Learning Curve Analyses in Spine Surgery: A Systematic Simulation-Based Critique of Methodologies.

BACKGROUND CONTEXT: Various statistical approaches exist to delineate learning curves in spine surgery. Techniques range from dividing cases into intervals for metric comparison, to employing regression and cumulative summation (CUSUM) analyses. However, their inherent inconsistencies and methodological flaws limit their comparability and reliability. PURPOSE: To critically evaluate the methodologies used in existing literature for studying learning curves in spine surgery and to provide recommendations for future research. STUDY DESIGN: Systematic literature review. METHODS: A comprehensive literature search was conducted using PubMed, Embase, and Scopus databases, covering articles from January 2010 to September 2023. For inclusion, articles had to evaluate the change in a metric of performance during human spine surgery across time/a case series. Results had to be reported in sufficient detail to allow for evaluation of individual performance rather than group/institutional performance. Articles were excluded if they included cadaveric/non-human subjects, aggregated performance data or no way to infer change across a number of cases. Risk of bias was assessed using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool. Surgical data were simulated using Python 3 and then examined via multiple commonly used analytic approaches including division into consecutive intervals, regression and CUSUM techniques . Results were qualitatively assessed to determine the effectiveness and limitations of each approach in depicting a learning curve. RESULTS: 113 studies met inclusion criteria. The majority of the studies were retrospective and evaluated a single-surgeon's experience. Methods varied considerably, with 66 studies using a single proficiency metric and 47 using more than one. Operating time was the most commonly used metric. Interval division was the simplest and most commonly used method yet inherent limitations prevent collective synthesis. Regression may accurately describe the learning curve but in practice is hampered by sample size and model choice. CUSUM analyses are of widely varying quality with some being fundamentally flawed and widely misinterpreted however, others provide a reliable view of the learning process. CONCLUSION: There is considerable variation in the quality of existing studies on learning curves in spine surgery. CUSUM analyses, when correctly applied, offer the most reliable estimates. To improve the validity and comparability of future studies, adherence to methodological guidelines is crucial. Multiple or composite performance metrics are necessary for a holistic understanding of the learning process.

Comparative surgical outcomes of navigated vs non-navigated posterior spinal fusions in ankylosing spondylitis patients.

INTRODUCTION: Ankylosing Spondylitis (AS) patients with acute spinal fractures represent a challenge for practicing spine surgeons due to difficult operative anatomy and susceptibility to complications. RESEARCH QUESTION: Does intraoperative CT-navigation improve outcomes in patients with ankylosing spondylitis undergoing surgery? METHODS: A retrospective review was carried out at our centre from 05/2016-06/2021 to identify AS patients presenting with a traumatic spinal fracture, managed surgically with posterior spinal fusion (PSF). Cohorts were categorised and compared for outcomes based on those who underwent PSF with intraoperative CT-navigation versus those surgically managed with traditional intraoperative fluoroscopy. RESULTS: 37 AS patients were identified. 29/37 (78.4%) underwent PSF. Intraoperative navigation was used in 14 (48.3%) cases. Mean age of the entire cohort was 67.6 years. No difference existed between the navigated and non-navigated groups for mean levels fused (5.35 vs 5.07; p â€‹= â€‹0.31), length of operation (217.9mins vs 175.3mins; p â€‹= â€‹0.07), overall length-of-stay (12 days vs 21.9 days; p â€‹= â€‹0.16), patients requiring HDU (3/14 vs 5/15; p â€‹= â€‹0.09) or ICU (5/14 vs 9/15; p â€‹= â€‹0.10), postoperative neurological improvement (1/14 vs 1/15; p â€‹= â€‹0.48) or deterioration (1/14 vs 0/15; p â€‹= â€‹0.15), intraoperative complications (2/14 vs 3/15; p â€‹= â€‹0.34), postoperative complications 4/14 vs 4/15; p â€‹= â€‹0.46), revision surgeries (3/14 vs 1/15; p â€‹= â€‹0.16) and 30-day mortality (0/14 vs 0/15). CONCLUSION: This is the first study that compares surgical outcomes of navigated vs non-navigated PSFs for AS patients with an acute spinal fracture. Although limited by its retrospective design and sample size, this study highlights the non-inferiority of intraoperative navigation as a surgical aid in a challenging cohort.

The efficacy of anchored stand-alone spacers in comparison to conventional cage and plate in anterior cervical discectomy and fusion surgery: A meta-analysis of randomised controlled trials for clinical and radiological outcomes.

Introduction: Anterior cervical discectomy and fusion (ACDF) is commonly performed with cage and plate constructs to stabilise diseased or injured cervical segments. Despite it being a commonly performed procedure, there are notable rates of associated morbidity reported in the literature. Stand-alone spacers represent a novel form of instrumentation to conventional cage and plate constructs. Research question: Do stand-alone spacers have improved operative characteristics and postoperative outcomes in ACDF cohorts when compared to cage and plate constructs? Methods: A systematic review and meta-analysis was conducted of PubMed/Medline, Embase and Google Scholar databases per the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes guidelines. Studies of interest included cage and plate instrumentation versus anchored stand-alone spacers for patients undergoing ACDF. Pre- and post-operative clinical and radiological outcomes were collated and compared for significance between cohorts. Results: 10 RCTs were identified and included with 779 patients total. Mean age of the entire cohort was 50.1 years. 62% (483/779) of the cohort were male. 384 patients underwent ACDF with stand-alone cage, while 395 had ACDF with conventional cage and plate. Stand-alone spacers significantly outperformed conventional instrumentation in terms of estimated blood loss (p < 0.01), total postoperative complications (p < 0.01), dysphagia rates (p = 0.04) and adjacent segment disease (p = 0.04). Non-inferiority was evident in both patient reported outcome measures and radiological outcomes. Conclusion: This meta-analysis highlights the efficacy of stand-alone spacers for the management of primarily cervical spondylitic disease for both single-level and multi-level pathology, and thus presents an attractive alternative to conventional instrumentation for patients undergoing ACDF surgery.

Accuracy of augmented reality-assisted pedicle screw placement: a systematic review.

OBJECTIVE: Conventional freehand methods of pedicle screw placement are associated with significant complications due to close proximity to neural and vascular structures. Recent advances in augmented reality surgical navigation (ARSN) have led to its adoption into spine surgery. However, little is known regarding its overall accuracy. The purpose of this study is to delineate the overall accuracy of ARSN pedicle screw placement across various models. METHODS: A systematic review was conducted of Medline/PubMed, Cochrane and Embase Library databases according to the PRISMA guidelines. Relevant data extracted included reports of pedicle screw placement accuracy and breaches, as defined by the Gertzbein-Robbins classification, in addition to deviation from pre-planned trajectory and entry point. Accuracy was defined as the summation of grade 0 and grade 1 events per the Gertzbein-Robbins classification. RESULTS: Twenty studies reported clinically accurate placed screws. The range of clinically accurate placed screws was 26.3-100%, with 2095 screws (93.1%) being deemed clinically accurate. Furthermore, 5.4% (112/2088) of screws were reported as grade two breaches, 1.6% (33/2088) grade 3 breaches, 3.1% (29/926) medial breaches and 2.3% (21/926) lateral breaches. Mean linear deviation ranged from 1.3 to 5.99 mm, while mean angular/trajectory deviation ranged 1.6°-5.88°. CONCLUSION: The results of this study highlight the overall accuracy of ARSN pedicle screw placement. However, further robust prospective studies are needed to accurately compare to conventional methods of pedicle screw placement.

Iliac crest bone graft versus cell-based grafts to augment spinal fusion: a systematic review and meta-analysis.

INTRODUCTION: Despite successful fusion rates with iliac crest bone graft (ICBG), donor-site morbidity and increased operating time remain a considerable limitation and drive the search for alternatives. In this systematic review, grafts with additional cellular supplementation were compared with ICBG for spinal arthrodesis. We compared safety, efficacy and long-term outcomes, thus providing the current and relevant evidence for orthopaedic surgeons to make informed choices regarding this rapidly developing field. METHODS: An electronic literature search was conducted according to the PRISMA guidelines by two independent reviewers for articles published up to 1st March 2023 using PubMed, EMBASE and the Cochrane Central Register of Controlled Trial. Cellular allografts were not included. The following data were extracted: Number of patients, type of graft, fusion assessment method, follow-up duration, fusion rates, clinical outcomes and complications. The methodological quality of evidence (MQOE) was assessed using the Risk of Bias 2 (RoB-2) tool and Risk of Bias In Non-Randomised Studies (ROBINS) tool developed by Cochrane for evaluating bias in randomised and non-randomised studies. RESULTS: Ten studies fulfiled the inclusion criteria, including 465 patients. The mean number of patients per study was 43.8 (std dev. 28.81, range 12-100). Two studies demonstrated cell-based therapy to be significantly more successful in terms of fusion rates compared to ICBG. However, the remaining eight demonstrated equivocal results. No study found that cell-based therapy was inferior. No difference was seen between the two groups in three studies who focused on degenerative cohorts. No difference in functional outcome scores was seen between the groups. A number of different preparation techniques for cell-based grafts were used throughout the studies. CONCLUSION: Cell-based therapy offers a promising alternative to ICBG in spinal fusion surgery, which could help reduce the associated morbidity to patients. This review found that cell-based therapy is non-inferior to iliac crest bone graft and may offer patients an alternative treatment option with fewer complications and reduced post-operative pain. However, the literature to date is limited by heterogeneity of the cell preparation and grafting process. Future research with a unified approach to the cell preparation process is required to fully delineate the potential advantages of this technology.

The correlation between altmetric score and traditional measures of article impact for studies published within the Surgeon Journal.

Alternative metrics, or altmetrics, have emerged as a promising tool for measuring the social impact of research, which is increasingly important in today's digital and social media-driven world. Altmetric Attention Score (AAS) is a weighted count of all the online attention garnered by a study, and it is currently unclear whether a relationship with traditional bibliometrics exists. The purpose of this article was to retrospectively review articles published in the Surgeon Journal from 2003 to 2020 to compare AAS with bibliometric parameters using an Independent t-test and Pearson's correlation analysis. There were statistically significant weakly positive relationships between AAS and sample size, number of reads, and number of citations. There was no statistically significant relationship between AAS and number of authors, H-index, or level of evidence. This study highlights the potential value of altmetrics by measuring the social impact of research as altmetrics can provide valuable information not captured by traditional metrics. It is currently unclear what the optimal balance of social and academic impact is in evaluating research impact and how altmetrics can be integrated into existing research frameworks.

An Assessment of the World's Contribution to Spine Trauma Care: A Bibliometric Analysis of Classifications and Surgical Management; An AO Spine Knowledge Forum Trauma Initiative.

STUDY DESIGN: Bibliometric analysis. OBJECTIVES: An analysis of the literature related to the assessment and management of spinal trauma was undertaken to allow the identification of top contributors, collaborations and research trends. METHODS: A search to identify original articles published in English between 2011 and 2020 was done using specific keywords in the Web of Science database. After screening, the top 300 most cited articles were analyzed using Biblioshiny R software. RESULTS: The highest number of contributions were from the Thomas Jefferson University, USA, University of Toronto and University of British Columbia, Canada. The top 3 most prolific authors were Vaccaro AR, Arabi B, and Oner FC. The USA and Canada were among the top contributing countries; Switzerland and Brazil had most multiple country co-authored articles. The most relevant journals were the European Spine Journal, Spine and Spine Journal. Three of the 5 most cited articles were about classification systems of fractures. The keyword analysis included clusters for different spinal regions, spinal cord injury, classification agreement and reliability studies, imaging related studies, surgical techniques and outcomes. CONCLUSIONS: The study identified the most impactful authors and affiliations, and determined the journals where most impactful research is published in the field. Study also compared the productivity and collaborations across countries. The study highlighted the impact of development of new classification systems, and identified research trends including instrumentation, fixation and decompression techniques, epidemiology and recovery after spinal trauma.

Biomimetic Inspired Hydrogels for Regenerative Vertebral Body Stenting.

PURPOSE OF REVIEW: This review aims to explore the potential of biomimetic hydrogels as an alternative to bone cement in vertebral body stenting (VBS), a minimally invasive treatment for vertebral compression fractures. RECENT FINDINGS: The use of bone cement in VBS procedures can lead to complications such as incomplete fracture reduction and cement leakage. Biomimetic hydrogels have gained significant attention as potential biomaterial alternatives for VBS due to their unique properties, including tuneable therapeutic and mechanical properties. Over the past decade, there has been significant advancements in the development of biomimetic hydrogels for bone regeneration, employing a wide range of approaches to enhance the structural and functional properties of hydrogels. Biomimetic hydrogels hold significant promise as safer and reparative alternatives to bone cement for VBS procedures. However, further research and development in this field are necessary to explore the full potential of hydrogel-based systems for vertebral bone repair.

Preclinical to clinical translation for intervertebral disc repair: Effects of species-specific scale, metabolism, and matrix synthesis rates on cell-based regeneration.

Background: A significant hurdle for potential cell-based therapies is the subsequent survival and regenerative capacity of implanted cells. While many exciting developments have demonstrated promise preclinically, cell-based therapies for intervertebral disc (IVD) degeneration fail to translate equivalent clinical efficacy. Aims: This work aims to ascertain the clinical relevance of both a small and large animal model by experimentally investigating and comparing these animal models to human from the perspective of anatomical scale and their cellular metabolic and regenerative potential. Materials and Methods: First, this work experimentally investigated species-specific geometrical scale, native cell density, nutrient metabolism, and matrix synthesis rates for rat, goat, and human disc cells in a 3D microspheroid configuration. Second, these parameters were employed in silico to elucidate species-specific nutrient microenvironments and predict differences in temporal regeneration between animal models. Results: This work presents in silico models which correlate favorably to preclinical literature in terms of the capabilities of animal regeneration and predict that compromised nutrition is not a significant challenge in small animal discs. On the contrary, it highlights a very fine clinical balance between an adequate cell dose for sufficient repair, through de novo matrix deposition, without exacerbating the human microenvironmental niche. Discussion: Overall, this work aims to provide a path towards understanding the effect of cell injection number on the nutrient microenvironment and the "time to regeneration" between preclinical animal models and the large human IVD. While these findings help to explain failed translation of promising preclinical data and the limited results emerging from clinical trials at present, they also enable the research field and clinicians to manage expectations on cell-based regeneration. Conclusion: Ultimately, this work provides a platform to inform the design of clinical trials, and as computing power and software capabilities increase in the future, it is conceivable that generation of patient-specific models could be used for patient assessment, as well as pre- and intraoperative planning.

Morbidity and mortality of traumatic cervical spinal cord injuries in a geriatric cohort.

BACKGROUND: Traumatic injuries are among the leading causes of death and disability worldwide. Major trauma presentations have seen a demographic shift recently from the young to the elderly, with significant associated neurological deficit. AIMS: To review the presentation and outcome of elderly patients presenting with cervical spinal injuries and associated neurological deficit that underwent surgical intervention in order to optimise treatment strategies. METHODS: A retrospective review was conducted at a national tertiary referral centre to analyse admission trends from June 2016 to July 2020 for outcomes of elderly patients (≥ 65) presenting with traumatic cervical spine injuries associated with spinal cord injuries (SCI). Demographic, clinical, and radiological characteristics were collected and analysed. RESULTS: Forty-two patients met the inclusion criteria. The most common mechanisms of injury (MOIs) were falls from standing (38.1%) and falls from height (≥ 2 m) (33.3%). Complete SCIs had increased mean LOS (57.6 vs 21.6 days; p = 0.013), postoperative complications (100% vs 60.6%; p = 0.022), life-threatening complications (57.1% vs 9.1%; p = 0.001), and 90-day mortality (37.5% vs 5.9%; p = 0.007) compared to incomplete SCIs. CONCLUSION: Elderly patients with complete SCIs have poorer outcomes and mortality than those with less extensive SCIs. They require more resources, have greater risk of complications, and have higher mortality than those with incomplete SCIs, with subsequent implications on optimal treatment strategies. More robust studies are needed to derive improved risk stratification tools for geriatric patients with spinal injuries.

The Incidence, Characteristics and Outcomes of Vertebral Artery Injury Associated with Cervical Spine Trauma: A Systematic Review.

STUDY DESIGN: Systematic Review. OBJECTIVES: Vertebral Artery Injury (VAI) is a potentially serious complication of cervical spine fractures. As many patients can be asymptomatic at the time of injury, the identification and diagnosis of VAI can often prove difficult. Due to the high rates of morbidity and mortality associated with VAI, high clinical suspicion is paramount. The purpose of this review is to elucidate incidence, diagnosis, treatment and outcomes of VAI associated with cervical spine injuries. METHODS: A systematic search of electronic databases was performed using 'PUBMED', 'EMBASE','Medline (OVID)', and 'Web of Science, for articles pertaining to traumatic cervical fractures with associated VAI. RESULTS: 24 studies were included in this systematic review. Data was included from 48 744 patients. In regards to the demographics of the focus groups that highlighted information on VAI, the mean average age was 46.6 (32.1-62.6). 75.1% (169/225) were male and 24.9% (56/225) were female. Overall incidence of VAI was 596/11 479 (5.19%). 190/420 (45.2%) of patients with VAI had fractures involving the transverse foramina. The right vertebral artery was the most commonly injured 114/234 (48.7%). V3 was the most common section injured (16/36 (44.4%)). Grade I was the most common (103/218 (47.2%)) injury noted. Collective acute hospital mortality rate was 32/226 (14.2%), ranging from 0-26.2% across studies. CONCLUSION: VAI secondary to cervical spine trauma has a notable incidence and high associated mortality rates. The current available literature is limited by a low quality of evidence. In order to optimise diagnostic protocols and treatment strategies, in addition to reducing mortality rates associated with VAI, robust quantitative and qualitative studies are needed.

Pharmacogenetic profiling and individualised therapy in the treatment of degenerative spinal conditions.

Patients presenting with degenerative spinal changes are often poor surgical candidates due to associated co-morbidities, frailty, or sarcopenia. Additionally, surgeries of a degenerative spine can prove difficult due to the distortion of normal surgical anatomy. Therefore, many patients are managed conservatively with a variety of modalities, including over-the-counter and prescription medications. Nevertheless, several patients do not experience adequate relief from pain with analgesic medications, precipitating multiple hospital visits, and usage of resources. As a result, back pain is regarded as a major economic burden, with total costs of associated treatment exceeding $100 billion annually. Pharmacogenetics is a relatively novel method of evaluating an individual's response to analgesic medications, through analysis of germline polymorphisms. It entails obtaining a genetic sample, often via buccal swab or peripheral blood sample, and genetic analysis achieved through either polymerase chain reaction +/- Sanger sequencing, microassays, restriction length fragment polymorphism analysis, or genetic library preparation and next generation sequencing. The potential efficacy of pharmacogenetic analysis has been highlighted across several specialities to date. However, a paucity of evidence exists regarding spine surgery populations. Nevertheless, regular prospective pharmacogenetic analysis may ultimately prove beneficial when concerning degenerative spinal cohorts due to aforementioned surgical and economic considerations. The purpose of this narrative review is to outline how metaboliser profile variants affect the pharmacokinetics of specific analgesia used to treat back pain, and to discuss the current potential and limitations of employing regular pharmacogenetic analysis for spine surgery populations with degenerative conditions.

Risk factors for distal junctional failure in long-construct instrumentation for adult spinal deformity.

PURPOSE: The aim of this study is to identify risk factors associated with postoperative DJF in long constructs for ASD. METHODS: A retrospective review was performed at a tertiary referral spine centre from 01/01/2007 to 31/12/2016. Demographic, clinical and radiographic parameters were collated for patients with DJF in the postoperative period and compared to those without DJF. Survival analyses were performed using univariate logistic regression to identify variables with a p value < 0.05 for inclusion in multivariate analysis. Spearman's correlations were performed where applicable. RESULTS: One hundred two patients were identified. 41 (40.2%) suffered DJF in the postoperative period, with rod fracture being the most common sign of DJF (13/65; 20.0%). Mean time to failure was 32.4 months. On univariate analysis, pedicle subtraction osteotomy (p = 0.03), transforaminal lumbar interbody fusion (p < 0.001), pre-op LL (p < 0.01), pre-op SVA (p < 0.01), pre-op SS (p = 0.02), postop LL (p = 0.03), postop SVA (p = 0.01), postop PI/LL (p < 0.001), LL correction (p < 0.001), SVA correction (p < 0.001), PT correction (p = 0.03), PI/LL correction (p < 0.001), SS correction (p = 0.03) all proved significant. On multivariate analysis, pedicle subtraction osteotomy (OR 27.3; p = 0.03), postop SVA (p < 0.01) and LL correction (p = 0.02) remained statistically significant as independent risk factors for DJF. CONCLUSION: Recently, DJF has received recognition as its own entity due to a notable postoperative incidence. Few studies to date have evaluated risk factors for DJF. The results of our study highlight that pedicle subtraction osteotomy, poor correction of lumbar lordosis, and sagittal vertical axis are significantly associated with postoperative occurrence of DJF.

The relationship between radiological paraspinal lumbar measures and clinical measures of sarcopenia in older patients with chronic lower back pain.

Objectives: Sarcopenia is postulated to be an influential factor in chronic low back pain. The aim of this study is to evaluate the relationship between traditional clinical measures of sarcopenia and novel radiographic methods which evaluate overall muscle status, such as adjusted psoas cross-sectional area (APCSA) and degree of fat infiltration (%FI) in paraspinal muscles, in patients with chronic low back pain. Methods: Prospective study performed at our institution from 01/01/19-01/04/19. Inclusion criteria were patients ≥65 years old not requiring surgical intervention presenting to a low back pain assessment clinic. Results: 25 patients were identified (mean age: 73 years, 62% male). On spearman's analyses, %FI shared a significant relationship with hand grip strength (r = -0.37; p=0.03), chair rise (r=0.38; p=0.03), SC (r=0.64; p<0.01), and visual analogue scale scores (r=-0.14; p=0.02). Comparably, a statistically significant correlation was evident between APCSA and %FI (r=-0.40; p=0.02) on analysis. Conclusion: The results of our study demonstrate a statistically significant relationship between APCSA and %FI in the multifidus and erector spinae muscles. Further significant associations of relatability were depicted with traditional clinical measures of sarcopenia. Thus, %FI may be a supplemental indicator of the sarcopenic status of patients presenting with chronic low back pain.

The Incidence, Risk Factors, and Complications Associated With Surgical Delay in Multilevel Fusion for Adult Spinal Deformity.

STUDY DESIGN: Retrospective database review. OBJECTIVES: The incidence and risk factors for surgical delay of multilevel spine fusion for adult spinal deformity (ASD), and the complications corresponding therewith, remain unknown. The objectives of this study are to assess the incidence and risk factors for unexpected delay of elective multilevel spinal fusions on the date of surgery as well as the postoperative complications associated with these delays. METHODS: We conducted a retrospective review of the ACS-NSQIP database on patients undergoing elective spinal instrumentation of greater than 7 levels for ASD between the years 2005 and 2015. Preoperative risk factors for delay and postoperative complications were compared between the cohorts of patients with and without surgical delays. RESULTS: Multivariate analysis of 1570 (15.6%) patients identified advanced age, male sex, American Society of Anesthesiologists (ASA) Class 4, and history of smoking as independent risk factors for delay. Patients experiencing surgical delay demonstrated longer operative times, increased intraoperative bleeding, longer hospitalizations, and significantly higher rates of postoperative complications. Patients experiencing delay demonstrated an almost 7-fold increase in mortality rate (3.4% vs 0.5%, P < .001). CONCLUSIONS: Delays in elective surgical care for spinal deformity are negatively related to patient outcomes. Advanced age, male sex, increased ASA class, and a history of smoking cigarettes place patients at risk for surgical delay of multilevel spinal fusion. Patients experiencing surgical delay are at higher risk for postoperative complications, including a 7-fold increase in mortality. These findings suggest that ASD surgery should be postponed in patients experiencing a delay, until modifiable risk factors can be medically optimized, and perhaps postponed indefinitely in those with nonmodifiable risk factors.