Review of mechanisms of expandable spine surgery devices.

INTRODUCTION: Expandable devices such as interbody cages, vertebral body reconstruction cages, and intravertebral body expansion devices are frequently utilized in spine surgery. Since the introduction of expandable implants in the early 2000s, the variety of mechanisms that drive expansion and implant materials have steadily increased. By examining expandable devices that have achieved commercial success and exploring emerging innovations, we aim to offer an in-depth evaluation of the different types of expandable cages used in spine surgery and the underlying mechanisms that drive their functionality. AREAS COVERED: We performed a review of expandable spinal implants and devices by querying the National Library of Medicine MEDLINE database and Google Patents database from 1933 to 2024. Five major types of mechanical jacks that drive expansion were identified: scissor, pneumatic, screw, ratchet, and insertion-expansion. EXPERT OPINION: We identified a trend of screw jack mechanism being the predominant machinery in vertebral body reconstruction cages and scissor jack mechanism predominating in interbody cages. Pneumatic jacks were most commonly found in kyphoplasty devices. Critically reviewing the mechanisms of expansion and identifying trends among effective and successful cages allows both surgeons and medical device companies to properly identify future areas of development.

Exploring tribology and material contact science in spine surgery: implications for implant design.

Tribology, an interdisciplinary field concerned with the science of interactions between surfaces in contact and their relative motion, plays a well-established role in the design of orthopedic implants, such as knee and hip replacements. However, its applications in spine surgery have received comparatively less attention in the literature. Understanding tribology is pivotal in elucidating the intricate interactions between metal, polymer, and ceramic components, as well as their interplay with the native human bone. Numerous studies have demonstrated that optimizing tribological factors is key to enhancing the longevity of joints and implants while simultaneously reducing complications and the need for revision surgeries in both arthroplasty and spinal fusion procedures. With an ever-growing and diverse array of spinal implant devices hitting the market for static and dynamic stabilization of the spine, it is important to consider how each of these devices optimizes these parameters and what factors may be inadequately addressed by currently available technology and methods. In this comprehensive review, the authors' objectives were twofold: 1) delineate the unique challenges encountered in spine surgery that could be addressed through optimization of tribological parameters; and 2) summarize current innovations and products within spine surgery that look to optimize tribological parameters and highlight new avenues for implant design and research.

Ergonomics, musculoskeletal disorders, and surgeon gender in spine surgery: a survey of practicing spine surgeons.

OBJECTIVE: The objective of this study was to gain a greater understanding of the burden of musculoskeletal disorders (MSDs) in spine surgeons, their impact on practice, and risk factors contributing to MSDs, including surgical instrument design and surgical ergonomics. METHODS: An anonymous REDCap survey was distributed via email to the departments of several academic and private centers across the United States, as well as to the AANS/CNS Women in Neurosurgery Section email list. Chi-square tests and Wilcoxon rank-sum tests were used to compare responses by gender. Multivariable linear regression analysis was performed to identify predictors of discomfort in instrument utilization. RESULTS: Survey responses were received from 120 spine surgeons (29.1% response rate), of which 73 were included in the analysis. A very high number of respondents had experienced an MSD (70.4%), 38.2% had undergone treatment for at least one MSD, and 13.4% had lost time at work for at least one MSD. Women were more likely than men to have lost time at work due to an MSD (22.6% vs 5.6%, p = 0.04). Women were more likely than men to report difficulty in instrument grip, comfort, and use on a 20-point Likert scale (mean 10.7 vs 15.2 points, p < 0.0001). This effect persisted when adjusting for glove size and days per week spent operating (p = 0.002). Specifically, women were less likely to agree that the handles of surgical instruments were an appropriate grip (p < 0.0001), that they rarely experienced difficulty when using them (p < 0.0001), and that they rarely needed to use two hands with instruments meant to be used with one hand (p = 0.0002). CONCLUSIONS: The MSD burden in spine surgeons is substantial. While there was no evidence of gender differences in MSD rates and severity, female surgeons report significantly more discomfort with the use of surgical instruments. There is a need for more investigation of MSD risk factors in spine surgeons and mitigation strategies. Gender differences in comfort in instrument use should be further explored and addressed by spine surgeons and device manufacturers.

Implications of Preoperative Depression for Lumbar Spine Surgery Outcomes: A Systematic Review and Meta-Analysis.

Importance: Comorbid depression is common among patients with degenerative lumbar spine disease. Although a well-researched topic, the evidence of the role of depression in spine surgery outcomes remains inconclusive. Objective: To investigate the association between preoperative depression and patient-reported outcome measures (PROMs) after lumbar spine surgery. Data Sources: A systematic search of PubMed, Cochrane Database of Systematic Reviews, Embase, Scopus, PsychInfo, Web of Science, and ClinicalTrials.gov was performed from database inception to September 14, 2023. Study Selection: Included studies involved adults undergoing lumbar spine surgery and compared PROMs in patients with vs those without depression. Studies evaluating the correlation between preoperative depression and disease severity were also included. Data Extraction and Synthesis: All data were independently extracted by 2 authors and independently verified by a third author. Study quality was assessed using Newcastle-Ottawa Scale. Random-effects meta-analysis was used to synthesize data, and I2 was used to assess heterogeneity. Metaregression was performed to identify factors explaining the heterogeneity. Main Outcomes and Measures: The primary outcome was the standardized mean difference (SMD) of change from preoperative baseline to postoperative follow-up in PROMs of disability, pain, and physical function for patients with vs without depression. Secondary outcomes were preoperative and postoperative differences in absolute disease severity for these 2 patient populations. Results: Of the 8459 articles identified, 44 were included in the analysis. These studies involved 21 452 patients with a mean (SD) age of 57 (8) years and included 11 747 females (55%). Among these studies, the median (range) follow-up duration was 12 (6-120) months. The pooled estimates of disability, pain, and physical function showed that patients with depression experienced a greater magnitude of improvement compared with patients without depression, but this difference was not significant (SMD, 0.04 [95% CI, -0.02 to 0.10]; I2 = 75%; P = .21). Nonetheless, patients with depression presented with worse preoperative disease severity in disability, pain, and physical function (SMD, -0.52 [95% CI, -0.62 to -0.41]; I2 = 89%; P < .001), which remained worse postoperatively (SMD, -0.52 [95% CI, -0.75 to -0.28]; I2 = 98%; P < .001). There was no significant correlation between depression severity and the primary outcome. A multivariable metaregression analysis suggested that age, sex (male to female ratio), percentage of comorbidities, and follow-up attrition were significant sources of variance. Conclusions and Relevance: Results of this systematic review and meta-analysis suggested that, although patients with depression had worse disease severity both before and after surgery compared with patients without depression, they had significant potential for recovery in disability, pain, and physical function. Further investigations are needed to examine the association between spine-related disability and depression as well as the role of perioperative mental health treatments.

Reliability of a Novel Classification System for Thoracic Disc Herniations.

STUDY DESIGN: This is a cross-sectional survey. OBJECTIVE: The aim was to assess the reliability of a proposed novel classification system for thoracic disc herniations (TDHs). SUMMARY OF BACKGROUND DATA: TDHs are complex entities varying substantially in many factors, including size, location, and calcification. To date, no comprehensive system exists to categorize these lesions. METHODS: Our proposed system classifies 5 types of TDHs using anatomic and clinical characteristics, with subtypes for calcification. Type 0 herniations are small (≤40% of spinal canal) TDHs without significant spinal cord or nerve root effacement; type 1 are small and paracentral; type 2 are small and central; type 3 are giant (>40% of spinal canal) and paracentral; and type 4 are giant and central. Patients with types 1 to 4 TDHs have correlative clinical and radiographic evidence of spinal cord compression. Twenty-one US spine surgeons with substantial TDH experience rated 10 illustrative cases to determine the system's reliability. Interobserver and intraobserver reliability were determined using the Fleiss kappa coefficient. Surgeons were also surveyed to obtain consensus on surgical approaches for the various TDH types. RESULTS: High agreement was found for the classification system, with 80% (range 62% to 95%) overall agreement and high interrater and intrarater reliability (kappa 0.604 [moderate to substantial agreement] and kappa 0.630 [substantial agreement], respectively). All surgeons reported nonoperative management of type 0 TDHs. For type 1 TDHs, most respondents (71%) preferred posterior approaches. For type 2 TDHs, responses were roughly equivalent for anterolateral and posterior options. For types 3 and 4 TDHs, most respondents (72% and 68%, respectively) preferred anterolateral approaches. CONCLUSIONS: This novel classification system can be used to reliably categorize TDHs, standardize description, and potentially guide the selection of surgical approach. Validation of this system with regard to treatment and clinical outcomes represents a line of future study.

Factors affecting retirement and workforce attrition in neurosurgery: results of a Council of State Neurosurgical Societies national survey.

OBJECTIVE: By 2030, the US will not have enough neurosurgeons to meet the clinical needs of its citizens. Replacement of neurosurgeons due to attrition can take more than a decade, given the time-intensive training process. To identify potential workforce retention targets, the authors sought to identify factors that might impact neurosurgeons' retirement considerations. METHODS: The Council of State Neurosurgical Societies surveyed practicing AANS-registered neurosurgeons via email link to an online form with 25 factors that were ranked using a Likert scale of importance regarding retirement from the field (ranging from 1 for not important to 3 for very important). All participants were asked: "If you could afford it, would you retire today?" RESULTS: A total of 447 of 3200 neurosurgeons (14%) responded; 6% had been in practice for less than 5 years, 19% for 6-15 years, 57% for 16-30 years, and 18% for more than 30 years. Practice types included academic (18%), hospital employed (31%), independent with academic appointment (9%), and full independent practice (39%). The most common practice size was between 2 and 5 physicians (46%), with groups of 10 or more being the next most common (20%). Career satisfaction, income, and the needs of patients were rated as the most important factors keeping neurosurgeons in the workforce. Increasing regulatory burden, decreasing clinical autonomy, and the burden of insurance companies were the highest rated for factors important in considering retirement. Subgroup analysis by career stage, practice size, practice type, and geographic region revealed no significant difference in responses. When considering if they would retire now, 45% of respondents answered "yes." Subgroup analysis revealed that midcareer neurosurgeons (16-25 years in practice) were more likely to respond "yes" than those just entering their careers or in practice for more than 25 years (p = 0.03). This effect was confirmed in multivariate logistic regression (p = 0.04). These surgeons found professional satisfaction (p = 0.001), recertification requirements (p < 0.001), and maintaining high levels of income (p = 0.008) important to maintaining employment within the neurosurgical workforce. CONCLUSIONS: This study demonstrates that midcareer neurosurgeons may benefit from targeted retention efforts. This effort should focus on maximizing professional satisfaction and financial independence, while decreasing the regulatory burden associated with certification and insurance authorization. End-of-career surgeons should be surveyed to determine factors contributing to resilience and persistence within the neurosurgical workforce.

Catalytic antioxidant nanoparticles mitigate secondary injury progression and promote functional recovery in spinal cord injury model.

Traumatic spinal cord injury exacerbates disability with time due to secondary injury cascade triggered largely by overproduction of reactive oxygen species (ROS) at the lesion site, causing oxidative stress. This study explored nanoparticles containing antioxidant enzymes (antioxidant NPs) to neutralize excess ROS at the lesion site and its impact. When tested in a rat contusion model of spinal cord injury, a single dose of antioxidant NPs, administered intravenously three hours after injury, effectively restored the redox balance at the lesion site, interrupting the secondary injury progression. This led to reduced spinal cord tissue inflammation, apoptosis, cavitation, and inhibition of syringomyelia. Moreover, the treatment reduced scar tissue forming collagen at the lesion site, protected axons from demyelination, and stimulated lesion healing, with further analysis indicating the formation of immature neurons. The ultimate effect of the treatment was improved motor and sensory functions and rapid post-injury weight loss recovery. Histological analysis revealed activated microglia in the spinal cord displaying rod-shaped anti-inflammatory and regenerative phenotype in treated animals, contrasting with amoeboid inflammatory and degenerative phenotype in untreated control. Overall data suggest that restoring redox balance at the lesion site shifts the dynamics in the injured spinal cord microenvironment from degenerative to regenerative, potentially by promoting endogenous repair mechanisms. Antioxidant NPs show promise to be developed as an early therapeutic intervention in stabilizing injured spinal cord for enhanced recovery.

A Pilot Remote Curriculum to Enhance Resident and Medical Student Understanding of Machine Learning in Healthcare.

BACKGROUND: Despite the expanding role of machine learning (ML) in health care and patient expectations for clinicians to understand ML-based tools, few for-credit curricula exist specifically for neurosurgical trainees to learn basic principles and implications of ML for medical research and clinical practice. We implemented a novel, remotely delivered curriculum designed to develop literacy in ML for neurosurgical trainees. METHODS: A 4-week pilot medical elective was designed specifically for trainees to build literacy in basic ML concepts. Qualitative feedback from interested and enrolled students was collected to assess students' and trainees' reactions, learning, and future application of course content. RESULTS: Despite 15 interested learners, only 3 medical students and 1 neurosurgical resident completed the course. Enrollment included students and trainees from 3 different institutions. All learners who completed the course found the lectures relevant to their future practice as clinicians and researchers and reported improved confidence in applying and understanding published literature applying ML techniques in health care. Barriers to ample enrollment and retention (e.g., balancing clinical responsibilities) were identified. CONCLUSIONS: This pilot elective demonstrated the interest, value, and feasibility of a remote elective to establish ML literacy; however, feedback to increase accessibility and flexibility of the course encouraged our team to implement changes. Future elective iterations will have a semiannual, 2-week format, splitting lectures more clearly between theory (the method and its value) and application (coding instructions) and will make lectures open-source prerequisites to allow tailoring of student learning to their planned application of these methods in their practice and research.

Surgical classification using natural language processing of informed consent forms in spine surgery.

OBJECTIVE: In clinical spine surgery research, manually reviewing surgical forms to categorize patients by their surgical characteristics is a crucial yet time-consuming task. Natural language processing (NLP) is a machine learning tool used to adaptively parse and categorize important features from text. These systems function by training on a large, labeled data set in which feature importance is learned prior to encountering a previously unseen data set. The authors aimed to design an NLP classifier for surgical information that can review consent forms and automatically classify patients by the surgical procedure performed. METHODS: Thirteen thousand two hundred sixty-eight patients who underwent 15,227 surgeries from January 1, 2012, to December 31, 2022, at a single institution were initially considered for inclusion. From these surgeries, 12,239 consent forms were classified based on the Current Procedural Terminology (CPT) code, categorizing them into 7 of the most frequently performed spine surgeries at this institution. This labeled data set was split 80%/20% into train and test subsets, respectively. The NLP classifier was then trained and the results demonstrated its performance on the test data set using CPT codes to determine accuracy. RESULTS: This NLP surgical classifier had an overall weighted accuracy rate of 91% for sorting consents into correct surgical categories. Anterior cervical discectomy and fusion had the highest positive predictive value (PPV; 96.8%), whereas lumbar microdiscectomy had the lowest PPV in the testing data (85.0%). Sensitivity was highest for lumbar laminectomy and fusion (96.7%) and lowest for the least common operation, cervical posterior foraminotomy (58.3%). Negative predictive value and specificity were > 95% for all surgical categories. CONCLUSIONS: Utilizing NLP for text classification drastically improves the efficiency of classifying surgical procedures for research purposes. The ability to quickly classify surgical data can be significantly beneficial to institutions without a large database or substantial data review capabilities, as well as for trainees to track surgical experience, or practicing surgeons to evaluate and analyze their surgical volume. Additionally, the capability to quickly and accurately recognize the type of surgery will facilitate the extraction of new insights from the correlations between surgical interventions and patient outcomes. As the database of surgical information grows from this institution and others in spine surgery, the accuracy, usability, and applications of this model will continue to increase.

Representativeness of the American Spine Registry: a comparison of patient characteristics with the National Inpatient Sample.

OBJECTIVE: The American Spine Registry (ASR) is a collaborative effort between the American Academy of Orthopaedic Surgeons and the American Association of Neurological Surgeons. The goal of this study was to evaluate how representative the ASR is of the national practice with spinal procedures, as recorded in the National Inpatient Sample (NIS). METHODS: The authors queried the NIS and the ASR for cervical and lumbar arthrodesis cases performed during 2017-2019. International Classification of Diseases, 10th Revision and Current Procedural Terminology codes were used to identify patients undergoing cervical and lumbar procedures. The two groups were compared for the overall proportion of cervical and lumbar procedures, age distribution, sex, surgical approach features, race, and hospital volume. Outcomes available in the ASR, such as patient-reported outcomes and reoperations, were not analyzed due to nonavailability in the NIS. The representativeness of the ASR compared to the NIS was assessed via Cohen's d effect sizes, and absolute standardized mean differences (SMDs) of < 0.2 were considered trivial, whereas > 0.5 were considered moderately large. RESULTS: A total of 24,800 arthrodesis procedures were identified in the ASR for the period between January 1, 2017, and December 31, 2019. During the same time period, 1,305,360 cases were recorded in the NIS. Cervical fusions comprised 35.9% of the ASR cohort (8911 cases) and 36.0% of the NIS cohort (469,287 cases). The two databases presented trivial differences in terms of patient age and sex for all years of interest across both cervical and lumbar arthrodeses (SMD < 0.2). Trivial differences were also noted in the distribution of open versus percutaneous procedures of the cervical and lumbar spine (SMD < 0.2). Among lumbar cases, anterior approaches were more common in the ASR than in the NIS (32.1% vs 22.3%, SMD = 0.22), but the discrepancy among cervical cases in the two databases was trivial (SMD = 0.03). Small differences were illustrated in terms of race, with SMDs < 0.5, and a more significant discrepancy was identified in the geographic distribution of participating sites (SMDs of 0.7 and 0.74 for cervical and lumbar cases, respectively). For both of these measures, SMDs in 2019 were smaller than those in 2018 and 2017. CONCLUSIONS: The ASR and NIS databases presented a very high similarity in proportions of cervical and lumbar spine surgeries, as well as similar distributions of age and sex, and distribution of open versus endoscopic approach. Slight discrepancies in anterior versus posterior approach among lumbar cases and patient race, and more significant discrepancies in geographic representation were also identified, yet decreasing trends in differences suggested the improving representativeness of the ASR over the course of time and its progressive growth. These conclusions are important to underline the external validity of quality investigations and research conclusions to be drawn from analyses in which the ASR is used.

Examining degenerative disease adjacent to lumbosacral transitional vertebrae: a retrospective cohort study.

OBJECTIVE: Bertolotti syndrome is a clinical diagnosis given to patients with low-back pain arising from a lumbosacral transitional vertebra (LSTV). While biomechanical studies have demonstrated abnormal torques and range of motion occurring at and above this type of LSTV, the long-term effects of these biomechanical changes on the LSTV adjacent segments are not well understood. This study examined degenerative changes at segments superjacent to the LSTV in patients with Bertolotti syndrome. METHODS: This study involved a retrospective comparison of patients between 2010 and 2020 with an LSTV and chronic back pain (Bertolotti syndrome) and control patients with chronic back pain with no LSTV. The presence of an LSTV was confirmed on imaging, and the caudal-most mobile segment above the LSTV was assessed for degenerative changes. Degenerative changes were assessed by grading the intervertebral disc, facets, degree of spinal stenosis, and spondylolisthesis using well documented grading systems. All computations were performed in R, version 4.1.0. All tests were two-sided, and p values < 0.05 was considered statistically significant. Separate logistic regression analyses were run with the associated dependent variables for each aim, with age at MRI and sex included as covariates. Odds ratios and 95% confidence intervals were computed. RESULTS: A total of 172 patients were included, 101 with Bertolotti syndrome and 71 controls. Control patients consisted of patients with low-back pain but no diagnosis of Bertolotti syndrome or an LSTV. Fifty-six Bertolotti (55.4%) and 27 control (38.0%) patients were female, (p = 0.03). After adjusting for age at MRI and sex, Bertolotti patients had pelvic incidence (PI) that was 9.83° greater than control patients (95% CI 5.15°-14.50°, p < 0.001). Sacral slope was not significantly different between the Bertolotti and control groups (beta estimate 3.10°, 95% CI -1.07° to 7.27°; p = 0.14). Bertolotti patients had 2.69 times higher odds of having a high disc grade at L4-5 (3-4 vs 0-2), compared with control patients (OR 2.69, 95% CI 1.28-5.90; p = 0.01). There were no significant differences between Bertolotti patients and controls for spondylolisthesis, facet grade, or spinal stenosis grade. CONCLUSIONS: Patients with Bertolotti syndrome had a significantly higher PI and were more likely to have adjacent-segment disease (ASD; L4-5) compared with control patients. However, after controlling for age and sex, PI and ASD did not appear to have a significant association within the cohort of Bertolotti patients. The altered biomechanics and kinematics in this condition may be a causative factor in this degeneration, although proof of causation is not possible in this study. This association may warrant closer follow-up protocols for patients being treated for Bertolotti syndrome, but further prospective studies are needed to establish if radiographic parameters can serve as an indicator for biomechanical alterations in vivo.

Metastatic Breast Cancer to the Spine: Incidence of Somatic Gene Alterations and Association of Targeted Therapies With Overall Survival.

BACKGROUND: The increase in use of targeted systemic therapies in cancer treatments has catalyzed the importance of identifying patient- and tumor-specific somatic mutations, especially regarding metastatic disease. Mutations found to be most prevalent in patients with metastatic breast cancer include TP53, PI3K, and CDH1. OBJECTIVE: To determine the incidence of somatic mutations in patients with metastatic breast cancer to the spine (MBCS). To determine if a difference exists in overall survival (OS), progression-free survival, and progression of motor symptoms between patients who do or do not undergo targeted systemic therapy after treatment for MBCS. METHODS: This is a retrospective study of patients with MBCS. Review of gene sequencing reports was conducted to calculate the prevalence of various somatic gene mutations within this population. Those patients who then underwent treatment (surgery/radiation) for their diagnosis of MBCS between 2010 and 2020 were subcategorized. The use of targeted systemic therapy in the post-treatment period was identified, and post-treatment OS, progression-free survival, and progression of motor deficits were calculated for this subpopulation. RESULTS: A total of 131 patients were included in the final analysis with 56% of patients found to have a PI3K mutation. Patients who received targeted systemic therapies were found to have a significantly longer OS compared with those who did not receive targeted systemic therapies. CONCLUSION: The results of this study demonstrate that there is an increased prevalence of PI3K mutations in patients with MBCS and there are a significant survival benefit and delay in progression of motor symptoms associated with using targeted systemic therapies for adjuvant treatment.

Characterizing the Next Generation of Neurosurgeons: A Descriptive Analysis and Publicly Available Web Application of Neurosurgery Residency Programs' Website Data.

OBJECTIVE: Neurosurgery program websites serve as a valuable resource for applicants. However, each website exists in isolation, and it can be difficult to understand the general trends in U.S. neurosurgery resident demographics. In the present study, we collected data from program websites and analyzed the trends in the demographics of the current U.S. neurosurgery residents. METHODS: We used a program list obtained from the American Association of Medical Colleges Electronic Residency Application System to extract data from the current resident complement listed in each program's website, including program, year in program, medical school, sex (male vs. female), graduate and/or PhD degrees, and assessed the trends during 7 years of resident data using linear regression. RESULTS: We identified 116 neurosurgery residency programs in the United States, with 111 providing information on their current resident complement, yielding a dataset of 1599 residents. Of these 1599 residents, 348 (22%) were female, 301 (19%) had a graduate degree in addition to an MD or DO degree, 151 (9.4%) had a PhD degree, 300 (19%) had matched at the program affiliated with their medical school, and 121 (7.6%) had graduated from a foreign medical school. The proportion of matriculating female residents had increased an average of 2.1% annually (95% confidence interval, 0.6%-3.7%) from 2015 to 2021. The other demographic data had not changed significantly during the same period. CONCLUSIONS: In addition to summarizing the current resident demographics, our analysis identified a significant increase in the proportion of female residents between 2015 (15.1%) and 2021 (25.6%). This publicly available dataset should enable additional analyses of the evolution of neurosurgery resident demographics.

Leveraging published randomized controlled trials to inform clinical trial design: a simulation-based study of laminectomy versus laminectomy and fusion.

OBJECTIVE: The US-based Spinal Laminectomy versus Instrumented Pedicle Screw (SLIP) trial reported improvement in disability following laminectomy with fusion versus laminectomy alone for patients with lumbar spondylolisthesis. Despite using similar methods, a concurrent Swedish trial investigating the same question did not reach the same conclusion. The authors performed a simulation-based analysis to elucidate potential causes of these divergent results. METHODS: The mean and standard deviation of the preoperative and 2-year postoperative Oswestry Disability Index (ODI) scores for each study group (laminectomy with fusion and laminectomy alone) were collected from the spondylolisthesis stratum of the Swedish trial and used to create a MATLAB simulator using linear transformations to predict postoperative ODI distributions. Applying this simulator to both varied and published preoperative ODI distributions from the SLIP trial, the authors simulated the results of the US-based trial using treatment effects from the Swedish study and compared simulated US results to those published in the SLIP trial. RESULTS: Simulated US results showed that as preoperative disability increased, the difference in postoperative ODI scores grew between treatment groups and increasingly favored laminectomy alone (p < 0.0001). In 100 simulations of a similarly sized US trial, the average mean change in ODI scores postoperatively was significantly higher than was published for laminectomy alone in the SLIP trial (-21.3 vs -17.9), whereas it was significantly lower than published for fusion (-16.9 vs -26.3). CONCLUSIONS: The expected benefit of surgical treatments for spondylolisthesis varied according to preoperative disability. Adapting Swedish-estimated treatment effects to the US context mildly overapproximated the improvement in postoperative disability scores for laminectomy, but more severely underapproximated the improvement reported for laminectomy and fusion in the SLIP trial. The observed heterogeneity between these studies is influenced more by patient response to fusion than response to laminectomy. This analysis paves the way for future studies on the impact of preoperative treatment group heterogeneity, differences in surgical methods, and empirical design on reported clinical benefits. Although bayesian reanalysis of published randomized controlled trial data is susceptible to biases that typically limit post hoc analyses, the authors' method offers a simple and cost-effective approach to improve the understanding of published clinical trial results and their implications for future studies.

A Dual-Screw Technique for Vertebral Compression Fractures via Robotic Navigation in the Osteopenic Lumbar Spine: An In-Vitro Biomechanical Analysis.

STUDY DESIGN: Biomechanical cadaveric study. OBJECTIVES: Multi-rod constructs maximize posterior fixation, but most use a single pedicle screw (PS) anchor point to support multiple rods. Robotic navigation allows for insertion of PS and cortical screw (CS) within the same pedicle, providing 4 points of bony fixation per vertebra. Recent studies demonstrated radiographic feasibility for dual-screw constructs for posterior lumbar spinal fixation; however, biomechanical characterization of this technique is lacking. METHODS: Fourteen cadaveric lumbar specimens (L1-L5) were divided into 2 groups (n = 7): PS, and PS + CS. VCF was simulated at L3. Bilateral posterior screws were placed from L2-L4. Load control (±7.5Nm) testing performed in flexion-extension (FE), lateral bending (LB), axial rotation (AR) to measure ROM of: (1) intact; (2) 2-rod construct; (3) 4-rod construct. Static compression testing of 4-rod construct performed at 5 mm/min to measure failure load, axial stiffness. RESULTS: Four-rod construct was more rigid than 2-rod in FE (P < .001), LB (P < .001), AR (P < .001). Screw technique had no significant effect on FE (P = .516), LB (P = .477), or AR (P = .452). PS + CS 4-rod construct was significantly more stable than PS group (P = .032). Stiffness of PS + CS group (445.8 ± 79.3 N/mm) was significantly greater (P = .019) than PS (317.8 ± 79.8 N/mm). Similarly, failure load of PS + CS group (1824.9 ± 352.2 N) was significantly greater (P = .001) than PS (913.4 ± 309.8 N). CONCLUSIONS: Dual-screw, 4-rod construct may be more stable than traditional rod-to-rod connectors, especially in axial rotation. Axial stiffness and ultimate strength of 4-rod, dual-screw construct were significantly greater than rod-to-rod. In this study, 4-rod construct was found to have potential biomechanical benefits of increased strength, stiffness, stability.

Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis.

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS: The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS: A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4-5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°). CONCLUSIONS: This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

STUDY DESIGN: Prospective randomized Food and Drug Administration investigational device exemption clinical trial. OBJECTIVE: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. SUMMARY OF BACKGROUND DATA: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. METHODS: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. RESULTS: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. CONCLUSIONS: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.