Microdiscectomy is the most commonly performed spine surgery in the world. Due to its technical simplicity and low complication rate, this was the first spine surgical procedure transitioning for one-day surgery. However, the economic assessment of this outpatient transition was never performed and the question on the real impact in the burden of spine care remains. This economic study aims to access the cost-utility of outpatient lumbar microdiscectomy when compared with the inpatient procedure. To do so, a cost-utility study was performed, adopting the hospital perspective. Direct medical costs were retrieved from the assessment of 20 patients undergoing outpatient lumbar microdiscectomy and 20 undergoing inpatient lumbar microdiscectomy, from a in a Portuguese NHS hospital. Utilities were calculated with quality-adjusted life-years were derived from Oswestry Disability Index values (ODI). ODI was assessed prospectively in outpatients in pre and 3- and 6-month post-operative evaluations. Inpatient ODI data were estimated from a meta-analysis. both probabilistic and deterministic sensitivity analyses were performed and incremental cost-effectiveness ratio (ICER) calculated. A willingness to pay (WTP) threshold of €60000/QALY gained with inpatient procedure was defined. Out results showed that inpatient procedure was cost-saving in all models tested. At 3-month assessment ICER ranged from €135753 to €345755/QALY, higher than the predefined WTP. At 6-month costs were lower and utilities were higher in outpatient, overpowering the inpatient procedure. Probabilistic sensitivity analysis showed that in 65% to 73% of simulations outpatient was the better option. The savings with outpatient were about 55% of inpatient values, with similar utility scores. No 30-day readmissions were recorded in either group. The mean admission time in inpatient group was 2.5 days. Since there is an overall agreement among spine surgeons that an uncomplicated inpatient MD would only need a one-day admission, an analysis reducing inpatient admission time for one day was also performed and outpatient remained cost-effective. In conclusion, as the first economic study on cost-utility of outpatient lumbar microdiscectomy, this study showed a significant reduction in costs, with a similar clinical outcome, proving this outpatient transition as cost-effective

Aims. Degenerative cervical spondylosis (DCS) is a common musculoskeletal disease that encompasses a wide range of progressive degenerative changes and affects all components of the cervical spine. DCS imposes very large social and economic burdens. However, its genetic basis remains elusive. Methods. Predicted whole-blood and skeletal muscle gene expression and genome-wide association study (GWAS) data from a DCS database were integrated, and functional summary-based imputation (FUSION) software was used on the integrated data. A transcriptome-wide association study (TWAS) was conducted using FUSION software to assess the association between predicted gene expression and DCS risk. The TWAS-identified genes were verified via comparison with differentially expressed genes (DEGs) in DCS RNA expression profiles in the Gene Expression Omnibus (GEO) (Accession Number: GSE153761). The Functional Mapping and Annotation (FUMA) tool for genome-wide association studies and Meta tools were used for gene functional enrichment and annotation analysis. Results. The TWAS detected 420 DCS genes with p < 0.05 in skeletal muscle, such as ribosomal protein S15A (RPS15A) (PTWAS = 0.001), and 110 genes in whole blood, such as selectin L (SELL) (PTWAS = 0.001). Comparison with the DCS RNA expression profile identified 12 common genes, including Apelin Receptor (APLNR) (PTWAS = 0.001, PDEG = 0.025). In total, 148 DCS-enriched Gene Ontology (GO) terms were identified, such as mast cell degranulation (GO:0043303); 15 DCS-enriched Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways were identified, such as the sphingolipid signalling pathway (ko04071). Nine terms, such as degradation of the extracellular matrix (R-HSA-1474228), were common to the TWAS enrichment results and the RNA expression profile. Conclusion. Our results identify putative susceptibility genes; these findings provide new ideas for exploration of the genetic mechanism of DCS development and new targets for preclinical intervention and clinical treatment. Cite this article: Bone Joint Res 2023;12(1):80–90

Aims. Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted. Methods. As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients. Results. Of the 90 patients screened, 77 passed the initial screening criteria. A total of 27 patients had a PI-LL mismatch and 23 had a dynamic spondylolisthesis. Following secondary inclusion and exclusion criteria, 31 patients were eligible for the study. Six patients were randomized and one underwent surgery during the study period. Given the low number of patients recruited and randomized, it was not possible to assess completion rates, quality of life, imaging, or health economic outcomes as intended. Conclusion. This study provides a unique insight into the prevalence of dynamic spondylolisthesis and PI-LL mismatch in patients with symptomatic spinal stenosis, and demonstrates that there is a need for a definitive RCT which stratifies for these groups in order to inform surgical decision-making. Nonetheless a definitive study would need further refinement in design and implementation in order to be feasible. Cite this article: Bone Jt Open 2023;4(8):573–579

Background. Over 55,000 spinal operations are performed annually in the NHS. Effective postoperative analgesia facilitates early mobilisation and assists rehabilitation and hospital discharge, but is difficult to achieve with conventional, opioid-based, oral analgesia. The clinical and cost-effectiveness of two alternative techniques, namely intrathecal opioid and the more novel erector-spinae plane blockade, is unknown. The Pain Relief After Instrumented Spinal Surgery (PRAISE) trial aims to evaluate these techniques. Methods. PRAISE is a multicentre, prospective, parallel group, patient-blinded, randomised trial, seeking to recruit 456 adult participants undergoing elective, posterior lumbar-instrumented spinal surgery from up to 25 NHS hospitals. Participants will be randomised 1:1:1 to receive (1) Usual Care with local wound infiltration, (2) Intrathecal Opioid plus Usual Care with local wound infiltration or (3) Erector Spinae Plane blockade plus Usual Care with no local wound infiltration. The primary outcome is pain on movement on a 100mm visual analogue scale at 24 hours post-surgery. Secondary outcomes include pain at rest, leg pain, quality of recovery (QoR-15), postoperative opioid consumption, time to mobilisation, length of hospital stay, health utility (EQ-5D-5L), adverse events and resource use. Parallel economic evaluation will estimate incremental cost-effectiveness ratios. Results. Differences in the primary outcome at 24 hours will be estimated by mixed-effects linear regression modelling, with fixed effects for randomisation factors and other important prognostic variables, and random effects for centre, using the as-randomised population. Treatment effects with 95% confidence intervals will be presented. Conclusion. The study is due to open in May 2024 and complete in 2026. Conflicts of Interest. No conflicts of interest declared. Sources of Funding. NIHR Health Technology Award – grant number NIHR153170. Trial presentations so far. APOMP 2023 and 2024; RCOA conference, York, November 2023; Faculty of Pain Management training day, London, February 2024

Surgical site infections following spinal surgery profoundly influence continued treatment, significantly impacting psychological and economic dimensions and clinical outcomes. Its reported incidence varies up to 20%, with the highest incidence amongst neuromuscular scoliosis and metastatic cord compression patients. We describe the first reported biphasic osteoconductive scaffold (Cerament G) with a logarithmic elution profile as a cumulative strategic treatment modality for adjacent spinal surgery infections. All patients who developed surgical site infections following instrumented fusion (May 2021-December 2021) had their demographics (age, sex), type and number of procedures, isolated organism, antibiotics given, comorbidities, and WHO performance status analysed. The infected wound was debrided to healthy planes, samples taken, and Cerament g applied. Thirteen patients were treated for deep SSI following spinal instrumentation and fusion procedures with intraoperative Cerament G application. There were four males and nine females with an average age of 40 ranging between 12 and 87. Nine patients underwent initial surgery for spinal deformity, and four were treated for fractures as index procedure. 77% of infections were attributable to MSSA and Cutibacteriousm acnes; others included Klebsiella, Pseudomonas and Streptococcus and targeted with multimodal cumulative therapy. A WHO performance score improved in 11 patients. In addition, there was no wound leak, and infection was eradicated successfully in 12/13 with a single procedure. This series shows the successful eradication of the infection and improved functional outcomes with Cerament G. However, the low numbers of patients in our series are an essential consideration for the broader applicability of this device

Purpose and background. To evaluate the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and advice (best practice advice [BPA]) for older adults with neurogenic claudication (NC) which is a debilitating spinal condition. Methods and results. A randomised controlled trial of 438 participants. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included Swiss Spinal Stenosis Questionnaire (symptoms), ODI walking item, 6-minute walk test (6MWT) and falls. The analysis was intention-to-treat. We collected the EQ5D and health and social care use to estimate cost-effectiveness. Participants were, on average, 74.9 years old (SD 6.0). There was no significant difference in ODI scores between groups at 12 months (adjusted mean difference (MD): −1.4 [95% Confidence Intervals (CI) −4.03,1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: −3.7 [95% CI −6.27, −1.06]). Symptoms followed a similar pattern. The BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA at 12 months. Probability that the BOOST programme is cost-effective ranged from 67%–89% across cost-effectiveness thresholds. Conclusions. The BOOST programme improves mobility and reduces falls in older adults with NC compared to BPA at 12 months follow-up. It is good value for the NHS. Future iterations of the programme will consider ways to reduce symptoms and disability long-term. Conflicts of interest: No conflicts of interest. Sources of funding: National Institute of Health Research – Programme for Applied Research NIHR - PTC-RP-PG-0213-20002: Better Outcomes for Older people with Spinal Trouble (BOOST). Publication and presentations: The clinical effectiveness paper has just been accepted for publication in the Journal of Gerontology Series A. The health economic analysis is not yet published. It was presented at the Physiotherapy UK conference and the International Back and Neck Pain Forum in 2021

Background:. Outcome after traumatic spinal fracture is difficult to predict. Some patients have ongoing pain while others make a good recovery and there is therefore considerable debate as to which fractures should be treated operatively. Delayed operations for ongoing pain post fracture are more expensive with a longer recovery. The sagittal balance of the spine may predict patient outcomes post fracture. Aim:. Identify subjects with stable spine fractures not requiring acute fixation and compare their sagittal parameters measured on initial standing x-ray with whether or not they have ongoing pain. Methods:. A retrospective review was undertaken of patients presenting with a spine fracture to North Bristol Trust over a five year period. Sagittal parameters on initial standing x-rays were measured. The presence or absence of pain at last follow up was recorded. Results:. 399 fractures were identified. 100 were taken to theatre for acute fixation. Only 120 of those remaining had x-rays available which allowed full sagittal parameters to be measured. Clinical outcomes were available on 97 of these subjects. The measurement of pelvic incidence was not found to be significantly different in the two groups (p=0.218). The differences in pelvic tilt between those with and without pain was significant (p=0.004). Conclusion:. A lower pelvic tilt correlates with pain post fracture. Whether this is predictive of pain or not is unclear. Further investigation is indicated to examine the clinical outcomes and economic impact on subjects presenting with a fracture of the spine as well as the economic impact to the health service

Background and Purpose. Non-specific chronic low back pain (NSCLBP) poses a significant disability and economic burden worldwide. Fear avoidance is suggested to contribute to its chronicity and reduced treatment effect. National guidelines recommend exercise as a component of multidisciplinary rehabilitation but its interaction with fear avoidance is ambiguous. This systematic review examined the effect of exercise-based interventions (EBIs) on fear avoidance NSCLBP. Methods and Results. RCTs comparing EBIs to usual care in adults with NSCLBP were included. A systematic search of CINAHL, Medline, EMBASE, Web of Science, Scopus and Cochrane Library (up to January 2019) revealed 10 eligible trials. Following risk of bias assessment, 6 studies were included for data extraction and narrative synthesis. EBIs were not found superior to usual care in reducing fear avoidance at any follow-up. There was evidence that reducing fear avoidance is probably not the mechanism through which EBIs affect pain and disability. In adherent patients, EBIs did not result in greater clinically relevant improvements in pain or disability than usual care, in the short- or intermediate-term. Conclusion. Addition of EBIs as part of multidisciplinary rehabilitation is not more beneficial than that of usual care in reducing fear avoidance in NSCLBP patients. However, the findings of this review are based on heterogenous studies presenting with methodological limitations. Further high-quality research is required to examine the review's findings and investigate current physiotherapy management of fear avoidance in NSCLBP. No conflicts of interest. No funding obtained

Introduction. Injectable hydrogels via minimally invasive surgery offer benefits to the healthcare system, reduced risk of infection, scar formation and the cost of treatment. Development of new treatments with the use of novel biomaterials requires significant pre-clinical testing and must comply with regulations before they can reach the bedside. In the European economic area (EEA) one of the first hurdles of this process is attaining the CE marking which protects the health, safety and environmental aspects of a product. Implanted materials fall under the class III medical device EU745 regulation standards. To attain the CE marking for a product parties must provide evidence of the materials safety with an investigational medicinal product dossier (IMPD). Methods and Results. We have been working to develop a new thermoresponsive injectable biomaterial hydrogel (NPgel) for the treatment of intervertebral disc (IVD) disease. A large part of the IMPD requires information on how the hydrogel physical properties change over time in bodily conditions. We have been studying 6 batches of NPgel over 18 months, tracking the materials wet/ dry weight, structure and composition. To date we have found that NPgel in liquids more similar to the body (with protein and salts) appear to be stable and safe, whilst those in distilled water swell and disintegrate over time. Subtle long-term changes to the material composition were found and we are currently investigating its ramifications. Conclusion. The study highlights the need to test materials in detail in physiologically representative environments before approaching the bedside and demonstrates promise for NPgel as a suitable CE candidate. Conflicts of interest: CS and CLM are named inventors on the patent for NPgel/BGel. Funded by the Medical Research Council and Versus Arthritis UK: SNiPER

Background and Purpose. The STarT Back approach comprises subgrouping of LBP patients according to risk of persistent LBP-related disability, and matches patients to appropriate treatments. In a clinical trial and implementation study, this stratified care approach was clinically and cost-effective compared to usual non-stratified care. However, the long-term cost- effectiveness is unknown, and could be established with decision modelling. A systematic review of model-based economic evaluations in LBP found shortcomings with existing models, including inadequate characterisation of the condition in health states and absence of long-term modelling. This study conceptualises the first decision model of this stratified care approach for LBP management, and assesses long-term cost-effectiveness. Methods. A cost-utility analysis from the NHS perspective compared stratified care with usual care, in patients consulting in primary care with non-specific LBP. A Markov state-transition model was constructed where long-term patient prognosis over ten years was dependent upon physical function achieved at twelve months. Consultation with experts helped define condition health states, inform the long-term modelling, and choice of sensitivity analyses. Results. Preliminary base-case results indicate this model of stratified care is cost-effective over a ten-year time horizon, delivering 0.10 additional quality-adjusted life years (QALYs) at a cost-saving of £100.27 per patient. Sensitivity analyses indicate the approach is likely to be cost-effective in all scenarios, and cost-saving in most, although sensitive to assumptions regarding long-term patient prognosis. Analysis from the societal perspective improved the associated cost-savings. Conclusion. It is likely that implementation of this stratified care model will help reduce unnecessary healthcare usage, whilst improving patient quality of life. No conflicts of interest. Funding: Research stipend for JAH by the Institute for Primary Care & Health Sciences, Keele University

A statement of the purposes of the study and background. Lower back pain (LBP) is one of the ten leading causes of disease burden globally, producing significant detrimental effects on physical and emotional wellbeing whilst having a substantial economic burden for society. There is an inverse relationship between socio-economic status and pain prevalence. The effectiveness of a locally run ‘Back to Fitness Programme’ (6-week education and exercise programme) in the most deprived local authority area in England was evaluated. A summary of the methods used and the results. Patients at Blackpool Hospitals NHS Trust over a 6-month timeframe were included. Initial data were collected from 49 patients (mean age 53.4 years, 67% female). The amount of final data collected varied per outcome measure due to a range of factors. Participants reported the programme had helped with their understanding of pain (n=16, 100%), ability to move around and function (n=15, 94%), and level of pain (n=14, 88%). Looking at Roland Morris Disability Questionnaire scores (n=17), 88% (n=15) of patients indicated a reduction (n=12, 71%) or no change (n=3, 18%) in perceived disability. The Pain Self Efficacy Questionnaire (n=18) showed that 78% (n=14) of participants perceived an increase in their average level of confidence to move despite pain. There was an overall improvement in understanding of pain reflected by Revised Neurophysiology of Pain Questionnaire scores (n=44): 89% (n=39) improved (n=36, 82%) or did not change (n=3, 7%). Regarding lumbar flexion post-programme (n=17), 77% (n=13) of participants demonstrated an improvement (n=9, 53%) or no change (n=4, 24%). Conclusion. The majority of clinical outcomes improved following participation, predominantly in relation to understanding of pain. Conflicts of interest: No conflicts of interest. Sources of funding: This study is supported by The University of Central Lancashire in partnership with The Blackpool Teaching Hospitals NHS Foundation Trust

Aims

To identify the incidence and risk factors for five-year same-site recurrent disc herniation (sRDH) after primary single-level lumbar discectomy. Secondary outcome was the incidence and risk factors for five-year sRDH reoperation.

Aims. The primary aim of this study was to evaluate the performance and safety of magnetically controlled growth rods in the treatment of early onset scoliosis. Secondary aims were to evaluate the clinical outcome, the rate of further surgery, the rate of complications, and the durability of correction. Patients and Methods. We undertook an observational prospective cohort study of children with early onset scoliosis, who were recruited over a one-year period and followed up for a minimum of two years. Magnetically controlled rods were introduced in a standardized manner with distractions performed three-monthly thereafter. Adverse events which were both related and unrelated to the device were recorded. Ten children, for whom relevant key data points (such as demographic information, growth parameters, Cobb angles, and functional outcomes) were available, were recruited and followed up over the period of the study. There were five boys and five girls. Their mean age was 6.2 years (2.5 to 10). Results. The mean coronal Cobb angle improved from 57.6° (40° to 81°) preoperatively, 32.8° (28° to 46°) postoperatively, and 41° (19° to 57°) at two years. Five children had an adverse event, with four requiring return to theatre, but none were related to the device. There were no neurological complications or infections. No devices failed. One child developed a proximal junctional kyphosis. The mean gain in spinal column height from T1 to S1 was 45.4 mm (24 to 81) over the period of the study. Conclusion. Magnetically controlled growth rods provide an alternative solution to traditional growing rods in the surgical management of children with early onset scoliosis, supporting growth of the spine while controlling curve progression. Their use has clear psychosocial and economic benefits, with the reduction of the need for repeat surgery as required with traditional growing rods. Cite this article: Bone Joint J 2018;100-B:507–15

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

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Lumbar spinal stenosis (LSS) is a common skeletal system disease that has been partly attributed to genetic variation. However, the correlation between genetic variation and pathological changes in LSS is insufficient, and it is difficult to provide a reference for the early diagnosis and treatment of the disease.

Aims

This study was performed to explore the effect of melatonin on pyroptosis in nucleus pulposus cells (NPCs) and the underlying mechanism of that effect.

Aims

People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial).

Aims

The escalating demand for medical resources to address spinal diseases as society ages is an issue that requires careful evaluation. However, few studies have examined trends in spinal surgery, especially unscheduled hospitalizations or surgeries performed after hours, through large databases. Our study aimed to determine national trends in the number of spine surgeries in Japan. We also aimed to identify trends in after-hours surgeries and unscheduled hospitalizations and their impact on complications and costs.

Aims

This study aimed, through bioinformatics analysis and in vitro experiment validation, to identify the key extracellular proteins of intervertebral disc degeneration (IDD).

Purpose. This review aims to explore the methodologies used for estimating the direct and indirect costs attributed to back pain in developed countries. Methods. Six databases were searched to uncover studies about the direct and indirect costs of back pain published in English upto November 2016. Data extracted included study characteristics, cost categories and analysis methods. Results were synthesised descriptively. Results. The search identified 8009 potential studies, of which 40 were included for data extraction. The included studies reported data from 14 industrialised countries with considerably varying methodologies. Most of the studies (n=25) followed a retrospective study design and cost perspective was largely societal (n=26). Nearly half of the selected studies included indirect costs in their analysis as well as direct costs; and the proportion of indirect costs in most of the studies far outweighed the direct costs (3:1 ratio). The analysis method used most frequently was the top-down approach (n=13) followed by bottom-up approach (n=7) and econometric methods (n=7). Inpatient costs and absenteeism costs were the most important cost drivers accounting for 12%−35% of the direct costs and 5%−67% of the indirect costs respectively. The healthcare costs associated with back pain in the UK were estimated at £1.6 billion in 1998 while the indirect costs ranged from £5 billion to £10.7 billion. Conclusions. This is the first methodological systematic review assessing the costs of back pain. Despite differences in methodology, the economic burden of back pain is significant. Development of guideline and standardisation of methodologies is needed for future studies. Conflict of interest: None. Sources of funding: None