Shapiro, Shane

Background: Platelet-rich plasma (PRP) is an emerging therapy that demonstrates potential benefits for knee osteoarthritis (OA); however, the accessibility of PRP remains limited, in part, because its use is not covered by insurance. Purpose: To identify factors contributing to health disparities in PRP treatment for knee OA using machine learning models. Study Design: Cross-sectional study; Level of evidence, 3. Methods: The authors collected data from electronic medical records at 2 upper Midwest medical centers (Mayo Clinic and Detroit Medical Center) from 2022 to 2023 encompassing demographic, socioeconomic, and clinical factors. Data collection encompassed age, sex, race, ethnicity, area deprivation index, marital status, income, rurality, insurance, employment, language, religion, treatment site, and region. Logistic regression and random forest models were applied to 3667 samples (80% training, 20% testing), comparing PRP recipients against a standard care group. Models were evaluated using 10-fold cross-validation to ensure robust performance assessment. Results: Logistic regression revealed that increased age, widowed status, lower income, rural residence, unemployment/disability, and Medicaid/Medicare insurance were associated with lower odds of receiving PRP. Upper-middle income, contracted insurance, and treatment at the Mayo-Arizona and Mayo-Florida sites were associated with higher odds. The model achieved areas under the curve of 0.83 (training set) and 0.82 (testing set). Random forest analysis identified distance to care, age, area deprivation index, income, and treatment site as top predictors, with areas under the curve of 0.92 (training) and 0.87 (testing). Conclusion: The current study demonstrated that both models discerned key barriers (income, distance to care, retirement status) and facilitators (regional differences) affecting PRP accessibility. These findings provide potential policy initiatives aimed at improving PRP access for underserved demographics, offering a quantitative blueprint to foster equitable access to regenerative therapies for knee OA.

Background Current literature has shown benefit of radial pressure wave (RPW) and focused shockwave (FSW) for management of proximal hamstring tendinopathy (PHT), although there remains a lack of consensus on treatment parameters and optimal patient positioning. Purpose The purpose of this narrative review and clinical commentary is to report what has been described for patient positioning during treatment of PHT with RPW or FSW and propose an alternative side lying approach. Methods A search was conducted of MEDLINE/PubMed and EMBASE electronic databases for studies published from January 2005 to January 2026. Key search terms included proximal hamstring tendinopathy, shockwave therapy, extracorporeal shockwave treatment, radial pressure wave, hamstring tendinosis, hamstring tendinitis, and hamstring pain. Studies were included if they evaluated RPW or FSW for the treatment of PHT. Results Six manuscripts were identified for inclusion, two randomized controlled trials (RCT), two retrospective reviews, and two case reports; a total of 217 patients (145 female, 72 male) with PHT were treated with RPW and/or FSW. One RCT provided an in-depth description of patient positioning during shockwave treatment with the patient supine, with the hip and knee flexed, compared to other manuscripts detailing clinical focusing techniques only. One case report involving a para swimmer included a figure of treatment with the patient in a prone position. Improvement in patient reported outcomes with RPW and/or FSW was noted, with one RCT showing no differences between physiotherapy compared to RPW and FSW treatment. Conclusion RPW and FSW have some evidence regarding their benefits for treatment of PHT but controlled studies are limited and no consensus on treatment protocols or patient positioning during treatment have been determined. The authors’ preferred approach in treating PHT involves having the patient side lying with the hip and knee flexed to allow patient and clinician comfort while also creating compression of the proximal hamstring about the ischial tuberosity. It remains unclear how variance in patient positioning affects patient-reported outcomes. Future studies using RPW and FSW should include documentation of patient positioning when evaluating RPW and FSW efficacy. Level of Evidence 5

Biologic augmentation, using substances like bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP), shows promise for improving outcomes in foot and ankle surgery, particularly in high-risk patients. Historically, autologous bone graft is the benchmark due to its trifecta of osteogenic, osteoinductive, and osteoconductive properties, despite its associated donor site morbidity. Current evidence supporting orthobiologics remains fragmented and inconclusive, with a lack of high-level randomized controlled trials (RCTs). BMAC shows fusion rates comparable to autograft in some foot and ankle applications, but PRP evidence is often conflicting due to a lack of preparation standardization. The regulatory environment is complex. The Food and Drug Administration (FDA) oversees human cells and tissues (HCT/Ps) through a tiered system: high-risk §351 products (eg, cultured stem cells) require rigorous premarket approval, whereas §361 products (eg, allograft bone) have minimal oversight. BMAC and PRP often bypass this through the Same Surgical Procedure Exemption or are regulated through their processing devices, meaning the biologics themselves are not FDA-approved therapeutics. This regulatory gap and direct-to-consumer marketing necessitate meticulous informed consent, transparently discussing the lack of specific FDA approval, limited evidence, and high out-of-pocket costs. Future success depends on standardized, prospective RCTs and a collaborative “middle-ground pathway” for regulatory approval.

Purpose To establish consensus statements via a modified Delphi process about ethics, transparency, regulation, and best practices for the use of orthobiologics in clinical practice for musculoskeletal pathology. Methods A consensus process on the regulation of orthobiologics at the provider level was conducted using a modified Delphi technique. Twenty orthopaedic surgeons, sports medicine physicians, or basic scientists participated. Each participant was a Biologic Association member organization representative and asked to participate because of their active interest in the field of orthobiologics. Levels of consensus were delineated according to the number of votes for each statement: no consensus, <80%; consensus, 80% to 89%; strong consensus, 90% to 99%; unanimous, 100%. Results The 26 consensus statements on orthobiologics resulted in 14 achieving unanimous consensus, 8 achieving strong consensus, 3 achieving consensus, and 1 did not achieve consensus. Overall, 85% of the statements reached either a unanimous or strong consensus. Of the statements regarding communication and transparency, 9 reached unanimous consensus, including information to convey and helpful tools to describe current orthobiologics, persistent misinformation, use of the word “stem cells,” “off‐label” use, and problems with the present regulatory environment. Five statements discussing the regulation of novel orthobiologics achieved unanimous consensus. These statements highlighted research regulation, safety, and suggested improvements to regulatory issues. The statement that did not achieve any consensus was on the regulatory processes that should be in place by an institution providing novel orthobiologic treatments. No statement reached a unanimous agreement on cost or ethical considerations. Conclusions This study successfully identified key consensus statements emphasizing the importance of ethics, transparency, and regulation in the use of orthobiologics, with 85% of statements reaching unanimous or strong consensus. These findings underscore the need for standardized communication, improved regulatory frameworks, and enhanced safety measures while highlighting persistent challenges in addressing cost and ethical considerations. Level of Evidence Level V, expert opinion.

Purpose To establish consensus statements on platelet‐rich plasma (PRP) for the treatment of musculoskeletal pathologies. Methods A consensus process on the treatment of PRP using a modified Delphi technique was conducted. Thirty‐five orthopaedic surgeons and sports medicine physicians participated in these consensus statements on PRP. The participants were composed of representatives of the Biologic Association, representing 9 international orthopaedic and musculoskeletal professional societies invited due to their active interest in the study of orthobiologics. Consensus was defined as achieving 80% to 89% agreement, strong consensus was defined as 90% to 99% agreement, and unanimous consensus was indicated by 100% agreement with a proposed statement. Results There was consensus on 62% of statements about PRP. Conclusions (1) PRP should be classified based on platelet count, leukocyte count, red blood count, activation method, and pure‐plasma versus fibrin matrix; (2) PRP characteristics for reporting in research studies are platelet count, leukocyte count, neutrophil count, red blood cell count, total volume, the volume of injection, delivery method, and the number of injections; (3) the prognostic factors for those undergoing PRP injections are age, body mass index, severity/grade of pathology, chronicity of pathology, prior injections and response, primary diagnosis (primary vs postsurgery vs post‐trauma vs psoriatic), comorbidities, and smoking; (4) regarding age and body mass index, there is no minimum or maximum, but clinical judgment should be used at extremes of either; (5) the ideal dose of PRP is undetermined; and (6) the minimal volume required is unclear and may depend on the pathology. Level of Evidence Level V, expert opinion.

Abstract: Many sports medicine physicians are currently considering introducing regenerative medicine into their practice. Regenerative medicine and the subclassification of orthobiologics are a complicated topic and have produced widely varying opinions. Although there is concern by government regulators, clinicians, scientists, patient advocacy organizations, and the media regarding the use of regenerative medicine products, there is also excitement about the potential benefits with growing evidence that certain regenerative medicine products are safe and potentially efficacious in treating musculoskeletal conditions. Sports medicine physicians would benefit from decision-making guidance about whether to introduce orthobiologics into their practice and how to do it responsibly. The purpose of this position statement is to provide sports medicine physicians with information regarding regenerative medicine terminology, a brief review of basic science and clinical studies within the subclassification of orthobiologics, regulatory considerations, and best practices for introducing regenerative medicine into clinical practice. This information will help sports medicine physicians make informed and responsible decisions about the role of regenerative medicine and orthobiologics in their practice.

» The glenohumeral (GH) joint ranks third on the list of the large joints that are most commonly affected by osteoarthritis, after the knee and the hip. » General nonsurgical modalities, including changes in daily activities, physical therapy, pharmacotherapy, and corticosteroid injections, constitute the mainstay of treatment. Most of these options, however, have shown moderate and short-term effectiveness. » Arthroplasty techniques have proven to be successful for elderly patients. Nevertheless, replacement options are not optimal for younger patients because their functional demands are higher and prostheses have a finite life span. » This has led to the search for new nonoperative treatment options to target this subgroup of patients. It has been suggested that orthobiologic therapies, including platelet-rich plasma (PRP) and cell therapies, present great promise and opportunity for the treatment of GH osteoarthritis. » Despite the promising results that have been shown by cell therapies and PRP for treating degenerative joint conditions, additional studies are needed to provide more definitive conclusions.

Update This article was updated on January 14, 2020, because of a previous error. On page 1, in the Abstract and the section entitled “Case Reports,” the word that had read “Genentech“ now reads “Genetech.” An erratum has been published: JBJS Case Connect. 2020 Feb 5;10(1):e0363ER. Case: The use of biologics is rapidly expanding. Over the past decade, there has been a significant increase in the number of cash-based “stem cell”/regenerative medicine clinics in the United States. These clinics provide cash-based services touting stem cell injections to cure a myriad of conditions. Largely, these clinics are unregulated and using injections in a non–Food and Drug Administration–approved manner. We report on 2 patients who presented with symptoms suggestive of septic arthritis following stem cell injections by cash-based local stem cell clinics. Case 1 involved a patient who developed septic arthritis following an injection of umbilical cord blood–derived cellular products (Genetech) and required an antibiotic spacer followed by a total hip arthroplasty. Case 2 involved a patient who developed a likely immune-mediated reaction following an injection of morselized human placental allograft tissue by a local chiropractic office at a cost of approximately $8,000. Conclusions: We present these cases to bring increased awareness to the issue and call for increased regulation of this practice.