Unique Spatial Transcriptomic Profiling of the Murine Femoral Fracture Callus: A Preliminary Report.

Fracture callus formation is a dynamic stage of bone activity and repair with precise, spatially localized gene expression. Metastatic breast cancer impairs fracture healing by disrupting bone homeostasis and imparting an altered genomic profile. Previous sequencing techniques such as single-cell RNA and in situ hybridization are limited by missing spatial context and low throughput, respectively. We present a preliminary approach using the Visium CytAssist spatial transcriptomics platform to provide the first spatially intact characterization of genetic expression changes within an orthopedic model of impaired fracture healing. Tissue slides prepared from BALB/c mice with or without MDA-MB-231 metastatic breast cancer cells were used. Both unsupervised clustering and histology-based annotations were performed to identify the hard callus, soft callus, and interzone for differential gene expression between the wild-type and pathological fracture model. The spatial transcriptomics platform successfully localized validated genes of the hard (Dmp1, Sost) and soft callus (Acan, Col2a1). The fibrous interzone was identified as a region of extensive genomic heterogeneity. MDA-MB-231 samples demonstrated downregulation of the critical bone matrix and structural regulators that may explain the weakened bone structure of pathological fractures. Spatial transcriptomics may represent a valuable tool in orthopedic research by providing temporal and spatial context.

Sponsorship of Clinical Trials Related to the Shoulder and Elbow: Trends Over Time and Comparative Analysis of Trial Characteristics by Sponsorship Type.

INTRODUCTION: Sponsorship trends have not been specifically evaluated for shoulder and elbow clinical trials, nor have trial characteristics been compared among shoulder and elbow trials sponsored by institutions, industries, and federal agencies. METHODS: ClinicalTrials.gov was queried for clinical trials using the terms 'shoulder' and 'elbow.' Trial characteristics were abstracted, including start year, intervention type, phase, randomization, and blinding. Univariate and multivariate analyses were performed to determine associations between sponsorship type and other trial characteristics. RESULTS: In total, 4,945 shoulder clinical trials and 1,517 elbow clinical trials were identified, of which 26 shoulder clinical trials and seven elbow clinical trials were excluded due to incomplete data. From 2000 to 2022, the number of shoulder and elbow trials initiated annually markedly increased driven by an increase in the number of institutional trials. Relative to trials with institutional sponsorship, industry sponsorship was independently associated with different intervention types, phase of study, lack of randomization, and blinding. DISCUSSION: From 2000 to 2022, the number of shoulder and elbow clinical trials initiated annually markedly increased, driven by an increase in institutionally sponsored trials. For clinical trials related to the shoulder, design characteristics were found to differ based on study sponsorship type. This suggests that the design characteristics of shoulder-related clinical trials are shifting over time.

Sponsorship of clinical trials related to the spine: Trends over time and comparative analysis of trial characteristics by sponsorship type.

Background: Clinical trials are crucial to advance products and procedures related to the spine. ClinicalTrials.gov is an internet-based registry and results database that catalogs trial characteristics, such as intervention types, phase, randomization, and blinding. Sponsorship trends have not been specifically evaluated for spine-related clinical trials, nor have trial characteristics been compared among spine-related trials sponsored by institutions, industries, and federal agencies. The purpose of this cross-sectional analysis of spine-related clinical trials was to characterize the types and trends of sponsorship for spine-related clinical trials, and compare trial characteristics among trials sponsored by institutions, industries, and federal agencies. Methods: ClinicalTrials.gov was queried for clinical trials started from the launch of ClinicalTrials.gov (February 29, 2000) through December 31, 2022, using the term "spine." Trial characteristics were abstracted, including start year, intervention type, phase, randomization, and blinding. Univariate and multivariate analyses were performed to determine associations between sponsorship type and other trial characteristics. Results: A total of 4,484 clinical trials were identified, of which 78 trials were excluded due to incomplete reporting of trial registration data. From 2000 through 2022, the number of spine-related trials initiated annually markedly increased (from 21 to 453, representing an increase of 2,057%). This was predominantly driven by an increase in the number of institutionally sponsored trials. Relative to trials with institutional sponsorship, industry sponsorship was independently associated with different intervention types, phases of study, lack of randomization, and lack of blinding. Relative to trials with institutional sponsorship, federal sponsorship was independently associated with intervention type, and phase of study. Conclusions: From 2000 through 2022, the number of spine-related clinical trials initiated annually markedly increased, driven by an increase in institutionally sponsored trials. Specific trial characteristics were more or less likely for industrially or federally sponsored trials relative to institutionally sponsored trials suggesting the types of clinical trials are shifting over time.

Bone Mass Changes Following Percutaneous Radiofrequency Ablation, Osteoplasty, Reinforcement, and Internal Fixation of Periacetabular Osteolytic Metastases.

BACKGROUND: The success of orthopedic interventions for periacetabular osteolytic metastases depends on the progression or regression of cancer-induced bone loss. PURPOSE: To characterize relative bone mass changes following percutaneous radiofrequency ablation, osteoplasty, cement reinforcement, and internal screw fixation (AORIF). METHODS: Of 70 patients who underwent AORIF at a single institution, 21 patients (22 periacetabular sites; average follow-up of 18.5 ± 12.3 months) had high-resolution pelvic bone CT scans, with at least one scan within 3 months following their operation (baseline) and a comparative scan at least 6 months post-operatively. In total, 73 CT scans were measured for bone mass changes using Hounsfield Units (HU). A region of interest was defined for the periacetabular area in the coronal, axial, and sagittal reformation planes for all CT scans. For 6-month and 1-year scans, the coronal and sagittal HU were combined to create a weight-bearing HU (wbHU). Three-dimensional volumetric analysis was performed on the baseline and longest available CT scans. Cohort survival was compared to predicted PathFx 3.0 survival. RESULTS: HU increased from baseline post-operative (1.2 ± 1.1 months) to most recent follow-up (20.2 ± 12.1 months) on coronal (124.0 ± 112.3), axial (140.3 ± 153.0), and sagittal (151.9 ± 162.4), p < 0.05. Grayscale volumetric measurements increased by 173.4 ± 166.4 (p < 0.05). AORIF median survival was 27.7 months (6.0 months PathFx3.0 predicted; p < 0.05). At 12 months, patients with >10% increase in wbHU demonstrated superior median survival of 36.5 months (vs. 26.4 months, p < 0.05). CONCLUSION: Percutaneous stabilization leads to improvements in bone mass and may allow for delays in extensive open reconstruction procedures.

Single-level Anterior Cervical Discectomy and Fusion Results in Lower Five-year Revisions than Posterior Cervical Foraminotomy in a Large National Cohort.

STUDY DESIGN: A retrospective cohort study using the 2010-2020 MSpine PearlDiver administrative data set. OBJECTIVE: To compare perioperative adverse events and five-year revisions for single-level anterior cervical discectomy and fusion (ACDF) versus posterior cervical foraminotomy (PCF). SUMMARY OF BACKGROUND DATA: Cervical disk disease can often be treated surgically using single-level ACDF or PCF. Prior studies have suggested that posterior approaches provide similar short-term outcomes as ACDF; however, posterior procedures may have an increased risk of revision surgery. MATERIALS AND METHODS: The database was queried for patients undergoing elective single-level ACDF or PCF (excluding cases performed for myelopathy, trauma, neoplasm, and/or infection). Outcomes, including specific complications, readmission, and reoperations, were assessed. Multivariable logistic regression was used to ascertain odds ratios (OR) of 90-day adverse events controlling for age, sex, and comorbidities. Kaplan-Meier survival analysis was performed to determine five-year rates of cervical reoperation in the ACDF and PCF cohorts. RESULTS: A total of 31,953 patients treated by ACDF (29,958, 93.76%) or PCF (1995, 6.24%) were identified. Multivariable analysis, controlling for age, sex, and comorbidities, demonstrated that PCF was associated with significantly greater odds of aggregated serious adverse events (OR 2.17, P <0.001), wound dehiscence (OR 5.89, P <0.001), surgical site infection (OR 3.66, P <0.001), and pulmonary embolism (OR 1.72, P =0.04). However, PCF was associated with significantly lower odds of readmission (OR 0.32, P <0.001), dysphagia (OR 0.44, P <0.001), and pneumonia (OR 0.50, P =0.004). At five years, PCF cases had a significantly higher cumulative revision rate compared with ACDF cases (19.0% vs. 14.8%, P <0.001). CONCLUSIONS: The current study is the largest to date to compare short-term adverse events and five-year revision rates between single-level ACDF and PCF for nonmyelopathy elective cases. Perioperative adverse events differed by procedure, and it was notable that the incidence of cumulative revisions was higher for PCF. These findings can be used in decision-making when there is clinical equipoise between ACDF and PCF.

Emergency department visits within 90 days of lumbar discectomy.

BACKGROUND CONTEXT: Lumbar discectomy is a common procedure following which emergency department (ED) visits may occur. Although many quality improvement initiatives target reemissions, ED visits may be more common, be a marker of quality of care, affect patient satisfaction, and contribute to health-care resource utilization and costs. PURPOSE: To analyze the timing and risk factors predicting ED utilization following lumbar discectomy and thereby facilitate better-targeted risk reduction. STUDY DESIGN/SETTING: Retrospective database review of the 2010 to April 30th, 2021, M157Ortho PearlDiver dataset. PATIENT SAMPLE: Single-level lumbar laminotomy/discectomy between 2010 and April 30th, 2021, in the PearlDiver M157Ortho dataset. OUTCOME MEASURES: Functional measures-ED utilization in the 90 days following lumbar discectomy, patient-level predictors for ED utilization, and number and type of reoperations performed in the 90 days following lumbar discectomy. METHODS: Lumbar laminotomies/discectomies were identified. Patients were excluded if additional procedures were performed or if there was not 90-day follow-up in the dataset. Patient factors were extracted, including age, sex, Elixhauser comorbidity index (ECI), region of the country in which their procedure was performed (Midwest, Northeast, South, West), and patient insurance plan (Commercial, Medicaid, Medicare). The incidence, timing, and frequency of ED utilization within 90 days of lumbar discectomy were then determined. Cohort average weekly ED utilization at 1-year postoperatively was calculated as a baseline for reference. Patient factors predictive of postoperative ED utilization were then determined with univariate and multivariate analyses. Primary diagnoses for ED visits were also categorized. Patients who underwent reoperation for complications related to lumbar discectomy following ED visits were determined, and types of reoperation procedures were characterized. RESULTS: Of 281,103 lumbar discectomy patients identified, ED visits within 90 days of surgery were identified for 28,632 (10.2%). Of note, 40.4% of these ED visits occurred in the first 2 postoperative weeks. Multivariate analysis revealed several independent predictors of ED utilization following lumbar discectomy, including: younger age (odds ratio [OR] 1.21 per decade decrease), female sex (OR 1.12 relative to male), higher ECI (OR 1.42 per 2-point increase), having surgery performed in the Northeast, Midwest, or West United States (OR 1.05, 1.17, and 1.13, respectively, relative to South), and Medicaid coverage (OR 1.89 relative to Medicare). Forty-three percent of ED visits were surgical site related, of which surgical site pain predominated at 34.2% of overall reasons. Of patients who visited the ED, 943 (3.3%) underwent reoperation in the subsequent 2 weeks. Laminectomy with nerve root decompression was the most performed reoperation (30.9%), followed by incision and drainage (22.5%), posterior nonsegmental instrumentation (10.3%), laminectomy facetectomy and foraminotomy (9.97%), repair of dural/CSF leak or pseudomeningocele with laminectomy (9.3%), repair of dural/CSF leak not requiring laminectomy (8.9%), arthrodesis (4.3%), and posterior segmental instrumentation (3.9%). CONCLUSIONS: Following lumbar discectomy, over 1 in 10 patients were found to visit the ED in the 90 days following their surgery, most commonly in the first 2 postoperative weeks. Specific patient characteristics were associated with such ED visits, with the most common primary diagnoses among ED visitors being surgical site pain. About 3.3% of patients who visited the ED underwent reoperation in the subsequent 2 weeks. Through identification of the timing, risk factors, primary reasons for, and risk of reoperation following ED utilization in the 90-day period after lumbar discectomy, care pathways can be modified to improve patient satisfaction, outcomes, and reduce excess health-care expenditures.

A Case Report of Allergic Hypersensitivity to Color Additives in Slurpee® Beverages.

Introduction: Many commercially available foods and beverages contain color additives to which patients may develop allergic hypersensitivity. Several color additives currently approved for commercial sale in the United States have raised health concerns to a varying degree as testing and evidence of carcinogenicity, genotoxicity, and hypersensitivity has thus far been inadequate. Common uses for color additives include baked goods (eg, cakes, pastries, candy), flavored dairy products such as yogurt, sports-themed drinks (eg, Gatorade® Fruit Punch), and red-dyed Slurpee® beverages. Methods: We present the case of a patient who experienced color additive-related allergic hypersensitivity reactions after consumption of Slurpee® beverages, which may place her at risk when consuming other commercially available beverages and food products containing color additives. Percutaneous skin testing and an oral challenge were administered using three different red color additives (two color additives for skin testing and one color additive for the oral challenge). Results: The specific color additive precipitating her symptoms was not conclusively identified. Review of the literature acknowledges the idea that further research into color additive-related allergy should be conducted as there are many commercially available color additives that can elicit hypersensitivity reactions after consumption. Conclusion: Current research shows that of the red color additives available, Citrus Red, Red No. 3, and Red No. 40 are recognized to elicit such reactions. In order to lessen the burden of color additive-related hypersensitivity in the general population, public education, increased research, and subsequent regulations should be implemented.

An Epidemiological Study of Cell Phone-Related Injuries of the Hand and Wrist Reported in United States Emergency Departments From 2011 to 2020.

Purpose: Increasing ownership and use of mobile phones has been recently linked to reports of hand and wrist pain from overuse, as well as more serious injuries related to distracted behaviors, such as falls and texting while driving. We describe the epidemiology of hand and wrist injuries presenting to US emergency departments from 2011 to 2020, which were associated with cell phone use using the Consumer Product Safety Commission's National Electronic Injury Surveillance System. Methods: The National Electronic Injury Surveillance System database was queried for treatment records from 2011 through to 2020 for all cell phone-related injuries of the lower arm, wrist, hand, and fingers. Using parameters provided by the National Electronic Injury Surveillance System database, there were 1,213 unique cases, yielding a total weighted estimate of 50,487 national cases presenting to emergency departments in the United States. Results: Between 2011 and 2020, the weighted estimate of annual cell phone-related injuries ranged from 3,389 to 7,320 cases. Falls were the most common cause of injury, accounting for 29.8% of estimated cases. The most common types of injuries were lacerations (22.3%). The national estimate of cell phone-related injury was the highest in the age range of 11-20 years (26.4%), followed by 21-30 years (22.2%). Women were affected more frequently than men (59.6% vs 40.4%). Conclusions: Upper extremity injuries related to cell phone use represent an increasing burden of disease to the US healthcare system. Raising awareness regarding cell phone-related injuries and in-home fall-prevention strategies, especially among elderly individuals, should be considered as means of decreasing the number of such injuries. Strategies for decreasing the burden of cell phone-related injuries occurring as a result of falls among teenagers and young adults should focus on minimizing distractions while using a cell phone. Limitations of the study include inaccuracies related to probability-weighted case estimation and limitations in reporting injuries. Clinical relevance: Knowledge of the burden of upper extremities injuries associated with this common handheld device can help to both raise awareness of this issue, as well as to potentially inform injury-prevention strategies.

Incidental Durotomy After Posterior Lumbar Decompression Surgery Associated With Increased Risk for Venous Thromboembolism.

INTRODUCTION: Incidental durotomies can occur during posterior lumbar decompression surgery. Not only can this slow patient recovery but many surgeons recommend a period of bed rest in these situations, which can further slow mobilization. This immobility might be associated with increased risk of venous thromboembolism (VTE) after spinal surgery. This study aims to determine whether incidental durotomies are associated with increased risk of VTE in patients undergoing lumbar decompression surgery. METHODS: Adult patients undergoing laminectomy or laminotomy (excluding any with concomitant fusion procedures) for degenerative etiologies and with a minimum of 90-day follow-up were identified from the MSpine Pearldiver dataset. Incidental durotomies were identified based on hospital administrative coding, and patient demographics, comorbidities, and the occurrence and timing of VTE (deep vein thrombosis [DVT] and/or pulmonary embolism) were defined. Univariate and multivariate analyses were performed. RESULTS: Of 156,488 lumbar decompression patients included in the study, incidental durotomies was noted for 2,036 (1.3%). Markedly more VTEs were observed in the first five days in the incidental durotomies group ( P < 0.001) but not incrementally any day after ( P > 0.05). On univariate analyses, a significant increased risk of VTE, DVT, and PE was observed ( P < 0.001 for each). On multivariate analyses controlling for age, sex, and comorbidities, odds were significantly increased for VTE (Odds ratios = 1.75, P < 0.001) and DVT (OR = 1.70, P < 0.001) but not independently significant for pulmonary embolism. DISCUSSION: Patients who have incidental durotomies during lumbar laminectomy or laminotomy surgery were found to have increased odds of VTE, primarily in the first five days. Although not all factors associated with this could be directly determined, slower mobilization would seem to be a likely contributing factor. Increasing mobilization and/or adjusting chemoprophylaxis in this group would seem appropriately considered.

Timing of Adverse Events Within 90 Days of Hip Fracture Surgery: A Database Study.

INTRODUCTION: Hip fracture surgery is associated with notable morbidity. Understanding the timing of adverse events can inform strategies for prevention and management. Owing to database limitations, many studies have limited postoperative follow-up to 30 days. However, adverse events may not have plateaued by this time. This study evaluated adverse events after hip fracture surgery out to 90 days. METHODS: Hip fracture surgeries in patients 65 years or older were identified in the 2010 to 2020 Q3 M91Ortho PearlDiver data set using administrative codes. The 90-day incidence and time of diagnosis of 10 common adverse events were determined and used to calculate median, interquartile range, and middle 80% for time of diagnosis. The number of events occurring before and after 30 days was also determined. RESULTS: A total of 258,834 hip fracture surgery patients were identified. On average, 70% of adverse events occurred in postoperative days 0 to 30 and 30% occurred in days 31 to 90. The percentage of events in days 31 to 90 ranged from 8% (transfusion) to 42% (wound dehiscence). Compared with patients with a 0- to 30-day adverse event, those with 31- to 90-day adverse events had higher average Elixhauser Comorbidity Index scores (8.6 vs. 7.8, P < 0.001) and a slightly greater proportion of men (31.5% vs. 30.2%, P < 0.001).For specific adverse events, the time of diagnosis (median; interquartile range; middle 80%) were as follows: transfusion (2 days; 1 to 4 days; 1 to 24 days), acute kidney injury (5; 2 to 26; 1 to 55), cardiac event (9; 3 to 35; 1 to 64), urinary tract infection (13; 3 to 39; 1 to 65), hematoma (14; 6 to 28; 3 to 52), pneumonia (15; 5 to 39; 2 to 66), venous thromboembolism (16; 5 to 40; 2 to 64), surgical site infection (23; 14 to 37; 7 to 56), sepsis (24; 9 to 48; 3 to 71), and wound dehiscence (26; 15 to 41; 7 to 64). DISCUSSION: Nearly one-third of 90-day adverse events after hip fracture surgery were found to occur after postoperative day 30. An understanding of the timing of adverse events is important for improving patient counseling and optimizing patient care.

Total Hip Arthroplasty Imageless Navigation Does Not Reduce 90-Day Adverse Events or Five-Year Revisions in a Large National Cohort.

BACKGROUND: Computer navigation is an increasingly utilized technology that is considered with total hip arthroplasty (THA). However, the evidence to support this practice is mixed. The current study leveraged a large national administrative database to compare 90-day adverse events as well as 5-year all-cause revision and dislocation rates following THA performed with and without imageless navigation. METHODS: From 2010 to 2020, a large national database was queried for THA cases performed for osteoarthritis. Cases with or without imageless navigation were matched at 1:4 based on age, sex, and Elixhauser Comorbidity Index (ECI) score. Ninety-day adverse events were assessed and compared with multivariate analyses. Five-year incidence of revision and dislocation were also assessed between cohorts. RESULTS: Use of THA imageless navigation increased from 2010 (2.5% of cases) to 2020 (5.5% of cases; P < .001). After matching, 11,990 THA patients with navigation and 47,948 without navigation were identified. Overall, 90-day adverse events were observed in 7.0% of the population. Multivariate analysis controlling for age, sex, and ECI demonstrated a difference in only one 90-day adverse event; wound dehiscence, which had higher odds in the navigation group (odds ratio, 1.60, P < .001). At 5 years, revisions for the navigated group were higher (4.4 versus 3.6%: P = .006), while dislocations were not significantly different. CONCLUSION: THA imageless navigation was not found to be associated with improved 90-day postoperative adverse events or differences in the 5-year rates of revision or dislocation. The current data were unable to identify clear advantages of this evolving technology for primary THA.

Healthcare Economics of a Coronavirus Disease 2019 Pop-Up Vaccination Center.

Introduction: Creation of pop-up vaccination sites at trusted community locations has been encouraged to address vaccine hesitancy and provide equitable access to COVID-19 vaccination in minority communities. This study sought to study the healthcare economics of a community-based COVID-19 pop-up vaccination center in terms of the following: costs associated with operating the vaccination center, analysis of billing data from patients who received the Moderna COVID-19 vaccine, and costs of hospitalization for COVID-19 which may be avoided with widespread vaccination. Methods: The pop-up vaccination center was located in Port Jefferson Station, NY, USA. Costs associated with operation of the COVID-19 pop-up vaccination center were quantified, itemized, and tabulated. Current Procedural Technology codes were used to identify patients who received the Moderna COVID-19 vaccine. Billing data were quantified for the cohort as well as per each patient to receive the vaccine. Costs associated with provision of urgent care, emergency, and hospital services to patients with COVID-19 were obtained. Results: The total cost to operate the vaccination center was $25,880. The vaccination center administered the initial dose of the Moderna COVID-19 vaccine to N=251 patients between March and May, 2021. The standard hospital costs for patients admitted to the medical ICU due to COVID-19 ranged from $8,913 to $190,714, per patient. Conclusion: Since the Moderna COVID-19 vaccine series is effective in preventing hospitalization for 93% of patients, this community-based vaccination center's administration of the vaccine series to 240 patients meant aversion of hospitalization due to COVID-19 related morbidity for 223 patients. Therefore, the true impact of this vaccination center, measured in averted hospital costs, ranges from $1,987,599 to $42,529,222.

Hidradenitis Suppurativa Leads to Increased Risk of Wound-Related Complications following Total Joint Arthroplasty.

Background: Hidradenitis suppurativa (HS) is a skin disorder characterized by inflammatory skin lesions that are most commonly in the inguinal and axillary regions. These skin lesions are common sites of bacterial growth and are thus a potential risk factor for infection following procedures such as total hip arthroplasty (THA) or total knee arthroplasty (TKA). Material and methods: Adult patients undergoing THA or TKA for degenerative etiologies were identified from PearlDiver datasets. For THA and TKA, HS patients were matched 1:4 with non-HS patients based on age, sex, and Elixhauser Comorbidity Index. The incidence of 90-day any, severe, minor, and specific adverse events was compiled and compared with multivariate analyses. Five-year revision rates were plotted on Kaplan-Meier survival curves and compared with log-rank tests. Results: For THA, 331,627 patients were identified, of which HS was noted for 481 patients (0.15%). For TKA, 274,161 patients were identified, of which HS was noted for 290 patients (0.11%). Following THA, HS patients had increased odds of wound dehiscence (odds ratio = 2.55, P = .002). Following TKA, HS patients had increased odds of surgical site infection (odds ratio = 1.95, P = .006). All other 90-day adverse events were not significantly different. There was no significant difference in 5-year implant survival in either procedure. Conclusions: HS is a rare but identified comorbidity for those undergoing THA or TKA. Although most 90-day adverse events and 5-year implant survival were similar to those without this condition, specific wound-related issues were elevated by roughly twofold. These findings could help inform patients and surgeons.

Analysis of the frequency, characteristics, and reasons for termination of shoulder- and elbow-related clinical trials.

BACKGROUND: Clinical trials are key to the advancement of products and procedures related to conditions of the shoulder and elbow. Unfortunately, many trials are terminated prior to completion. CLINICALTRIALS: gov is a registry and results database maintained by the National Library of Medicine that catalogs trial characteristics and tracks overall recruitment status (eg, ongoing, completed, terminated) for each study as well as reasons for termination. Reasons for trial termination have not been specifically evaluated for shoulder- and elbow-related clinical trials. The current study set out to quantify completed and terminated shoulder- and elbow-related clinical trials, assess reasons for termination, and determine independent predictors of termination by comparing characteristics of completed and terminated trials. METHODS: The ClinicalTrials.gov database was queried on August 6, 2021, for all completed and terminated interventional studies registered to date using all available shoulder- and elbow-related search terms. Trial characteristics and reason for termination were abstracted. Univariate and multivariate analyses were performed using trial characteristics to determine independent predictors for trial termination. RESULTS: For shoulder-related trials, a total of 662 completed or terminated trials were identified and characterized, of which 51 (8%) were noted to have been terminated. For elbow-related trials, a total of 126 completed or terminated were identified and characterized, of which 16 (13%) were terminated. Difficulties with participant recruitment and/or retention was the individual reason most frequently reported for trial termination, accounting for 51% of terminated shoulder-related trials and 38% of terminated elbow-related trials. For shoulder-related trials, multivariate analysis of primary trial characteristics demonstrated increased odds of trial termination for industry-sponsorship (odds ratio [OR] = 4.2, P = .001) relative to sponsorship from local groups, and blinded studies (OR = 45.8, P = .0003) relative to studies that did not implement any form of blinding. For elbow-related trials, logistic regression did not reveal any of the primary trial characteristics evaluated to be correlated with odds of termination. CONCLUSION: Shoulder- and elbow-related clinical trials were terminated at a rate of 8% and 13%, respectively. Difficulties in the recruitment and/or retention of participants were the reason most frequently reported for trial termination. For shoulder-related trials, industry sponsorship and studies with blinding were identified as independent predictors of termination. Given the ethical considerations and the opportunity costs associated with terminated studies, independent predictors and reasons for trial termination should be considered and addressed when possible to increase the rate of clinical trial completion.

Marfan syndrome and adolescent idiopathic scoliosis patients have similar 90-day postoperative outcomes and 5-year reoperation rates after spinal deformity surgery.

PURPOSE: Outcomes after spinal deformity surgery in patients with Marfan syndrome (MFS) are poorly characterized given the rarity of the condition. Updated analyses from nationally representative samples, and comparison to outcomes after more commonly performed procedures for conditions such as adolescent idiopathic scoliosis (AIS) could help define the relative risks. METHODS: Using the 2010-2020 PearlDiver administrative databases, patients who underwent posterior spinal fusion for > 7 segments were extracted. MFS patients were matched 1:4 to AIS patients based on age, sex, and Elixhauer comorbidity index (ECI). Ninety-day outcomes and 5-year reoperation rates were compared. Significance was set at p < 0.05. RESULTS: In total, 206 MFS patients were matched to 825 AIS patients. After adjusting for age, sex, and ECI, multivariate odds ratios (OR) for 90-day any, serious, and minor adverse events, as well as readmissions, were not significantly different for those with MFS compared to those with AIS (p > 0.05 for each). Five-year reoperation rates were also not significantly different (13.1% for the MFS cohort and 13.0% for the AIS cohort (no difference by log-rank, p = 0.9). CONCLUSION: While deformity surgery is much less commonly performed for MFS than AIS, it is not uncommonly considered for patients with this condition. Despite some known technical challenges for MFS deformity surgery, the current study leveraged a large, national database to find that 90-day adverse events and 5-year reoperations were not different for matched MFS and AIS patients undergoing deformity surgery. For select patients, these findings should be useful for surgical planning and patient counseling.

Analysis of the Frequency, Characteristics, and Reasons for Termination of Spine-related Clinical Trials.

STUDY DESIGN: Cross-sectional analysis of completed and terminated spine-related clinical trials in the ClinicalTrials.gov registry. OBJECTIVE: The aim was to quantify completed and terminated spine-related clinical trials, assess reasons for termination, and determine predictors of termination by comparing characteristics of completed and terminated trials. SUMMARY OF BACKGROUND DATA: Clinical trials are key to the advancement of products and procedures related to the spine. Unfortunately, trials may be terminated before completion. ClinicalTrials.gov is a registry and results database maintained by the National Library of Medicine that catalogs trial characteristics and tracks overall recruitment status (eg, ongoing, completed, terminated) for each study as well as reasons for termination. Reasons for trial termination have not been specifically evaluated for spine-related clinical trials. METHODS: The ClinicalTrials.gov database was queried on July 20, 2021 for all completed and terminated interventional studies registered to date using all available spine-related search terms. Trial characteristics and reason for termination, were abstracted. Univariate and multivariate analyses were performed determine predictors of trial termination. RESULTS: A total of 969 clinical trials were identified and characterized (833 completed, 136 terminated). Insufficient rate of participant accrual was the most frequently reported reason for trial termination, accounting for 33.8% of terminated trials.Multivariate analysis demonstrated increased odds of trial termination for industry-sponsorship [odds ratio (OR)=1.59] relative to sponsorship from local groups, device studies (OR=2.18) relative to investigations of drug or biological product(s), and phase II (OR=3.07) relative to phase III studies ( P <0.05 for each). CONCLUSIONS: Spine-related clinical trials were found to be terminated 14% of the time, with insufficient accrual being the most common reason for termination. With significant resources put into clinical studies and the need to advance scientific objectives, predictors, and reasons for trial termination should be considered and optimized to increase the completion rate of trials that are initiated.

The Case of a Janitorial Supervisor With Occupational Asthma Complicated by the Mixed Colonization of the Respiratory Tract by Candida albicans and Alternaria spp.

Patients on immunosuppressant agents, including oral corticosteroids, are susceptible to fungal colonization despite being otherwise immunologically intact. This case report highlights a state-of-the-art biological modifier therapy for the complex care of a patient with refractory occupational asthma, allergic rhinitis, and mixed fungal colonization. A dyspneic 38-year-old male janitor with steroid-dependent occupational asthma refractory to omalizumab therapy was colonized with Candida and Alternaria following a promotion to a managerial position in a moldy office. He was treated with itraconazole and systemic steroids. Pulmonary workup revealed moderate obstructive ventilatory defect, peripheral airway hyperresponsiveness, and eosinophilic airway inflammation. Three additional biological modifiers (reslizumab, benralizumab, and dupilumab) were administered to this patient. His asthma was ultimately controlled with reslizumab and dupilumab. Fractional exhaled nitric oxide (FeNO) normalized after dupilumab monotherapy, enabling the patient to taper off chronic prednisone therapy. Various occupational exposures are crucial epidemiologic factors related to infection and go hand-in-glove with long-term prednisone treatment towards increasing susceptibility to fungal colonization. Steroid-sparing anti-interleukin-5 (IL-5) agents and dupilumab should be considered as alternative treatment options for patients, such as ours, with eosinophilic, prednisone-dependent asthma refractory to omalizumab therapy.

Allergy and Lung Injury Among Rescue Workers Exposed to the World Trade Center Disaster Assessed 17 Years After Exposure to Ground Zero.

OBJECTIVE: Investigate the following in rescue and cleanup workers exposed to the World Trade Center (WTC) disaster 17 years post-fallout: (1) allergic hypersensitivity; (2) spirometry; (3) impulse oscillometry; and (4) the reversibility of airway hyperresponsiveness and distal airways narrowing pre- and post-bronchodilator. METHODS: In subjects (n = 54) referred to our clinic from the WTC Health Program for management of allergy-immunology services, environmental allergy testing, impulse oscillometry (IOS), and spirometry results were retrospectively reviewed to determine the long-term impact of exposure to the WTC fallout. RESULTS: Rescue and cleanup workers exposed to the WTC fallout had a high incidence of allergic hypersensitivity and had evidence of permanent small airways dysfunction characterized by distal airways narrowing and airway hyperresponsiveness. CONCLUSION: Following exposure to the WTC disaster, the patients in our cohort developed allergic hypersensitivity and severe lung injury with only partial reversibility.