Midterm Analysis of a Randomized Control Trial Comparing Orthobiologic Treatment of Rotator Cuff Tears with Exercise Therapy

TOBI Faculty, Dr. Christopher Centeno, and colleagues recently published a midterm analysis of their randomized control trial of the treatment of rotator cuff tears with bone marrow concentration and platelet products compared to conventional home exercise therapy.  Rotator cuff disorders affect nearly 30-50% of the US population over the age of 50. The rate of success with conservative treatment with exercise therapy and pain management varies widely from 15-85% effectiveness.

Based on a recent meta-analysis of 57 randomized controlled trials, which found no difference between surgery versus conservative management of full-thickness rotator cuff tears, Dr. Centeno and colleagues designed their own study to observe the effectiveness of using bone marrow concentrate and platelet products to treat rotator cuff tears. Contrary to animal models that have demonstrated poor tendon-bone interface regeneration after surgery, bone marrow concentrate contains multipotent stem cells and immune-supportive cells that effectively contribute to tissue healing. The exact mechanism pertinent to the ability of bone marrow concentrate to produce the outcomes demonstrated in this midterm analysis is unclear. Evidence strongly suggests that the mechanism of tissue healing is promoted through paracrine secretion of growth factors and immune-signaling products.

The primary objective of this prospective, randomized controlled, crossover study is to compare patient-reported clinical outcomes for bone marrow concentrate treatment versus exercise therapy. Participants were divided into two groups: BMC treatment group, and an exercise therapy group. However, exercise therapy patients were allowed to crossover into the treatment group after at least 3 months, if improvement was lacking. Primary outcomes are measured with the use of the (DASH) survey, along with a numeric pain scale as a secondary outcome measurement. Furthermore, pre- and posttreatment MRI imaging of the shoulder were presented side-by-side using a computer-based randomization sequence. With the physician blinded to patient and image order, three physicians were consulted to independently compare and identify the image that demonstrated the healthier tendon based on overall appearance. This provided an added layer of objectivity in assessment of study results.

Throughout June 2013 to July 2017, patients with rotator cuff tears were enrolled in this study. The study continues to enroll new participants; but at the time of this midterm analysis, only patients who had completed at least 12 months posttreatment are included in this review. Although data collection is essentially incomplete at the time of this review, Dr. Centeno and colleagues feel it is important to present current data in lieu of an enrollment period that is taking longer than anticipated. Midterm analysis of study results demonstrate encouraging data regarding improvement of pain and function as well as radiographic appearance at the 24-month follow-up after bone marrow concentrate treatment. The treatment group demonstrated significant reductions in pain and increases in function when compared to baseline and when compared to the exercise group at 3 and 6 months, and those improvements continued out to 24-month follow-up.

A Minimal Clinically Important Difference (MCID) was set at a 2-point reduction in the numeric pain scale, and a 10-point reduction on the DASH survey.  Primary outcomes with respect to function showed 61% of the treatment group met MCID criteria at 3 months, and 91% of subjects in the treatment group met MCID criteria by 12 months, and improvements were maintained throughout 24 months of the study.  In contrast, only 40% of subjects in the exercise therapy group met MCID criteria by 3 months. Secondary outcomes with respect to pain reached statistically significant improvements at all post-treatment time points (3m, 6m, 12m, 24m) starting as early as 1 month in the treatment group. The exercise therapy group did not show statistically significant improvements in either pain or function before crossover. Ten out of 11 patients initially randomized to the exercise therapy group crossed over into the treatment group by the 6-month mark. Physician-blinded comparison of pre- and posttreatment MRIs demonstrated a consensus pick of the posttreatment MRI as the healthier tendon. Moreover, the tear size assessment showed a mean decrease of 26% after bone marrow concentrate treatment.

Great work Dr. Centeno and colleagues! We look forward to a complete analysis at the conclusion of this study. Access the midterm review here.

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