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Background: Patients surgically treated for lumbar spinal stenosis or cervical radiculopathy report improvement in approximately two out of three cases. Advancements in Machine Learning and the utility of large datasets have enabled the development of prognostic prediction models within spine surgery. This trial investigates if the use of the postoperative outcome prediction model, the Dialogue Support, can alter patient-reported outcome and satisfaction compared to current practice., Methods: This is a prospective, multicenter clinical trial. Patients referred to a spine clinic with cervical radiculopathy or lumbar spinal stenosis will be screened for eligibility. Participants will be assessed at baseline upon recruitment and at 12 months follow-up. The Dialogue Support will be used on all participants, and they will thereafter be placed into either a surgical or a non-surgical treatment arm, depending on the decision made between patient and surgeon. The surgical treatment group will be studied separately based on diagnosis of either cervical radiculopathy or lumbar spinal stenosis. Both the surgical and the non-surgical group will be compared to a retrospective matched control group retrieved from the Swespine register, on which the Dialogue Support has not been used. The primary outcome measure is global assessment regarding leg/arm pain in the surgical treatment group. Secondary outcome measures include patient satisfaction, Oswestry Disability Index (ODI), EQ-5D, and Numeric Rating Scales (NRS) for pain. In the non-surgical treatment group primary outcome measures are EQ-5D and mortality, as part of a selection bias analysis., Discussion: The findings of this study may provide evidence on whether the use of an advanced digital decision tool can alter patient-reported outcomes after surgery., Trial Registration: The trial was retrospectively registered at ClinicalTrials.gov on April 17th, 2023, NCT05817747., Protocol Version: 1., Trial Design: Clinical multicenter trial., (© 2024. The Author(s).)

Abstract: Current research indicates that spinal cord stimulation (SCS) has a positive short-term impact on outcomes, such as quality of life, pain, and productivity in patients with chronic neuropathic pain. However, there is a need for studies on larger population samples. This study used data from Swedish national registers to analyze change and predictors of sick leave and disability pension 2 years before and after SCS treatment. Patients with SCS implanted between 2006 and 2017, and a reference group consisting of 5 individuals matched to each SCS patient without replacement with respect to age, sex, and region of residence, were included. A difference-in-difference approach was used to compare the average change (2 years after treatment vs 2 years before treatment) in net disability days and indirect cost related to disability days for the SCS group, compared with the average change for the reference group. The results showed that SCS treatment in Sweden is associated with a decrease of 21 disability days and consequent decrease in indirect cost of €4127 in working age patients. Large work loss prior to index date was also demonstrated (average 214 days before 1 year), indicating a significant burden on the patient, employers, and the society at large. The number of disability days varied considerably depending on age, sex, socioeconomic variables, and comorbidities; however, the effect of SCS seemed to have little association with patient characteristics. This economic benefit needs to be considered, as well as the clinical outcome, when evaluating the full societal value of SCS., (Copyright © 2022 International Association for the Study of Pain.)

Purpose: The Oswestry Disability Index (ODI) and the Neck Disability Index (NDI) scoring algorithms used by the Swedish spine register (Swespine) until April 2022 handled missing items somewhat differently than the original algorithms. The purpose of the current study was to evaluate possible differences in the ODI and NDI scores between the Swespine and the original scoring algorithms., Methods: Patients surgically treated for degenerative conditions of the lumbar or cervical spine between 2003-2019 (lumbar) and 2006-2019 (cervical) were identified in Swespine. Preoperative and 1-year postoperative ODI/NDI data were used to evaluate differences between the Swespine and the original ODI/NDI algorithms with adjustment for at most 1 or 2 missing items using mean imputation., Results: The preoperative as well as the 1-year postoperative ODI/NDI were approximately 1 unit out of 100 smaller for the Swespine algorithm, irrespective of adjustment model. The differences between preoperative and postoperative ODI/NDI scores were similar between the Swespine and the original scoring algorithms. There were occasional statistically significant differences between the preoperative-postoperative differences due to large sample sizes., Conclusions: The Swespine algorithms, used until April 2022, underestimated the ODI and NDI by approximately 1 out of 100 units compared with the original algorithms. In addition, there were no statistically significant differences between the original algorithms when adjusting for at most 1 or 2 missing items. The algorithm has now been changed, also for historical data., (© 2022. The Author(s).)

Purpose: To evaluate the predictive precision of the Dialogue Support, a tool for additional help in shared decision-making before surgery of the degenerative spine., Methods: Data in Swespine (Swedish national quality registry) of patients operated between 2007 and 2019 found the development of prediction algorithms based on logistic regression analyses, where socio-demographic and baseline variables were included. The algorithms were tested in four diagnostic groups: lumbar disc herniation, lumbar spinal stenosis, degenerative disc disease and cervical radiculopathy. By random selection, 80% of the study population was used for the prediction of outcome and then tested against the actual outcome of the remaining 20%. Outcome measures were global assessment of pain (GA), and satisfaction with outcome., Results: Calibration plots demonstrated a high degree of concordance on a group level. On an individual level, ROC curves showed moderate predictive capacity with AUC (area under the curve) values 0.67-0.68 for global assessment and 0.6-0.67 for satisfaction., Conclusion: The Dialogue Support can serve as an aid to both patient and surgeon when discussing and deciding on surgical treatment of degenerative conditions in the lumbar and cervical spine., Level of Evidence: I., (© 2021. The Author(s).)

Patients with degenerative hip and lumbar spine disorders requiring surgery in both locations is fairly common in clinical practice. We investigated if the order of total hip replacement (THR) and lumbar spinal stenosis surgery (LSSS) influences patient-reported outcomes (PROs). We used data from the Swedish Hip Arthroplasty Register (SHAR) and the Swedish Spine Register (Swespine), on patients operated with THR and LSSS in years 2002 to 2012. To increase the probability of having symptomatic disorders in both locations at the time of the first surgery, we only included patients with both LSSS and THR performed within 2 years. Linear and logistic regression analyses adjusted for age, sex, preoperative PROs, and time between surgeries were used to investigate the association between order of surgeries and the generic PRO measurements EQ-5D and EQ VAS. Eighty-four patients had THR prior to LSSS and 171 patients LSSS prior to THR. Linear regression showed that LSSS prior to THR was associated with higher EQ-5D index (B = 0.09, 95% confidence interval [CI] 0.03-0.16) and EQ VAS (B = 5.6, 95% CI 0.4-10.9) 1 year after the last surgery. Logistic regression showed that the odds ratio [OR] for not having any problems in the "pain" (OR = 3.0, 95% CI 1.5-6.3) and "anxiety/depression" (OR = 2.3, 95% CI 1.3-4.1) dimensions were higher for LSSS before THR. In our cohort, LSSS before THR was associated with better health-related quality of life outcomes compared to the reverse order. The results from our cohort can be helpful in a clinical situation where the physician gives advice to an individual patient when choosing the order of procedures. However, further studies are necessary in order to confirm these results in other cohorts. At present, standard of care remains that order of surgery should be individualized for each patient, with guidance from the operating surgeons., (© 2020 The Authors. Journal of Orthopaedic Research® published by Wiley Periodicals LLC on behalf of Orthopaedic Research Society.)

Infection has been proposed as a cause of back pain in individuals with Modic changes. This review summarises the knowledge on this topic in Scandinavia. A Norwegian randomized controlled trial could not replicate results in favor of antibiotic treatment for such patients. A Danish study demonstrated that patients with low back pain and Modic changes had similar physical disability-scores and less sick leave due to back pain than individuals without Modic changes at long-term follow-up (>10 years). A Swedish study displayed equal bacterial presence in discs of patients operated for lumbar disc herniation and in control patients, indicating that the presence of bacteria is caused by contamination during the surgical procedure and is not related to back pain.

This report is based on results from three research groups in Sweden (Fritzell et al), Denmark (Udby et al), and Norway (Bråten et al). The groups have conducted studies published in international journals in 2019 [8-10]. The results complement each other and strongly suggest that antibiotics, in the absence of clear signs of a clinically relevant infection (discitis/spondylitis), should not be used for back pain with or without leg pain. The Swedish study showed that bacteria found in the disc/vertebra during surgery are very likely due to contamination [8], the Danish study showed that patients with Modic Changes (MC) on MR in the long term were not associated with more back pain or functional impairment than in patients without MC [9], and the Norwegian study showed that antibiotics for residual back pain after previous disc herniation had no better clinical effect than placebo [10]. Antibiotic resistance is one of the biggest threats to public health today and in the future.

Objective: Spinal cord stimulation (SCS), a minimally invasive treatment option for long-term neuropathic pain, has been shown to be effective in patients with persisting neuropathic pain after spine surgery. However, little is known about the long-term cost and quality-of-life (QoL) patterns in SCS-treated patients. The aim is to describe the use of SCS, costs, pre-spine-surgery and post-spine-surgery QoL, and reported pain intensity, in patients who have undergone spine surgery and subsequent SCS implantation. The results will be related to outcome and cost in spine surgery patients in general., Materials and Methods: A research database comprised from six Swedish national and regional registers, and the spine surgery quality-of-care register Swespine was utilized. Two cohorts were identified: all patients who had spine surgery (N = 73,765) and patients who had spine surgery and subsequent SCS implantation (N = 239). Costs were analyzed before and after spine surgery for both cohorts, as well as before and after SCS implantation for the second cohort. QoL was explored by estimating patient-reported outcome measures such as pain intensity, Oswestry Disability Index, and EuroQol-5Dimensions from spine surgery up to five years post-spine surgery., Results: In spine surgery patients, mean QoL and pain intensity levels improved following surgery. Patients subsequently treated with SCS had lower reported QoL and higher costs before the initial spine surgery, and spine surgery did not lead to any substantial improvements, however, costs decreased following SCS implantation in these patients., (© 2019 International Neuromodulation Society.)

Study Design: Observational study of prospectively collected data., Objectives: Patients with chronic low back pain resistant to nonoperative treatment often face a poor prognosis for recovery. The aim of the current study was to compare the variation and outcome of surgical treatment of degenerative disc disease in the Scandinavian countries based on The International Consortium for Health Outcomes Measurement core spine data sets., Methods: Anonymized individual level data from 3 national registers were pooled into 1 database. At the time of surgery, the patient reports data on demographics, lifestyle topics, comorbidity, and data on health-related quality of life such as Oswestry Disability Index, Euro-Qol-5D, and back and leg pain scores. The surgeon records diagnosis, type of surgery performed, and complications. One-year follow-ups are obtained with questionnaires. Baseline and 1-year follow-up data were analyzed to expose any differences between the countries., Results: A total of 1893 patients were included. At 1-year follow-up, 1315 (72%) patients responded. There were statistically significant baseline differences in age, smoking, comorbidity, frequency of previous surgery and intensity of back and leg pain. Isolated fusion was the primary procedure in all the countries ranging from 84% in Denmark to 76% in Sweden. There was clinically relevant improvement in all outcome measures except leg pain., Conclusions: In homogenous populations with similar health care systems the treatment traditions can vary considerably. Despite variations in preoperative variables, patient reported outcomes improve significantly and clinically relevant with surgical treatment., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2019.)

Purpose: To compare bacterial findings in pain-generating degenerated discs in adults operated on for lumbar disc herniation (LDH), and mostly also suffering from low back pain (LBP), with findings in adolescent patients with non-degenerated non-pain-generating discs operated on for scoliosis, and to evaluate associations with Modic signs on magnetic resonance imaging (MRI). Cutibacterium acnes (Propionibacterium acnes) has been found in painful degenerated discs, why it has been suggested treating patients with LDH/LBP with antibiotics. As multidrug-resistant bacteria are a worldwide concern, new indications for using antibiotics should be based on solid scientific evidence., Methods: Between 2015 and 2017, 40 adults with LDH/LBP (median age 43, IQR 33-49) and 20 control patients with scoliosis (median age 17, IQR 15-20) underwent surgery at seven Swedish hospitals. Samples were cultured from skin, surgical wound, discs and vertebrae. Genetic relatedness of C. acnes isolates was investigated using single-nucleotide polymorphism analysis. DNA samples collected from discs/vertebrae were analysed using 16S rRNA-based PCR sequencing. MRI findings were assessed for Modic changes., Results: No bacterial growth was found in 6/40 (15%) LDH patients, compared with 3/20 (15%) scoliosis patients. Most positive samples in both groups were isolated from the skin and then from subcutis or deep within the wound. Of the four disc and vertebral samples from each of the 60 patients, 235/240 (98%) were DNA negative by bacterial PCR. A single species, C. acnes, was found exclusively in the disc/vertebra from one patient in each group. In the LDH group, 29/40 (72%) patients had at least one sample with growth of C. acnes, compared to 14/20 (70%) in the scoliosis group. Bacterial findings and Modic changes were not associated., Conclusions: Cutibacterium acnes found in discs and vertebrae during surgery for disc herniation in adults with degenerated discs may be caused by contamination, as findings in this group were similar to findings in a control group of young patients with scoliosis and non-degenerated discs. Furthermore, such findings were almost always combined with bacterial findings on the skin and/or in the wound. There was no association between preoperative Modic changes and bacterial findings. Antibiotic treatment of lumbar disc herniation with sciatica and/or low back pain, without signs of clinical discitis/spondylitis, should be seriously questioned. These slides can be retrieved under Electronic Supplementary Material.

Purpose: Yearly incidence of surgery for symptomatic lumbar disc herniation varies and is 29/100,000 in Sweden, 46/100,000 in Denmark and 58/100,000 in Norway. This variation was used to study whether differences in surgical incidence were associated with differences in preoperative patient characteristics as well as patient-reported outcomes., Methods: Data from the national spine registers in Sweden, Denmark and Norway during 2011-2013 were pooled, and 9965 individuals, aged 18-65 years, of which 6468 had one-year follow-up data, were included in the study. Both absolute and case-mix-adjusted comparisons of the primary outcome Oswestry Disability Index (ODI) and the secondary outcomes EQ-5D-3L, and Numerical Rating Scale (NRS) for leg and back pain were performed. Case-mix adjustment was done for baseline age, sex, BMI, smoking, co-morbidity, duration of leg pain and preoperative value of the dependent variable., Results: Mean improvement in the outcome variables exceeded previously described minimal clinical important change in all countries. Mean (95% CI) final scores of ODI were 18 (17-18), 19 (18-20) and 15 (15-16) in Sweden, Denmark and Norway, respectively. Corresponding results of EQ-5D-3L were 0.74 (0.73-0.75), 0.73 (0.72-0.75) and 0.75 (0.74-0.76). Results of NRS leg and back pain behaved similarly. Case-mix adjustment did not alter the findings substantially., Conclusion: We found no clear association between incidence of surgery for lumbar disc herniation and preoperative patient characteristics as well as outcome, and the differences between the countries were lower than the minimal clinical important difference in all outcomes. These slides can be retrieved under Electronic Supplementary Material.

Study Design: Retrospective register-based study using Swedish registers and data prospectively collected in quality register Swespine., Objective: Analyze the association of societal costs and spine surgery outcome in low back pain (LBP) patients based on patient reported outcome measures (PROMs)., Summary of Background Data: Studies show that LBP has a substantial impact on societal cost. There are indications that the burden diverges over different patient groups, but little is known about cost patterns in relation to PROMs of LBP surgery., Methods: We utilized a database with data from six registers. All lumbar spine surgery patients registered in Swespine 2000 to 2012 were identified. Swespine collects PROMs Global Assessment of pain improvement (GA), Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and EuroQol five-dimension scale (EQ-5D). A literature search was conducted to identify threshold changes in ODI, VAS, and EQ-5D representing a significant improvement or deterioration as defined by the minimal clinically important difference (MCID). We categorized patients into groups by their GA response at 2-year follow-up and estimated mean changes in ODI, VAS, and EQ-5D for each group. These changes were compared with the MCID thresholds to determine a GA-anchored classification of surgical outcomes. Costs consisted of out/inpatient care, sick leave, early retirement, and pharmaceuticals., Results: In total, 12,350 patients were included. GA 1-2 ("pain has disappeared"/"pain is much improved") were labeled successful surgery outcomes (67%), GA 3 ("pain somewhat improved"), undetermined (16%), and GA 4-5 ("no change in pain"/"pain has worsened") unsuccessful (17%). Costs of the unsuccessful and undetermined were higher than of the successful during the entire study period, with differences increasing markedly post-surgery. For the successful, a downward cost trend was observed; costs almost returned to the level observed 3 years pre-surgery. No such trend was observed in the other groups., Conclusion: Identifying patients with higher probability of responding to surgery could lead to improved health and substantial societal cost savings., Level of Evidence: 3.

Purpose: Lumbar spinal stenosis (LSS) can be surgically treated, with variable outcome. Studies have linked socioeconomic factors to outcome, but no nation-wide studies have been performed. This register-based study, including all patients surgically treated for LSS during 2008-2012 in Sweden, aimed to determine predictive factors for the outcome of surgery., Methods: Clinical and socioeconomic factors with impact on outcome in LSS surgery were identified in several high-coverage registers, e.g., the national quality registry for spine surgery (Swespine, FU-rate 70-90%). Multivariate regression analyses were conducted to assess their effect on outcome. Two patient-reported outcome measures, Global Assessment of leg pain (GA) and the Oswestry Disability Index (ODI), as well as length of sick leave after surgery were analyzed., Results: Clinical and socioeconomic factors significantly affected health outcome (both GA and ODI). Some predictors of a good outcome (ODI) were: being born in the EU, reporting no back pain at baseline, a high disposable income and a high educational level. Some factors predicting a worse outcome were previous surgery, having had back pain more than 2 years, having comorbidities, being a smoker, being on social welfare and being unemployed., Conclusions: The study highlights the relevance of adding socioeconomic factors to clinical factors for analysis of patient-reported outcomes, although the causal pathway of most predictors' impact is unknown. These findings should be further investigated in the perspective of treatment selection for individual LSS patients. The study also presents a foundation of case mix algorithms for predicting outcome of surgery for LSS. These slides can be retrieved under Electronic Supplementary Material.

Background Context: Decompression surgery for lumbar spinal stenosis (LSS) is the most common spinal procedure in the elderly. To avoid persisting low back pain, adding arthrodesis has been recommended, especially if there is a coexisting degenerative spondylolisthesis. However, this strategy remains controversial, resulting in practice-based variation., Purpose: The present study aimed to evaluate in a pragmatic study if surgical selection criteria and variation in use of arthrodesis in three Scandinavian countries can be linked to variation in treatment effectiveness., Study Design: This is an observational study based on a combined cohort from the national spine registries of Norway, Sweden, and Denmark., Patient Sample: Patients aged 50 and older operated during 2011-2013 for LSS were included., Outcome Measures: Patient-Reported Outcome Measures (PROMs): Oswestry Disability Index (ODI) (primary outcome), Numeric Rating Scale (NRS) for leg pain and back pain, and health-related quality of life (Euro-Qol-5D) were reported. Analysis included case-mix adjustment. In addition, we report differences in hospital stay., Methods: Analyses of baseline data were done by analysis of variance (ANOVA), chi-square, or logistic regression tests. The comparisons of the mean changes of PROMs at 1-year follow-up between the countries were done by ANOVA (crude) and analysis of covariance (case-mix adjustment)., Results: Out of 14,223 included patients, 10,890 (77%) responded at 1-year follow-up. Apart from fewer smokers in Sweden and higher comorbidity rate in Norway, baseline characteristics were similar. The rate of additional fusion surgery (patients without or with spondylolisthesis) was 11% (4%, 47%) in Norway, 21% (9%, 56%) in Sweden, and 28% (15%, 88%) in Denmark. At 1-year follow-up, the mean improvement for ODI (95% confidence interval) was 18 (17-18) in Norway, 17 (17-18) in Sweden, and 18 (17-19) in Denmark. Patients operated with arthrodesis had prolonged hospital stay., Conclusions: Real-life data from three national spine registers showed similar indications for decompression surgery but significant differences in the use of concomitant arthrodesis in Scandinavia. Additional arthrodesis was not associated with better treatment effectiveness., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Purpose: To estimate the societal costs of low back pain with/without radiating leg pain (LBP). LBP is a major burden in terms of both personal suffering and societal costs., Methods: Patients visiting healthcare providers with a LBP-diagnosis in the Western region of Sweden (Västra Götaland) in 2008-2011 were identified in national registers and an administrative patient database. Direct healthcare costs and indirect costs in terms of sick leave and early retirement were summarized over time periods called LBP episodes, starting with a LBP-related healthcare contact or work absence due to LBP and ended when 6 months had elapsed without any LBP-related healthcare contact or work absence., Results: The mean total cost per episode was estimated at €2753 with a mean duration of 51 days. There was a sharp increase in total cost the first month after the LBP episode started and a marked decrease from the second month. Total cost leveled off at a higher level during the 2 years after episode start compared with the 2 years before episode start. The total economic burden of LBP in Sweden including all LBP episodes that started in 2011 was estimated at €740 million, or €78 per capita., Conclusions: LBP has an apparent impact on the overall resource use and work loss. The results indicate that there is a high short-term cost increase at the beginning of an LBP episode, but also that the costs decrease in the long term after the LBP symptoms have come to clinical attention. These slides can be retrieved under Electronic Supplementary Material.

We investigated the difference between postoperative rehabilitation with or without adjunctive intermittent pneumatic compression therapy following distal radial fracture treated with volar plating. A total of 115 patients were randomized to a control or to an experimental group. After 4 weeks of immobilization the experimental group received intermittent pneumatic compression therapy in addition to conventional postoperative rehabilitation. Primary outcome up to 1 year postoperatively was assessed using the Canadian Occupational Performance Measure. No significant differences between groups were found. There were no clinically relevant differences regarding the secondary outcome measures swelling, strength, pain and flexibility. We conclude that postoperative intermittent pneumatic compression treatment had no major benefits. The results of the present study do not support general use of intermittent pneumatic compression initiated 4 weeks following volar plating surgery for distal radial fracture., Level of Evidence: I.

The coexistence of degenerative disorders from the hip joint and the lumbar spine, known as "the hip-spine syndrome," is a common encounter in clinical practice. These degenerative conditions may cause similar symptoms which often entail diagnostic challenges in determining the origin of pain. Lumbar back surgery (LBS) with fusion and/or decompression, and total hip replacement (THR) are both often successful interventions. However, the knowledge is limited about the post-operative patient-reported outcome (PRO) following LBS in the presence of a prior THR. The aims of this study were to compare 1-year post-operative patient-reported outcome measures (PROMs) following lumbar back surgery (LBS) in patients with and without a prior total hip replacement (THR). Data from Swespine and the Swedish Hip Arthroplasty Register were linked in order to identify the study group of patients with THR prior to LBS. The study group (n = 220) and a matched control group (n = 220) with isolated LBS was defined by using a step-wise selection process. Linear- and logistic regression analyses adjusted for age, sex and pre-operative PROMs demonstrated that THR prior to LBS was associated with worse back-pain (VAS) at 1-year follow-up (B = 5.3, 95%CI: 0.3;10.3). However, previous THR did not influence the EQ-5D index (B = 0.01, 95%CI: -0.05;0.06), EQ VAS (B = -3.0, 95%CI: -6.9;1.0), leg pain (B = 1.5, 95%CI: -4.0;7.0), Oswestry Disability Index (B = 2.6, 95%CI: -0.5;5.6) or satisfaction (OR = 1.1, 97.5%CI 0.7;1.6). This knowledge is important to communicate prior to LBS in order to set proper expectations on surgical outcomes. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:2484-2490, 2018., (© 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.)

Aims: To develop a health economic model to evaluate the long-term costs and outcomes over the healthcare treatment pathway for patients with low back pain (LBP)., Materials and Methods: A health economic model, consisting of a decision tree structure with a Markov microsimulation model at the end of each branch, was created. Patients were followed from first observed clinical presentation with LBP until the age of 100 years or death. The underlying data to populate the model were based on Swedish national and regional registry data on healthcare resource use and sickness insurance in patients presenting with LBP in the Swedish region Västra Götaland during 2008-2012. Costs (outpatient healthcare visits, inpatient bed days, pharmaceuticals, productivity loss), EUR 2016, and quality-of-life based on EQ-5D data from the registries and published estimates were summarized over the lifetime of the patients with 3% annual discount. A lost quality-adjusted life year (QALY) was valued at €70,000., Results: Mean lifetime total cost was estimated at €47,452/patient, of which indirect costs were 57%. Total lifetime economic burden for all patients coming to clinical presentation in Sweden per year was €8.8bn. The average LBP patient was estimated to face a loss of 2.7 QALYs over their lifetime compared with the general population. For all patients in Sweden coming to clinical presentation in 1 year this gives 505,407 QALYs lost, valued at €35.3bn. Adding the economic burden, the total societal burden amounts to €44.1bn., Conclusion: This pathway model shows that most patients with LBP receive conservative care, and a minority consume high-cost healthcare interventions like surgery. The model could be used to see broad economic effects of different patterns of healthcare provision in sub-groups with LBP and to estimate where it is possible to influence these pathways to increase utility for patients and for society.

Study Design: Analysis of Swedish national and regional register data., Objectives: The aim of this study was to characterize healthcare resource utilization, productivity loss, and costs of patients with low back pain (LBP) with or without leg pain, who have been referred from primary care settings to orthopedic specialist care., Summary of Background Data: Register data on outpatient and inpatient care, work absence, drug prescriptions, socioeconomics, and mortality were extracted for patients visiting orthopedic specialists for LBP in the Swedish region Västra Götaland (1.6 million inhabitants in 2015) in 2008 to 2011 (4 years)., Methods: Patients were followed with regard to resource use and costs during "LBP episodes," defined as the time period from the first visit to an orthopedic specialist ("index-point") until the last observed resource use registered with an LBP diagnosis. Patients were also followed during fixed time periods of 2 years before and 2 years after the index-point., Results: In total, 16,329 LBP episodes were identified (13,931 unique patients), in six diagnosis groups. Mean societal cost per LBP episode was estimated at &OV0556;6466 (SD 21,884), where indirect cost constituted 74% and half of the 26% remaining direct costs were owing to hospital inpatient care. Patients underwent surgery in 10% of the episodes (n = 1583). Cost per LBP episode varied between diagnosis groups, with a range of &OV0556;18,668 to &OV0556;40,774 in episodes with surgery and &OV0556;978 to &OV0556;10,379 in episodes without surgery. Assessment of the fixed time period of 2 years before and after index-point showed that costs increased gradually during the year before in all groups and declined the year after in all groups., Conclusion: The marked decline in total costs the year after referral to an orthopaedic specialist indicates that the treatment provided, regardless of treatment, has an effect and also likely improves the quality of life for the patient., Level of Evidence: 4.

Background Context: Current literature suggests that in the long-term, fusion of the lumbar spine in chronic low back pain (CLBP) does not result in an outcome clearly better than structured conservative treatment modes., Purpose: This study aimed to assess the long-term outcome of lumbar fusion in CLBP, and also to assess methodological problems in long-term randomized controlled trials (RCTs)., Study Design: A prospective randomized study was carried out., Patient Sample: A total of 294 patients (144 women and 150 men) with CLBP of at least 2 years' duration were randomized to lumbar fusion or non-specific physiotherapy. The mean follow-up time was 12.8 years (range 9-22). The follow up rate was 85%; exclusion of deceased patients resulted in a follow-up rate of 92%., Outcome Measures: Global Assessment (GA) of back pain, Oswestry Disability Index (ODI), visual analogue scale (VAS) for back and leg pain, Zung depression scale were determined. Work status, pain medication, and pain frequency were also documented., Methods: Standardized outcome questionnaires were obtained before treatment and at long-term follow-up. To optimize control for group changers, four models of data analysis were used according to (1) intention to treat (ITT), (2) "as treated" (AT), (3) per protocol (PP), and (4) if the conservative group automatically classify group changers as unchanged or worse in GA (GCAC). The initial study was sponsored by Acromed (US$50,000-US$100,000)., Results: Except for the ITT model, the GA, the primary outcome measure, was significantly better for fusion. The proportion of patients much better or better in the fusion group was 66%, 65%, and 65% in the AT, PP, and GCAC models, respectively. In the conservative group, the same proportions were 31%, 37%, and 22%, respectively. However, the ODI, VAS back pain, work status, pain medication, and pain frequency were similar between the two groups., Conclusions: One can conclude that from the patient's perspective, reflected by the GA, lumbar fusion surgery is a valid treatment option in CLBP. On the other hand, secondary outcome measures such as ODI and work status, best analyzed by the PP model, indicated that substantial disability remained at long-term after fusion as well as after conservative treatment. The lack of objective outcome measures in CLBP and the cross-over problem transforms an RCT to an observational study, that is, Level 2 evidence. The discrepancy between the primary and secondary outcome measures prevents a strong conclusion on whether to recommend fusion in non-specific low back pain., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The efficacy of fusion surgery in addition to decompression surgery in patients who have lumbar spinal stenosis, with or without degenerative spondylolisthesis, has not been substantiated in controlled trials., Methods: We randomly assigned 247 patients between 50 and 80 years of age who had lumbar spinal stenosis at one or two adjacent vertebral levels to undergo either decompression surgery plus fusion surgery (fusion group) or decompression surgery alone (decompression-alone group). Randomization was stratified according to the presence of preoperative degenerative spondylolisthesis (in 135 patients) or its absence. Outcomes were assessed with the use of patient-reported outcome measures, a 6-minute walk test, and a health economic evaluation. The primary outcome was the score on the Oswestry Disability Index (ODI; which ranges from 0 to 100, with higher scores indicating more severe disability) 2 years after surgery. The primary analysis, which was a per-protocol analysis, did not include the 14 patients who did not receive the assigned treatment and the 5 who were lost to follow-up., Results: There was no significant difference between the groups in the mean score on the ODI at 2 years (27 in the fusion group and 24 in the decompression-alone group, P=0.24) or in the results of the 6-minute walk test (397 m in the fusion group and 405 m in the decompression-alone group, P=0.72). Results were similar between patients with and those without spondylolisthesis. Among the patients who had 5 years of follow-up and were eligible for inclusion in the 5-year analysis, there were no significant differences between the groups in clinical outcomes at 5 years. The mean length of hospitalization was 7.4 days in the fusion group and 4.1 days in the decompression-alone group (P<0.001). Operating time was longer, the amount of bleeding was greater, and surgical costs were higher in the fusion group than in the decompression-alone group. During a mean follow-up of 6.5 years, additional lumbar spine surgery was performed in 22% of the patients in the fusion group and in 21% of those in the decompression-alone group., Conclusions: Among patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis, decompression surgery plus fusion surgery did not result in better clinical outcomes at 2 years and 5 years than did decompression surgery alone. (Funded by an Uppsala institutional Avtal om Läkarutbildning och Forskning [Agreement concerning Cooperation on Medical Education and Research] and others; Swedish Spinal Stenosis Study ClinicalTrials.gov number, NCT01994512.).

Purpose: Does lumbar fusion lead to accelerated adjacent segment disc degeneration (ASDD) or is it explained by genetics and aging? The influence of genetics on ASDD remains to be explored. This study assesses whether the disc space height adjacent to a fused segment is associated with candidate gene single nucleotide polymorphisms (SNPs)., Methods: Patients with low back pain from four RCTs (N = 208 fusion; 77 non-operative treatment) underwent standing plain radiography and genetic analyses at 13 ± 4 years follow-up. Disc space height was measured using a validated computer-assisted distortion-compensated roentgen analysis technique and reported in standard deviations from normal values. Genetic association analyses included 34 SNPs in 25 structural, inflammatory, matrix degrading, apoptotic, vitamin D receptor and OA-related genes relevant to disc degeneration. These were analysed for their association with disc space height (after adjusting for age, gender, smoking, duration of follow-up and treatment group) first, separately, and then together in a stepwise multivariable model., Results: Two SNPs from the IL18RAP gene (rs1420106 and rs917997) were each associated with a lower disc space height at the adjacent level (B = -0.34, p = 0.04 and B = -0.35, p = 0.04, respectively) and the MMP-9 gene SNP rs20544 was associated with a greater disc space height (B = 0.35, p = 0.04). Age (p < 0.001) and fusion (p < 0.008) were also significant variables in each analysis. The total explained variance in disc space height was for each SNP model 13-14 %, with 11-12 % of this being accounted for by the given SNP, 64-67 % by age and 19-22 % by fusion. In the multivariable regression analysis (with nine SNPs selected for entry, along with the covariates) the total explained variance in disc space height was 23 %, with the nine SNPs, age and fusion accounting for 45, 45 and 7 % of this, respectively., Conclusions: Age was the most significant determinant of adjacent segment disc space height followed by genetic factors, specifically inflammatory genes. Fusion explained a statistically significant but small proportion of the total variance. Much of the variance remained to be explained.

Purpose: To examine the association between COMT and OPRM1 gene polymorphisms and pain and disability at baseline and long-term follow-up in patients treated for chronic low back pain (LBP)., Methods: 371 of 767 unrelated European patients recruited from four randomised trials underwent genetic analyses at mean 11.4 years follow-up. 274 patients had fusion and 97 had non-operative treatment. Association analyses included disability, pain, five single nucleotide polymorphisms (SNPs) in the COMT gene, and one SNP in the OPRM1 gene. Analyses were adjusted for age, gender, smoking, analgesics and treatment., Results: Disability at baseline was significantly associated with COMT SNPs rs4818 (p = 0.02), rs6269 (p = 0.007), rs4633 (p = 0.04) rs2075507 (p = 0.009), two haplotypes (p < 0.002), age, gender and smoking (p ≤ 0.002). No significant associations with clinical variables were observed for OPRM1, or for COMT at long-term follow-up., Conclusions: Results suggest that genetic factors are partly responsible for the variation in disability levels in patients presenting with chronic LBP being considered for surgery; in contrast, genetics has no influence on the long-term outcome of treatment.

Background: Lumbar disc herniation (LDH) is a common indication for lumbar spine surgery. The proportion of patients having a second surgery within 2 years varies in the literature between 0.5% and 24%, with recurrent herniation being the most common cause. Several studies have not found any relevant outcome differences between patients undergoing surgery for primary LDH and patients undergoing reoperation for a recurrent LDH, but these studies have limitations, including small sample size and retrospective design., Questions/purposes: We (1) compared patient-reported outcomes between patients operated on for primary LDH and patients reoperated on for recurrent LDH within 1 year after index surgery and (2) determined risk factors for worse outcomes., Methods: We obtained data from the Swedish National Spine Register, Swespine, where patient-reported outcomes are collected using mailed protocols at 1, 2, 5, and 10 years after surgery. Of the 13,562 patients identified who underwent LDH between January 2000 and May 2011, 13,305 (98%) underwent primary surgery for LDH and 257 (2%) underwent reoperation for a recurrent LDH within the first year. Patient-reported outcomes at 1 to 2 years were available for 8497 patients (63%), 8350 of 13,305 (63%) in the primary LDH group and 147 of 257 (57%) in the recurrent LDH group (p = 0.068). We compared leg and back pain (VAS: 0-100), function (Oswestry Disability Index [ODI]: 0-100), quality of life (EQ-5D: -0.59 to 1.0), patient satisfaction, and global assessment of leg pain between groups. We also analyzed rsik factors for worse global assessment and satisfaction., Results: Mean (95% CI) differences in improvement between groups favoring patients with primary LDH were VAS leg pain 9 (4-14), ODI 6 (3-9), and EQ-5D 0.09 (0.04-0.15). While statistically significant, these effect sizes may be lower than the minimal clinically important differences often referred to. Percentage of satisfied patients was 79% and 58% in the primary and recurrent LDH groups, respectively (p < 0.001), and percentage of patients with no or better leg pain (global assessment) was 74% and 65%, respectively (p = 0.008). Reoperation for recurrent LDH represented the largest independent risk for dissatisfaction; this factor and smoking represented similar risks for less improvement in leg pain., Conclusions: Repeat surgery for a recurrent LDH was performed with good probability for improvement, although not as good as for primary LDH surgery, and patients undergoing repeated surgery were less satisfied. Studies on risk factors for recurrence are warranted., Level of Evidence: Level II, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

Background and Purpose: Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set., Patients and Methods: An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions., Results: Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on pre-existing tools., Interpretation: The outcome measures recommended here are structured around specific etiologies of LBP, span a patient's entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver.

Background and Purpose: We performed a systematic review and a survey in order to (1) evaluate the evidence for the impact of spine registries on the quality of spine care, and with that, on patient-related outcomes, and (2) evaluate the methodology used to organize, analyze, and report the "quality of spine care" from spine registries., Methods: To study the impact, the literature on all spinal disorders was searched. To study methodology, the search was restricted to degenerative spinal disorders. The risk of bias in the studies included was assessed with the Newcastle-Ottawa scale. Additionally, a survey among registry representatives was performed to acquire information about the methodology and practice of existing registries., Results: 4,273 unique references up to May 2014 were identified, and 1,210 were eligible for screening and assessment. No studies on impact were identified, but 34 studies were identified to study the methodology. Half of these studies (17 of the 34) were judged to have a high risk of bias. The survey identified 25 spine registries, representing 14 countries. The organization of these registries, methods used, analytical approaches, and dissemination of results are presented., Interpretation: We found a lack of evidence that registries have had an impact on the quality of spine care, regardless of whether intervention was non-surgical and/or surgical. To improve the quality of evidence published with registry data, we present several recommendations. Application of these recommendations could lead to registries showing trends, monitoring the quality of spine care given, and ultimately improving the value of the care given to patients with degenerative spinal disorders.

Study Design: Cross-sectional analysis of long-term follow-up (LTFU) data from 4 randomized controlled trials of operative versus nonoperative treatment for chronic low back pain., Objective: To examine the influence of spinal fusion on adjacent segment disc space height as an indicator of disc degeneration at LTFU., Summary of Background Data: There is ongoing debate as to whether adjacent segment disc degeneration results from the increased mechanical stress of fusion., Methods: Plain standing lateral radiographs were obtained at LTFU (mean, 13 ± 4 yr postrandomization) in 229 of 464 (49%) patients randomized to surgery and 140 of 303 (46%), to nonoperative care. Disc space height and posteroanterior displacement were measured for each lumbar segment using a validated computer-assisted distortion compensated roentgen analysis technique. Values were reported in units of standard deviations above or below age and sex-adjusted normal values. Patient-rated outcomes included the Oswestry Disability Index and pain scales., Results: Radiographs were usable in 355 of 369 (96%) patients (259 fusion and 96 nonoperative treatment). Both treatment groups showed significantly lower values for disc space height of the adjacent segment than norm values. There was a significant difference between treatment groups for the disc space height of the cranial adjacent segment (in both as-treated and intention-to-treat analyses). The mean treatment effect of fusion on adjacent segment disc space height was -0.44 SDs (95% CI, -0.77 to -0.11; P = 0.01; as-treated analysis); there was no group difference for posteroanterior displacement (0.18 SDs, 95% confidence interval, -0.28 to 0.64, P = 0.45). Adjacent level disc space height and posteroanterior displacement were not correlated with Oswestry Disability Index or pain scores at LTFU (r = 0.010-0.05; P > 0.33)., Conclusion: Fusion was associated with lower disc space height at the adjacent segment after an average of 13 years of FU. The reduced disc space height had no influence on patient self-rated outcomes (pain or disability)., Level of Evidence: 2.

Study Design: Randomized clinical trial with 2-year follow-up., Objective: To evaluate the cost-effectiveness of total disc replacement (TDR) versus multidisciplinary rehabilitation (MDR) in patients with chronic low back pain (CLBP)., Summary of Background Data: The existing studies on CLBP report cost-effectiveness of fusion surgery versus disc replacement and fusion versus rehabilitation. This study evaluated the cost-effectiveness of TDR versus MDR., Methods: Between April 2004 and May 2007, 173 patients with CLBP (>1 yr) were randomized to TDR (n = 86) or MDR (n = 87). Treatment effects (Euro Qol 5D [EQ-5D] and Short Form 6D [SF-6D]) and relevant direct and indirect costs at 6 weeks and at 3, 6, 12, and 24 months after treatment were assessed. Gain in quality-adjusted life years (QALYs) after 2 years was estimated. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio., Results: The mean QALYs gained (standard deviation) using EQ-5D was 1.29 (0.53) in the TDR group and 0.95 (0.52) in the MDR group, a significant difference of 0.34 (95% confidence interval 0.18-0.50). The mean total cost per patient in the TDR group was &OV0556;87,622 (58,351) compared with &OV0556;74,116 (58,237) in the MDR group, which was not significantly different (95% confidence interval: -4041 to 31,755). The incremental cost-effectiveness ratio for the TDR procedure varied from &OV0556;39,748 using EQ-5D (TDR cost-effective) to &OV0556;128,328 using SF-6D (TDR not cost-effective). The dropout rate was 20% (15% TDR group, 24% MDR group). Five patients moved from the MDR to the TDR group, whereas 9 patients randomized to TDR declined surgery. Using per-protocol analysis instead of intention-to-treat analysis indicated that TDR was not cost-effective, irrespective of the use of EQ-5D or SF-6D., Conclusion: In this study, TDR was cost-effective compared with MDR after 2 years when using EQ-5D for assessing QALYs gained and a willingness to pay of &OV0556;74,600 (kr500,000/QALY). TDR was not cost-effective when SF-6D was used; therefore, our results should be interpreted with caution. Longer follow-up is needed to accurately assess the cost-effectiveness of TDR., Level of Evidence: 2.

Introduction: Swespine, the Swedish National Spine Register, has existed for 20 years and is in general use within the country since over 10 years regarding degenerative lumbar spine disorders. Today there are protocols for registering all disorders of the entire spinal column., Materials and Methods: Patient-based pre- and postoperative questionnaires, completed before surgery and at 1, 2, 5 and 10 years postoperatively. Among patient-based data are VAS pain, ODI, SF-36 and EQ-5D. Postoperatively evaluation of leg and back pain as compared to preoperatively ("global assessment"), overall satisfaction with outcome and working conditions are registered in addition to the same parameters as preoperatively evaluation. A yearly report is produced including an analytic part of a certain topic, in this issue disc prosthesis surgery. More than 75,000 surgically treated patients are registered to date with an increasing number yearly. The present report includes 7,285 patients; 1-, 2- and 5-year follow-up data of previously operated patients are also included for lumbar disorders as well as for disc prosthesis surgery., Results: For the degenerative lumbar spine disorders (disc herniation, spinal stenosis, spondylolisthesis and DDD) significant improvements are seen in all aspects as exemplified by pronounced improvement regarding EQ-5D and ODI. Results seem to be stable over time. Spinal stenosis is the most common indication for spine surgery. Disc prosthesis surgery yields results on a par with fusion surgery in disc degenerative pain. The utility of spine surgery is well documented by the results., Conclusion: Results of spine surgery as documented on a national basis can be utilized for quality assurance and quality improvement as well as for research purposes, documenting changes over time and bench marking when introducing new surgical techniques. A basis for international comparisons is also laid.

Study Design: A multicenter, randomized, controlled, cost-effectiveness analysis., Objective: To assess the cost-effectiveness of balloon kyphoplasty (BKP) compared with standard medical treatment (control) in patients with acute/subacute (<3 months) vertebral compression fracture (VCF) due to osteoporosis., Summary of Background Data: Patients with a VCF due to osteoporosis are common and will increase in number in an aging population, putting a substantial strain on health care. Selected patients may benefit from stabilizing the fracture with cement through BKP, a minimally invasive procedure. BKP has been reported to give good short-time clinical results, and economic modeling has suggested that the procedure could be cost-effective after 2 years compared with standard treatment., Methods: Hospitalized patients with back pain due to VCF were randomized to BKP or to control using a computer-generated random list. All costs associated with VCF and cost-effectiveness were reported primarily from the perspective of society. We used EQ-5D to assess quality of life (QoL). The accumulated quality-adjusted life years (QALYs) gained and costs/QALY gained were assessed using intention to treat., Results: Between February 2003 and December 2005, a total of 63 out of 67 Swedish patients were analyzed: BKP (n = 32) and control (n = 31). Societal cost per patient for BKP was SEK 160,017 (SD = 151,083) = €16,668 (SD = 15,735), and for control SEK 84,816 (SD = 40,954) = €8835 (SD = 4266), a significant difference of 75,198 (95% confidence intervals [CI] = 16,037-120,104) = €7833 (95% CI = 1671-12,511). The accumulated difference in QALYs was 0.085 (95% CI = -0.132 to 0.306) in favor of BKP. Cost/QALY gained using BKP was SEK 884,682 = €92,154 and US $134,043., Conclusion: In this randomized controlled trial, it was not possible to demonstrate that BKP was cost-effective compared with standard medical treatment in patients treated for an acute/subacute vertebral fracture due to osteoporosis. However, sensitivity analysis indicated a certain degree of uncertainty, which needs to be considered.

Study Design: Systematic review., Objective: To determine if the presence of isthmic spondylolisthesis modifies the effect of treatment (fusion vs. multidimensional supervised rehabilitation) in patients with chronic low back pain (CLBP)., Summary of Background Data: Results of spinal surgery for CLBP are variable. It is unclear whether patients with CLBP and isthmic spondylolisthesis have more success with surgery versus a multidimensional supervised rehabilitation program when compared with those with CLBP but without spondylolisthesis., Methods: A systematic search was conducted in MEDLINE and the Cochrane Collaboration Library for articles published through January 2011. Randomized controlled trials (RCTs) were included that compared spine fusion versus multidimensional supervised rehabilitation in patients with and without isthmic spondylolisthesis. Standardized mean differences (SMDs) and risk differences were calculated for common outcomes, and then compared to determine potential heterogeneity of treatment effect. The final strength of the body of literature was expressed as "high," "moderate," or "low" confidence that the evidence reflects the true effect., Results: No studies were found that directly compared the two subgroups. Three RCTs compared fusion with supervised nonoperative care in patients with CLBP without isthmic spondylolisthesis; one RCT evaluated these treatments in patients with isthmic spondylolisthesis. There were study differences in patient characteristics, type of fusion, the nature of the rehabilitation, outcomes assessed, and length of follow-up. The SMDs for pain in favor of fusion were modest at 2 years for those without isthmic spondylolisthesis, but large in favor of fusion for those with isthmic spondylolisthesis compared with rehabilitation. Similarly, the SMDs for function in patients without isthmic spondylolisthesis compared with rehabilitation was small at 2 years, but appreciably higher in favor of fusion in patients with isthmic spondylolisthesis., Conclusion: The overall strength of evidence evaluating whether the presence of isthmic spondylolisthesis modifies the effect of fusion compared with rehabilitation patients with CLBP is "low." Fusion should be considered for patients with low back pain and isthmic spondylolisthesis who have failed nonoperative treatment., Clinical Recommendations: We recommend considering fusion for patients with isthmic spondylolisthesis and lower back pain who have failed nonoperative treatment., Recommendation: Weak.

This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (-45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the "non-difference" in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (-73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time.

Background Context: Sex life and sexual function may be affected by low back pain (LBP). Sexual dysfunction after anterior lumbar fusion is reported in both men and women, but focus is mainly on impaired male biological function (retrograde ejaculation) as this may cause infertility. This has led to concern as to whether anterior surgery should be employed in men, at least in younger age groups., Purpose: To investigate how chronic low back pain (CLBP) of assumed discogenic origin affects sex life and sexual function in patients considered for surgical treatment, whether this is affected by surgical treatment (total disc replacement [TDR] or posterolateral fusion [PLF]/posterior lumbar interbody fusion [PLIF]), and if so, are there differences between the surgical procedures undertaken., Study Design: A randomized controlled trial comparing TDR and instrumented lumbar spine fusion, performed either as a PLF or PLIF., Patient Sample: One hundred fifty-two patients were included in this randomized controlled trial to compare the effect on CLBP of either TDR via an anterior retroperitoneal approach or instrumented posterior lumbar fusion, PLF or PLIF., Outcome Measures: Global assessment of back pain, back pain (visual analog scale [VAS] 0-100), function (Oswestry Disability Index [ODI] 0-100), quality of life (EQ5D [EuroQol] 0-1), and answers on specific sexual function., Methods: Outcome was assessed using data from the Swedish Spine Register (SweSpine). In ODI, one question, ODI 8, reflects the impact of back pain on sex life. This question was analyzed separately. Patients also answered a gender-specific questionnaire preoperatively and at the 2-year follow-up to determine any sexual dysfunction regarding erection, orgasm, and ejaculation. Follow-up was at 1 and 2 years., Results: Before surgery, 34% reported that their sex life caused some extra LBP, and an additional 30% that their sex life was severely restricted by LBP. After surgery, sex life improved in both groups, with a strong correlation to a reduction of LBP. The gender-specific questionnaire used to measure sexual function after 2 years revealed no negative effect of TDR or Fusion in men regarding erection or retrograde ejaculation. However, 26% of all men in the Fusion group, compared with 3% in the TDR group, reported postoperative deterioration in the ability to achieve orgasm, despite a reduction of LBP., Conclusions: Impairment of sex life appears to be related to CLBP. An improvement in sex life after TDR or lumbar fusion was positively correlated to a reduction in LBP. Total disc replacement in this study, performed through an anterior retroperitoneal approach, was not associated with greater sexual dysfunction compared with instrumented lumbar fusion performed either as a PLF or as a PLIF. Sexual function, expressed as orgasm, deteriorated in men in the Fusion group postoperatively, in spite of this group reporting less LBP after 2 years.

The Swedish Spine Register enables monitoring of surgical activities focusing on changes in trends over time, techniques utilized and outcome, when implemented in general clinical practice. Basic requirements for a prosperous register are unity within the profession, mainly patient-based documentation and a well functioning support system. This presentation focuses on the development and design of the register protocol, problems encountered and solutions found underway. Various examples on how the results can be presented and utilized are given as well as validation. Register data demonstrate significant gender differences in lumbar disc herniation surgery with females having more pain, lower quality of life and more pronounced disability preoperatively while improvement after surgery is similar between genders. Quality of life after surgery for degenerative disorders is significantly improved for disc herniation, stenosis, spondylolisthesis and disc degenerative disorders. Over the last 10 years, surgical treatment for spinal stenosis has increased gradually while disc herniation surgery decreases regarding yearly number of procedures. An added function to the register enables more complex prospective clinical studies to include register data together with data suitable for the individual study. A common core set of demographic, surgical and outcome parameters would enable comparisons of clinical studies within and between nations.

This systematic review updates the understanding of the evidence base for balloon kyphoplasty (BKP) in the management of vertebral compression fractures. Detailed searches of a number of electronic databases were performed from March to April 2006. Citation searches of included studies were undertaken and no language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression. Combined with previous evidence, a total of eight comparative studies (three against conventional medical therapy and five against vertebroplasty) and 35 case series were identified. The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. In direct comparison to conventional medical management, patients undergoing BKP experienced superior improvements in pain, functionality, vertebral height and kyphotic angle at least up to 3-years postprocedure. Reductions in pain with BKP appeared to be greatest in patients with newer fractures. Uncontrolled studies suggest gains in health-related quality of life at 6 and 12-months following BKP. Although associated with a finite level of cement leakage, serious adverse events appear to be rare. Osteoporotic vertebral compression fractures appear to be associated with a higher level of cement leakage following BKP than non-osteoporotic vertebral compression fractures. In conclusion, there are now prospective studies of low bias, with follow-up of 12 months or more, which demonstrate balloon kyphoplasty to be more effective than medical management of osteoporotic vertebral compression fractures and as least as effective as vertebroplasty. Results from ongoing RCTs will provide further information in the near future.

Study Design: Systematic review and meta-regression., Objectives: To compare the efficacy and safety of balloon kyphoplasty and vertebroplasty for the treatment of vertebral compression fractures, and to examine the prognostic factors that predict outcome., Summary of Background Data: A previous systematic review of vertebroplasty by Levine et al in 2000 identified seven case series studies and no controlled studies., Methods: A number of electronic databases were searched through March 1, 2004. Citation searches of included studies were undertaken and contact was made with experts in the field. No language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression., Results: The following studies were included: balloon kyphoplasty (three nonrandomized comparative studies against conventional medical therapy and 13 case series), vertebroplasty (one nonrandomized comparative study against conventional medical care and 57 cases series), balloon kyphoplasty versus vertebroplasty (one nonrandomized comparative study). The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. At this time, there is no good quality direct comparative evidence of balloon kyphoplasty versus vertebroplasty. From indirect comparison of case series evidence, the procedures appear to provide similar gains in pain relief while for balloon kyphoplasty there is better documentation of gains in patient functionality and quality of life. The level of cement leakage and number of reported adverse events (pulmonary emboli and neurologic injury) in balloon kyphoplasty was significantly lower than for vertebroplasty. These findings were confirmed by meta-regression analysis., Conclusions: There is Level III evidence to support balloon kyphoplasty and vertebroplasty as effective therapies in the management of patients with symptomatic osteoporotic vertebral compression fractures refractory to conventional medical therapy. Although there was a good ratio of benefit to harm for both procedures, balloon kyphoplasty appears to offer the better adverse event profile. These conclusions need to be updated on the basis of the findings of ongoing randomized controlled trials.

Sexual dysfunction after anterior lumbar fusion has mainly been focused on male biological function (retrograde ejaculation). The aim of the present study is to assess the effect of fusion surgery for chronic low back pain on the sex-related quality of life. Apart from routine prospective questionnaires, additional gender-specific mailed questionnaires produced retrospective data on sexual enjoyment and function after 2 years of follow-up. Patients randomised to non-surgical treatment and anterior or posterior fusion were compared. We found that surgically treated patients had a significantly better sex life than those non-surgically treated. The improved sex life was significantly associated with the reduced back pain. The improvement after anterior fusion, however, was counteracted by a trend towards disturbed orgasm and genital sensation in women, and a significant disturbance of ejaculation and genital sensation in men. In view of the increased frequency of anterior lumbar surgery with the strong promotion of disc replacement, the findings in the present small retrospective pilot study should be tested in larger prospective trials.

Today there is growing awareness among spine surgeons of the advantages in using registers to facilitate the analyses and reporting of treatment outcome. The Swedish Spine register is among the first to be used on a national scale and annual reports are published in international journals. In this paper we discuss our experiences and lessons learned from a paper-based version in 1993, to an online web-based solution in 2005. We emphasise the advantages of registers being owned by the national spine society, a support function available during working hours, online feedback to participating departments and professional assistance in designing a register program for web use. Hopefully, our experiences will be of help to colleagues who are planning to start registering.

A local inflammatory and potentially painful response, of which the ultimate cause is unknown, has been described in nervous tissues in contact with degenerated disc material in patients with low back and leg pain. With the rationale that a possible cause of such inflammation could be bacterial infection, we utilized PCR (polymerase chain reaction) amplification of the 16S rRNA (ribosomal RNA) gene followed by gene sequencing, to investigate whether bacterial DNA might be detected in the degenerative discs of 10 patients operated for disc herniation or post-discectomy syndrome. One patient with disc hernia harbored DNA homologous to Bacillus cereus, and in one patient suffering from post-discectomy syndrome, Citrobacter braaki/freundii DNA was detected. The finding demonstrates that 16S rRNA PCR can be a useful tool in search of bacterial DNA in degenerated discs, which in turn may be indicative of low-grade infection, manifesting itself only as pain rather than as clinical infection.