Updates in the Early Management of Acute Spinal Cord Injury.

Spinal cord injury (SCI) is a leading cause of disability worldwide, and effective management is necessary to improve clinical outcomes. Many long-standing therapies including early reduction and spinal cord decompression, methylprednisolone administration, and optimization of spinal cord perfusion have been around for decades; however, their efficacy has remained controversial because of limited high-quality data. This review article highlights studies surrounding the role of early surgical decompression and its role in relieving mechanical pressure on the microvascular circulation thereby reducing intraspinal pressure. Furthermore, the article touches on the current role of methylprednisolone and identifies promising studies evaluating neuroprotective and neuroregenerative agents. Finally, this article outlines the expanding body of literature evaluating mean arterial pressure goals, cerebrospinal fluid drainage, and expansive duroplasty to further optimize vascularization to the spinal cord. Overall, this review aims to highlight evidence for SCI treatments and ongoing trials that may markedly affect SCI care in the near future.

State-of-the-art Applications of Patient-Reported Outcome Measures in Spinal Care.

Patient-reported outcome measures (PROMs) assign objective measures to patient's subjective experiences of health, pain, disability, function, and quality of life. PROMs can be useful for providers in shared decision making, outcome assessment, and indicating patients for surgery. In this article, we provide an overview of the legacy PROMs used in spinal care, recent advancements in patient-reported outcomes, and future directions in PROMs. Recent advances in patient-reported outcome assessments have included standardization of measurement tools, integration of data collection into workflow, and applications of outcome measures in predictive models and decision-making tools. Continual appraisal of instruments and incorporation into artificial intelligence and machine learning analytics will continue to augment the delivery of high-value spinal care.

Evaluating Outcomes of Spinopelvic Fixation for Patients Undergoing Long Segment Thoracolumbar Fusion with a Prior Total Hip Arthroplasty.

INTRODUCTION: Understanding the relationship between spinal fusion and its effects on relative spinopelvic alignment in patients with prior total hip arthroplasty (THA) is critical. However, limited data exist on the effects of long spinal fusions on hip alignment in patients with a prior THA. Our objective was to compare clinical outcomes and changes in hip alignment between patients undergoing long fusion to the sacrum versus to the pelvis in the setting of prior THA. METHODS: Patients with a prior THA who underwent elective thoracolumbar spinal fusion starting at L2 or above were retrospectively identified. Patients were placed into one of two groups: fusion to the sacrum or pelvis. Preoperative, six-month postoperative, one-year postoperative, and delta spinopelvic and acetabular measurements were measured from standing lumbar radiographs. RESULTS: A total of 112 patients (55 sacral fusions, 57 pelvic fusions) were included. Patients who underwent fusion to the pelvis experienced longer length of stay (LOS) (8.31 vs. 4.21, P < 0.001) and less frequent home discharges (30.8% vs. 61.9%, P = 0.010), but fewer spinal revisions (12.3% vs. 30.9%, P = 0.030). No difference was observed in hip dislocation rates (3.51% vs. 1.82%, P = 1.000) or hip revisions (5.26% vs. 3.64%, P = 1.000) based on fusion construct. Fusion to the sacrum alone was an independent predictor of an increased spine revision rate (odds ratio: 3.56, P = 0.023). Patients in the pelvic fusion group had lower baseline lumbar lordosis (LL) (29.2 vs. 42.9, P < 0.001), six-month postoperative LL (38.7 vs. 47.3, P = 0.038), and greater 1-year ∆ pelvic incidence-lumbar lordosis (-7.98 vs. 0.21, P = 0.032). CONCLUSION: Patients with prior THA undergoing long fusion to the pelvis experienced longer LOS, more surgical complications, and lower rate of spinal revisions. Patients with instrumentation to the pelvis had lower LL preoperatively with greater changes in LL and pelvic incidence-lumbar lordosis postoperatively. No differences were observed in acetabular positioning, hip dislocations, or THA revision rates between groups.

Diversity in Orthopaedic Surgery Medical Device Clinical Trials: An Analysis of the Food and Drug Administration Safety and Innovation Act.

INTRODUCTION: Demographic factors contribute markedly to orthopaedic surgery outcomes. However, women and minorities have been historically excluded from clinical trials. The United States passed the Safety and Innovation Act (Food and Drug Administration Safety and Innovation Act [FDA-SIA]) in 2012 to increase study diversity and mandate reporting of certain demographics. The purpose of this study was to investigate demographic reporting and analysis among high-risk orthopaedic medical device trials and evaluate the effectiveness of the FDA-SIA in increasing diversity of study enrollment. METHODS: The premarket approval database was queried for all original submissions approved by the Orthopedic Advisory Committee from January 1, 2003, to July 1, 2022. Study demographics were recorded. Weighted means of race, ethnicity, and sex were compared before and after FDA-SIA implementation with the US population. RESULTS: We identified 51 orthopaedic trials with unique study data. Most Food and Drug Administration device trials reported age (98.0%) and sex (96.1%), but only 49.0% and 37.3% reported race and ethnicity, respectively. Only 23 studies analyzed sex, six analyzed race, and two analyzed ethnicity. Compared with the US population, participants were overwhelmingly White (91.36% vs. 61.63%, P < 0.001) with a significant underrepresentation of Black (3.65% vs. 12.41%, P = 0.008), Asian (0.86% vs. 4.8%, P = 0.030), and Hispanic participants (3.02% vs. 18.73%, P < 0.001) before 2013. The FDA-SIA increased female patient enrollment (58.99% vs. 47.96%, P = 0.021) but did not increase the enrollment of racial or ethnic minorities. CONCLUSION: Despite efforts to increase the generalizability of studies within the FDA-SIA, orthopaedic medical devices still fail to enroll diverse populations and provide demographic subgroup analysis. The study populations within these trials do not represent the populations for whom these devices will be indicated in the community. The federal government must play a stronger role in mandating study diversity, enforcing appropriate statistical analysis of the demographic subgroups, and executing measures to ensure compliance. LEVEL OF EVIDENCE: I.