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Abstract Introduction The objective of this analysis is to evaluate the improvement in spinal pain with ixekizumab, placebo, and adalimumab based on objective measures of inflammation response in patients with ankylosing spondylitis (AS). Methods The COAST-V 52-week, double-blind, placebo-controlled, randomized phase III trial examined the efficacy of ixekizumab in patients with active AS; adalimumab was used as an active reference arm. Treatment effects on reduction in pain were assessed by objective measures of controlled and persisting inflammation (defined by magnetic resonance imaging [MRI], C-reactive protein [CRP], or MRI + CRP status). Pathway analysis was used to analyze treatment effect that was not attributable to reduction in inflammation biomarkers. Results In patients with AS, when inflammation was controlled as assessed by MRI, patients treated with ixekizumab experienced a reduction in spinal pain at night (SP-N, numeric rating scale, ixekizumab mean = − 3.9, p

Background Infectious spondylodiscitis is a debilitating condition and evidence-based medicine dictates confirming the diagnosis before treatment. Computed tomography–guided spinal biopsy plays a major role and hence we would like to determine its utility in current clinical practice. Purpose The purpose of this study is to determine the percentage of confirmatory positives of CT-guided spinal biopsy in patients who were clinicoradiologically diagnosed with infectious spondylitis. Material and Methods A retrospective analysis of patients who underwent CT-guided biopsy for suspected infectious spondylodiscitis from 2017 to 2021 in a tertiary medical center was done. The data were filtered and obtained from the electronic database of the institution. Results In all, 259 patients underwent CT-guided biopsy of the spine. The procedure provided confirmatory results in 149 (57.5%) biospecimens. Histopathology examination was confirmatory in 95 (36.6%) of the 241 biospecimens sent. The Mycobacteria Growth Indicator Tube (MGIT) was confirmatory in 51 (19.9%) of the 250 biospecimens sent and drug resistance was seen in 6/51 (11.7%) biospecimens. Xpert TB provided confirmatory results in 72 (27.8%) of the 254 biospecimens sent and rifampicin resistance was seen in 16/72 (22.2%) biospecimens. Bacterial culture was confirmatory in 29 (11.2%) of the 250 biospecimens sent. The complication documented in this study was 0.3%. Conclusion CT-guided spinal biopsy for suspected vertebral osteomyelitis is a safe and effective minimally invasive procedure. It demonstrates a positive yield in more than half of the patients. Knowing the outcome, the patients can be appropriately counseled prior to the procedure. CT-guided biopsy results were affected by prior administration of ATT (antitubercular therapy) in suspected tuberculous spondylitis patients.

Mucin-domain glycoproteins are densely O-glycosylated proteins with unique secondary structure that imparts a large influence on cellular environments. Here, the authors develop a technique to selectively enrich and characterize mucin-domain glycoproteins from cell lysate and patient biofluids.

With increase in the elderly population and improved survival among patients with malignancies, the rates of patients presenting with metastatic involvement of the spine is on the rise. Surgical management of spinal metastasis requires a multidisciplinary approach and surgery is a key component of multimodality management of metastatic spinal lesions. A PubMed search of relevant articles was performed and a narrative review of available pertinent literature in English language is presented.

The goal of treatment in patients with spinal metastasis is palliation, that is, to improve the quality of remaining life as judged by alleviation of pain, preservation or restoration of neurology, and improvement in function. Local control of the spinal metastasis not only influences the overall survival of a cancer patient but is vital to maintain treatment benefits for the duration of the patient`s survival. However, cancer therapy––both surgical and nonsurgical––carries a significant risk of complications, morbidity, and even mortality. Decision-making regarding the most appropriate treatment strategy is vital when treating terminally ill patients with spinal metastatic disease.

Study Design Retrospective case series. Purpose This study aimed to examine the efficacy of composite grip strength as a marker of surgical outcome in patients with moderate to severe degenerative cervical myelopathy. Overview of Literature Degenerative cervical myelopathy causes loss of dexterity, muscle strength, and sensations in the hand. The impact of surgical management on improvement in composite grip strength has received scant attention. Methods This retrospective study was performed on degenerative cervical myelopathy patients with a complete composite grip strength assessment between January 2013 to January 2019. The Biometrics E-link hand kit was used for the assessment. The following parameters were measured: maximum grip strength, sustained grip strength, three-jaw pinch, maximum key pinch, and sustained key pinch. The pre- and postoperative functional status was assessed using the Nurick grade and the modified Japanese Orthopaedic Association (mJOA) score. Results A total of 40 patients were included in the study. The mean patient age was 51.9 years. The mean preoperative Nurick grade was 3.5 and the mJOA score was 10.9. The anterior approach was used in 25 patients, and the posterior approach was used in 15 patients. Four patients developed complications. Degenerative cervical myelopathy resulted in decreased handgrip and pinch strength as compared to normative Indian data. There was a significant improvement in the postoperative composite grip strength for all five parameters. There was no differential improvement between the anterior and posterior surgical groups. The improvement in the composite grip strength correlated with the improvement in functional scores. Conclusions Composite grip strength analysis is an objective method for assessing the impact of degenerative cervical myelopathy on grip strength and monitoring the postoperative improvement. Decompressive surgery resulted in global improvement in all the parameters of composite grip strength.

Study Design Retrospective case series. Purpose This study aimed to analyze how the sagittal spinopelvic alignment is influenced by an attempted surgical reduction of the L5–S1 segment in patients with high-grade spondylolisthesis (HGS). Overview of Literature Conventional treatment strategies stress the importance of achieving fusion across the lumbosacral junction in patients with HGS. The role of reduction in this subset of patients is controversial. Methods This is a retrospective case series of 35 patients with Meyerding grades III, IV, or V spondylolisthesis who underwent surgical treatment in our institution. Before and after surgery, we took standing lateral radiographs from L1 vertebra to pelvis, including the femoral heads, and measured the slip grade, pelvic incidence, sacral slope, pelvic tilt, lumbosacral angle, and lumbar lordosis. Patients were subdivided into “balanced” and “unbalanced” pelvis groups. To determine the effect and correlation of reduction on these spinopelvic parameters, we statistically compared the pre- and postoperative measurements. Results The average follow-up was 9 months (range, 3–169 months). Slip grade improved from an average 74.0%±13.2% to 30.0%±14.0% (p

Study Design Prospective cohort study. Purpose To evaluate the association between nutritional parameters related to postoperative surgical site infections and duration of hospital stay and intensive care unit (ICU) stay in patients undergoing major spine surgery. Overview of Literature Malnutrition is highly prevalent in surgical patients. Malnourished patients are considered to be at higher risk for postoperative morbidity and mortality due to impaired wound healing, delayed inflammation, impaired fibroblast proliferation, and collagen synthesis. Decreased lymphocyte count also impairs the ability of the immune system to eradicate or prevent infection, which predisposes these patients to infections. However, this association between malnutrition and postoperative morbidity is not consistent across studies, thus necessitating further investigation. Methods The values of serum albumin, prealbumin, total lymphocyte counts, and transferrin were documented preoperatively and postoperatively on day 5 for all patients undergoing major spine surgery (surgery involving instrumentation of at least three motion segments). In addition, patients’ surgical wound healing status, duration of hospital stay, and duration of ICU stay in the postoperative period were documented. Finally, the statistical correlation between the nutritional markers and these complications was determined. Results Low postoperative prealbumin levels was significantly associated with increased complication rates. ICU stay demonstrated a statistically significant association with low postoperative albumin, prealbumin, and transferrin levels. Similarly, we observed that low postoperative albumin and prealbumin levels could significantly predict the need for prolonged hospital stay in patients undergoing major spine surgery. Conclusions The magnitude of the decrease in nutritional status due to surgery with respect to albumin and prealbumin levels is a significant (p

Degenerative spondylolisthesis is one of the commonest spinal pathologies encountered in the aging population. The clinical presentation of degenerative spondylolisthesis can be highly variable, and a large proportion of patients can be managed non-operatively. Operative treatment is reserved for patients with activity limiting disability. Decompression alone can be offered to patients with no radiological or clinical evidence of segmental instability. Fusion procedures have shown high rates of clinical success, although long-term effects such as adjacent segment degeneration have spurred the evolution of non-fusion technologies. These newer options have shown evidence of motion preservation, although long-term clinical benefits have yet to be confirmed.

Purpose: The purpose of the study was to determine the rate and predictors of return to work (RTW) after surgery for cervical spondylotic myelopathy (CSM). Overview of Literature: RTW is arguably the most important outcome following spine surgery from a patient’s perspective. But, to the best of our knowledge, there have been no reports in the English literature describing RTW among patients undergoing surgery for moderate-to-severe CSM. Materials and Methods: We included adult patients with CSM with Nurick grade ≥ 3 who underwent surgery. They were divided into two groups: those who returned to work within 6 months (group 1) and those who did not (group 2) and their outcomes were analyzed. Results: A total of 34 patients were included in the study. Baseline characteristics were comparable between the groups. Only 18 (52.9%) patients returned to work by 6 months. The nature of work had a statistically significant association with RTW by 6 months (P = 0.005) with failure to RTW specifically seen in manual laborers. Age, body mass index, symptom duration, pre-operative absenteeism, smoking, diabetes mellitus, number of levels operated, surgical approach, and post-operative complications did not have significant association with RTW. Better functional outcomes were seen in patients who returned to work as calculated using Nurick grade (P = 0.000) and modified Japanese Orthopedic Association score (P = 0.001). All the patients who returned to work and 75% of the patients who did not RTW were satisfied with the outcome of surgery (P = 0.039). Conclusion: In spite of functional improvement, CSM was associated with poor RTW with manual laborers being the most vulnerable group. This study will help surgeons modulate patient expectations as well as provide a platform for counseling them.

Study Design A biomechanical study. Purpose To determine the actual load path and compare pullout strengths as a function of screw size used in revision surgeries using postmortem human subject specimens. Overview of Literature Pedicle screw fixation has become the standard of care in the surgical management of spinal instability. However, pullout failures are widely observed in osteoporotic spines and treated by revision surgeries using a higher diameter screw, performing cement augmentation, or increasing the levels of fixation. While the peak forces to final pullout are reported, the actual load path to achieve the final force level is not available. Methods Six osteoporotic lumbar spines (L2–L5) were instrumented with 5.5×40 mm polyaxial screws and loaded along the axis of the screw using a material testing machine according to American Society for Testing of Materials 543-07 test protocol. Tests were again conducted by replacing them with 6.5×40 mm (group A) or 7.5×40 mm (group B) screws. Force-displacement data were grouped and load paths (mean±1 standard deviation) were compared. Results Pullout strength decreased by 36% when the size of the revision screw was increased by 1 mm, while it increased by 35% when the size of the revision screw was increased by 2 mm compared to the index screw value. While the morphologies of the load paths were similar in all cases, they differ between the two groups: the larger screw responded with generally elevated stiffer path than the smaller screw, suggesting that revision surgery using a larger screw has more purchase along the inserted body-pedicle axis. Conclusions A larger screw enhances strength and increases biomechanical stability in revision surgeries, although the final surgical decision is made by the clinician, which includes the patient’s anatomy and associated characteristics.

Study Design Retrospective study. Purpose To report the prevalence of patients with multidrug-resistant (MDR) tubercular spondylodiscitis and their outcomes. Additionally, to assess the role of Xpert MTB/RIF assay in early detection of MDR tuberculosis. Overview of Literature MDR tuberculosis is increasing globally. The World Health Organization (WHO) has strongly recommended Xpert MTB/RIF assay for early detection of tuberculosis. Methods From 2006 to 2015, a retrospective study was conducted on patients treated for MDR tuberculosis of the spine. Only patients whose diagnosis was confirmed using either culture and/or the Xpert MTB/RIF assay were included. Diagnostic method, treatment regimen, time taken to initiate second-line antituberculosis treatment (ATT), drug-related complications, and cost of medications were analyzed. All patients with MDR were treated according to the WHO recommendations for 2 years. The outcome parameters analyzed included clinical, biochemical, and radiological criteria to assess healing status. Results From 2006 to 2015, a total of 730 patients were treated for tubercular spondylodiscitis. Of those, 36 had MDR tubercular spondylitis (prevalence, 4.9%), and three had extremely drug resistant tubercular spondylitis (prevalence, 0.4%). In this study, 30 patients, with a mean age of 29 years and a mean post-treatment follow-up of 24 months, were enrolled. The majority (77%) had secondary MDR, 17 (56%) underwent surgery, and 26 (87%) completed treatment for 2 years and were healed. Drug-related complications (33%) included ototoxicity, hypothyroidism, and hyperpigmentation of the skin. The average time taken for initiation of second line ATT for MDR patients with Xpert MTB/RIF assay as the diagnostic tool was 18 days, when compared to patients for whom the assay was not available which was 243 days. Conclusions The prevalence of MDR tubercular spondylodiscitis was 4.9%. In total, 87% of patients were healed with adequate treatment. The sensitivity and specificity of the Xpert MTB/RIF assay to detect MDR was 100% and 92.3%, respectively.

Study Design Retrospective case series. Purpose The aim of this study was to analyze functional and radiological outcomes in patients with culture-negative pyogenic vertebral osteomyelitis (PVO). Overview of Literature There were only few literature available for these group of patients. Methods Patients with biopsy-positive but culture-negative PVO were included. We analyzed records for data on demography, comorbidities, coexisting infections, neurological status, prior antibiotic therapy, pre- and postoperative erythrocyte sedimentation rate, C-reactive protein levels, and Oswestry Disability Index, and Japanese Orthopedics Association scores. Results Sixty-one patients were included, of which data of 45 patients were available for follow-up. The patients were predominantly males (71%), with a mean age of 53.2 years. Seventy-seven percent patients had comorbidities. Echocardiography, blood culture, and urine culture were performed on 8%, 24%, and 18% of patients, respectively. Thirty-one percent patients had neurological deficits. Computed tomography-guided biopsy was performed on 67% patients. Fifty-two percent patients were treated surgically, and 48% were treated non-surgically. Nineteen percent patients were treated according to the results of cultures from other foci, and the rest were treated empirically. For the initial 2 weeks, all patients were treated with intravenous antibiotics empirically or based on culture from other foci. This treatment was followed by 10 weeks of oral cloxacillin/cephalexin for gram-positive organisms or ciprofloxacin for gram-negative organisms. The mean follow-up time was 18 months (range, 12–120 months). All patients had improvement in Japanese Orthopedics Association, Oswestry Disability Index, and Visual Analog Scale scores (p

Study Design Retrospective case series. Purpose The aim of the study is to report the clinical characteristics, early diagnosis, management, and outcome of children with multidrug-resistant (MDR) tubercular spondylodiscitis and to assess the early detection of rifampicin resistance using the Xpert MTB/ RIF assay. Overview of Literature MDR tuberculosis is on the rise, especially in developing countries. The incidence rate of MDR has been reported as 8.9% in children. Methods A retrospective study of children aged

Study Design A biomechanical study of pedicle-screw pullout strength. Purpose To develop a decision tree based on pullout strength for evaluating pedicle-screw instrumentation. Overview of Literature Clinically, a surgeon’s understanding of the holding power of a pedicle screw is based on perioperative intuition (which is like insertion torque) while inserting the screw. This is a subjective feeling that depends on the skill and experience of the surgeon. With the advent of robotic surgery, there is an urgent need for the creation of a patient-specific surgical planning system. A learning-based predictive model is needed to understand the sensitivity of pedicle-screw holding power to various factors. Methods Pullout studies were carried out on rigid polyurethane foam, representing extremely osteoporotic to normal bone for different insertion depths and angles of a pedicle screw. The results of these experimental studies were used to build a pullout-strength predictor and a decision tree using a machine-learning approach. Results Based on analysis of variance, it was found that all the factors under study had a significant effect (p

Abstract Baricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor approved for the treatment of rheumatoid arthritis (RA) that was independently predicted, using artificial intelligence (AI) algorithms, to be useful for COVID‐19 infection via proposed anti‐cytokine effects and as an inhibitor of host cell viral propagation. We evaluated the in vitro pharmacology of baricitinib across relevant leukocyte subpopulations coupled to its in vivo pharmacokinetics and showed it inhibited signaling of cytokines implicated in COVID‐19 infection. We validated the AI‐predicted biochemical inhibitory effects of baricitinib on human numb‐associated kinase (hNAK) members measuring nanomolar affinities for AAK1, BIKE, and GAK. Inhibition of NAKs led to reduced viral infectivity with baricitinib using human primary liver spheroids. These effects occurred at exposure levels seen clinically. In a case series of patients with bilateral COVID‐19 pneumonia, baricitinib treatment was associated with clinical and radiologic recovery, a rapid decline in SARS‐CoV‐2 viral load, inflammatory markers, and IL‐6 levels. Collectively, these data support further evaluation of the anti‐cytokine and anti‐viral activity of baricitinib and support its assessment in randomized trials in hospitalized COVID‐19 patients.

Study Design A biomechanical study. Purpose A new biomechanical model of the vertebra has been developed that accounts for the inhomogeneity of bone and the contribution of the pedicle toward the holding strength of a pedicle screw. Overview of Literature Pullout strength studies are typically carried out on rigid polyurethane foams that represent the homogeneous vertebral framework of the spine. However, the contribution of the pedicle region, which contributes to the inhomogeneity in this framework, has not been considered in previous investigations. Therefore, we propose a new biomechanical model that can account for the vertebral inhomogeneity, especially the contribution of the pedicles toward the pullout strength of the pedicle screw. Methods A bilayer foam model was developed by joining two foams representing the pedicle and the vertebra. The results of the pullout strength tests performed on the foam models were compared with those from the tests performed on the cadaver lumbar vertebra. Results Significant differences (p 0.05) in the pullout strength of pedicle screws between osteoporotic (0.85±0.08 kN) and extremely osteoporotic bone models (0.94±0.08 kN), but there was a significant difference (p 0.05) in pullout strength between cadaver and bilayer foam model in normal bones. Conclusions The new synthetic bone model that reflects the contribution of the pedicles to the pullout strength of the pedicle screws could provide a more efficacious means of testing pedicle-screw pullout strength. The bilayer model can match the pullout strength value of normal lumbar vertebra bone whereas the monolayer foam model was able to match that of the extremely osteoporotic lumbar vertebra.

Study DesignRetrospective clinical analysis.PurposeTo delineate the clinical presentation of melioidosis in the spine and to create awareness among healthcare professionals, particularly spine surgeons, regarding the diagnosis and treatment of melioidotic spondylitis.Overview of LiteratureMelioidosis is an emerging disease, particularly in developing countries, associated with a high mortality rate. Its causative pathogen, Burkholderia pseudomallei, has been labeled as a bio-terrorism agent.MethodsWe performed a retrospective analysis of patients who were culture positive for B. pseudomallei. Assessment of patients was performed using clinical, radiological, and blood parameters. Clinical measures included pain, neurological deficit, and return to work. Radiological measures included plain radiography of the spine and magnetic resonance imaging. Blood tests included erythrocyte sedimentation rate and C-reactive protein levels.ResultsFour patients having melioidosis with spondylitis were evaluated. All of them had diabetes mellitus; three had multiple abscesses which required incision and drainage. Their clinical spectrum was similar to that of tuberculous spondylitis; all had back pain and radiology revealed infective spondylodiscitis with prevertebral and paravertebral collections with psoas abscess. Three patients underwent ultrasound-guided drainage of the psoas abscess and one had aspiration of the subcutaneous abscess. Bacteriological cultures showed presence of B. pseudomallei, and histopathology showed non-caseating granulomatous inflammation. All patients were treated with intravenous Ceftazidime for 2 weeks, followed by oral bactrim double strength and Doxycycline for 20 weeks. All patients improved with treatment and were healed at follow up.ConclusionsMelioidosis presents with a clinical spectrum similar to that of tuberculosis. A diagnosis of melioidotic spondylitis should be considered, particularly in patients with diabetes with neutrophilic leukocytosis and clinical-radiological features suggestive of infective spondylodiscitis. Bacteriological culture and histopathology helps in differentiating the two conditions. Health education for healthcare professionals is important for correctly diagnosing this disease.

Study DesignBiomechanical study.PurposeTo determine the effect of density, insertion angle and reinsertion on pull-out strength of pedicle screw in single and two screw-rod configurations.Overview of LiteraturePedicle screw pull-out studies have involved single screw construct, whereas two screws and rod constructs are always used in spine fusions. Extrapolation of results using the single screw construct may lead to using expensive implants or increasing the fusion levels specifically in osteoporotic bones.MethodsSingle screw and two screw pull-out strength tests were carried out according to American Society for Testing and Materials F 543-07 on foam models to test the effect of density, insertion angle and reinsertion using poly axial pedicle screws.ResultsBone density was the most significant factor deciding the pull-out strength in both single and two screw constructs. The difference in pull-out strength between single screw and two screw configurations in extremely osteoporotic bone model (80 kg/m3) was 78%, whereas in the normal bone model it was 48%. Axial pull-out value was highest for the single screw configuration; in the two screw configuration the highest pull-out strength was at 10°–15°. There was an 18% reduction in pull-out strength due to reinsertion in single screw configuration. The reinsertion effect was insignificant in the two screw configuration.ConclusionsA significant difference in response of various factors on holding power of pedicle screw between single and two-screw configurations is evident. The percentage increase in pull-out strength between single and two screw constructs is higher for osteoporotic bone when compared to normal bone. Reinsertion has no significant effect on pull-out strength in the two screw rod configuration.