Mautner, Kenneth

Abstract Background Osteoarthritis is a leading cause of disability worldwide, and cell‐based treatments including adipose‐derived and bone marrow aspirate have been sought by the lay and medical community as treatment options. Objective To perform a scoping review of published literature on cell‐based injections allowed by the U.S. Food and Drug Administration for the treatment of osteoarthritis to synthesize existing evidence and identify research gaps for future evaluation. Methods A comprehensive search of five databases was executed from inception through January 2, 2025. Studies that met the inclusion criteria were original research studies written in English on Food and Drug Administration‐allowed cell‐based treatments in adults with osteoarthritis of any joint. Results The database search yielded 4257 unique records. After screening, 84 studies met the inclusion criteria, encompassing 9996 patients and a total of 10,508 procedures. The primary research study designs were cohort studies ( n = 62), focused on treatment of knee osteoarthritis ( n = 63), and described bone marrow aspirate ( n = 42) and adipose‐derived ( n = 42) treatments. Postprocedure monitoring ranged from 6 weeks to 5 years, with most studies ≤1 year ( n = 59). Patient‐reported outcomes were reported in 83 of 84 studies; few provided imaging outcomes including magnetic resonance imaging ( n = 9) or radiographs ( n = 2). Conclusion This review identified limited randomized controlled trials, limited studies outside the knee, limited description of cell‐based treatments, and treatment protocols, along with inconsistent patient‐reported outcomes limited to 1 year in most studies. We propose establishing reporting guidelines in research on cell‐based therapies.

Abstract Adipose‐derived cellular therapies (AD‐CTs) are increasingly used in orthopedics, yet the field lacks a standardized framework for classifying these heterogeneous products. Although prior efforts have standardized platelet‐rich plasma and bone marrow‐derived mesenchymal stromal cells, AD preparations remain inconsistently defined and poorly characterized. AD‐CTs encompass a range of products including enzymatically derived stromal vascular fraction, culture‐expanded adipose‐derived mesenchymal stromal cells (AD‐MSCs), and mechanically processed adipose tissue (AD‐MPT),each with distinct regulatory, cellular, and structural profiles. Unlike stromal vascular fraction and AD‐MSCs, which can be quantified using conventional assays, the intact extracellular matrix in AD‐MPTs complicates objective characterization. This paper introduces the Mechanical Processing (Harvesting) of Adipose Tissue classification system as a novel framework for standardizing the reporting of AD‐MPT harvesting and processing techniques that provides a structured approach to nomenclature and reporting. The system aims to enhance study comparability, facilitate research replication, and support the responsible advancement of adipose‐based therapies in musculoskeletal medicine.

Objective: Orthobiologics are increasingly sought-after interventions in sports medicine for treatment of musculoskeletal injuries and conditions. Despite this trend, differences exist across sports medicine fellowship programs regarding foundational knowledge, educational curricula, and practical experience with orthobiologic therapies (eg, platelet-rich plasma, bone marrow aspirate concentrate, microfragmented adipose tissue). This represents an important educational gap for those training in sports medicine fellowships. To address this gap, an educational toolkit was envisioned with the sports medicine fellowship director and trainee in mind. Data Sources: Collective observations from physician experts in sports medicine education established the variations in curricula and expertise of graduating fellows. A literature review was conducted to source English-language peer reviewed articles from the online PubMed database. The scope of this project did not include an independent systematic analysis or statistical assessments. Main Results: An educational toolkit consisting of 12 adaptable modules was developed, each with a suggested reading list from the published literature. The modules may be rearranged to support each program's learning schedule. The information and lessons contained herein may be valuable to all healthcare providers interested in the evidence-based application of orthobiologics and insightful interpretation of related research. Conclusions: By implementing an educational toolkit, sports medicine fellowships may improve the quality of education on orthobiologics. This is intended to improve the knowledge and skill set of fellowship graduates, thus promoting the scientific, responsible use of orthobiologic interventions.

Abstract Objective The goal of this study was to examine if differing platelet counts in platelet‐rich plasma (PRP) formulations affected overall pain and function outcomes when compared to hyaluronic acid or placebo control saline injections. Design/Methods We conducted a systematic review and meta‐analysis (International Prospective Register of Systematic Reviews CRD42022340057) evaluating randomized controlled trials comparing injections of PRP to hyaluronic acid (HA) or saline (NS) control in patients with mild or moderate knee osteoarthritis. All studies used a validated outcome measure that examined pain, function, or overall patient global assessment. Study PRP interventions were subclassified as investigating the total number of platelets delivered in a low dose (1–5 billion total deliverable platelets), moderate dose (5–10 billion total deliverable platelets), or high dose (greater than 10 billion total deliverable platelets) injected into the joint. Results A total of 32 trials met inclusion criteria. All three PRP groups had significant improvements in validated patient‐reported outcomes when compared to HA. Both the “low” and “high” platelet count groups resulted in a moderate effect size, respectively (standardized mean difference [SMD] = .47; 95% confidence interval [CI] .05–0.89, p < .01; SMD = .68; 95% CI .26–1.09, p < .01). Only the “moderate” (SMD = 1.48; 95% CI .71–2.58 p < .01) platelet count group resulted in large effect size on validated patient‐reported outcomes. When compared to NS, all three PRP groups resulted in significant large effect sizes when examining pain reduction. Conclusions When compared to HA, PRP with platelet counts between 1 and 10 billion total deliverable platelets may result in a larger decrease in pain symptoms when compared to platelet counts greater than 10 billion at 6 months. In addition, platelet counts between 5 and 10 billion total deliverable platelets may be associated with greater improvement in functional outcomes.

Objectives While extracorporeal shockwave therapy (ESWT) may be an efficacious adjunctive treatment option for musculoskeletal injuries, current research is limited by significant heterogeneity within treatment protocols. This study aims to establish international expert consensus recommendations on ESWT terminology, parameters, procedural considerations, contraindications and side effects in the application of ESWT to sports injuries. Methods A systematic literature search was performed on the use of ESWT for musculoskeletal and sports medicine injuries to identify potential panellists, followed by the development of a steering committee-led questionnaire. A three-stage, modified Delphi questionnaire was provided to a panel of 41 international clinical and research experts across 13 countries. Panellists had the opportunity to suggest edits to existing statements or recommend additional statements in Round 1. Consensus was defined as≥75% agreement. Results All 41 panellists completed Rounds 1, 2 and 3. Consensus was reached on 69/118 statements (58.5%), including recommendations on terminology and fundamental concepts, indications for use, procedural aspects for tendinopathy and bone pathologies, treatment correlations with imaging, periprocedural and postprocedural considerations, absolute and relative contraindications and potential side effects. Of the 49 statements that did not reach consensus, 17/49 (34.7%) were related to procedural aspects of bone pathology. Conclusion This international panel presents recommendations on ESWT terminology, indications and treatment considerations to guide ESWT use and decision-making by sports medicine clinicians. While our panel supported the use of ESWT in the treatment of bone pathologies, certain procedural aspects of ESWT specific to these injuries did not reach consensus and require further investigation.

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.

ObjectivesTo 1) determine the types and frequency of complications within 3 months following ultrasound‐guided surgical procedures, and 2) identify any patient demographics, co‐morbidities, or procedural characteristics that were associated with an increased risk of complications.MethodsA retrospective chart review was performed at six Sports Medicine clinics across the United States. The Clavien‐Dindo classification was used to categorize procedural complications on a 5‐point scale from 1, representing any deviation in post‐procedure care without requiring pharmacological or invasive treatment to 5, representing death. Generalized Estimating Equations for binomial outcomes with a logit link were used to estimate the overall and procedure‐specific 3‐month complication rates.ResultsAmong 1902 patients, 8.1% (n = 154) had diabetes and 6.3% (n = 119) were current smokers. The analysis included 2,369 procedures, which were performed in either the upper extremity (44.1%, n = 1045) or lower extremity (55.2%, n = 1308) regions. The most common procedure was ultrasound‐guided tenotomy (69.9%, n = 1655). Additional procedures included, trigger finger release (13.1%, n = 310), tendon scraping (8.0%, n = 189), carpal tunnel release (5.4%, n = 128), soft tissue release (2.1%, n = 50), and compartment fasciotomy (1.6%, n = 37). Overall, there was a complication rate of 1.2% (n = 29 complications; 95% CI: 0.8–1.7%). Individual procedures had complication rates that ranged from 0 to 2.7%. There were 13 Grade I complications in 13 patients, 12 Grade II complications in 10 patients, 4 Grade III complications in 4 patients, and 0 Grade IV or V complications. No associations between complication risk and any patient demographics (age, sex, BMI), co‐morbidities (diabetes, smoker), or procedure characteristics (type, region) were identified.ConclusionThis retrospective review provides an evidence‐based estimate supporting the low level of risk associated with ultrasound‐guided surgical procedures for patients from a variety of geographical settings who are seeking care at private and academic‐affiliated clinics.

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.

Abstract: Sports ultrasound is commonly used by sports medicine physicians to enhance diagnostic and procedural accuracy. This expert consensus statement serves as an update to the 2015 American Medical Society for Sports Medicine recommended sports ultrasound curriculum for sports medicine fellowships. Although written in the context of the American sports medicine fellowship training model, we present a stepwise progression in both diagnostic and interventional sports ultrasound that may be applicable to the broader sports medicine community. The curriculum is divided into 12 units with each unit including didactic instructional sessions, practical hands-on instruction, independent scanning practice sessions, and mentored clinical experience. To assist with prioritization of learning, we have organized relevant pathology and procedures as essential, desirable, and optional. The expanded content can serve as an outline for continuing education postfellowship or for any physician to further advance their sports ultrasound knowledge and skill. We also provide updated scanning protocols, sample milestones, and a sample objective structured clinical examination (OSCE) to aid fellowships with implementation of the curriculum and ongoing assessment of fellow progress.