjects will complete the study following the 2 year follow-up visit.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Regenexx SD
Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged tendon.
Regenexx SD
stem cell treatment
Exercise Therapy
Subjects will be instructed in a set of appropriate rotator cuff strengthening exercises and given an instructional hand-out to take home.
Exercise Therapy
exercise therapy control
Interventions
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Regenexx SD
stem cell treatment
Exercise Therapy
exercise therapy control
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Regenexx, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Centeno, MD
Role: PRINCIPAL_INVESTIGATOR
Centeno-Schultz Clinic
Locations
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Centeno-Schultz Clinic
Broomfield, Colorado, United States
Countries
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References
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Centeno CJ, Fausel Z, Dodson E, Berger DR, Steinmetz NJ. Percutaneous bone marrow concentrate and platelet products versus exercise therapy for the treatment of rotator cuff tears: a randomized controlled, crossover trial with 2-year follow-up. BMC Musculoskelet Disord. 2024 May 18;25(1):392. doi: 10.1186/s12891-024-07519-6.
Centeno C, Fausel Z, Stemper I, Azuike U, Dodson E. A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis. Stem Cells Int. 2020 Jan 30;2020:5962354. doi: 10.1155/2020/5962354. eCollection 2020.
Other Identifiers
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RSI2012-RCT01
Identifier Type: -
Identifier Source: org_study_id