Abstract
Objectives:
Orthobiologic therapies have recently gained popularity in orthopaedic surgery as potential treatment options that can be used to manage the symptoms of musculoskeletal conditions. However, the market for these products remains unregulated by the Food and Drug Administration (FDA), giving rise to a wide range of available yet untested products. There are growing concerns related to patient safety and product efficacy, but also in regard to the amount of money being charged by providers for these treatments Thus, the purpose of this study was to investigate the current market for orthobiologic injections for knee osteoarthritis in a large, metropolitan city and determine 1) the willingness of providers to disclose the cost of an injection prior to an appointment; 2) the cost of injections if disclosed; 3) the cellular source of injections being advertised as “stem cell” products; and 4) whether there are differences in the market for orthobiologics within and outside of orthopaedic sports medicine practices.
Methods:
Orthopaedic sports medicine providers in the Chicagoland area were identified through the American Orthopaedic Society for Sports Medicine (AOSSM) and Arthroscopy Association of North America (AANA) registries of sports medicine physicians seeing patients in at least one location within the Chicagoland area. Non orthopaedic clinics (including chiropractors, pain management physicians, and self-advertised “regenerative medicine” clinics) offering orthobiologic injections were compiled using Yelp! and Google search for listings and reviews containing the following key words: “PRP” or “platelet-rich plasma” or “platelet rich plasma,” “SCT” or “stem cells” or “amniotic tissue injections” or “adipose stem cell injections,” and “BMAC” or “bone marrow aspirate concentrate.” A single author [BLINDED] contacted every clinic via a common telephone script, which was modified from an existing study. Data was collected for each site on the types of injections offered, whether price was disclosed over the phone, the price of injections offered, and the source of alternative “stem cell” injections if they were provided. Prices were explicitly specified as being for one injection of one joint.
Results:
A total of 25 orthopaedic sports medicine practices (comprising 80 AOSSM/AANA surgeons) and 40 non orthopaedic clinics offered at least one of either PRP, “stem cell,” and/or BMAC injections over the phone (Table 1). There was no difference in the likelihood of providing PRP injections (p = 0.698) or BMAC injections (p = 0.340). However, non orthopaedic clinics were significantly more likely to offer “stem cell” injections (p < 0.001). There was no difference in the willingness to disclose the price of PRP without an appointment (p = 0.269), willingness to disclose the price of “stem cell” injections (p = 0.302), willingness to disclose price of BMAC (p = 0.528), or willingness to disclose the source of what each clinic advertised as “stem cell” injections (p = 0.302). While the average price of a BMAC injection was not different between provider types (p = 0.238), the average price of a single PRP injection was significantly higher (p = 0.011) and significantly more variable (F statistic = 0.139; p < 0.001) at non orthopaedic clinics (Figure 1). Similarly, the average price of a single “stem cell” injection was significantly higher (p < 0.001) and significantly more variable (F statistic = 0.080; p = 0.025) at non orthopaedic clinics. Most commonly, alternative “stem cell” products included amniotic-based injections, which are currently discouraged for distribution or use based upon the most recent FDA guidance document.
Conclusions:
When compared to orthopaedic sports medicine providers, non orthopaedic clinics providing orthobiologic treatments in the Chicagoland area are more likely to offer alternative “stem cell” injections and charge a significantly greater and more variable amount per PRP and “stem cell” injection. Unfortunately, there was liberal use of the terms “regenerative medicine” and “stem cell” therapies in the face of increased scrutiny related to the FDA’s current position on cell-based therapies. Future studies should examine these trends on a national scale to assess compliance with FDA regulations on orthobiologics, as well as establish standards of price for these treatments.
