Robotic Versus Navigation Assisted Posterior Lumbar Fusion: A National Database Study.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Compare perioperative adverse events and reoperations between navigation-assisted and robotic-assisted posterior lumbar fusion. SUMMARY OF BACKGROUND DATA: Navigation has become increasingly utilized for posterior lumbar fusion (PLF). More recently, robotic assistance systems have been gaining traction. However, the incremental advantage of these systems has been unclear in the literature. METHODS: Patients undergoing one to three level PLF (with or without anterior or posterior interbody fusion) were identified from the 2015-2022 M161Ortho PearlDiver Database using CPT codes. Navigation assistance was identified based on CPT coding and robotic assistance was based on ICD-10 procedural coding. Navigation-assisted cases were matched 4:1 to robotic assisted patients based on age, sex, Elixhauser Comorbidity Index, number of levels fuse, and concomitant anterior fusion. Incidence of 90-day adverse outcomes were assessed and compared with multivariable logistical regression. Bonferroni correction was applied for multiple testing. Rate of reoperation was assessed using a Kaplan-Meier survival analysis. RESULTS: From 2015 to 2022, there has been a significant increase in both navigation and robotic assisted lumbar fusions, with navigation-assisted surgery being significantly more common. After matching, there were 2,401 navigation-assisted cases and 651 robotic-assisted cases. On multivariate analysis, there no significant differences in 90-day any, severe, or minor adverse events. There was a significant increase odd of readmissions in the robotic cohort (OR: 1.77, P<0.001). There were no differences in three-year reoperation rates between the navigation-assisted and robotic-assisted cohorts (95.8% versus 94.0%, P=0.30). CONCLUSIONS: As spinal navigation has been gaining popularity and robotic assistance is starting to be further utilized, the incremental advantage of different techniques may be questioned. While further study and technique evolution are ongoing, the current study was not able to demonstrate 90-day or 3-year incremental advantages for robotics relative to navigation based on the metrics evaluated.

A 10-year perspective on the question of whether surgeries for adolescent idiopathic scoliosis are "one and done"?

PURPOSE: Posterior scoliosis fusion (PSF) for adolescent idiopathic scoliosis (AIS) is considered a highly successful surgery with excellent outcomes. However, especially as many patients "graduate" from their pediatric surgeons, there is the need to quantify the long-term outcomes of such surgeries. METHODS: The 2010-2022 Pearldiver M161 dataset was queried for those who were 10 to 18 years old with AIS undergoing PSF with at least 10 years follow-up. Patient characteristics were abstracted. Reoperations were identified based on coding for any subsequent thoracic/lumbar surgery/revision. The 10-year reoperation rate and reasons for reoperation were determined, and multivariate regression was performed to determine risk factors. RESULTS: In total, 3,373 AIS PSF patients were identified. Of the study cohort, 324 (9.6%) underwent reoperation within 10-years with an interquartile range for timing of surgery of 81-658 days, of which 29.6% were done for infection. Reoperations were done within the first three months for 152 (46.9% of reoperations), three months to 2 years for 97 (29.9%), and 2 years to 10 years for 74 (22.8%). Based on multivariate regression, need for reoperation was associated with male sex (OR: 1.70), asthma (OR: 1.36) and greater than thirteen segments of instrumentation (OR: 1.48) (p < 0.05 for each) but not age, other comorbidities, or insurance. CONCLUSIONS: The current study of a large national AIS PSF population found 9.6% to undergo reoperation in the 10 years following their index operation. Although specifics about the curve pattern could not be determined, the reoperation incidence and correlation with specific risk factors are notable and important for patient counselling.

Physical Therapy Utilization Following Single Level Posterior Lumbar Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Characterize physical therapy (PT) utilization following single-level posterior lumbar fusion (PLF). SUMMARY OF BACKGROUND DATA: PLF is a common procedure that is increasing in frequency. Following such surgeries, PT may be considered to facilitate mobilization and return to activities. However, the usage of such therapy has not been well-characterized in the literature. METHODS: Patients undergoing single-level PLF were identified from the 2010-2021 PearlDiver administrative database. These patients were stratified based on usage of therapy, home versus outpatient therapy, and timing of therapy within the year following surgery. To determine predictors of therapy, patient characteristics were determined and multivariable regressions were performed. RESULTS: A total of 213,240 patients undergoing single-level PLF were identified, of which therapy was done in the year following surgery for 63,231 (29.0%, of which home therapy accounted for 16.5% of therapy visits). Of those who utilized PT, the average number of visits was 10.6±10.6. Home therapy peaked within the first month following surgery and outpatient therapy peaked at month two. Factors associated with any PT following PLF in decreasing odds ratio (OR) were: having commercial insurance (OR: 1.68), being from the Northeast (OR:1.41), age (OR: 1.13 for 70+ of age) female sex (OR: 1.09), and ECI (OR: 1.04 per point) (P<0.001 for all). Of those who received therapy, factors associated with home PT utilization were: being from the Northeast (OR: 2.55), age (OR: 1.91 for 70+ of age), Medicaid insurance (OR: 1.48), female sex (OR: 1.39), and interbody fusion (OR:1.07) (P<0.001 for all). CONCLUSIONS: Following single-level PLF, the minority of patients received home or outpatient PT. Of those that did, there was significant variation in the number of visits, with nonmedical factors such as insurance plan and geographic region being strongly associated suggesting room for more consistent practice patterns. LEVEL OF EVIDENCE: III.

Low Back Pain: Utilization of Urgent Cares Relative to Emergency Departments.

STUDY DESIGN/SETTING: Retrospective study. OBJECTIVE: To understand why patients utilize emergency departments (EDs) versus urgent care centers for low back pain (LBP). SUMMARY OF BACKGROUND DATA: LBP is a common reason for ED visits. In the setting of trauma or recent surgery, the resources of EDs may be needed. However, urgent care centers may be appropriate for other cases. MATERIALS AND METHODS: Adult patients below 65 years of age presenting to the ED or urgent care on the day of diagnosis of LBP were identified from the 2019 PearlDiver M151 administrative database. Exclusion criteria included history of radiculopathy or sciatica, spinal surgery, spinal cord injury, other traumatic, neoplastic, or infectious diagnoses in the 90 days prior, or Medicare insurance. Patient age, sex, Elixhauser comorbidity index, geographic region, insurance, and management strategies were extracted. Factors associated with urgent care relative to ED utilization were assessed using multivariable analysis. RESULTS: Of 356,284 LBP patients, ED visits were identified for 345,390 (96.9%) and urgent care visits for 10,894 (3.1%). Factors associated with urgent care use relative to the ED were: geographic region [relative to Midwest; Northeast odds ratio (OR): 5.49, South OR: 1.54, West OR: 1.32], insurance (relative to Medicaid; commercial OR: 4.06), lower Elixhauser comorbidity index (OR: 1.28 per two-point decrease), and higher age (OR: 1.10 per decade), female sex (OR: 1.09), and use of advanced imaging (OR: 0.08) within 1 week ( P <0.001 for all). CONCLUSIONS: Most patients presenting for a first diagnosis of isolated LBP went to the ED relative to urgent care. The greatest drivers of urgent care versus ED utilization for LBP were insurance type and geographic region. Utilization of advanced imaging was higher among ED patients, but rates of surgical intervention were similar between those seen in the ED and urgent care.

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.

Rheumatoid arthritis patients are at increased risk for adverse events following lumbar discectomy.

BACKGROUND CONTEXT: Lumbar discectomy is a common procedure for which patients with rheumatoid arthritis (RA) may be considered. RA is an autoinflammatory disease that may predispose patients to postoperative adverse outcomes. PURPOSE: To assess the relative odds of adverse events after lumbar discectomy for those with versus without RA in a large, national, administrative dataset. STUDY DESIGN/SETTING: Retrospective cohort study using the 2010 to 2020 MSpine PearlDiver dataset. PATIENT SAMPLE: After exclusion of patients under 18 years old, those with any trauma, neoplasm, or infection diagnosis within the month before lumbar discectomy, and any patients who had any alternative lumbar spinal surgery performed on the same day as lumbar discectomy, we identified 36,479 lumbar discectomy patients. 2,937 (8.1%) of these patients had a prior diagnosis of RA. After matching 4:1 by patient age, sex, and Elixhauser Comorbidity Index (ECI, a longitudinal measure of patient comorbidity burden generated via ICD-9 and 10 diagnosis codes), 8,485 lumbar discectomy patients without RA and 2,149 with RA were included. OUTCOME MEASURES: Incidence of severe and minor adverse events in the 90-days following lumbar discectomy, predictive factors for adverse events within 90-days of lumbar discectomy, risk of adverse events within 90-days of lumbar discectomy stratified by patient medication regimen, 5-year survival to reoperation following lumbar discectomy. METHODS: Patients undergoing lumbar discectomy were identified from the PearlDiver MSpine dataset. The subset of those with versus without RA were identified and matched 1:4 based on patient age, sex, and ECI scores. The incidence of 90-day adverse events in the two groups was determined and compared by univariate and multivariate analyses. Subgroup analysis was performed based on RA medications being taken. RESULTS: Matched lumbar discectomy patients with RA (n=2,149) and without RA (n=8,485) were identified. Controlling for patient age, sex, and ECI, those with RA were at significantly higher odds of any (odds ratio [OR] 3.30), severe (OR 2.78), and minor (OR 3.30) adverse events (p<.0001 for all). Stratifying by medications being taken (and relative to those without RA), there was increasing odds of all adverse events (AAE) based on potency of medications (no biologic or disease modifying antirheumatic drugs [DMARDs] OR 2.33, DMARDs only OR 3.86, biologic±DMARDs OR 5.69 (p<.0001 for all). Despite this, no statistically significant difference in 5-year survival from subsequent lumbar surgery was found between those with versus without RA (p=.1000). CONCLUSIONS: Lumbar discectomy patients with RA were found to be at significantly higher risk for 90-day adverse events following lumbar discectomy, and this was incrementally greater for those on increasingly suppressive medications. Lumbar discectomy patients with RA bear specific consideration and perioperative monitoring when considered for lumbar discectomy.

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.

Home and Outpatient Physical Therapy Utilization Following Total Ankle Replacement.

Background: Physical therapy (PT) following total ankle replacement (TAR) is often considered, but guidelines for its use are not standardized. Although patient factors may dictate recommendations, this retrospective cohort study aims to characterize baseline utilization practices to set the stage for establishing generalizable recommendations. Methods: TAR patients were identified from the 2010-2019 M91 Ortho PearlDiver data set based on administrative coding. Patient factors were extracted, including age, sex, Elixhauser Comorbidity Index (ECI), region of the country in which patients' surgery was performed (Midwest, Northeast, South, West), and insurance plan (commercial, Medicaid, Medicare). The incidence, timing, and frequency of home or outpatient PT utilization in the 90 days following TAR were identified. Inpatient PT was not captured. Univariate and multivariate logistic regression analyses allowed identification of predictive factors for PT utilization. Results: Of 5412 TAR patients identified, postoperative PT services were used by 2453 (45.3%). Most PT was outpatient (38.3% of the study population) compared to home (4.1% of the study population). Weekly utilization of PT was greatest in the first week following surgery (17.7% of PT visits) and thereafter followed a roughly bell-shaped curve, with utilization greatest at 7 weeks following surgery (14.9% of PT visits).Independent predictors of PT utilization following TAR included having surgery performed in the Midwest (relative to the South, OR 1.37, P < .0001), Northeast (OR 1.20, P = .0217), or West (OR 1.26, P < .0021) and having commercial (relative to Medicare, OR 1.87, P < .0001) or Medicaid insurance (OR 1.46, P = .0239). Conclusion: Of 5412 TAR patients, 42.5% used PT within 90 days of surgery. PT utilization was highest in the first and seventh weeks following surgery, and demographic predictors of PT use were defined. Through identification of timing and predictors of PT utilization following TAR, PT care pathways may be better defined. Level of Evidence: Level III, retrospective cohort study.

Emergency Department Visits Within 90 Days of Total Ankle Replacement.

Background: Total ankle replacement (TAR) utilization in the United States has steeply increased in recent decades. Emergency department (ED) visits following TAR impacts patient satisfaction and health care costs and warrant exploration. Methods: This retrospective cohort study utilized the 2010 to 2019 M91Ortho PearlDiver data set to identify TAR patients with at least 90 days of follow-up. PearlDiver contains billing claims data across all sites of care throughout the United States for all indications for care. Patient factors extracted included age, sex, Elixhauser Comorbidity Index (ECI), region of the country in which surgery was performed, insurance plan, and postoperative hospital length of stay. Ninety-day postoperative ED visit incidence, timing, frequency, and primary diagnoses were identified and compared to 1-year postoperative ED visit baseline data. Univariate and multivariate logistic regression analyses were used to determine risk factors for ED visits. Results: Of 5930 TAR patients identified, ED visits within 90 days were noted for 497 (8.4%) patients. Of all ED visits, 32.0% occurred within 2 weeks following surgery. Multivariate analysis revealed several predictors of ED utilization: younger age (odds ratio [OR] 1.35 per decade decrease), female sex (OR 1.20), higher ECI (OR 1.32 per 2-point increase), TAR performed in the western US (OR 1.34), and Medicaid coverage (OR 2.70; 1.71-4.22 relative to Medicare) (P < .05 each). Surgical site issues comprised 78.0% of ED visits, with surgical site pain (57.0%) as the most common problem. Conclusion: Of 5930 TAR patients, 8.4% returned to the ED within 90 days of surgery, with predisposing demographic factors identified. The highest incidence of ED visits was in the first 2 postoperative weeks, and surgical site pain was the most common reason. Pain management pathways following TAR should be able to be adjusted to minimize the occurrence of postoperative ED visits, thereby improving patient experiences and decreasing health care utilization/costs. Level of Evidence: Level III, retrospective cohort study.

Risk factors for venous thromboembolism following fractures isolated to the foot and ankle fracture.

OBJECTIVE: Venous thromboembolism (VTE) is an uncommon, but potentially morbid, complication following foot and ankle fractures. Current standard is to not administer thromboprophylaxis to patients with such injuries. Nonetheless, patient and fracture factors might affect this risk/benefit consideration. The goal of this study was to determine what patients are most at risk. METHODS: The M53Ortho Pearldiver database was used to identify patients with fractures isolated to the foot and ankle that were treated non-operatively or operatively. Patients with pilon, other appendicular fractures remote from the foot and ankle, and other traumatic injuries were excluded. The 90-day occurrence of VTE was identified based on codes for deep vein thrombosis or pulmonary embolism. Characteristics of those patients who did and did not have VTEs were compared using chi-square analyses. Multivariate logistical regression was then performed to determined factors independently associated with VTE. Finally, timing of VTE relative to fracture was analyzed. RESULTS: A total of 298,886 patients with isolated foot or ankle fractures were identified, of which 1,661 (0.56%) had VTE in the 90 days following fracture. In terms of timing, 27.3% occurred in the first week, and 49.8% occurred in the first three weeks. Independent risk factors for VTE included (in decreasing order):prior VTE (odd ratio [OR] = 25.44), factor V Leiden (OR = 24.34), active cancer (OR = 1.84), specific fracture relative to metatarsal fracture (multiple fractures [OR: 1.51], ankle fracture [OR = 1.51], and calcaneus fracture [OR = 1.24]), surgical treatment (OR = 1.41), male sex (OR = 1.19), greater Elixhauser index (OR = 1.05), and increasing age (OR:1.05 per decade) (p<0.05 for each). CONCLUSIONS: The present study found that, although only 0.56% of isolated foot and ankle fractures had a VTE within ninety days. Defined risk factors, such as Factor V Leiden, prior VTE, surgical treatment, active cancer, specific fracture patterns, and surgical treatment significantly affected the odds of their occurrence.

Single-level posterior lumbar fusions in patients with Ehlers Danlos Syndrome not found to be associated with increased postoperative adverse events or five-year reoperations.

Background: Ehlers Danlos Syndrome (EDS) is a rare connective tissue disorder that results from mutations in collagen genes. Potentially related to laxity and resultant degenerative changes, adult EDS patients may require posterior lumbar fusion (PLF). However, with low numbers, adequately powered outcome studies have been limited. The purpose of this study was to investigate risk of complications, readmissions and reoperations in adult patients with EDS following single-level PLF. Methods: A retrospective study using the 2010 to 2020 MSpine Pearldiver dataset was performed. Adult patients undergoing single-level PLF (excluding any with anterior procedures) with and without EDS for which at least 90-day follow up was available were identified. Any cases performed for trauma, tumor, or infection were excluded.Single-level PLF EDS patients were then matched 1:4 with PLF non-EDS patients based on age, sex, and Elixhauser Comorbidity Index (ECI). Rates of ninety-day any, severe, and minor adverse events as well as readmissions were tabulated and compared with chi-square tests. Multivariate logistical regression was then performed (controlling for age, sex, and ECI).Reoperation surgeries over five years were assessed, Kaplan-Meier survival curves generated, and curves of those with and without EDS were compared with log rank test. Results: In total, there were 170,100 single-level PLF case identified, of which 242 (0.14%) had EDS. After matching, there were 957 without EDS and 239 with EDS. On multivariate regression, there were no significant differences in 90-day any, severe, or minor adverse events, or readmissions (p>0.05 for each). Over five years, there were also not significant differences in rates of reoperation (p> 0.05). Conclusions: For EDS patients undergoing PLF, the current study identified similar 90-day adverse events and 5-year reoperation rates compared to those without EDS. These findings may be useful for patient counseling and surgical planning for those with this rare condition.

Analysis of factors leading to early termination in glioblastoma-related clinical trials.

PURPOSE: Terminated clinical trials are an inefficient use of financial, patient, and administrative resources. We reviewed ClinicalTrials.gov for completed and terminated clinical trials for glioblastoma multiforme (GBM) and compared reported characteristics of completed and terminated trials to identify factors associated with early trial termination. METHODS: ClinicalTrials.gov was queried to identify all completed and terminated GBM-related clinical trials. Trial characteristics were examined and the reason for trial termination was determined. Univariate analysis by Pearson's chi-square and a multivariate logistic regression were performed to identify independent predictors of early trial termination. RESULTS: We identified 886 completed and terminated GBM-related trials between 2003 and 2020. Of these, 175 (19.8%) were terminated prior to completion. The most common reason for termination was participant accrual difficulties, accounting for 63 (36.0%) terminated trials. Trial termination was associated with trials that reported a primary purpose of diagnosis relative to treatment (OR = 2.952, p = 0.001). CONCLUSION: Early termination of clinical trials investigating interventions for the treatment of GBM is associated with diagnostic trials relative to therapeutic trials. Patient accrual difficulties are the most commonly identified reason for early trial termination. Predictors of trial termination should be considered when designing GBM-related clinical trials to minimize the odds of early trial termination.

Emergency department visits within 90 days of single-level anterior cervical discectomy and fusion.

Background: Postoperative readmissions are a commonly used metric for quality-of-care initiatives, but emergency department (ED) visits have received far less attention despite their substantial impact on patient satisfaction and healthcare spending. The current study described the incidence and timing of ED visits following single-level ACDF, determined predictive factors and reasons for ED utilization, and compared reimbursement for patients with and without ED use. Methods: Single-level ACDF procedures from 2010-2020 were identified in PearlDiver using CPT codes. Patients' age, sex, Elixhauser comorbidity index (ECI) score, region of the country, and insurance coverage were extracted. The incidence, timing, and primary diagnoses for 90-day ED visits and readmissions were determined, as well as total 90-day reimbursement. Variables were compared using univariate analysis and multivariate logistic regression. Results: Out of 90,298 patients, 90-day ED visits were identified for 10,701 (11.9%), with the greatest incidence in postoperative weeks 1-2. Readmissions were identified for 3,325 (3.7%) patients. Independent predictors of ED utilization included younger age (OR 1.25 per 10-year decrease, p<0.001), greater ECI score (OR 1.40 per 2-point increase, p<0.001), and insurance type (relative to Medicare, Medicaid [OR 2.15, p<0.001] and commercial plans [OR 1.14, p=0.004]). In postoperative weeks 1-2, 51% of primary ED diagnoses involved the surgical site, while 23% involved the surgical site in weeks 3-13. Compared to patients without ED visits, those who visited the ED had 65% greater mean 90-day reimbursement (p<0.001). Conclusions: More than three times as many patients in the current study were found to present to the ED than be readmitted within ninety days of surgery. The identified predictive factors and reasons for ED visits can direct attention to high-risk patients and common postoperative issues. Additional postoperative counseling and integrated care pathways may reduce ED visits, thereby improving patient care and reducing healthcare spending.

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.

Adverse Events After Posterior Lumbar Fusion Are Not Sufficiently Characterized With 30-day Follow-up: A Database Study.

INTRODUCTION: Many studies track outcomes after procedures, such as posterior lumbar fusion (PLF), for only 30 days because of database limitations. However, adverse events may not have plateaued by this time. Thus, this study used an alternate database to evaluate the timing of adverse events for 90 days after PLF. METHODS: Adult PLF patients were identified from the 2010 to 2020 Q2 M53Ortho PearlDiver administrative data set. Ninety-day rates of multiple adverse events were determined. The time of diagnosis for each event in the 90-day postoperative period was determined. Data were dichotomized by occurrence in days 0 to 30 and 31 to 90. Median, interquartile range, and middle 80% for the time of diagnosis were determined for each adverse event. RESULTS: Of 51,915 patients undergoing PLF, 7,141 (13.8%) had an adverse event within 90 days of PLF. Of these, 5,174 (72.5%) experienced an event within 30 days and 2,544 (35.6%) after 30 days. For individual adverse outcomes studied, the percent that occurred 31 to 90 days after surgery ranged from 9% to 42%. The time of diagnosis (median; interquartile range; middle 80%) for each adverse event was as follows: transfusion (2 days; 2 to 5 days; 1 to 26 days), acute kidney injury (9; 2 to 29; 1 to 60), hematoma (9; 4 to 20; 3 to 39), cardiac event (11; 3 to 43; 1 to 71), pneumonia (12; 4 to 38; 2 to 68), venous thromboembolism (15; 6 to 33; 3 to 62), sepsis (19; 9 to 39; 4 to 63), surgical site infection (21; 14 to 34; 8 to 48), urinary tract infection (22; 8 to 49; 4 to 72), and wound dehiscence (27; 17 to 39; 9 to 54). DISCUSSION: This study highlights the importance of looking past the 30-day mark for adverse events after PLF because approximately one-third of adverse events in this study were diagnosed 31 to 90 days after surgery. This can affect research studies, patient counseling about the incidence of specific adverse events, and the development of mechanisms for surveillance at key time points.

Emergency Department Visits Within 90 Days of Anterior Cruciate Ligament Reconstruction.

Background: Emergency department (ED) visits after orthopaedic surgery such as anterior cruciate ligament reconstruction (ACLR) affect patients and health care systems and should be better understood. Purpose: To determine the incidence, predictors, and reasons for ED visits within 90 days after ACLR. Study Design: Descriptive epidemiologic study. Methods: Patients who had undergone ACLR between 2010 and 2020 were identified in a national database, and 90-day ED visits, readmissions, risk factors, and primary diagnoses for visits were determined. One-year postoperative data were used to establish baseline weekly ED visits for the cohort. Patient age, sex, Elixhauser comorbidity index, region of the country (Northeast, Midwest, West, South), and insurance coverage (Medicare, Medicaid, and commercial) were extracted, and these variables were compared using univariate analysis and multivariate logistic regression. Results: Out of 81,179 patients, ED visits were identified for 6764 (8.3%), and readmissions were identified for 592 (0.7%). Overall, 5300 patients had 1 ED visit, 1020 patients had 2 visits, 275 patients had 3 visits, and 169 patients had ≥4 or more visits; visits occurred within 2 weeks of surgery 38% of the time. Notably, weekly visits returned to baseline at week 3. Independent predictors of ED utilization from multivariate analysis were insurance type (relative to commercial insurance: Medicaid [odds ratio [OR], 2.41; 95% CI, 2.23-2.60] and Medicare [OR, 1.38; 95% CI, 1.19-1.60]), higher Elixhauser comorbidity index (per 2-point increase: OR, 2.24; 95% CI, 2.18-2.29), younger age (per 10-year decrease: OR, 1.23; 95% CI, 1.21-1.24), female sex (OR, 1.05; 95% CI, 1.02-1.08), and region of the country (relative to the West: Midwest [OR, 1.33; 95% CI, 1.26-1.39], Northeast [OR, 1.24; 95% CI, 1.18-1.30], and South [OR, 1.17; 95% CI, 1.12-1.23]). In the first 2 weeks, 67.5% of ED visits were for issues involving the surgical site, most commonly surgical-site pain (29% of all visits). In the total 90-day period, 39.4% of visits involved the surgical site. Conclusion: Within 90 days of ACLR, >8% of patients visited the ED, while 0.7% were readmitted. ED visits increased in the first 2 postoperative weeks and returned to baseline rates around week 3. Within the first 2 weeks, two-thirds of visits involved the surgical site. Younger patients, patients with greater comorbidity burden, those in certain regions of the country, and those with Medicaid had greater odds of ED utilization.

Clinical outcomes following one-, two-, three-, and four-level anterior cervical discectomy and fusion: a national database study.

BACKGROUND CONTEXT: Anterior cervical discectomy and fusion (ACDF) is a common surgical procedure. There is markedly less data on outcomes after three- and four-level cases than one- and two-level cases. PURPOSE: To compare perioperative 90-day adverse events and 5-year reoperation rates between isolated one-, two-, three-, and four-level ACDF cases. STUDY DESIGN/SETTING: Retrospective review of a large national database. PATIENT SAMPLE: Overall, 97,081 patients undergoing ACDF were identified, of which one-level cases were 42,382 (43.7%), two-level cases were 24,055 (24.8%), three-level cases were 28,293 (29.1%), and four-level cases were 2,361 (2.4%). OUTCOME MEASURES: Ninety-day adverse events and 5-year reoperation rates. METHODS: The 2010 to Q1 2020 PearlDiver database was queried to identify patients who underwent elective ACDF for degenerative pathology without corpectomy or concomitant posterior procedures. Univariate and multivariate analyses were performed to compare outcomes of subcohorts with varying number of levels addressed by ACDF. RESULTS: Of the 97,081 cases identified, patient characteristics and complication rates differed between the cohorts defined by levels treated. Univariate analyses revealed statistically different rates of 90-day any, serious, and minor adverse event rates between the groups, but the differences were all less than 2.5%. Readmission rates were statistically different by 2.9%, dysphagia by 3.2%, and prolonged length of stay by 6.3%.By multivariate analyses, three-level ACDF cases were not found to have greater 90-day adverse outcomes than two-level cases. Four-level ACDF cases were found to have significantly greater odds ratios of readmission, dysphagia, and prolonged length of stay (relative to one-level cases, OR 1.28, 1.63, and 1.97, respectively) but not other 90-day adverse events. Reoperation rates at five years for one-, two-, three-, and four-level cases were 13.0%, 13.5%, 15.0%, and 22.1%, respectively (log-rank p<.001). CONCLUSIONS: The current study represents one of the largest comparative studies of patients undergoing one-, two-, three-, and four-level ACDF. While odds of 90-day adverse events were not greater for three- versus two-level cases, four-level cases had several that were higher odds than one-level cases. Reoperation and dysphagia rates were higher for four-level cases than lesser levels. While these outcomes were found to be acceptable, they should help guide hospital planning and patient counseling.