Various types of cellular injection have become a popular and costly treatment option for patients with knee osteoarthritis despite a paucity of literature establishing relative efficacy to each other or corticosteroid injections. Here we aimed to identify the safety and efficacy of cell injections from autologous bone marrow aspirate concentrate, autologous adipose stromal vascular fraction and allogeneic human umbilical cord tissue-derived mesenchymal stromal cells, in comparison to corticosteroid injection (CSI). The study was a phase 2/3, four-arm parallel, multicenter, single-blind, randomized, controlled clinical trial with 480 patients with a diagnosis of knee osteoarthritis (Kellgren–Lawrence II–IV). Participants were randomized to the three different arms with a 3:1 distribution. Arm 1: autologous bone marrow aspirate concentrate (n = 120), CSI (n = 40); arm 2: umbilical cord tissue-derived mesenchymal stromal cells (n = 120), CSI (n = 40); arm 3: stromal vascular fraction (n = 120), CSI (n = 40). The co-primary endpoints were the visual analog scale pain score and Knee injury and Osteoarthritis Outcome Score pain score at 12 months versus baseline. Analyses of our primary endpoints, with 440 patients, revealed that at 1 year post injection, none of the three orthobiologic injections was superior to another, or to the CSI control. In addition, none of the four groups showed a significant change in magnetic resonance imaging osteoarthritis score compared to baseline. No procedure-related serious adverse events were reported during the study period. In summary, this study shows that at 1 year post injection, there was no superior orthobiologic as compared to CSI for knee osteoarthritis. ClinicalTrials.gov Identifier: NCT03818737
Introduction:Physician shortages across the United States will affect access to orthopaedic care for patients. Orthopaedic surgery is predicted to have one of the largest shortages among surgical subspecialties by 2025, which will disproportionally affect patients in medically underserved areas. This study examines characteristics and experiences of graduating medical students interested in orthopaedic surgery who intend to practice in underserved areas (IPUAs).Methods:We analyzed deidentified data of AAMC Graduation Questionnaire respondents who matriculated between 2007 to 2008 and 2011 to 2012. Forty-eight thousand ninety-six (83.91%) had complete demographic, financial, and medical school elective data and were included in the study cohort. Multivariable logistic regression was performed to determine the correlation between student characteristics and intention to pursue orthopaedic surgery and IPUAs.Results:Of the 48,096 students with complete information, 2,517 (5.2%) intended to pursue a career in orthopaedic surgery. Among the orthopaedic students, men were less likely than women to report IPUAs (adjusted odds ratio [aOR], 0.6; 95% CI, 0.4-0.8). Students who identified as Black/African American (aOR, 5.0; 95% CI, 3.0-8.2) or Hispanic (aOR, 2.0; 95% CI, 1.1-3.5) were more likely than White students to report IPUAs. Medical students who intend to pursue orthopaedics and received a scholarship (aOR, 1.5; 95% CI, 1.1-2.0), participated in community research (aOR, 1.8; 95% CI, 1.4-2.3), or had a global health experience (aOR, 1.9; 95% CI, 1.5-2.5) were more likely to report IPUAs.Discussion:If orthopaedic surgeons who reported as medical students who reported IPUAs actually do so, recruiting and retaining more sex and race/ethnically diverse orthopaedic surgeons could reduce the impact of the impending shortage of orthopaedic surgeons in underserved areas. IPUA is correlated to medical school experiences related to cultural competency including global health experiences and community-based research projects.