In their introduction, the authors state that "Despite an increase in the number of operations performed and enhanced surgical techniques, unacceptably high rates of failure of up to 94% still occur." They point out that this has driven intense scientific and commercial interest in "biologics" (platelet-rich plasma, stem cells, and biomaterials) as a possible means for enhancing the healing of attempted cuff repairs.
In their review, these authors note that
(1) among the many types of biologic augmentation, there is considerable heterogeneity of the content, quality, and quantity of growth factors used in platelet-rich plasma and bone marrow aspirate concentrate, and conclusions from individual studies may not necessarily be generalizable to other formulations within the group.
(2) current Level-I evidence suggests that universal use of platelet-rich plasma provides no significant clinical benefit in rotator cuff repair.
(3) although some evidence exists for the use of stem cells from bone marrow aspirate concentrate and the use of biologic grafts, results from Level-I studies are lacking and
(3) although some evidence exists for the use of stem cells from bone marrow aspirate concentrate and the use of biologic grafts, results from Level-I studies are lacking and
(4) level-I trials focused on the evaluation of clinical outcomes (i.e. using the Simple Shoulder Test, the American Shoulder and Elbow Surgeons score, the University of California at Los Angeles shoulder score, or the Constant score) should be performed to help to determine the appropriate use of biologic augmentation in rotator cuff surgical procedures.
Comment: As these authors indicate, all of the scientific and commercial interest in biologics needs to be evaluated in terms of well controlled studies showing that clinical outcomes are better for patients receiving biologics in comparison to comparable patients not receiving them. These studies need to be carried out in recognition of the observation that over 10 million individuals are living with cuff tears and at most 4% of them get surgery each year. It is commonly observed that patients with cuff tears can respond to physical therapy. Furthermore, patients are commonly clinically improved after cuff repair surgery whether or not the surgery is successful in restoring the integrity of the cuff. From a clinical standpoint, therefore, biologics are going to need to make a big difference in order to justify their cost.
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