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.

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.

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.

ISSLS PRIZE in Clinical Science 2022: Epidemiology, risk factors and clinical impact of juvenile Modic changes in paediatric patients with low back pain.

PURPOSE: It's a long-held belief that Modic changes (MC) occur only in adults, with advanced age, and are highly associated with pain and adverse outcomes. The following study addressed the epidemiology, risk factors and clinical relevance of MC in young paediatric patients. METHODS: Two hundred and seven consecutive patients with no history of deformities, neoplasms, trauma, or infections were included in this ambispective study. MRIs were utilized to assess MCs and types, and other degenerative disc/endplate abnormalities. Subject demographics, duration of symptoms, clinic visits, conservative management (physical therapy, NSAIDs, opioids, injections) and surgery were noted. RESULTS: The mean age was 16.5 years old (46.9% males), 14% had MCs and they occurred throughout the spine. Subject baseline demographics were similar between MCs and non-MCs patients (p > 0.05). Modic type 2 (50%) was the most common type (type 1:27.1%; type 3:18.8%; mixed:4.7%). Multivariate analyses noted that endplate damage (OR: 11.36), disc degeneration (OR: 5.81), disc space narrowing (OR: 5.77), Schmorl's nodes (OR: 4.30) and spondylolisthesis (OR: 3.55) to be significantly associated with MCs (p < 0.05). No significant differences in conservative management were noted between Modic and non-MCs patients (p > 0.05). Among surgery patients (n = 44), 21% also had MCs (p = 0.134). Symptom-duration was significantly greater in MC patients (p = 0.049). CONCLUSION: Contrary to traditional dogma, robust evidence now exists noting that MCs and their types can develop in children. Our findings give credence to the "Juvenile" variant of MCs, whereby its implications throughout the lifespan need to be assessed. Juvenile MCs have prolonged symptoms and related to specific structural spine phenotypes.

Artificial intelligence in spine care: current applications and future utility.

PURPOSE: The field of artificial intelligence is ever growing and the applications of machine learning in spine care are continuously advancing. Given the advent of the intelligence-based spine care model, understanding the evolution of computation as it applies to diagnosis, treatment, and adverse event prediction is of great importance. Therefore, the current review sought to synthesize findings from the literature at the interface of artificial intelligence and spine research. METHODS: A narrative review was performed based on the literature of three databases (MEDLINE, CINAHL, and Scopus) from January 2015 to March 2021 that examined historical and recent advancements in the understanding of artificial intelligence and machine learning in spine research. Studies were appraised for their role in, or description of, advancements within image recognition and predictive modeling for spinal research. Only English articles that fulfilled inclusion criteria were ultimately incorporated in this review. RESULTS: This review briefly summarizes the history and applications of artificial intelligence and machine learning in spine. Three basic machine learning training paradigms: supervised learning, unsupervised learning, and reinforced learning are also discussed. Artificial intelligence and machine learning have been utilized in almost every facet of spine ranging from localization and segmentation techniques in spinal imaging to pathology specific algorithms which include but not limited to; preoperative risk assessment of postoperative complications, screening algorithms for patients at risk of osteoporosis and clustering analysis to identify subgroups within adolescent idiopathic scoliosis. The future of artificial intelligence and machine learning in spine surgery is also discussed with focusing on novel algorithms, data collection techniques and increased utilization of automated systems. CONCLUSION: Improvements to modern-day computing and accessibility to various imaging modalities allow for innovative discoveries that may arise, for example, from management. Given the imminent future of AI in spine surgery, it is of great importance that practitioners continue to inform themselves regarding AI, its goals, use, and progression. In the future, it will be critical for the spine specialist to be able to discern the utility of novel AI research, particularly as it continues to pervade facets of everyday spine surgery.

Artificial intelligence and spine imaging: limitations, regulatory issues and future direction.

BACKGROUND: As big data and artificial intelligence (AI) in spine care, and medicine as a whole, continue to be at the forefront of research, careful consideration to the quality and techniques utilized is necessary. Predictive modeling, data science, and deep analytics have taken center stage. Within that space, AI and machine learning (ML) approaches toward the use of spine imaging have gathered considerable attention in the past decade. Although several benefits of such applications exist, limitations are also present and need to be considered. PURPOSE: The following narrative review presents the current status of AI, in particular, ML, with special regard to imaging studies, in the field of spinal research. METHODS: A multi-database assessment of the literature was conducted up to September 1, 2021, that addressed AI as it related to imaging of the spine. Articles written in English were selected and critically assessed. RESULTS: Overall, the review discussed the limitations, data quality and applications of ML models in the context of spine imaging. In particular, we addressed the data quality and ML algorithms in spine imaging research by describing preliminary results from a widely accessible imaging algorithm that is currently available for spine specialists to reference for information on severity of spine disease and degeneration which ultimately may alter clinical decision-making. In addition, awareness of the current, under-recognized regulation surrounding the execution of ML for spine imaging was raised. CONCLUSIONS: Recommendations were provided for conducting high-quality, standardized AI applications for spine imaging.

Artificial intelligence in predicting early-onset adjacent segment degeneration following anterior cervical discectomy and fusion.

PURPOSE: Anterior cervical discectomy and fusion (ACDF) is a common surgical treatment for degenerative disease in the cervical spine. However, resultant biomechanical alterations may predispose to early-onset adjacent segment degeneration (EO-ASD), which may become symptomatic and require reoperation. This study aimed to develop and validate a machine learning (ML) model to predict EO-ASD following ACDF. METHODS: Retrospective review of prospectively collected data of patients undergoing ACDF at a quaternary referral medical center was performed. Patients > 18 years of age with > 6 months of follow-up and complete pre- and postoperative X-ray and MRI imaging were included. An ML-based algorithm was developed to predict EO-ASD based on preoperative demographic, clinical, and radiographic parameters, and model performance was evaluated according to discrimination and overall performance. RESULTS: In total, 366 ACDF patients were included (50.8% male, mean age 51.4 ± 11.1 years). Over 18.7 ± 20.9 months of follow-up, 97 (26.5%) patients developed EO-ASD. The model demonstrated good discrimination and overall performance according to precision (EO-ASD: 0.70, non-ASD: 0.88), recall (EO-ASD: 0.73, non-ASD: 0.87), accuracy (0.82), F1-score (0.79), Brier score (0.203), and AUC (0.794), with C4/C5 posterior disc bulge, C4/C5 anterior disc bulge, C6 posterior superior osteophyte, presence of osteophytes, and C6/C7 anterior disc bulge identified as the most important predictive features. CONCLUSIONS: Through an ML approach, the model identified risk factors and predicted development of EO-ASD following ACDF with good discrimination and overall performance. By addressing the shortcomings of traditional statistics, ML techniques can support discovery, clinical decision-making, and precision-based spine care.

Pediatric Back Pain: A Scoring System to Guide Use of Magnetic Resonance Imaging.

BACKGROUND: The prevalence of back pain in the pediatric population is increasing, and the workup of these patients presents a clinical challenge. Many cases are selflimited, but failure to diagnose a pathology that requires clinical intervention can carry severe repercussions. Magnetic resonance imaging (MRI) carries a high cost to the patient and health care system, and may even require procedural sedation in the pediatric population. The aim of this study was to develop a scoring system based on pediatric patient factors to help determine when an MRI will change clinical management. METHODS: This is a retrospective cohort analysis of consecutive pediatric patients who presented to clinic with a chief complaint of back pain between 2010 and 2018 at single orthopaedic surgery practice. Comprehensive demographic and presentation variables were collected. A predictive model of factors that influence whether MRI results in a change in management was then generated using cross-validation least absolute shrinkage and selection operator logistic regression analysis. RESULTS: A total of 729 patients were included, with a mean age of 15.1 years (range: 3 to 20 y). Of these, 344 (47.2%) had an MRI. A predictive model was generated, with nocturnal symptoms (5 points), neurological deficit (10 points), age (0.7 points per year), lumbar pain (2 points), sudden onset of pain (3.25 points), and leg pain (3.75 points) identified as significant predictors. A combined score of greater than 9.5 points for a given patient is highly suggestive that an MRI will result in a change in clinical management (specificity: 0.93; positive predictive value: 0.92). CONCLUSIONS: A predictive model was generated to help determine when ordering an MRI may result in a change in clinical management for workup of back pain in the pediatric population. The main factors included the presence of a neurological deficit, nocturnal symptoms, sudden onset, leg pain, lumbar pain, and age. Care providers can use these findings to better determine if and when an MRI might be appropriate. LEVEL OF EVIDENCE: Level III-diagnostic study.

Telemedicine in research and training: spine surgeon perspectives and practices worldwide.

PURPOSE: To utilize a global survey to elucidate spine surgeons' perspectives towards research and resident education within telemedicine. METHODS: A cross-sectional, anonymous email survey was circulated to the members of AO Spine, an international organization consisting of spine surgeons from around the world. Questions were selected and revised using a Delphi approach. A major portion of the final survey queried participants on experiences with telemedicine in training, the utility of telemedicine for research, and the efficacy of telemedicine as a teaching tool. Responses were compared by region. RESULTS: A total of 485 surgeons completed the survey between May 15, 2020 and May 31, 2020. Though most work regularly with trainees (83.3%) and 81.8% agreed that telemedicine should be incorporated into clinical education, 61.7% of respondents stated that trainees are not present during telemedicine visits. With regards to the types of clinical education that telemedicine could provide, only 33.9% of respondents agreed that interpretation of physical exam maneuvers can be taught (mean score = - 0.28, SD = ± 1.13). The most frequent research tasks performed over telehealth were follow-up of imaging (28.7%) and study group meetings (26.6%). Of all survey responses provided by members, there were no regional differences (p > 0.05 for all comparisons). CONCLUSIONS: Our study of spine surgeons worldwide noted high agreement among specialists for the implantation of telemedicine in trainee curricula, underscoring the global acceptance of this medium for patient management going forward. A greater emphasis towards trainee participation as well as establishing best practices in telemedicine are essential to equip future spine specialists with the necessary skills for navigating this emerging platform.

Provider confidence in the telemedicine spine evaluation: results from a global study.

PURPOSE: To utilize data from a global spine surgeon survey to elucidate (1) overall confidence in the telemedicine evaluation and (2) determinants of provider confidence. METHODS: Members of AO Spine International were sent a survey encompassing participant's experience with, perception of, and comparison of telemedicine to in-person visits. The survey was designed through a Delphi approach, with four rounds of question review by the multi-disciplinary authors. Data were stratified by provider age, experience, telemedicine platform, trust in telemedicine, and specialty. RESULTS: Four hundred and eighty-five surgeons participated in the survey. The global effort included respondents from Africa (19.9%), Asia Pacific (19.7%), Europe (24.3%), North America (9.4%), and South America (26.6%). Providers felt that physical exam-based tasks (e.g., provocative testing, assessing neurologic deficits/myelopathy, etc.) were inferior to in-person exams, while communication-based aspects (e.g., history taking, imaging review, etc.) were equivalent. Participants who performed greater than 50 visits were more likely to believe telemedicine was at least equivalent to in-person visits in the ability to make an accurate diagnosis (OR 2.37, 95% C.I. 1.03-5.43). Compared to in-person encounters, video (versus phone only) visits were associated with increased confidence in the ability of telemedicine to formulate and communicate a treatment plan (OR 3.88, 95% C.I. 1.71-8.84). CONCLUSION: Spine surgeons are confident in the ability of telemedicine to communicate with patients, but are concerned about its capacity to accurately make physical exam-based diagnoses. Future research should concentrate on standardizing the remote examination and the development of appropriate use criteria in order to increase provider confidence in telemedicine technology.

Spine surgeon perceptions of the challenges and benefits of telemedicine: an international study.

INTRODUCTION: While telemedicine usage has increased due to the COVID-19 pandemic, there remains little consensus about how spine surgeons perceive virtual care. The purpose of this study was to explore international perspectives of spine providers on the challenges and benefits of telemedicine. METHODS: Responses from 485 members of AO Spine were analyzed, covering provider perceptions of the challenges and benefits of telemedicine. All questions were optional, and blank responses were excluded from analysis. RESULTS: The leading challenges reported by surgeons were decreased ability to perform physical examinations (38.6%), possible increased medicolegal exposure (19.3%), and lack of reimbursement parity compared to traditional visits (15.5%). Fewer than 9.0% of respondents experienced technological issues. On average, respondents agreed that telemedicine increases access to care for rural/long-distance patients, provides societal cost savings, and increases patient convenience. Responses were mixed about whether telemedicine leads to greater patient satisfaction. North Americans experienced the most challenges, but also thought telemedicine carried the most benefits, whereas Africans reported the fewest challenges and benefits. Age did not affect responses. CONCLUSION: Spine surgeons are supportive of the benefits of telemedicine, and only a small minority experienced technical issues. The decreased ability to perform the physical examination was the top challenge and remains a major obstacle to virtual care for spine surgeons around the world, although interestingly, 61.4% of providers did not acknowledge this to be a major challenge. Significant groundwork in optimizing remote physical examination maneuvers and achieving legal and reimbursement clarity is necessary for widespread implementation.

What is the Rate of Revision Discectomies After Primary Discectomy on a National Scale?

BACKGROUND: Lumbar discectomy has been shown to be clinically beneficial in numerous studies for appropriately selected patients. Some patients, however, undergo revision discectomy, with previously reported estimates of revisions ranging from 5.1% to 7.9%. No study to date has been able to precisely quantify the rate of revision surgery over numerous years on a national scale. QUESTIONS/PURPOSE: We performed a survival analysis for lumbar discectomy on a national scale using a life-table analysis to answer the following questions: (1) What is the rate of revision discectomy on a national scale over 5 to 7 years for patients undergoing primary discectomy alone? (2) Are there differences in revision discectomy rates based on age of patient, region of the country, or the payer type? METHODS: The Medicare 5% National Sample Administrative Database (SAF5) and a large national database from Humana Inc (HORTHO) were used to catalog the number of patients undergoing a lumbar discectomy. Both of these databases have been cited in numerous peer-reviewed publications during the previous 5 years and routinely are audited by PearlDiver Inc. We identified patients using relevant ICD-9 codes and Current Procedural Terminology (CPT) codes, including ICD-9 72210 (lumbar disc displacement) for disc herniation. We used appropriate CPT codes to identify patients who had a lumbar discectomy. We analyzed patients undergoing additional surgery including those who had repeat discectomy (CPT-63042: laminotomy, reexploration single interspace, lumbar) and patients who had additional more-extensive decompressive procedures with or without fusion after their primary procedure. Revision surgery rates were calculated for patients 65 years and older and those younger than 65 years and for each database (Humana Inc and Medicare). Patients from the two databases also were analyzed based on four distinct geographic regions in the United States where their surgery occurred. There were a total of 7520 patients who underwent a lumbar discectomy for an intervertebral disc displacement with at least 5 years of followup in the HORTHO and SAF5 databases. We used cumulative incidence of revision surgery to estimate the survivorship of these patients. RESULTS: In the HORTHO (2613 patients) and SAF5 (4907 patients) databases, 147 patients (5.6%; 95% CI, 1.8%-9.2%) and 305 patients (6.2%; 95% CI, 3.5%-8.9%) had revision surgery at 7 years after the index discectomy respectively. Survival analysis showed survival rates greater than 93% (95% CI, 91%-98%) for all of the cohorts for a primary discectomy up to 7 years after the surgery. The survivorship was lower for patients younger than 65 years (93% [95% CI, 87%-99%, 1016 of 1091] versus 95% [95% CI, 90%-100%, 1450 of 1522], p = 0.02). When nondiscectomy lumbar surgeries were included, the survivorship of patients younger than 65 years remained lower (83% [95% CI, 76%-89%, 902 of 1091] versus 87% [95% CI, 82%-92%, 1324 of 1522], p = 0.02). There was no difference in revision discectomy rates across geographic regions (p = 0.41) at 7 years. Similarly, there was no difference in additional nondiscectomy lumbar surgery rates (p = 0.68) across geographic regions at 7 years. There was no difference in survivorship rates between patients covered by Medicare (94% [95% CI, 91%-97%], 4602 of 4907) versus Humana Inc (94% [95% CI, 90%-98%], 2466 of 2613) (p = 0.31). CONCLUSIONS: Our study shows rates of cumulative survival after an index lumbar discectomy with revision discectomy as the endpoint. We hope these data allow physicians to offer accurate advice to patients regarding the risk of revision surgery for patients of all ages during 5 to 7 years after their index procedure to enhance shared decision making in spinal surgery. These data also will help public policymakers and accountable care organizations accurately allocate scarce resources to patients with symptomatic lumbar disc herniation. LEVEL OF EVIDENCE: Level III, therapeutic study.

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.

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.

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.

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.

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.

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.