Gut microbiome dysbiosis is associated with lumbar degenerative spondylolisthesis in symptomatic patients.

Background: Lumbar degenerative spondylolisthesis (LDS), characterized as degeneration of the intervertebral disc and structural changes of the facet joints, is a condition with varying degrees of instability that may lead to pain, canal stenosis, and subsequent surgical intervention. However, the etiology of LDS remains inconclusive. Gut microbiome dysbiosis may stimulate systemic inflammation in various disorders. However, the role of such dysbiosis upon spine health remains under-studied. The current study assessed the association of gut microbiome dysbiosis in symptomatic patients with or without LDS. Methods: A cross-sectional analysis within the framework of a prospective study was performed. DNA was extracted from fecal samples collected from adult symptomatic patients with (n = 21) and without LDS (n = 12). Alpha and beta diversity assessed differences in fecal microbial community between groups. Taxon-by-taxon analysis identified microbial features with differential relative abundance between groups. Subject demographics and imaging parameters were also assessed. Results: There was no significant group differences in age, sex, race, body mass index, smoking/alcohol history, pain profiles, spinopelvic alignment, and Modic changes (p >0.05). LDS subjects had significantly higher disc degeneration severity (p = 0.018) and alpha diversity levels compared to non-LDS subjects (p = 0.002-0.003). Significant differences in gut microbial community structure were observed between groups (p = 0.046). Subjects with LDS exhibited distinct differences at the phylum level, with a significantly higher Firmicutes to Bacteroidota ratio compared to non-LDS (p = 0.003). Differential relative abundance analysis identified six taxa with significant differences between the two groups, with LDS demonstrating an increase in putative pro-inflammatory bacteria (Dialister, CAG-352) and a decrease in anti-inflammatory bacteria (Slackia, Escherichia-Shigella). Conclusion: This study is the first to report a significant association of gut microbiome dysbiosis and LDS in symptomatic patients, noting pro-inflammatory bacterial taxa. This work provides a foundation for future studies addressing the role of the gut microbiome in association with spine health and disease.

Is ABO blood type a risk factor for adjacent segment degeneration after lumbar spine fusion?

PURPOSE: This study aimed to explore associations between ABO blood type and postoperative adjacent segment degeneration/disease (ASD) following lumbar spine fusion, as well as evaluate differences in spinopelvic alignment, perioperative care, postoperative complications, and patient-reported outcome measures (PROMs). METHODS: An ambispective study was performed. Patients who underwent posterolateral or posterior lumbar interbody fusion were included. Demographic, perioperative and postoperative, clinical, and blood type information was recorded. Pre- and post-operative radiographic imaging was analyzed for alignment parameters and development of ASD. RESULTS: 445 patients were included, representing O+ (36.0%), O- (5.2%), A+ (36.2%), A- (6.3%), B+ (12.1%), B- (1.6%), and AB+ (2.7%) blood types. Most patients were female (59.1%), and had a mean age of 60.3 years and BMI of 31.1 kg/m2. Postoperatively, groups did not differ in duration of the hospital (p = 0.732) or intensive care unit (p = 0.830) stay, discharge disposition (p = 0.504), reoperation rate (p = 0.192), or in-hospital complication rate (p = 0.377). Postoperative epidural hematoma was most common amongst A + patients (p = 0.024). Over a mean of 11.0 months of follow-up, all patients exhibited similar improvement in PROMs, with 132 (29.7%) patients developing radiographic evidence of ASD. B + patients were significantly more likely than A + and O + patients to develop spondylolisthesis and ASD (p < 0.05). No significant differences in sagittal alignment parameters and number of levels of fusion were found (p > 0.05). CONCLUSIONS: This is the first large-scale study to address and demonstrate proof-of-principle that ABO blood type, a non-modifiable risk factor, is associated with ASD following lumbar spine fusion.

Clinical management of bone loss in cervical total disc arthroplasty: literature review and treatment recommendations.

PURPOSE: Cervical total disc replacement (cTDR) has been established as an alternative treatment for degenerative cervical radiculopathy and myelopathy. While the rate of complications for cTDR is reasonably low, recent studies have focused on bone loss after cTDR. The purpose of this work is to develop a clinical management plan for cTDR patients with evidence of bone loss. To guide our recommendations, we undertook a review of the literature and aimed to determine: (1) how bone loss was identified/imaged, (2) whether pre- or intraoperative assessments of infection or histology were performed, and (3) what decision-making and revision strategies were employed. METHODS: We performed a search of the literature according to PRISMA guidelines. Included studies reported the clinical performance of cTDR and identified instances of cervical bone loss. RESULTS: Eleven case studies and 20 cohort studies were reviewed, representing 2073 patients with 821 reported cases of bone loss. Bone loss was typically identified on radiographs during routine follow-up or by computed tomography (CT) for patients presenting with symptoms. Assessments of infection as well as histological and/or explant assessment were sporadically reported. Across all reviewed studies, multiple mechanisms of bone loss were suspected, and severity and progression varied greatly. Many patients were reportedly asymptomatic, but others experienced symptoms like progressive pain and paresthesia. CONCLUSION: Our findings demonstrate a critical gap in the literature regarding the optimal management of patients with bone loss following cTDR, and treatment recommendations based on our review are impractical given the limited amount and quality evidence available. However, based on the authors' extensive clinical experience, close follow-up of specific radiographic observations and serial radiographs to assess the progression/severity of bone loss and implant changes are recommended. CT findings can be used for clinical decision-making and further follow-up care. The pattern and rate of progression of bone loss, in concert with patient symptomatology, should determine whether non-operative or surgical intervention is indicated. Future studies involving implant retrieval, histopathological, and microbiological analysis for patients undergoing cTDR revision for bone loss are needed.

Presentation and management of infection in total disc replacement: A review.

Background: Total disc replacement (TDR) is widely used in the treatment of cervical and lumbar spine pathologies. Although TDR infection, particularly delayed infection, is uncommon, the results can be devastating, and consensus on clinical management remains elusive. In this review of the literature, we asked: (1) What are the reported rates of TDR infection; (2) What are the clinical characteristics of TDR infection; and (3) How has infection been managed for TDR patients? Methods: We performed a search of the literature using PubMed and Embase to identify studies that reported TDR infection rates, the identification and management of TDR infection, or TDR failures with positive cultures. Twenty database studies (17 focusing on the cervical spine and 3 on the lumbar spine) and 10 case reports representing 15 patients were reviewed along with device Summary of Safety and Effectiveness Data reports. Results: We found a lack of clarity regarding how infection was diagnosed, indicating a variation in clinical approach and highlighting the need for a standard definition of TDR infection. Furthermore, while reported infection rates were low, the absence of a clear definition prevented robust data analysis and may contribute to underreporting in the literature. We found that treatment strategy and success rely on several factors including patient symptoms and time to onset, microorganism type, and implant positioning/stability. Conclusions: Although treatment strategies varied throughout the extant literature, common practices in eliminating infection and reconstructing the spine emerged. The results will inform future work on the creation of a more robust definition of TDR infection and as well as recommendations for management.

Delayed Infection After Cervical Disc Arthroplasty: A Case Report and Review of the Literature.

STUDY DESIGN: Case report and literature review. OBJECTIVE: To report the relatively rare complication of delayed infection after cervical disc arthroplasty (CDA). BACKGROUND: Delayed infection of the M6 device has been a rarely reported complication, with all cases described outside of the United States. The reliability of positive intraoperative cultures remains an ongoing debate. METHODS: Cases were reviewed, and findings were summarized. A literature review was performed and discussed, with special consideration to current reports of delayed M6 infection, etiology, and utility of intraoperative cultures. RESULTS: We present a case of delayed infection 6 years after primary 1-level CDA with the M6 device. At revision surgery, gross purulence was encountered. Intraoperative cultures finalized with Staphylococcus epidermidis and Cutibacterium acnes. The patient was revised with removal of the M6 and conversion to anterior cervical discectomy and fusion. A prolonged course of intravenous antibiotics was followed by an oral course for suppression. At the final follow-up, the patient's preoperative symptoms had resolved. CONCLUSION: Delayed infection after CDA is a rare complication, with ongoing debate regarding the reliability of positive cultures. We describe an infected M6 and demonstrate the utility of implant removal, conversion to anterior cervical discectomy and fusion, and long-term antibiotics as definitive treatment. LEVEL OF EVIDENCE: Level V-case report and literature review.

Proposal for a classification system of radiographic bone changes after cervical disc replacement.

BACKGROUND: The goal of this study is to propose a classification system with a common nomenclature for radiographic observations of periprosthetic bone changes following cTDR. METHODS: Aided by serial plain radiographs from recent cTDR cases (34 patients; 44 devices), a panel of experts assembled for the purpose of creating a classification system to aid in reproducibly and accurately identifying bony changes and assessing cTDR radiographic appearance. Subdividing the superior and inferior vertebral bodies into 3 equal sections, observed bone loss such as endplate rounding, cystic erosion adjacent to the endplate, and cystic erosion not adjacent to the endplate, is recorded. Determining if bone loss is progressive, based on serial radiographs, and estimating severity of bone loss (measured by the percentage of end plate involved) is recorded. Additional relevant bony changes and device observations include radiolucent lines, heterotopic ossification, vertebral body olisthesis, loss of core implant height, and presence of device migration, and subsidence. RESULTS: Serial radiographs from 19 patients (25 devices) implanted with a variety of cTDR designs were assessed by 6 investigators including clinicians and scientists experienced in cTDR or appendicular skeleton joint replacement. The overall agreement of assessments ranged from 49.9% (95% bootstrap confidence interval 45.1-73.1%) to 94.7% (95% CI 86.9-100.0%). There was reasonable agreement on the presence or absence of bone loss or radiolucencies (range: 58.4% (95% CI 51.5-82.7%) to 94.7% (95% CI 86.9-100.0%), as well as in the progression of radiolucent lines (82.9% (95% CI 74.4-96.5%)). CONCLUSIONS: The novel classification system proposed demonstrated good concordance among experienced investigators in this field and represents a useful advancement for improving reporting in cTDR studies.

Discovery of circulating blood biomarkers in patients with and without Modic changes of the lumbar spine: a preliminary analysis.

PURPOSE: The following study aimed to determine the existence of blood biomarkers in symptomatic patients with or without lumbar Modic changes (MC). METHODS: A cross-sectional sub-analyses of a prospective cohort was performed. Fasting blood samples were collected from patients with and without lumbar MC who had undergone spinal fusion or microdiscectomy. An 80-plex panel and CCL5/RANTES were used to assess preoperative plasma cytokine concentrations. Patient demographics and imaging phenotypes were also assessed. RESULTS: Thirty-one subjects were analysed (n = 18 no MC; n = 13 MC). No significant differences were found in age, sex, body mass index, smoking and alcohol history, and surgical procedure (i.e. fusion, decompression) between the two groups (p > 0.05). Several statistically significant blood biomarkers in MC patients were identified, including elevated levels of C-C Motif Chemokine Ligand 5 (CCL5, p = 0.0006), while Macrophage Migration Inhibitory Factor (MIF) was significantly lower (p = 0.009). Additionally, C-X-C Motif Chemokine Ligand 5 (CXCL5, p = 0.052), Pentraxin 3 (PTX3, p = 0.06) and Galectin-3 (Gal-3, p = 0.07) showed potential relevance. Moreover, MC patients exhibited significantly higher levels of disc degeneration (p = 0.0001) and displacement severity (p = 0.020). Based on multivariate analyses and controlling for disc degeneration/displacement, CCL5 (OR 1.02; 95% CI 1.002-1.033; p = 0.028) and MIF (OR 0.60; 95% CI 0.382-0.951; p = 0.030) were independently associated with MC patients. CONCLUSION: This "proof-of-concept" study is the first to identify specific and significantly circulating blood biomarkers associated with symptomatic patients with lumbar MC, independent of disc alterations of degeneration and/or bulges/herniations. Specifically, differences in CCL5 and MIF protein levels were significantly noted in MC patients compared to those without MC.

Preserving privacy in big data research: the role of federated learning in spine surgery.

PURPOSE: Integrating machine learning models into electronic medical record systems can greatly enhance decision-making, patient outcomes, and value-based care in healthcare systems. Challenges related to data accessibility, privacy, and sharing can impede the development and deployment of effective predictive models in spine surgery. Federated learning (FL) offers a decentralized approach to machine learning that allows local model training while preserving data privacy, making it well-suited for healthcare settings. Our objective was to describe federated learning solutions for enhanced predictive modeling in spine surgery. METHODS: The authors reviewed the literature. RESULTS: FL has promising applications in spine surgery, including telesurgery, AI-based prediction models, and medical image segmentation. Implementing FL requires careful consideration of infrastructure, data quality, and standardization, but it holds the potential to revolutionize orthopedic surgery while ensuring patient privacy and data control. CONCLUSIONS: Federated learning shows great promise in revolutionizing predictive modeling in spine surgery by addressing the challenges of data privacy, accessibility, and sharing. The applications of FL in telesurgery, AI-based predictive models, and medical image segmentation have demonstrated their potential to enhance patient outcomes and value-based care.

Predictive factors of symptomatic lumbar pseudoarthrosis following multilevel primary lumbar fusion.

Background: Lumbar spinal fusion surgery is a well-established treatment for various spinal disorders. However, one of its complications, pseudoarthrosis, poses a significant concern. This study aims to explore the incidence, time and predictive factors contributing to pseudoarthrosis in patients who have undergone lumbar fusion surgery over a 10-year period. Methods: Data for this research was sourced from the PearlDiver database where insurance claims of patients who underwent multilevel lumbar spinal fusion between 01/01/2010 and 10/31/2022 were examined for claims of pseudoarthrosis within the 10 years of their index procedure. A variety of demographic, comorbid, and surgical factors were assessed, including age, gender, Elixhauser Comorbidity Index (ECI), surgical approach, substance use disorders and history of spinal disorders. Statistical analyses, including chi-squared tests, multivariate analysis, and cox survival analysis were employed to determine significant associations. Results: Among the 76,337 patients included in this retrospective study, 2.70% were diagnosed with symptomatic lumbar pseudoarthrosis at an average of 7.38 years in a 10-year follow-up. Multivariate and Cox hazard analyses revealed that significant predictors of symptomatic pseudoarthrosis development following multilevel primary lumbar fusion include vitamin D deficiency, osteoarthritis, opioid and NSAID use, tobacco use, and a prior history of congenital spine disorders. Conclusions: In summary, this study revealed a 2.70% incidence of symptomatic lumbar pseudoarthrosis within 10 years of the index procedure. It highlighted several potential predictive factors, including comorbidities, surgical approaches, and substance use disorders, associated with the development of symptomatic pseudoarthrosis. Future research should focus on refining our understanding of these factors to improve patient outcomes and optimize healthcare resource allocation.

Risk of Subsequent Fusion After Isolated Decompression of Lumbar Facet Cysts.

INTRODUCTION: Lumbar facet cysts represent a potential source of nerve root compression in elderly patients. Isolated decompression without fusion has proven to be a reasonable treatment option in properly indicated patients. However, the risk of lumbar fusion after isolated decompression and facet cyst excision has yet to be elucidated. METHODS: The PearlDiver database was reviewed for patients undergoing isolated laminectomy for lumbar facet cyst from January 2015 to December 2018 using Current Procedural Terminology coding. Patients undergoing concomitant fusion or additional decompression, as well as those diagnosed with preexisting spondylolisthesis or without a minimum of 5-year follow-up, were excluded. Rates of subsequent lumbar fusion and potential risk factors for subsequent fusion were identified. Statistical analysis included descriptive statistics, chi square test, and multivariate logistic regression. Results were considered significant at P < 0.05. RESULTS: In total, 10,707 patients were ultimately included for analysis. At 5-year follow-up, 727 (6.79%) of patients underwent subsequent lumbar fusion after initial isolated decompression. Of these, 301 (2.81% of total patients, 41.4% of fusion patients) underwent fusion within the first year after decompression. Multivariate analysis identified chronic kidney disease, hypertension, and osteoarthritis as risk factors for requiring subsequent lumbar fusion at 5 years following the index decompression procedure ( P < 0.033; all). CONCLUSION: Patients undergoing isolated decompression for lumbar facet cysts undergo subsequent lumbar fusion at a 5-year rate of 6.79%. Risk factors for subsequent decompression include chronic kidney disease, hypertension, and osteoarthritis. This study will assist spine surgeons in appropriately counseling patients on expected postoperative course and potential risks of isolated decompression.

Exploring the incidence and risk factors of reoperation for symptomatic adjacent segment disease following cervical decompression and fusion.

Background: Patients with long-term follow-up after cervical decompression and fusion have often been noted to have development of adjacent segment degeneration with a smaller subset of these patients progressing to adjacent segment disease (ASD), which results in the development of new symptomatic radiculopathy or myelopathy referable to a site either directly above or below a prior fused segment. The cause of ASD is multifactorial often involving natural age-related progression of spondylosis, accelerated progression following cervical decompression and fusion, operative technique, and patient-related factors. The effect of age at the time of index cervical decompression and fusion on the need for reoperation for ASD is not fully understood. This study aims to establish underlying risk factors for the development of symptomatic cervical ASD following cervical decompression and fusion requiring reoperation in patients of various age groups. Methods: A retrospective database review of patients aged 20 or greater with insurance claims of primary cervical decompression and fusion over the course of 11 years and 10 months (January 01, 2010-October 31, 2022) was conducted using an insurance claims database. The primary outcome was to evaluate the incidence of cervical ASD requiring reoperation amongst patients stratified by age at the time of their primary procedure. Secondary outcomes included an evaluation of various risk factors for ASD following cervical decompression and fusion including surgeon-controlled factors such as the number of levels fused and approach taken, patient cervical pathology including cervical disc disorder and cervical spondylosis, and underlying patient medical comorbidities including osteoporosis and vitamin D deficiency, and substance use. Results: A total of 60,292 patient records were analyzed, where the overall reoperation incidence for symptomatic ASD was 6.57%, peaking at 8.12% among those aged 30 to 39 and decreasing with age. Regression analysis revealed ages lower than 50 years as more predictive for the development of symptomatic ASD requiring reoperation. Multivariate regression analysis identified predictive factors for reoperation, including age, Elixhauser Comorbidity Index (ECI), multiple-level surgery, cervical spondylosis, cervical disc disorder, osteoporosis, and vitamin D deficiency. Notably, these factors had a variable impact across various age groups, as revealed by subgroup analysis. Conclusions: The incidence of reoperation secondary to symptomatic ASD is 6.57%, highest in those aged 30 to 39. The surgical approach had no significant impact on the need for reoperation, but multiple-level fusions posed a consistent risk in the development of symptomatic ASD requiring reoperation. Patient factors like degenerative disc disease, spondylosis, osteoporosis, and vitamin D deficiency were associated, urging further age-specific risk assessment and nonoperative intervention exploration.

Prosthesis design and likelihood of achieving physiological range of motion after cervical disc arthroplasty: analysis of range of motion data from 1,173 patients from 7 IDE clinical trials.

BACKGROUND CONTEXT: The functional goals of cervical disc arthroplasty (CDA) are to restore enough range of motion (ROM) to reduce the risk of accelerated adjacent segment degeneration but limit excessive motion to maintain a biomechanically stable index segment. This motion-range is termed the "Physiological mobility range." Clinical studies report postoperative ROM averaged over all study subjects but they do not report what proportion of reconstructed segments yield ROM in the Physiological mobility range following CDA surgery. PURPOSE: To calculate the proportion of reconstructed segments that yield flexion-extension ROM (FE-ROM) in the Physiological mobility range (defined as 5°-16°) by analyzing the 24-month postoperative data reported by clinical trials of various cervical disc prostheses. STUDY DESIGN/SETTING: Analysis of 24-month postoperative FE-ROM data from clinical trials. PATIENT SAMPLE: Data from 1,173 patients from single-level disc replacement clinical trials of 7 cervical disc prostheses. OUTCOME MEASURES: 24-month postoperative index-level FE-ROM. METHODS: The FE-ROM histograms reported in Food and Drug Administration-Investigational Device Exemption (FDA-IDE) submissions and available for this analysis were used to calculate the frequencies of implanted levels with postoperative FE-ROM in the following motion-ranges: Hypomobile (0°-4°), Physiological (5°-16°), and Hypermobile (≥17°). The ROM histograms also allowed calculation of the average ROM of implanted segments in each of the 3 motion-ranges. RESULTS: Only 762 of 1,173 patients (implanted levels) yielded 24-month postCDA FE-ROM in the physiological mobility range (5°-16°). The proportions ranged from 60% to 79% across the 7 disc-prostheses, with an average of 65.0%±6.2%. Three-hundred and two (302) of 1,173 implanted levels yielded ROM in the 0°-4° range. The proportions ranged from 15% to 38% with an average of 25.7%±8.9%. One-hundred and nine (109) of 1,173 implanted levels yielded ROM of ≥17° with a range of 2%-21% and an average proportion of 9.3%±7.9%. The prosthesis with built-in stiffness due to its nucleus-annulus design yielded the highest proportion (103/131, 79%) of implanted segments in the physiological mobility range, compared to the cohort average of 65% (p<.01). Sixty-five of the 350 (18.6%) discs implanted with the 2 mobile-core designs in this cohort yielded ROM≥17° as compared to the cohort average of 9.3% (109/1,173) (p<.05). At 2-year postCDA, the "hypomobile" segments moved on average 2.4±1.2°, those in the "physiological-mobility" group moved 9.4±3.2°, and the hypermobile segments moved 19.6±2.6°. CONCLUSIONS: Prosthesis design significantly influenced the likelihood of achieving FE-ROM in the physiological mobility range, while avoiding hypomobility or hypermobility (p<.01). Postoperative ROM averaged over all study subjects provides incomplete information about the prosthesis performance - it does not tell us how many implanted segments achieve physiological mobility and how many end up with hypomobility or hypermobility. We conclude that the proportion of index levels achieving postCDA motions in the physiological mobility range (5°-16°) is a more useful outcome measure for future clinical trials.

Medicare procedural costs in ambulatory surgery centers versus hospital outpatient departments for spine surgeries.

OBJECTIVE: Multiple studies have demonstrated the safety of outpatient spine surgery, with reports of equivalent to improved patient outcomes compared with inpatient procedures. This has resulted in the increased use of outpatient surgery over time. However, there remains a paucity of literature evaluating the difference in costs between ambulatory surgery center (ASC)- and hospital outpatient department (HOPD)-based procedures for Medicare beneficiaries. METHODS: Publicly available data from Centers for Medicare & Medicaid Services were accessed via the Medicare Procedure Price Lookup tool. Current Procedural Terminology (CPT) codes were used to identify spine-specific procedures approved for the outpatient setting by CMS. Procedures were grouped into decompression (cervical, thoracic, and lumbar), fusion/instrumentation (cervical, lumbar, and sacroiliac), and kyphoplasty/vertebroplasty cohorts, as well as an overall cohort. Data regarding total costs, facility fees, surgeon reimbursement, Medicare payments, and patient copayments were extracted for each procedure. Descriptive statistics were used to calculate means and standard deviations. Differences between ASC- and HOPD-associated costs were analyzed using the Mann-Whitney U-test. RESULTS: Twenty-one individual CPT codes approved by Medicare for the ASC and/or HOPD setting were identified. Decompression procedures were associated with a significantly lower total cost ($4183 ± $411.07 vs $7583.67 ± $410.89, p < 0.001), facility fees ($2998 ± $0 vs $6397 ± $0, p < 0.001), Medicare payments ($3345.75 ± $328.80 vs $6064.75 ± $328.80, p < 0.001), and patient payments ($835.58 ± $82.13 vs $1515.58 ± $82.13, p < 0.001) in ASCs compared with HOPDs. Fusion/instrumentation procedures had significantly lower facility fees ($10,436.6 ± $2347.51 vs $14,161 ± $2147.07, p = 0.044) and Medicare payments ($9501.2 ± $1732.42 vs $13,757 ± $2037.58, p = 0.009) in ASCs, as well as a trend toward lower total costs ($11,876.8 ± $2165.22 vs $15,601.2 ± $2016.06, p = 0.076). Patient payments in the HOPD setting were significantly lower in the fusion/instrumentation cohort ($1843.6 ± $73.42 vs $2374.4 ± $433.48, p = 0.009). In the kyphoplasty/vertebroplasty cohort, there was no statistically significant difference between ASCs and HOPDs, despite lower overall costs in the ASC for all variables. Surgeon fees were the same regardless of setting for all procedures (p > 0.99). When combining decompression, fusion/instrumentation, and kyphoplasty/vertebroplasty CPT codes into a single cohort, ASC setting was associated with significant cost savings in total cost, facility fees, Medicare payments, and patient payments. CONCLUSIONS: In general, performing spine surgeries in ASCs is associated with cost savings compared with HOPDs. This was demonstrated for decompression and fusion/instrumentation, and kyphoplasty/vertebroplasty Medicare-approved outpatient procedures.

Prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study.

BACKGROUND CONTEXT: Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. PURPOSE: To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. STUDY DESIGN: Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. PATIENT SAMPLE: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. OUTCOME MEASURES: The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. METHODS: Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. RESULTS: At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). CONCLUSIONS: Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes.

Comparison of clinical outcomes in patients undergoing one- and two-level minimally invasive lumbar microdiscectomy.

OBJECTIVE: Herniated nucleus pulposus (HNP) is one of the most common lumbar spine conditions treated surgically, often through a minimally invasive surgery (MIS) microdiscectomy approach. This technique attempts to reduce damage to the paraspinal muscular-ligamentous envelope. However, there are currently limited data regarding comparative outcomes using patient-reported outcome measures (PROMs) for one- and two-level MIS discectomies. The aim of this study was to quantify comparative clinical outcomes in patients undergoing one-level and two-level MIS lumbar microdiscectomy for HNP using PROMs. METHODS: The authors performed a retrospective review of patients undergoing MIS lumbar microdiscectomy between 2004 and 2019 for the primary diagnosis of HNP at a single academic institution. All patients had a minimum 1-year follow-up. Patient demographics and comorbidities were collected to establish baselines between cohorts. PROMs and minimal clinically important differences (MCIDs) were used to examine the patient's perception of operative success. Bivariate and multivariate linear/logistic regression analyses were used to compare one- and two-level discectomies. The bivariate analysis included the t-test and chi-square test, which were used to assess continuous and categorical variables, respectively. Statistical significance was established at p < 0.05. RESULTS: A total of 293 patients underwent one-level (n = 250) or two-level (n = 43) MIS discectomies. The mean follow-ups for the one- and two-level cohorts were 50.4 (SD 35.5) months and 61.6 (SD 39.8) months, respectively. Fewer female patients underwent two-level discectomies, and BMI and operative duration were higher in the two-level group (p < 0.001). Recurrent herniation requiring reoperation was recorded at rates of 6.80% and 11.6% in the one- and two-level groups, respectively (p = 0.270). Pre- and postoperative PROMs were largely similar between the cohorts; however, patients undergoing one-level discectomy had greater improvement in leg pain, and a significantly greater proportion of these patients achieved MCID for the leg pain visual analog scale score (p < 0.001). CONCLUSIONS: At the 1-year clinical follow-up, patients who underwent two-level discectomy had significantly less improvement in leg pain scores with lower achievement of MCID for leg pain improvement than patients undergoing one-level procedures. At the 1-year follow-up, there were no other significant differences in PROMs between the two cohorts. Given these findings, patients should be counseled regarding the anticipated outcomes to better manage expectations. Further studies are warranted to examine the long-term clinical outcomes associated with single- and multilevel MIS discectomy.

The Effect of Intraoperative Prone Position on Psoas Morphology and Great Vessel Anatomy: Consequences for Prone Lateral Approach to the Lumbar Spine.

BACKGROUND: This study sought to quantify radiographic differences in psoas morphology, great vessel anatomy, and lumbar lordosis between supine and prone intraoperative positioning to optimize surgical planning and minimize the risk of neurovascular injury. METHODS: Measurements on supine magnetic resonance imaging and prone intraoperative computed tomography with O-arm from L2 to L5 levels included the anteroposterior and mediolateral proximity of the psoas, aorta, inferior vena cava (IVC), and anterior iliac vessels to the vertebral body. Psoas transverse and longitudinal diameters, psoas cross-sectional area, total lumbar lordosis, and segmental lordosis were assessed. RESULTS: Prone position produced significant psoas lateralization, especially at more caudal levels (P < 0.001). The psoas drifted slightly anteriorly when prone, which was non-significant, but the magnitude of anterior translation significantly decreased at more caudal segments (P = 0.038) and was lowest at L5 where in fact posterior retraction was observed (P = 0.032). When prone, the IVC (P < 0.001) and right iliac vein (P = 0.005) migrated significantly anteriorly, however decreased anterior displacement was seen at more caudal levels (P < 0.001). Additionally, the IVC drifted significantly laterally at L5 (P = 0.009). Mean segmental lordosis significantly increased when prone (P < 0.001). CONCLUSION: Relative to the vertebral body, the psoas demonstrated substantial lateral mobility when prone, and posterior retraction specifically at L5. IVC and right iliac vein experienced significant anterior mobility-particularly at more cephalad levels. Prone position enhanced segmental lordosis and may be critical to optimizing sagittal restoration.

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.

The Effect of Changes in Segmental Lordosis on Global Lumbar and Adjacent Segment Lordosis After L5-S1 Anterior Lumbar Interbody Fusion.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVE: Restoration of lordosis in lumbar fusion reduces low back pain, decreases adjacent segment degeneration, and improves postoperative outcomes. However, the potential effects of changes in segmental lordosis on adjacent-level and global lordosis remain less understood. This study aims to examine the relationships between segmental (SL), adjacent-level, and global lumbar lordosis following L5-S1 Anterior Lumbar Interbody Fusion (ALIF). METHODS: 80 consecutive patients who underwent single-level L5-S1 ALIF were divided into 3 groups based on the degree of change (∆) in index-level segmental lordosis: <5° (n = 23), 5°-10° (n = 29), >10° (n = 28). Radiographic parameters measured included global lumbar, segmental, and adjacent level lordosis, sacral slope, pelvic tilt, pelvic incidence, and PI-LL mismatch. RESULTS: Patients with ∆SL 5°-10° or ∆SL >10° both showed significant increases in global lumbar lordosis from preoperative to final follow-up. However, patients with ∆SL >10° showed statistically significant losses in adjacent level lordosis at both immediate postoperative and final follow-up compared to preoperative. When comparing patients with ∆SL >10° to those with ∆SL 5-10°, there were no significant differences in global lumbar lordosis at final follow-up, due to significantly greater losses of adjacent level lordosis in these patients. CONCLUSION: The degree of compensatory loss of lordosis at the adjacent level L4-L5 correlated with the extent of segmental lordosis creation at the index L5-S1 level. This may suggest that the L4 to S1 segment acts as a "harmonious unit," able to accommodate only a certain amount of lordosis and further increases in segmental lordosis may be mitigated by loss of adjacent-level lordosis.

Deep phenotyping the cervical spine: automatic characterization of cervical degenerative phenotypes based on T2-weighted MRI.

PURPOSE: Radiological degenerative phenotypes provide insight into a patient's overall extent of disease and can be predictive for future pathological developments as well as surgical outcomes and complications. The objective of this study was to develop a reliable method for automatically classifying sagittal MRI image stacks of cervical spinal segments with respect to these degenerative phenotypes. METHODS: We manually evaluated sagittal image data of the cervical spine of 873 patients (5182 motion segments) with respect to 5 radiological phenotypes. We then used this data set as ground truth for training a range of multi-class multi-label deep learning-based models to classify each motion segment automatically, on which we then performed hyper-parameter optimization. RESULTS: The ground truth evaluations turned out to be relatively balanced for the labels disc displacement posterior, osteophyte anterior superior, osteophyte posterior superior, and osteophyte posterior inferior. Although we could not identify a single model that worked equally well across all the labels, the 3D-convolutional approach turned out to be preferable for classifying all labels. CONCLUSIONS: Class imbalance in the training data and label noise made it difficult to achieve high predictive power for underrepresented classes. This shortcoming will be mitigated in the future versions by extending the training data set accordingly. Nevertheless, the classification performance rivals and in some cases surpasses that of human raters, while speeding up the evaluation process to only require a few seconds.

Does disc distraction after cervical total disc arthroplasty impact range of motion and patient-reported outcomes?

OBJECTIVE: Total disc arthroplasty (TDA) has been established as a safe and effective alternative to anterior cervical discectomy and fusion for the treatment of cervical spine pathology. However, there remains a paucity of studies in the literature regarding the amount of disc height distraction that can be tolerated, as well as its impact on kinematic and clinical outcomes. METHODS: Patients who underwent 1- or 2-level cervical TDA with a minimum follow-up of 1 year with lateral flexion/extension and patient-reported outcome measures (PROMs) were included. Middle disc space height was measured on preoperative and 6-week postoperative lateral radiographs to quantify the magnitude of disc space distraction, and patients were grouped into < 2-mm distraction and > 2-mm distraction groups. Radiographic outcomes included operative segment lordosis, segmental range of motion (ROM) on flexion/extension, cervical (C2-7) ROM on flexion/extension, and heterotopic ossification (HO). General health and disease-specific PROMs were compared at the preoperative, 6-week, and final postoperative time points. The independent-samples t-test and chi-square test were used to compare outcomes between groups, while multivariate linear regression was used to adjust for baseline differences. RESULTS: Fifty patients who underwent cervical TDA at 59 levels were included in the analysis. Distraction < 2 mm was seen at 30 levels (50.85%), while distraction > 2 mm was observed at 29 levels (49.15%). Radiographically, after adjustment for baseline differences, C2-7 ROM was significantly greater in the patients who underwent TDA with < 2-mm disc space distraction at final follow-up (51.35° ± 13.76° vs 39.19° ± 10.52°, p = 0.002), with a trend toward significance in the early postoperative period. There were no significant postoperative differences in segmental lordosis, segmental ROM, or HO grades. After the authors controlled for baseline differences, < 2-mm distraction of the disc space led to significantly greater improvement in visual analog scale (VAS)-neck scores at 6 weeks (-3.68 ± 3.12 vs -2.24 ± 2.70, p = 0.031) and final follow-up (-4.59 ± 2.74 vs -1.70 ± 3.03, p = 0.008). CONCLUSIONS: Patients with < 2-mm disc height difference had increased C2-7 ROM at final follow-up and significantly greater improvement in neck pain after controlling for baseline differences. Limiting differences in disc space height to < 2 mm affected C2-7 ROM but not segmental ROM, suggesting that less distraction may result in more harmonious kinematics between all cervical levels.