Search

Acute cervical osteomyelitis due to an epidural abscess and pyogenic spondylodiscitis in an immunosuppressed patient with progressive myelopathy is a challenge for the reconstructive surgeon. This report presents our novel approach to treat such a condition in a 56-year-old patient in whom antibiotic treatment and decompression of the medulla by laminectomy of C4-C6 failed. Under general anesthesia, debridement of all infected tissue, including anterior corpectomy of C4-C6, was performed. Simultaneously, a free vascularized fibula graft (FVFG) was harvested, adapted to the bone defect, and anastomosed to the superior thyroid artery and external jugular vein. The graft was stabilized with an anterior plate. A scheduled posterior stabilization was performed 1 week later. Staphylococcus aureus was cultured from bone samples and was treated with antibiotics. The postoperative course was uncomplicated besides a dorsal midline defect 6 weeks postoperatively that was closed with a sensate midline-based perforator flap. Five years on, the patient is infection free, and regular control computed tomography and magnetic resonance imaging scan images show progressive fusion and hypertrophy of the fibula to C3/C7 vertebrae. An FVFG combined with posterior stabilization could be a promising primary salvage procedure in cases with progressive myelopathy caused by acute cervical osteomyelitis due to spinal infection. The FVFG contributes to blood circulation, delivery of antibiotics, and an immunological response to the infected wound bed and can stimulate rapid fusion and hypertrophy over time., Competing Interests: The authors have no financial interest to declare in relation to the content of this article. This study was supported by a grant from the publication fund of UiT, The Arctic University of Norway., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons.)

Background and Objectives: Degenerative cervical myelopathy (DCM) is a frequent cause of spinal cord dysfunction, and surgical treatment is considered safe and effective. Long-term results after surgery are limited. This study investigated long-term clinical outcomes through data from the Norwegian registry for spine surgery., Methods: Patients operated at the university hospitals serving Central and Northern Norway were approached for long-term follow-up after 3 to 8 years. The primary outcome was change in the Neck Disability Index, and the secondary outcomes were changes in the European Myelopathy Scale score, quality of life (EuroQoL EQ-5D); numeric rating scales (NRS) for headache, neck pain, and arm pain; and perceived benefit of surgery assessed by the Global Perceived Effect scale from 1 year to long-term follow-up., Results: We included 144 patients operated between January 2013 and June 2018. In total, 123 participants (85.4%) provided patient-reported outcome measures (PROMs) at long-term follow-up. There was no significant change in PROMs from 1 year to long-term follow-up, including Neck Disability Index (mean 1.0, 95% CI -2.1-4.1, P = .53), European Myelopathy Scale score (mean -0.3, 95% CI -0.7-0.1, P = .09), EQ-5D index score (mean -0.02, 95% CI -0.09-0.05, P = .51), NRS neck pain (mean 0.3 95% CI -0.2-0.9, P = .22), NRS arm pain (mean -0.1, 95% CI -0.8-0.5, P = .70), and NRS headache (mean 0.4, 95% CI -0.1-0.9, P = .11). According to Global Perceived Effect assessments, 106/121 patients (87.6%) reported to be stable or improved ("complete recovery," "much better," "slightly better," or "unchanged") at long-term follow-up compared with 88.1% at 1 year. Dichotomizing the outcome data based on severity of DCM did not demonstrate significant changes either., Conclusion: Long-term follow-up of patients undergoing surgery for DCM demonstrates persistence of statistically significant and clinically meaningful improvement across a wide range of PROMs., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Congress of Neurological Surgeons.)

Background and Objectives: Functional status, pain, and quality of life usually improve after surgery for degenerative cervical myelopathy (DCM), but a subset of patients report worsening. The objective was to define cutoff values for worsening on the Neck Disability Index (NDI) and identify prognostic factors associated with worsening of pain-related disability 12 months after DCM surgery., Methods: In this prognostic study based on prospectively collected data from the Norwegian Registry for Spine Surgery, the NDI was the primary outcome. Receiver operating characteristics curve analyses were used to obtain cutoff values, using the global perceived effect scale as an external anchor. Univariable and multivariable analyses were performed using mixed logistic regression to evaluate the relationship between potential prognostic factors and the NDI., Results: Among the 1508 patients undergoing surgery for myelopathy, 1248 (82.7%) were followed for either 3 or 12 months. Of these, 317 (25.4%) were classified to belong to the worsening group according to the mean NDI percentage change cutoff of 3.3. Multivariable analyses showed that smoking (odds ratio [OR] 3.4: 95% CI 1.2-9.5: P < .001), low educational level (OR 2.5: 95% CI 1.0-6.5: P < .001), and American Society of Anesthesiologists grade >II (OR 2.2: 95% CI 0.7-5.6: P = .004) were associated with worsening. Patients with more severe neck pain (OR 0.8: 95% CI 0.7-1.0: P = .003) and arm pain (OR 0.8: 95% CI 0.7-1.0; P = .007) at baseline were less likely to report worsening., Conclusion: We defined a cutoff value of 3.3 for worsening after DCM surgery using the mean NDI percentage change. The independent prognostic factors associated with worsening of pain-related disability were smoking, low educational level, and American Society of Anesthesiologists grade >II. Patients with more severe neck and arm pain at baseline were less likely to report worsening at 12 months., (Copyright © Congress of Neurological Surgeons 2024. All rights reserved.)

Importance: Lumber disc herniation surgery can reduce pain and disability. However, a sizable minority of individuals experience minimal benefit, necessitating the development of accurate prediction models., Objective: To develop and validate prediction models for disability and pain 12 months after lumbar disc herniation surgery., Design, Setting, and Participants: A prospective, multicenter, registry-based prognostic study was conducted on a cohort of individuals undergoing lumbar disc herniation surgery from January 1, 2007, to May 31, 2021. Patients in the Norwegian Registry for Spine Surgery from all public and private hospitals in Norway performing spine surgery were included. Data analysis was performed from January to June 2023., Exposures: Microdiscectomy or open discectomy., Main Outcomes and Measures: Treatment success at 12 months, defined as improvement in Oswestry Disability Index (ODI) of 22 points or more; Numeric Rating Scale (NRS) back pain improvement of 2 or more points, and NRS leg pain improvement of 4 or more points. Machine learning models were trained for model development and internal-external cross-validation applied over geographic regions to validate the models. Model performance was assessed through discrimination (C statistic) and calibration (slope and intercept)., Results: Analysis included 22 707 surgical cases (21 161 patients) (ODI model) (mean [SD] age, 47.0 [14.0] years; 12 952 [57.0%] males). Treatment nonsuccess was experienced by 33% (ODI), 27% (NRS back pain), and 31% (NRS leg pain) of the patients. In internal-external cross-validation, the selected machine learning models showed consistent discrimination and calibration across all 5 regions. The C statistic ranged from 0.81 to 0.84 (pooled random-effects meta-analysis estimate, 0.82; 95% CI, 0.81-0.84) for the ODI model. Calibration slopes (point estimates, 0.94-1.03; pooled estimate, 0.99; 95% CI, 0.93-1.06) and calibration intercepts (point estimates, -0.05 to 0.11; pooled estimate, 0.01; 95% CI, -0.07 to 0.10) were also consistent across regions. For NRS back pain, the C statistic ranged from 0.75 to 0.80 (pooled estimate, 0.77; 95% CI, 0.75-0.79); for NRS leg pain, the C statistic ranged from 0.74 to 0.77 (pooled estimate, 0.75; 95% CI, 0.74-0.76). Only minor heterogeneity was found in calibration slopes and intercepts., Conclusion: The findings of this study suggest that the models developed can inform patients and clinicians about individual prognosis and aid in surgical decision-making.

Purpose: To provide an overview of the The Norwegian Degenerative spondylolisthesis and spinal stenosis (NORDSTEN)-study and the organizational structure, and to evaluate the study population., Methods: The NORDSTEN is a multicentre study with 10 year follow-up, conducted at 18 public hospitals. NORDSTEN includes three studies: (1) The randomized spinal stenosis trial comparing the impact of three different decompression techniques; (2) the randomized degenerative spondylolisthesis trial investigating whether decompression surgery alone is as good as decompression with instrumented fusion; (3) the observational cohort tracking the natural course of LSS in patients without planned surgical treatment. A range of clinical and radiological data are collected at defined time points. To administer, guide, monitor and assist the surgical units and the researchers involved, the NORDSTEN national project organization was established. Corresponding clinical data from the Norwegian Registry for Spine Surgery (NORspine) were used to assess if the randomized NORDSTEN-population at baseline was representative for LSS patients treated in routine surgical practice., Results: A total of 988 LSS patients with or without spondylolistheses were included from 2014 to 2018. The clinical trials did not find any difference in the efficacy of the surgical methods evaluated. The NORDSTEN patients were similar to those being consecutively operated at the same hospitals and reported to the NORspine during the same time period., Conclusion: The NORDSTEN study provides opportunity to investigate clinical course of LSS with or without surgical interventions. The NORDSTEN-study population were similar to LSS patients treated in routine surgical practice, supporting the external validity of previously published results., Trial Registration: ClinicalTrials.gov; NCT02007083 10/12/2013, NCT02051374 31/01/2014 and NCT03562936 20/06/2018., (© 2023. The Author(s).)

Purpose: To review and describe the development, methods and cohort of the lumbosacral part of the Norwegian registry for spine surgery (NORspine)., Methods: NORspine was established in 2007. It is government funded, covers all providers and captures consecutive cases undergoing operations for degenerative disorders. Patients' participation is voluntary and requires informed consent. A set of baseline-, process- and outcome-variables (3 and 12 months) recommended by the International Consortium for Health Outcome Measurement is reported by surgeons and patients. The main outcome is the Oswestry disability index (ODI) at 12 months., Results: We show satisfactory data quality assessed by completeness, timeliness, accuracy, relevance and comparability. The coverage rate has been 100% since 2016 and the capture rate has increased to 74% in 2021. The cohort consists of 60,647 (47.6% women) cases with mean age 55.7 years, registered during the years 2007 through 2021. The proportions > 70 years and with an American Society of Anaesthesiologists' Physical Classification System (ASA) score > II has increased gradually to 26.1% and 19.3%, respectively. Mean ODI at baseline was 43.0 (standard deviation 17.3). Most cases were operated with decompression for disc herniation (n = 26,557, 43.8%) or spinal stenosis (n = 26,545, 43.8%), and 7417 (12.2%) with additional or primary fusion. The response rate at 12 months follow-up was 71.6%., Conclusion: NORspine is a well-designed population-based comprehensive national clinical quality registry. The register's methods ensure appropriate data for quality surveillance and improvement, and research., (© 2023. The Author(s).)

Study Design: Prospective pharmacoepidemiologic study., Objective: To investigate clinical and sociodemographic factors associated with persistent opioid use in the years following spine surgery among patients with persistent opioid use preceding lumbar spine surgery., Summary of Background Data: It is unknown whether successful spine surgery leads to a cessation of preoperative persistent opioid use., Materials and Methods: Data from the Norwegian Registry for Spine Surgery and the Norwegian Prescription Database were linked for patients operated for degenerative lumbar spine disorders between 2007 and 2017. The primary outcome measure was persistent opioid use in the second year after surgery. Functional disability was measured with the Oswestry Disability Index (ODI). Factors associated with persistent opioid use in the year before, and two years following, surgery were identified using multivariable logistic regression analysis. The variables included in the analysis were selected based on their demonstrated role in prior studies., Results: The prevalence of persistent opioid use was 8.7% in the year before surgery. Approximately two-thirds of patients also met the criteria for persistent opioid use the second year after surgery. Among patients who did not meet the criteria for persistent opioid use the year before surgery, 991 (3.3%) patients developed persistent opioid use in the second year following surgery. The strongest association was exhibited by high doses of benzodiazepines in the year preceding surgery (OR 1.7, 95% CI 1.26 to 2.19, P <0.001). Among patients without persistent opioid use, the most influential factor associated with new-onset persistent opioid use in the second year after surgery was the use of high doses of benzodiazepines (OR 1.8, 95% CI 1.26 to 2.44, P <0.001), high doses of z -hypnotics (OR 2.6, 95% CI 2.10 to 3.23, P <0.001) and previous surgery at the same lumbar level (OR 1.37, 95% CI 1.11 to 1.68, P =0.003)., Conclusion: A substantial proportion of patients reported sustained opioid use after surgery. Patients with persistent opioid use before surgery should be supported to taper off opioid treatment. Special efforts appear to be required to taper off opioid use in patients using high doses of benzodiazepines., Level of Evidence: 2; Prospective observational study., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort. This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS. The proportion reaching a PASS decreased from 66.0% (95% confidence interval (CI) 65.4 to 66.7) in cases with no previous operation to 22.0% (95% CI 15.2 to 30.3) in cases with four or more previous operations (p < 0.001). The odds of not reaching a PASS were 2.1 (95% CI 1.9 to 2.2) in cases with one previous operation, 2.6 (95% CI 2.3 to 3.0) in cases with two, 4.4 (95% CI 3.4 to 5.5) in cases with three, and 6.9 (95% CI 4.5 to 10.5) in cases with four or more previous operations. The ODI raw and change scores and the secondary outcomes showed similar trends. We found a dose-response relationship between increasing number of previous operations and inferior outcomes among patients operated for degenerative conditions in the lumbar spine. This information should be considered in the shared decision-making process prior to elective spine surgery., Competing Interests: None declared., (© 2023 Author(s) et al.)

Background: Loss to follow-up may bias outcome assessments in medical registries. This cohort study aimed to analyze and compare patients who failed to respond with those that responded to the Norwegian Registry for Spine Surgery (NORspine)., Methods: We analyzed a cohort of 474 consecutive patients operated for lumbar spinal stenosis at four public hospitals in Norway during a two-year period. These patients reported sociodemographic data, preoperative symptoms, and Oswestry Disability Index (ODI), numerical rating scales (NRS) for back and leg pain to NORspine at baseline and 12 months postoperatively. We contacted all patients who did not respond to NORspine after 12 months. Those who responded were termed responsive non-respondents and compared to 12 months respondents., Results: One hundred forty (30%) did not respond to NORspine 12 months after surgery and 123 were available for additional follow-up. Sixty-four of the 123 non-respondents (52%) responded to a cross-sectional survey done at a median of 50 (36-64) months after surgery. At baseline, non-respondents were younger 63 (SD 11.7) vs. 68 (SD 9.9) years (mean difference (95% CI) 4.7 years (2.6 to 6.7); p =  < 0.001) and more frequently smokers 41 (30%) vs. 70 (21%) RR (95%CI) = 1.40 (1.01 to 1.95); p = 0.044. There were no other relevant differences in other sociodemographic variables or preoperative symptoms. We found no differences in the effect of surgery on non-respondents vs. respondents (ODI (SD) = 28.2 (19.9) vs. 25.2 (18.9), MD (95%CI) = 3.0 ( -2.1 to 8.1); p = 0.250)., Conclusion: We found that 30% of patients did not respond to NORspine at 12 months after spine surgery. Non-respondents were somewhat younger and smoked more frequently than respondents; however, there were no differences in patient-reported outcome measures. Our findings suggest that attrition bias in NORspine was random and due to non-modifiable factors., (© 2023. The Author(s).)

Background/context: Some patients do not improve after surgery for lumbar spinal stenosis (LSS), and surgical treatment implies a risk for complications and deterioration. Patient selection is of paramount importance to improve the overall clinical results and identifying predictive factors for failure is central in this work., Purpose: We aimed to explore predictive factors for failure and worsening after surgery for LSS., Study Design /setting: Retrospective observational study on prospectively collected data from a national spine registry with a 12-month follow-up., Patient Sample: We analyzed 11,873 patients operated for LSS between 2007 and 2017 in Norway, included in the Norwegian registry for spine surgery (NORspine). Twelve months after surgery, 8919 (75.1%) had responded., Outcome Measures: Oswestry Disability Index (ODI) 12 months after surgery., Methods: Predictors were assessed with uni- and multivariate logistic regression, using backward conditional stepwise selection and a significance level of 0.01. Failure (ODI>31) and worsening (ODI>39) were used as dependent variables., Results: Mean (95%CI) age was 66.6 (66.4-66.9) years, and 52.1% were females. The mean (95%CI) preoperative ODI score was 39.8 (39.4-40.1). All patients had decompression, and 1494 (12.6%) had an additional fusion procedure. Twelve months after surgery, the mean (95%CI) ODI score was 23.9 (23.5-24.2), and 2950 patients (33.2%) were classified as failures and 1921 (21.6%) as worse. The strongest predictors for failure were duration of back pain > 12 months (OR [95%CI]=2.24 [1.93-2.60]; p<.001), former spinal surgery (OR [95%CI]=2.21 [1.94-2.52]; p<.001) and age>70 years (OR (95%CI)=1.97 (1.69-2.30); p<.001). Socioeconomic variables increased the odds of failure (ORs between 1.36 and 1.62). The strongest predictors for worsening were former spinal surgery (OR [95%CI]=2.04 [1.77-2.36]; p<.001), duration of back pain >12 months (OR [95%CI]=1.83 [1.45-2.32]; p<.001) and age >70 years (OR [95%CI]=1.79 [1.49-2.14]; p<.001). Socioeconomic variables increased the odds of worsening (ORs between 1.33-1.67)., Conclusions: After surgery for LSS, 33% of the patients reported failure, and 22% reported worsening as assessed by ODI. Preoperative duration of back pain for longer than 12 months, former spinal surgery, and age above 70 years were the strongest predictors for increased odds of failure and worsening after surgery., Competing Interests: Declaration of Competing Interest The authors declare that they have no known potential conflicts of interest influencing the work with this paper. None of the authors have received financial support to complete this study., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: By using data from the Norwegian Registry for Spine Surgery, we wanted to develop and validate prediction models for non-success in patients operated with anterior surgical techniques for cervical degenerative radiculopathy (CDR)., Methods: This is a multicentre longitudinal study of 2022 patients undergoing CDR surgery and followed for 12 months to find prognostic models for non-success in neck disability and arm pain using multivariable logistic regression analysis. Model performance was evaluated by area under the receiver operating characteristic curve (AUC) and a calibration test. Internal validation by bootstrapping re-sampling with 1000 repetitions was applied to correct for over-optimism. The clinical usefulness of the neck disability model was explored by developing a risk matrix for individual case examples., Results: Thirty-eight percent of patients experienced non-success in neck disability and 35% in arm pain. Loss to follow-up was 35% for both groups. Predictors for non-success in neck disability were high physical demands in work, low level of education, pending litigation, previous neck surgery, long duration of arm pain, medium-to-high baseline disability score and presence of anxiety/depression. AUC was 0.78 (95% CI, 0.75, 0.82). For the arm pain model, all predictors for non-success in neck disability, except for anxiety/depression, were found to be significant in addition to foreign mother tongue, smoking and medium-to-high baseline arm pain. AUC was 0.68 (95% CI, 0.64, 0.72)., Conclusion: The neck disability model showed high discriminative performance, whereas the arm pain model was shown to be acceptable. Based upon the models, individualized risk estimates can be made and applied in shared decision-making with patients referred for surgical assessment., (© 2022. The Author(s).)

Background: The Norwegian registry for spine surgery (NORspine) is a national clinical quality registry which has recorded more than 10,000 operations for degenerative conditions of the cervical spine since 2012. Registries are large observational cohorts, at risk for attrition bias. We therefore aimed to examine whether clinical outcomes differed between respondents and non-respondents to standardized questionnaire-based 12-month follow-up., Methods: All eight public and private providers of cervical spine surgery in Norway report to NORspine. We included 334 consecutive patients who were registered with surgical treatment of degenerative conditions in the cervical spine in 2018 and did a retrospective analysis of prospectively collected register data and data on non-respondents' outcomes collected by telephone interviews. The primary outcome measure was patient-reported change in arm pain assessed with the numeric rating scale (NRS). Secondary outcome measures were change in neck pain assessed with the NRS, change in health-related quality of life assessed with EuroQol 5 Dimensions (EQ-5D), and patients' perceived benefit of the operation assessed by the Global Perceived Effect (GPE) scale., Results: At baseline, there were few and small differences between the 238 (71.3%) respondents and the 96 (28.7%) non-respondents. We reached 76 (79.2%) non-respondents by telephone, and 63 (65.6%) consented to an interview. There was no statistically significant difference between groups in change in NRS score for arm pain (3.26 (95% CI 2.84 to 3.69) points for respondents and 2.77 (1.92 to 3.63) points for telephone interviewees) or any of the secondary outcome measures., Conclusions: The results indicate that patients lost to follow-up were missing at random. Analyses of outcomes based on data from respondents can be considered representative for the complete register cohort, if patient characteristics associated with attrition are controlled for., (© 2022. The Author(s).)

Aims: The number of patients undergoing surgery for degenerative cervical radiculopathy has increased. In many countries, public hospitals have limited capacity. This has resulted in long waiting times for elective treatment and a need for supplementary private healthcare. It is uncertain whether the management of patients and the outcome of treatment are equivalent in public and private hospitals. The aim of this study was to compare the management and patient-reported outcomes among patients who underwent surgery for degenerative cervical radiculopathy in public and private hospitals in Norway, and to assess whether the effectiveness of the treatment was equivalent., Methods: This was a comparative study using prospectively collected data from the Norwegian Registry for Spine Surgery. A total of 4,750 consecutive patients who underwent surgery for degenerative cervical radiculopathy and were followed for 12 months were included. Case-mix adjustment between those managed in public and private hospitals was performed using propensity score matching. The primary outcome measure was the change in the Neck Disability Index (NDI) between baseline and 12 months postoperatively. A mean difference in improvement of the NDI score between public and private hospitals of ≤ 15 points was considered equivalent. Secondary outcome measures were a numerical rating scale for neck and arm pain and the EuroQol five-dimension three-level health questionnaire. The duration of surgery, length of hospital stay, and complications were also recorded., Results: The mean improvement from baseline to 12 months postoperatively of patients who underwent surgery in public and private hospitals was equivalent, both in the unmatched cohort (mean NDI difference between groups 3.9 points (95% confidence interval (CI) 2.2 to 5.6); p < 0.001) and in the matched cohort (4.0 points (95% CI 2.3 to 5.7); p < 0.001). Secondary outcomes showed similar results. The duration of surgery and length of hospital stay were significantly longer in public hospitals. Those treated in private hospitals reported significantly fewer complications in the unmatched cohort, but not in the matched cohort., Conclusion: The clinical effectiveness of surgery for degenerative cervical radiculopathy performed in public and private hospitals was equivalent 12 months after surgery.Cite this article: Bone Joint J  2023;105-B(1):64-71.

Purpose: To compare patient-reported outcomes (PROMs) following surgery for degenerative cervical myelopathy (DCM) among patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) versus those without rheumatic diseases., Methods: Data were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in the Neck Disability Index (NDI) at 1 year. Secondary endpoints included the European Myelopathy Score (EMS), quality of life (EuroQoL-5D [EQ-5D]), numeric rating scales (NRS) for headache, neck pain, and arm pain, and complications., Results: Among 905 participants operated between 2012 and 2018, 35 had RA or AS. There were significant improvements in all PROMs at 1 year and no statistically significant difference between the cohorts in mean change in NDI (- 0.64, 95% CI - 8.1 to 6.8, P = .372), EQ-5D (0.10, 95% CI - 0.04 to 0.24, P = .168), NRS neck pain (- 0.8, 95% CI - 2.0 to 0.4, P = .210), NRS arm pain (- 0.6, 95% CI - 1.9 to 0.7, P = .351), and NRS headache (- 0.5, 95% CI - 1.7 to 0.8, P = .460)., Discussion and Conclusion: Our study adds to the limited available evidence that surgical treatment cannot only arrest further progression of myelopathy but also improve functional status, neurological outcomes, and quality of life in patients with rheumatic disease., (© 2022. The Author(s).)

Importance: The use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking., Objective: To investigate the efficacy of spinal cord burst stimulation, which involves the placement of an implantable pulse generator connected to electrodes with leads that travel into the epidural space posterior to the spinal cord dorsal columns, in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders., Design, Setting, and Participants: This placebo-controlled, crossover, randomized clinical trial in 50 patients was conducted at St Olavs University Hospital in Norway, with study enrollment from September 5, 2018, through April 28, 2021. The date of final follow-up was May 20, 2022., Interventions: Patients underwent two 3-month periods with spinal cord burst stimulation and two 3-month periods with placebo stimulation in a randomized order. Burst stimulation consisted of closely spaced, high-frequency electrical stimuli delivered to the spinal cord. The stimulus consisted of a 40-Hz burst mode of constant-current stimuli with 4 spikes per burst and an amplitude corresponding to 50% to 70% of the paresthesia perception threshold., Main Outcomes and Measures: The primary outcome was difference in change from baseline in the self-reported Oswestry Disability Index (ODI; range, 0 points [no disability] to 100 points [maximum disability]; the minimal clinically important difference was 10 points) score between periods with burst stimulation and placebo stimulation. The secondary outcomes were leg and back pain, quality of life, physical activity levels, and adverse events., Results: Among 50 patients who were randomized (mean age, 52.2 [SD, 9.9] years; 27 [54%] were women), 47 (94%) had at least 1 follow-up ODI score and 42 (84%) completed all stimulation randomization periods and ODI measurements. The mean ODI score at baseline was 44.7 points and the mean changes in ODI score were -10.6 points for the burst stimulation periods and -9.3 points for the placebo stimulation periods, resulting in a mean between-group difference of -1.3 points (95% CI, -3.9 to 1.3 points; P = .32). None of the prespecified secondary outcomes showed a significant difference. Nine patients (18%) experienced adverse events, including 4 (8%) who required surgical revision of the implanted system., Conclusions and Relevance: Among patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, after placement of a spinal cord stimulator resulted in no significant difference in the change from baseline in self-reported back pain-related disability., Trial Registration: ClinicalTrials.gov Identifier: NCT03546738.

Background: The aim of this study was to investigate whether clinical outcomes in patients aged ≥ 70 undergoing decompressive surgery for degenerative cervical myelopathy (DCM) differ from those of younger patients (50-70 years) at 1 year., Methods: Data were obtained from the Norwegian Registry for Spine Surgery (NORspine). Among 651 patients included, 177 (27.2%) were ≥ 70 years old. The primary outcome was change in the Neck Disability Index (NDI). Secondary outcomes were changes in the European Myelopathy Score (EMS), quality of life (EuroQoL EQ-5D), numeric rating scales (NRS) for headache, neck pain, and arm pain, and complications., Results: Significant improvements in all patient-reported outcomes (PROMs) were detected for both age cohorts at 1 year. For the two age cohorts combined, there was a statistically significant improvement in the NDI score (mean 9.2, 95% CI 7.7 to 10.6, P < 0.001). There were no differences between age cohorts in mean change of NDI (- 8.9 vs. - 10.1, P = 0.48), EQ-5D (0.13 vs. 0.17, P = 0.37), or NRS pain scores, but elderly patients experienced a larger improvement in EMS (0.7 vs. 1.3, P = 0.02). A total of 74 patients (15.6%) in the younger cohort and 43 patients (24.3%) in the older cohort experienced complications or adverse effects within 3 months of surgery, mainly urinary and respiratory tract infections., Conclusion: Surgery for DCM was associated with significant improvement across a wide range of PROMs for both younger and elderly patients. Surgery for DCM should not be denied based on age alone., (© 2022. The Author(s).)

During the last decades, there has been an increase in the rate of surgery for degenerative disorders of the cervical spine and in the use of supplementary private health insurance. Still, there is limited knowledge about the differences in characteristics of patients operated in public and private hospitals. Therefore, we aimed at comparing sociodemographic-, clinical- and patient management data on patients operated for degenerative cervical radiculopathy and degenerative cervical myelopathy in public and private hospitals in Norway. This was a cross-sectional study on patients in the Norwegian Registry for Spine Surgery operated for degenerative cervical radiculopathy and degenerative cervical myelopathy between January 2012 and December 2020. At admission for surgery, we assessed disability by the following patient reported outcome measures (PROMs): neck disability index (NDI), EuroQol-5D (EQ-5D) and numerical rating scales for neck pain (NRS-NP) and arm pain (NRS-AP). Among 9161 patients, 7344 (80.2%) procedures were performed in public hospitals and 1817 (19.8%) in private hospitals. Mean age was 52.1 years in public hospitals and 49.7 years in private hospitals (P < 0.001). More women were operated in public hospitals (47.9%) than in private hospitals (31.6%) (P < 0.001). A larger proportion of patients in private hospitals had high education (≥ 4 years of college or university) (42.9% vs 35.6%, P < 0.001). Patients in public hospitals had worse disease-specific health problems than those in private hospitals: unadjusted NDI mean difference was 5.2 (95% CI 4.4 - 6.0; P < 0.001) and adjusted NDI mean difference was 3.4 (95% CI 2.5 - 4.2; P < 0.001), and they also had longer duration of symptoms (P < 0.001). Duration of surgery (mean difference 29 minutes, 95% CI 27.1 - 30.7; P < 0.001) and length of hospital stay (mean difference 2 days, 95% CI 2.3 - 2.4; P < 0.001) were longer in public hospitals. In conclusion, patients operated for degenerative cervical spine in private hospitals were healthier, younger, better educated and more often men. They also had less and shorter duration of symptoms and seemed to be managed more efficiently. Our findings indicate that access to cervical spine surgery in private hospitals could be skewed in favour of patients with higher socioeconomic status., (© 2022. The Author(s).)

Objective: To examine outcomes and complications following microdiscectomy for recurrent lumbar disc herniation., Methods: Prospectively collected data for patients operated at the Department of Neurosurgery, St. Olavs University Hospital, Norway, were obtained from the Norwegian Registry for Spine Surgery from May 2007 through July 2016. All patients underwent lumbar microdiscectomy. The primary outcome was change in the Oswestry Disability Index (ODI) at one year. Secondary endpoints were change in quality of life measured with EuroQol 5 Dimensions (EQ-5D), back and leg pain measured with numerical rating scales (NRS), complications, and duration of surgery and hospital stays., Results: 276 patients were enrolled in the study. A total of 161 patients (58.3%) completed one-year follow-up. The mean improvement in ODI at one year was 27.1 points (95% CI 23.1 to 31.0, P <0.001). The mean improvement in EQ-5D at one year of 0.47 points (95% CI 0.40-0.54, P <0.001), representing a large effect size (Cohens D ​= ​1.3). The mean improvement in back pain and leg pain NRS were 4.3 points (95% CI 2.2-3.2, P <0.001) and 3.8 points (95% CI 2.8-3.9, P <0.001), respectively. Nine patients (3.3%) experienced intraoperative complications, and 15 (5.5%) out of 160 patients reported complications within three months following hospital discharge., Conclusions: This study shows that patients operated for recurrent lumbar disc herniation in general report significant clinical improvement., (© 2022 The Authors.)

Study Design: Prospective pharmacoepidemiological study., Objective: To investigate the use of prescription opioids 2 years following degenerative lumbar spine surgery., Summary of Background Data: There are limited data providing details to evaluate patterns of opioid use. The number of patients is often limited and data on opioid use following some of the most common surgical procedures are lacking., Methods: Data from the Norwegian Registry for Spine Surgery and the Norwegian Prescription Database were linked on an individual level. The primary outcome measure was persistent opioid use the second year after surgery. Functional disabilitywas measured with the Oswestry disability index (ODI). Study participants were operated between 2007 and 2017., Results: Among 32,886 study participants, 2754 (8.4%) met criteria for persistent opioid use the second year after surgery. Among persistent opioid users in the second year after surgery, 64% met the criteria for persistent opioid use the year preceding surgery. Persistent opioid use the year preceding surgery (odds ratio [OR] 31.10, 95% confidence interval [CI] 26.9-36.0, P  = 0.001), use of high doses of benzodiazepines (OR 1.62, 95% CI 1.30-2.04, P  = 0.001), and use of high doses of z-hypnotics (OR 1.90, 95% CI 1.58-2.22, P  = 0.001) the year before surgery were associated with increased risk of persistent opioid use the second year after surgery. A higher ODI score at 1 year was observed in persistent opioid users compared with non-persistent users (41.5 vs. 18.8 points) and there was a significant difference in ODI change (-13.7 points). Patients with persistent opioid use in the year preceding surgery were less likely to achieve a minimal clinically important ODI change at 1 year compared with non-persistent users (37.7% vs. 52.6%, P  = 0.001)., Conclusion: Patients with or at risk of developing persistent opioid should be identified and provided counseling and support to taper off opioid treatment.Level of Evidence: 2., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Purpose: Data quality is essential for all types of research, including health registers. However, data quality is rarely reported. We aimed to assess the accuracy of data in a national spine register (NORspine) and its agreement with corresponding data in electronic patient records (EPR)., Methods: We compared data in NORspine registry against data in (EPR) for 474 patients operated for spinal stenosis in 2015 and 2016 at four public hospitals, using EPR as the gold standard. We assessed accuracy using the proportion correctly classified (PCC) and sensitivity. Agreement was quantified using Kappa statistics or interaclass correlation coefficient (ICC)., Results: The mean age (SD) was 66 (11) years, and 54% were females. Compared to EPR, surgeon-reported perioperative complications displayed weak agreement (kappa (95% CI) = 0.51 (0.33-0.69)), PCC of 96%, and a sensitivity (95% CI) of 40% (23-58%). ASA classification had a moderate agreement (kappa (95%CI) = 0.73 (0.66-0.80)). Comorbidities were underreported in NORspine. Perioperative details had strong to excellent agreements (kappa (95% CI) ranging from 0.76 ( 0.68-0.84) to 0.98 (0.95-1.00)), PCCs between 93% and 99% and sensitivities (95% CI) between 92% (0.84-1.00%) and 99% (0.98-1.00%). Patient-reported variables (height, weight, smoking) had excellent agreements (kappa (95% CI) between 0.93 (0.89-0.97) and 0.99 (0.98-0.99))., Conclusion: Compared to electronic patient records, NORspine displayed weak agreement for perioperative complications, moderate agreement for ASA classification, strong agreement for perioperative details, and excellent agreement for height, weight, and smoking. NORspine underreported perioperative complications and comorbidities when compared to EPRs. Patient-recorded data were more accurate and should be preferred when available., (© 2022. The Author(s).)

Importance: Operations for lumbar spinal stenosis is the most often performed surgical procedure in the adult lumbar spine. This study reports the clinical outcome of the 3 most commonly used minimally invasive posterior decompression techniques., Objective: To compare the effectiveness of 3 minimally invasive posterior decompression techniques for lumbar spinal stenosis., Design, Setting, and Participants: This randomized clinical trial used a parallel group design and included patients with symptomatic and radiologically verified lumbar spinal stenosis without degenerative spondylolisthesis. Patients were enrolled between February 2014 and October 2018 at the orthopedic and neurosurgical departments of 16 Norwegian public hospitals. Statistical analysis was performed in the period from May to June 2021., Interventions: Patients were randomized to undergo 1 of the 3 minimally invasive posterior decompression techniques: unilateral laminotomy with crossover, bilateral laminotomy, and spinous process osteotomy., Main Outcomes and Measures: Primary outcome was change in disability measured with Oswestry Disability Index (ODI; range 0-100), presented as mean change from baseline to 2-year follow-up and proportions of patients classified as success (>30% reduction in ODI). Secondary outcomes were mean change in quality of life, disease-specific symptom severity measured with Zurich Claudication Questionnaire (ZCQ), back pain and leg pain on a 10-point numeric rating score (NRS), patient perceived benefit of the surgical procedure, duration of the surgical procedure, blood loss, perioperative complications, number of reoperations, and length of hospital stay., Results: In total, 437 patients were included with a median (IQR) age of 68 (62-73) years and 230 men (53%). Of the included patients, 146 were randomized to unilateral laminotomy with crossover, 142 to bilateral laminotomy, and 149 to spinous process osteotomy. The unilateral laminotomy with crossover group had a mean change of -17.9 ODI points (95% CI, -20.8 to -14.9), the bilateral laminotomy group had a mean change of -19.7 ODI points (95% CI, -22.7 to -16.8), and the spinous process osteotomy group had a mean change of -19.9 ODI points (95% CI, -22.8 to -17.0). There were no significant differences in primary or secondary outcomes among the 3 surgical procedures, except a longer duration of the surgical procedure in the bilateral laminotomy group., Conclusions and Relevance: No differences in clinical outcomes or complication rates were found among the 3 minimally invasive posterior decompression techniques used to treat patients with lumbar spinal stenosis., Trial Registration: ClinicalTrials.gov Identifier: NCT02007083.

Background: Knowledge about the variation in treatment rates is needed to assess whether the access to health services is equitable. The objective of this study was to investigate the rates of surgical treatment of degenerative cervical spine disease in Norway and the Northern Norway Regional Health Authority area and the local coverage in the Northern Norway Regional Health Authority area, and to assess the activity in the region., Material and Method: We included cervical spine procedures recorded in the Norwegian Patient Registry from the years 2014-18 and estimated age-standardised treatment rates for Norway, the health regions and health trusts in Northern Norway Regional Health Authority. We estimated the local coverage as the proportion of patients resident in the Northern Norway Regional Health Authority area who had undergone surgery at the University Hospital of North Norway in Tromsø., Results: The treatment rate remained stable at an average of 29.6 surgical procedures per 100 000 inhabitants (aged 18-105) per year. The rate for residents in the Northern Norway Regional Health Authority area was 23.0 procedures per 100 000 inhabitants per year (78 % of the national average). The rates in Finnmark and the areas of residence served by the University Hospital of North Norway were close to the national average. Residents in the Nordland and Helgeland areas had lower rates in each year of the study period, with an average of 16.6 and 18.1 procedures per 100 000 inhabitants per year respectively. This corresponds to 56 % and 61 % of the national average. Local coverage in the Northern Norway Regional Health Authority area increased from 69 % in 2014 to 91 % in 2018., Interpretation: The treatment rate for degenerative cervical spine disease was lower in the Northern Norway Regional Health Authority area than in the rest of Norway. For this to be compensated and the local coverage to be increased to 100 %, we have estimated that the activity needs to be increased by approximately 35 surgical procedures per year.

Study Design: Observational multicenter study., Objective: The aim of this study was to evaluate changes in pain during sexual activity after surgery for lumbar spinal stenosis (LSS)., Summary of Background Data: There are limited data available on sexual function in patients undergoing surgery for LSS., Methods: Data were retrieved from the Norwegian Registry for Spine Surgery. The primary outcome was change in pain during sexual activity at 1 year, assessed by item number eight of the Oswestry disability index questionnaire. Secondary outcome measures included Oswestry Disability Index, EuroQol-5D, and numeric rating scale scores for back and leg pain., Results: Among the 12,954 patients included, 9908 (76.5%) completed 1-year follow-up. At baseline 9579 patients (73.9%) provided information about pain during sexual activity, whereas 7424 (74.9%) among those with complete follow-up completed this item. Preoperatively 2528 of 9579 patients (26.4%) reported a normal sex-life without pain compared with 4294 of 7424 patients (57.8%) at 1 year. Preoperatively 1007 (10.5%) patients reported that pain prevented any sex-life, compared with 393 patients (5.3%) at 1 year. At baseline 7051 of 9579 patients (73.6%) reported that sexual activity caused pain, and among these 3145 of 4768 responders (66%) reported an improvement at 1 year. A multivariable regression analysis showed that having a life partner, college education, and working until time of surgery were predictors of improvement in pain during sexual activity. Current tobacco smoking, pain duration >12 months, previous spine surgery, and complications occurring within 3 months were negative predictors., Conclusion: This study clearly demonstrates that a large proportion of patients undergoing surgery for LSS experienced an improvement in pain during sexual activity at 1 year.Level of Evidence: 2., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Indications and optimal timing for surgical treatment of degenerative cervical myelopathy (DCM) remain unclear, and data from daily clinical practice are warranted., Objective: To investigate clinical outcomes following decompressive surgery for DCM., Methods: Data were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in the neck disability index (NDI) 1 yr after surgery. Secondary endpoints were the European myelopathy score (EMS), quality of life (EuroQoL 5D [EQ-5D]), numeric rating scales (NRS) for headache, neck pain, and arm pain, complications, and perceived benefit of surgery assessed by the Global Perceived Effect (GPE) scale., Results: We included 905 patients operated between January 2012 and June 2018. There were significant improvements in all patient-reported outcome measures (PROMs) including NDI (mean -10.0, 95% CI -11.5 to -8.4, P < .001), EMS (mean 1.0, 95% CI 0.8-1.1, P < .001), EQ-5D index score (mean 0.16, 95% CI 0.13-0.19, P < .001), EQ-5D visual analogue scale (mean 13.8, 95% CI 11.7-15.9, P < .001), headache NRS (mean -1.1, 95% CI -1.4 to -0.8, P < .001), neck pain NRS (mean -1.8, 95% CI -2.0 to -1.5, P < .001), and arm pain NRS (mean -1.7, 95% CI -1.9 to -1.4, P < .001). According to GPE scale assessments, 229/513 patients (44.6%) experienced "complete recovery" or felt "much better" at 1 yr. There were significant improvements in all PROMs for both mild and moderate-to-severe DCM. A total of 251 patients (27.7%) experienced adverse effects within 3 mo., Conclusion: Surgery for DCM is associated with significant and clinically meaningful improvement across a wide range of PROMs., (© Congress of Neurological Surgeons 2021.)

Background Context: Criteria for success after surgical treatment of lumbar spinal stenosis (LSS) have been defined previously; however, there are no clear criteria for failure and worsening after surgery as assessed by patient-reported outcome measures (PROMs)., Purpose: We aimed to quantify changes in standard PROMs that most accurately identified failure and worsening after surgery for LSS., Study Design /setting: Retrospective analysis of prospective national spine registry data with 12-months follow-up., Patient Sample: We analyzed 10,822 patients aged 50 years and older operated in Norway during a decade, and 8,258 (76%) responded 12 months after surgery., Outcome Measures (proms): We calculated final scores, absolute changes, and percentage changes for Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for back and leg pain (0-10), and EuroQol-5D (EQ-5D). These 12 PROM derivates were compared to the Global Perceived Effect (GPE), a 7-point Likert scale., Methods: We used ODI, NRS back and leg pain, and EQ-5D 12 months after surgery to identify patients with failure (no effect) and worsening (clinical deterioration). The corresponding GPE at 12-months was graded as failure (GPE=4-7) and worsening (GPE=6-7) and used as an external criterion. To quantify the most accurate cut-off values corresponding to failure and worsening, we calculated areas under the curves (AUCs) of receiver operating characteristics (ROC) curves for the respective PROM derivates., Results: Mean (95% CI) age was 68.3 (68.1 - 68.5) years, and 52% were females. There were 1,683 (20%) failures, and 476 (6%) patients were worse after surgery. The mean (95% CI) pre- and postoperative ODIs were 39.8 (39.5 - 40.2) and 23.7 (23.3 - 24.1), respectively. At 12 months, the mean difference (95% CI) in ODI was 16.1 (15.7 - 16.4), and the mean (95% CI) percentage improvement 38.8% (37.8 - 38.8). The PROM derivates identified failure and worsening accurately (AUC>0.80), except for the absolute change in EQ-5D. The ODI derivates were most accurate to identify both failure and worsening. We found that less than 20% improvement in ODI most accurately identified failure (AUC=0.89 [95% CI: 0.88 to 0.90]), and an ODI final score of 39 points or more most accurately identified worsening (AUC =0.91 [95% CI: 0.90 - 0.92])., Conclusions: In this national register study, ODI derivates were most accurate to identify both failure and worsening after surgery for degenerative lumbar spinal stenosis. We recommend use of ODI percentage change and ODI final score for further studies of failure and worsening in elective spine surgery., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To develop a prognostic model for failure and worsening 1 year after surgery for lumbar disc herniation., Methods: This multicenter cohort study included 11,081 patients operated with lumbar microdiscectomy, registered at the Norwegian Registry for Spine Surgery. Follow-up was 1 year. Uni- and multivariate logistic regression analyses were used to assess potential prognostic factors for previously defined cut-offs for failure and worsening on the Oswestry Disability Index scores 12 months after surgery. Since the cut-offs for failure and worsening are different for patients with low, moderate, and high baseline ODI scores, the multivariate analyses were run separately for these subgroups. Data were split into a training (70%) and a validation set (30%). The model was developed in the training set and tested in the validation set. A prediction (%) of an outcome was calculated for each patient in a risk matrix., Results: The prognostic model produced six risk matrices based on three baseline ODI ranges (low, medium, and high) and two outcomes (failure and worsening), each containing 7 to 11 prognostic factors. Model discrimination and calibration were acceptable. The estimated preoperative probabilities ranged from 3 to 94% for failure and from 1 to 72% for worsening in our validation cohort., Conclusion: We developed a prognostic model for failure and worsening 12 months after surgery for lumbar disc herniation. The model showed acceptable calibration and discrimination, and could be useful in assisting physicians and patients in clinical decision-making process prior to surgery., (© 2021. The Author(s).)

Study Design: A cross-sectional study with a test-retest design., Objective: To translate and culturally adapt the numerical rating scale (NRS) for neck pain intensity and the Neck Disability Index (NDI), and asses their measurement properties in a Nepalese neck pain population., Summary of Background Data: Neck pain is one of the most common musculoskeletal disorders in Nepal. Research on neck pain disorders has been hampered by lack of standardized patient-reported outcome measures (PROMs) in Nepali language. Therefore, we aimed at validating a Nepali version of the NDI and NRS neck pain., Methods: At Dhulikhel hospital in Nepal, 150 patients with neck pain and/or cervical radiculopathy completed the translated self-administered questionnaires. We had made one cultural adaption of the NDI driving item in the final Nepali version. Relative reliability was analyzed with intraclass correlation coefficient (ICC 2.1) and absolute reliability with the smallest detectable change (SDC). Internal consistency was assessed by Cronbach alpha. Construct and discriminative validity was assessed by Spearman correlation for a priori hypotheses, receiver-operating characteristics curves, and analysis of variance. Time spent and assistance needed to complete the questionnaires were used to assess feasibility., Results: Test-restest reliability was excellent with ICC (95% confidence intervals) of 0.87 (0.66, 0.94) for NDI and 0.97 (0.94, 0.99) for NRS neck pain. The absolute reliability was acceptable (a SDC of 1.6 for NRS and 9.3 for NDI) and a Cronbach alpha (internal consistency) of 0.70 for NDI, as well as acceptable construct validity, discriminative validity, and feasibility., Conclusion: The Nepali versions of the NRS neck pain and NDI can be recommended for assessing pain and disability among patients with neck pain and cervical radiculopathy, but their responsiveness to change remains to be tested.Level of Evidence: 2., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)

Study Design: Observational multicenter study., Objective: The aim of this study was to evaluate changes in pain during sexual activity after surgery for lumbar disc herniation (LDH)., Summary of Background Data: There are limited data available on sexual function in patients undergoing surgery for LDH., Methods: Data were retrieved from the Norwegian Registry for Spine Surgery. The primary outcome was change in pain during sexual activity at one year, assessed by item number eight of the Oswestry disability index (ODI) questionnaire. Secondary outcome measures included ODI, EuroQol-5D (EQ-5D), and numeric rating scale (NRS) scores for back and leg pain., Results: Among the 18,529 patients included, 12,103 (64.8%) completed 1-year follow-up. At baseline, 16,729 patients (90.3%) provided information about pain during sexual activity, whereas 11,130 (92.0%) among those with complete follow-up completed this item. Preoperatively 2586 of 16,729 patients (15.5%) reported that pain did not affect sexual activity and at 1 year, 7251 of 11,130 patients (65.1%) reported a normal sex-life without pain. Preoperatively, 2483 (14.8%) patients reported that pain prevented any sex-life, compared to 190 patients (1.7%) at 1 year. At baseline, 14,143 of 16,729 patients (84.5%) reported that sexual activity caused pain, and among these 7232 of 10,509 responders (68.8%) reported an improvement at 1 year. A multivariable regression analysis showed that having a life partner, college education, working until time of surgery, undergoing emergency surgery, and increasing ODI score were predictors of improvement in pain during sexual activity. Increasing age, tobacco smoking, increasing body mass index, comorbidity, back pain >12 months, previous spine surgery, surgery in two or more lumbar levels, and complications occurring within 3 months were negative predictors., Conclusion: This study clearly demonstrates that a large proportion of patients undergoing surgery for LDH experienced an improvement in pain during sexual activity at 1 year., Level of Evidence: 2.

Background: The objective of this study was to investigate whether the service provision for lumbar spine surgery within the Northern Norway Regional Health Authority area complies with the distribution of functions that has been decided for the hospitals in the region, and whether there are any geographical variations in service provision. We therefore studied the treatment rates in Norway as a whole and in the Northern Norway Regional Health Authority area, and assessed the activity in the region., Material and Method: We included lumbar spine procedures in the Norwegian Patient Registry from the years 2014-2018 in a retrospective analysis and estimated treatment rates standardised by sex and age for Norway as a whole, the health regions and the health enterprises in Northern Norway Regional Health Authority. We estimated the local coverage as the proportion of patients who had undergone surgery in a hospital within their own area of residence., Results: The treatment rate for lumbar spine surgery in Norway amounted to approximately 120 procedures per 100 000 inhabitants per year for the entire period. The number of spine procedures nationwide increased from 5 995 in 2014 to 6 494 in 2018 because of a general population growth. The treatment rates for fractures and simple spine procedures were approximately identical throughout Norway, but the rate for complex spine procedures among residents within the area of Northern Norway Regional Health Authority amounted to 57 % of the national average. Local coverage within the Northern Norway Regional Health Authority area increased from 60 % to 84 % during the period. The local hospital functions for simple spine procedures at Nordland and Helgeland hospitals (approximately 30 %) and the regional function for complex spine surgery at the University Hospital of North Norway (55 %) had a low degree of local coverage., Interpretation: The treatment rate for complex spine procedures and the local coverage for all surgical procedures for degenerative lumbar spine disease were lower within the Northern Norway Regional Health Authority area than in the country as a whole. For this to be compensated in this region, we have estimated that the activity needs to be increased by approximately 170 procedures per year.

Background Context: Defining clinically meaningful success criteria from patient-reported outcome measures (PROMs) is crucial for clinical audits, research and decision-making., Purpose: We aimed to define criteria for a successful outcome 3 and 12 months after surgery for cervical degenerative radiculopathy on recommended PROMs., Study Design: Prospective cohort study with 12 months follow-up., Patient Sample: Patients operated at one or two levels for cervical radiculopathy included in the Norwegian Registry for Spine Surgery (NORspine) from 2011 to 2016., Outcome Measures: Neck disability index (NDI), Numeric Rating Scale for neck pain (NRS-NP) and arm pain (NRS-AP), health-related quality-of-life EuroQol 3L (EQ-5D), general health status (EQ-VAS)., Methods: We included 2,868 consecutive cervical degenerative radiculopathy patients operated for cervical radiculopathy in one or two levels and included in the Norwegian Registry for Spine Surgery (NORspine). External criterion to determine accuracy and optimal cut-off values for success in the PROMs was the global perceived effect scale. Success was defined as "much better" or "completely recovered." Cut-off values were assessed by analyzing the area under the receiver operating curves for follow-up scores, mean change scores, and percentage change scores., Results: All PROMs showed high accuracy in defining success and nonsuccess and only minor differences were found between 3- and 12-month scores. At 12 months, the area under the receiver operating curves for follow-up scores were 0.86 to 0.91, change scores were 0.74 to 0.87, and percentage change scores were 0.74 to 0.91. Percentage scores of NDI and NRS-AP showed the best accuracy. The optimal cut-off values for each PROM showed considerable overlap across those operated due to disc herniation and spondylotic foraminal stenosis., Conclusions: All PROMs, especially NDI and NRS-AP, showed good to excellent discriminative ability in distinguishing between a successful and nonsuccessful outcome after surgery due to cervical radiculopathy. Percentage change scores are recommended for use in research and clinical practice., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Surgery on extraforaminal lumbar disc herniation (ELDH) is a commonly performed procedure. Operating on this type of herniation is known to come with more difficulties than on the frequently seen paramedian lumbar disc herniation (PLDH). However, no comparative data are available on the effectiveness and safety of this operation. We sought out to compare clinical outcomes at 1 year following surgery for ELDH and PLDH., Methods: Data were collected through the Norwegian Registry for Spine Surgery (NORspine). The primary outcome measure was change at 1 year in the Oswestry Disability Index (ODI). Secondary outcome measures were quality of life measured with EuroQol 5 dimensions (EQ-5D); and numeric rating scales (NRSs)., Results: Data of a total of 1750 patients were evaluated in this study, including 72 ELDH patients (4.1%). One year after surgery, there were no differences in any of the patient reported outcome measurements (PROMs) between the two groups. PLDH and ELDH patients experienced similar changes in ODI (- 30.92 vs. - 34.00, P = 0.325); EQ-5D (0.50 vs. 0.51, P = 0.859); NRS back (- 3.69 vs. - 3.83, P = 0.745); and NRS leg (- 4.69 vs. - 4.46, P = 0.607) after 1 year. The proportion of patients achieving a clinical success (defined as an ODI score of less than 20 points) at 1 year was similar in both groups (61.5% vs. 52.7%, P = 0.204)., Conclusions: Patients operated for ELDH reported similar improvement after 1 year compared with patients operated for PLDH.

Objective: To examine outcomes and complications following first-time lumbar microdiscectomy., Methods: Prospective data for patients operated on between May 2007 and July 2016 were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in Oswestry Disability Index (ODI) score at 1 year. Secondary endpoints were change in quality of life measured with EuroQol 5 Dimensions, back and leg pain measured with numeric rating scales, and perioperative complications within 3 months of surgery., Results: For all enrolled patients (N = 1219) enrolled, mean improvement in ODI at 1 year was 33.3 points (95% confidence interval [CI] 31.7 to 34.9, P < 0.001). Mean improvement in EuroQol 5 Dimensions at 1 year of 0.52 point (95% CI 0.49 to 0.55, P < 0.001) represents a large effect size (Cohen's d = 1.6). Mean improvements in back pain and leg pain numeric rating scales were 3.9 points (95% CI 3.6 to 4.1, P < 0.001) and 5.0 points (95% CI 4.8 to 5.2, P < 0.001), respectively. There were 18 surgical complications in 1219 patients and 63 medical complications in 846 patients. The most common complication was micturition problems at 3 months following surgery (n = 25, 2.1%). In multivariate analysis, ODI scores of 21-40 (hazard ratio [HR] 14.5, 95% CI 1.1 to 27.9, P = 0.035), 41-60 (HR 27.5, 95% CI 13.4 to 41.7, P < 0.001), 61-80 (HR 47.4, 95% CI 33.4 to 61.4, P < 0.001) and >81 (HR 66.7, 95% CI 51.1 to 82.2, P < 0.001) were identified as positive predictors for ODI improvement at 1 year, whereas age ≥65 (HR -0.9, 95% CI -0.3 to -1.5, P = 0.004) was identified as a negative predictor for ODI improvement., Conclusions: Microdiscectomy for lumbar disc herniation is an effective and safe treatment., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: There is limited evidence on the comparative performance of private and public healthcare. Our aim was to compare outcomes following surgery for lumbar disc herniation (LDH) in private versus public hospitals., Methods: Data were obtained from the Norwegian registry for spine surgery. Primary outcome was change in Oswestry disability index (ODI) 1 year after surgery. Secondary endpoints were quality of life (EuroQol EQ-5D), back and leg pain, complications, and duration of surgery and hospital stays., Results: Among 5221 patients, 1728 in the private group and 3493 in the public group, 3624 (69.4%) completed 1-year follow-up. In the private group, mean improvement in ODI was 28.8 points vs 32.3 points in the public group (mean difference - 3.5, 95% CI - 5.0 to - 1.9; P for equivalence < 0.001). Equivalence was confirmed in a propensity-matched cohort and following mixed linear model analyses. There were differences in mean change between the groups for EQ-5D (mean difference - 0.05, 95% CI - 0.08 to - 0.02; P = 0.002) and back pain (mean difference - 0.2, 95% CI - 0.2, - 0.4 to - 0.004; P = 0.046), but after propensity matching, the groups did not differ. No difference was found between the two groups for leg pain. Complication rates was lower in the private group (4.5% vs 7.2%; P < 0.001), but after propensity matching, there was no difference. Patients operated in private clinics had shorter duration of surgery (48.4 vs 61.8 min) and hospital stay (0.7 vs 2.2 days)., Conclusion: At 1 year, the effectiveness of surgery for LDH was equivalent in private and public hospitals.

Background: A vast body of literature has documented regional variations in healthcare utilization rates. The extent to which such variations are "unwarranted" critically depends on whether there are corresponding variations in patients' needs. Using a unique medical registry, the current paper investigated any associations between utilization rates and patients' needs, as measured by two patient-reported outcome measures (PROMs)., Methods: This observational panel study merged patient-level data from the Norwegian Patient Registry (NPR), Statistics Norway, and the Norwegian Registry for Spine Surgery (NORspine) for individuals who received surgery for degenerative lumbar spine disorders in 2010-2015. NPR consists of hospital administration data. NORspine includes two PROMs: the generic health-related quality of life instrument EQ-5D and the disease-specific, health-related quality of life instrument Oswestry Disability Index (ODI). Measurements were assessed at baseline and at 3 and 12 months post-surgery and included a wide range of patient characteristics. Our case sample included 15,810 individuals. We analyzed all data using generalized estimating equations., Results: Our results show that as treatment rates increase, patients have better health at baseline. Furthermore, increased treatment rates are associated with smaller health gain., Conclusion: The correlation between treatment rates and patients health indicate the presence of unwarranted variation in treatment rates for lumbar spine disorders.

Study Design: Prospective multicenter cohort study., Objective: To investigate (1) the discriminative ability and cutoff estimates for success 12 months after surgery for lumbar disc herniation on the Oswestry Disability Index (ODI) raw score compared with a change and a percentage change score and (2) to what extent these clinical outcomes depend on the baseline disability., Methods: A total of 6840 patients operated for lumbar disc herniation from the Norwegian Registry for Spine Surgery (NORspine) were included. In receiver operating characteristic (ROC) curve analyses, a global perceived effect (GPE) scale (1-7) was used an external anchor. Success was defined as categories 1-2, "completely recovered" and "much better." Cutoffs for success for subgroups with different preoperative disability were also estimated., Results: When defining success after surgery for lumbar disc herniation, the accuracy (sensitivity, specificity, area under the curve, 95% CI) for the ODI raw score (0.83, 0.87, 0.930, 0.924-0.937) was comparable to the ODI percentage change score (0.85, 0.85, 0.925, 0.918-0.931), and higher than the ODI change score (0.79, 0.73, 0.838, 0.830-0.852). The cutoff for success was highly dependent on the amount of baseline disability (low-high), with cutoffs ranging from 13 to 28 for the ODI raw score and 39% to 66% for ODI percentage change. The ODI change score (points) was not as accurate., Conclusion: The 12-month ODI raw score, like the ODI percentage change score, can define a successful outcome with excellent accuracy. Adjustment for the baseline ODI score should be performed when comparing outcomes across groups, and one should consider using cutoffs according to preoperative disability (low, medium, high ODI scores)., 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: 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.

Background: Studies from different Western countries have reported a rapid increase in spinal surgery rates, an increase that exceeds by far the growing incidence rates of spinal disorders in the general population. There are few studies covering all lumbar spine surgery and no previous studies from Norway., Objectives: The purpose of this study was to investigate trends in all lumbar spine surgery in Norway over 15 years, including length of hospital stay, and rates of complications and reoperations., Design: A longitudinal observational study over 15 years using hospital patient administrative data and sociodemographic data from the National Registry in Norway., Setting and Participants: Patients aged ≥18 years discharged from Norwegian public hospitals between 1999 and 2013., Outcome Measures: Annual rates of simple (microsurgical discectomy, decompression) and complex surgical procedures (fusion, disc prosthesis) in the lumbar spine., Results: The rate of lumbar spine surgery increased by 54%, from 78 (95% CI (75 to 80)) to 120 (107 to 113) per 100 000, from 1999 to 2013. More men had simple surgery whereas more women had complex surgery. Among elderly people over 75 years, lumbar surgery increased by a factor of five during the 15-year period. The rates of complications were low, but increased from 0.7% in 1999 to 2.4% in 2013., Conclusions: There was a substantial increase in lumbar spine surgery in Norway from 1999 to 2013, similar to trends in other Western world countries. The rise in lumbar surgery among elderly people represents a significant workload and challenge for health services, given our aging population., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: The aims of this study were to determine the rates of surgical complications, reoperations, and readmissions following herniated lumbar disc surgery, and to investigate the impact of sociodemographic factors and comorbidity on the rate of such unfavourable events., Patients and Methods: This was a longitudinal observation study. Data from herniated lumbar disc operations were retrieved from a large medical database using a combination of procedure and diagnosis codes from all public hospitals in Norway from 1999 to 2013. The impact of age, gender, geographical affiliation, education, civil status, income, and comorbidity on unfavourable events were analyzed by logistic regression., Results: Of 34 639 operations, 2.7% (95% confidence interval (CI) 2.6 to 2.9) had a surgical complication, 2.1% (95% CI 2.0 to 2.3) had repeat surgery within 90 days, 2.4% (95% CI 2.2 to 2.5) had a non-surgical readmission within 90 days, and 6.7% (95% CI 6.4 to 6.9) experienced at least one of these unfavourable events. Unfavourable events were found to be associated with advanced age and comorbidity., Conclusion: The results suggest that surgical complications are less frequent than previously suggested. There are limited associations between sociodemographic patient characteristics and unfavourable events. Cite this article: Bone Joint J 2019;101-B:470-477.

Study Design: Retrospective administrative database study., Objective: To assess temporal and regional trends, and length of hospital stay, in lumbar spinal stenosis (LSS) surgery in Norwegian public hospitals from 1999 to 2013., Summary of Background Data: Studies from several countries have reported increasing rates of LSS surgery over the last decades. No such data have been presented from Norway., Methods: A database consisting of discharges from all Norwegian public hospitals was established. Inclusion criteria were discharges including a surgical procedure of lumbar spinal decompression and/or fusion in combination with an International Statistical Classification of Diseases and Related Health Problems, 10th Revision diagnosis of Spinal Stenosis (M48.0) or Other Spondylosis with Radiculopathy (M47.2), and a patient age of 18 years or older. Discharges with diagnoses indicating deformity, that is, spondylolisthesis or scoliosis were not included., Results: During the 15-year period, 19,543 discharges were identified. The annual rate of decompressions increased from 10.7 to 36.2 and fusions increased from 2.5 to 4.4 per 100,000 people of the general Norwegian population. The proportion of fusion surgery decreased from 19.3% to 10.9%. Among individuals older than 65 years, the annual rate of surgery per 10,000, including both decompressions and fusions, more than quadrupled from 40.2 to 170.3. The regional variation was modest, differing with a factor of 1.4 between the region with the highest and the lowest surgical rates. The mean length of hospital stay decreased from 11.0 (standard deviation 8.0) days in 1999 to 5.0 (4.6) days in 2013, but patients who received fusion surgery stayed on average 3.6 days longer than those who received decompression only., Conclusion: The rate of LSS surgery more than tripled in Norway from 1999 to 2013. The mean length of hospital stay was reduced from 11 to 5 days., Level of Evidence: N/A.

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.)

Objective: To evaluate the association between obesity and outcomes after microdiscectomy for lumbar disc herniation., Methods: The primary outcome measure was change in Oswestry Disability Index (ODI) at 1 year after surgery. Obesity was defined as body mass index (BMI) ≥30. Prospective data were retrieved from the Norwegian Registry for Spine Surgery., Results: We enrolled 4932 patients, 4018 nonobese and 914 obese. For patients with complete 1-year follow-up (n = 3381) the mean improvement in ODI was 31.2 points (95% confidence interval 30.4-31.9, P < 0.001). Improvement in ODI was 31.4 points in nonobese and 30.1 points in obese patients (P = 0.182). Obese and nonobese patients were as likely to achieve a minimal clinically important difference (84.2 vs. 82.7%, P = 0.336) in ODI (≥10 points improvement). Obesity was identified as a negative predictor for ODI improvement in a multiple regression analysis (BMI 30-34.99; P < 0.001, BMI ≥35; P = 0.029). Obese and nonobese patients experienced similar improvement in Euro-Qol-5 scores (0.48 vs. 0.49 points, P = 0.441) as well as back pain (3.7 vs. 3.5 points, P = 0.167) and leg pain (4.7 vs. 4.8 points, P = 0.654), as measured by the Numeric Rating Scale. Duration of surgery was shorter for nonobese patients (55.7 vs. 65.3 minutes, P ≤ 0.001). Nonobese patients experienced fewer complications compared with obese patients (6.1% vs. 8.3%, P = 0.017). Obese patients had slightly longer hospital stays (2.0 vs. 1.8 days, P = 0.004)., Conclusions: Although they had more minor complications, obese individuals experienced improvement after lumbar microdiscectomy for lumbar disc herniation similar to that of nonobese individuals., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: To compare clinical outcomes at 1 year following single-level lumbar microdiscectomy in daily tobacco smokers and nonsmokers., Methods: Data were collected through the Norwegian Registry for Spine Surgery. The primary endpoint was a change in the Oswestry Disability Index (ODI) at 1 year. Secondary endpoints were change in quality of life measured with EuroQol 5 Dimensions (EQ-5D), leg and back pain measured with a numerical rating scale (NRS), and rates of surgical complications., Results: A total of 5514 patients were enrolled, including 3907 nonsmokers and 1607 smokers. A significant improvement in ODI was observed for the entire cohort (mean, 31.1 points; 95% confidence interval [CI], 30.4-31.8; P < 0.001). Nonsmokers experienced a greater improvement in ODI at 1 year compared with smokers (mean, 4.1 points; 95% CI, 2.5-5.7; P < 0.001). Nonsmokers were more likely to achieve a minimal important change (MIC), defined as an ODI improvement of ≥10 points, compared with smokers (85.5% vs. 79.5%; P < 0.001). Nonsmokers experienced greater improvements in EQ-5D (mean difference, 0.068; 95% CI, 0.04-0.09; P < 0.001), back pain NRS (mean difference, 0.44; 95% CI, 0.21-0.66; P < 0.001), and leg pain NRS (mean difference, 0.54; 95% CI, 0.31-0.77; P < 0.001). There was no difference between smokers and nonsmokers in the overall complication rate (6.2% vs. 6.7%; P = 0.512). Smoking was identified as a negative predictor for ODI change in a multiple regression analysis (P < 0.001)., Conclusions: Nonsmokers reported a greater improvement in ODI at 1 year following microdiscectomy, and smokers were less likely to experience an MIC. Nonetheless, significant improvement was also found among smokers., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Purpose: In clinical decision-making, it is crucial to discuss the probability of adverse outcomes with the patient. A large proportion of the outcomes are difficult to classify as either failure or success. Consequently, cutoff values in patient-reported outcome measures (PROMs) for "failure" and "worsening" are likely to be different from those of "non-success". The aim of this study was to identify dichotomous cutoffs for failure and worsening, 12 months after surgical treatment for lumbar disc herniation, in a large registry cohort., Methods: A total of 6840 patients with lumbar disc herniation were operated and followed for 12 months, according to the standard protocol of the Norwegian Registry for Spine Surgery (NORspine). Patients reporting to be unchanged or worse on the Global Perceived Effectiveness (GPE) scale at 12-month follow-up were classified as "failure", and those considering themselves "worse" or "worse than ever" after surgery were classified as "worsening". These two dichotomous outcomes were used as anchors in analyses of receiver operating characteristics (ROC) to define cutoffs for failure and worsening on commonly used PROMs, namely, the Oswestry Disability Index (ODI), the EuroQuol 5D (EQ-5D), and Numerical Rating Scales (NRS) for back pain and leg pain., Results: "Failure" after 12 months for each PROM, as an insufficient improvement from baseline, was (sensitivity and specificity): ODI change <13 (0.82, 0.82), ODI% change <33% (0.86, 0.86), ODI final raw score >25 (0.89, 0.81), NRS back-pain change <1.5 (0.74, 0.86), NRS back-pain % change <24 (0.85, 0.81), NRS back-pain final raw score >5.5 (0.81, 0.87), NRS leg-pain change <1.5 (0.81, 0.76), NRS leg-pain % change <39 (0.86, 0.81), NRS leg-pain final raw score >4.5 (0.91, 0.85), EQ-5D change <0.10 (0.76, 0.83), and EQ-5D final raw score >0.63 (0.81, 0.85). Both a final raw score >48 for the ODI and an NRS >7.5 were indicators for "worsening" after 12 months, with acceptable accuracy., Conclusion: The criteria with the highest accuracy for defining failure and worsening after surgery for lumbar disc herniation were an ODI percentage change score <33% for failure and a 12-month ODI raw score >48. These cutoffs can facilitate shared decision-making among doctors and patients, and improve quality assessment and comparison of clinical outcomes across surgical units. In addition to clinically relevant improvements, we propose that rates of failure and worsening should be included in reporting from clinical trials.

Background Context: Lumbar total disc replacement (TDR) is a treatment option for selected patients with chronic low back pain (LBP) that is non-responsive to conservative treatment. The long-term results of disc replacement compared with multidisciplinary rehabilitation (MDR) have not been reported previously., Purpose: We aimed to assess the long-term relative efficacy of lumbar TDR compared with MDR., Design: We undertook a multicenter randomized controlled trial at five university hospitals in Norway., Patient Sample: The sample consisted of 173 patients aged 25-55 years with chronic LBP and localized degenerative changes in the lumbar intervertebral discs., Outcome Measures: The primary outcome was self-reported physical function (Oswestry Disability Index [ODI]) at 8-year follow-up in the intention-to-treat population. Secondary outcomes included self-reported LBP (visual analogue scale [VAS]), quality of life (EuroQol [EQ-5D]), emotional distress (Hopkins Symptom Checklist [HSCL-25]), occupational status, patient satisfaction, drug use, complications, and additional back surgery., Methods: Patients were randomly assigned to lumbar TDR or MDR. Self-reported outcome measures were collected 8 years after treatment. The study was powered to detect a difference of 10 ODI points between the groups. The study has not been funded by the industry., Results: A total of 605 patients were screened for eligibility, of whom 173 were randomly assigned treatment. Seventy-seven patients (90%) randomized to surgery and 74 patients (85%) randomized to rehabilitation responded at 8-year follow-up. Mean improvement in the ODI was 20.0 points (95% confidence interval [CI] 16.4-23.6, p≤.0001) in the surgery group and 14.4 points (95% CI 10.7-18.1, p≤.0001) in the rehabilitation group. Mean difference between the groups at 8-year follow-up was 6.1 points (95% CI 1.2-11.0, p=.02). Mean difference in favor of surgery on secondary outcomes were 9.9 points on VAS (95% CI 0.6-19.2, p=.04) and 0.16 points on HSCL-25 (95% CI 0.01-0.32, p=.04). There were 18 patients (24%) in the surgery group and 4 patients (6%) in the rehabilitation group who reported full recovery (p=.002). There were no significant differences between the groups in EQ-5D, occupational status, satisfaction with care, or drug use. In the per protocol analysis, the mean difference between groups was 8.1 ODI points (95% CI 2.3-13.9, p=.01) in favor of surgery. Forty-three of 61 patients (70%) in the surgery group and 26 of 52 patients (50%) in the rehabilitation group had a clinically important improvement (15 ODI points or more) from baseline (p=.03). The proportion of patients with a clinically important deterioration (six ODI points or more) was not significantly different between the groups. Twenty-one patients (24%) randomized to rehabilitation had crossed over and had undergone back surgery since inclusion, whereas 12 patients (14%) randomized to surgery had undergone additional back surgery. One serious adverse event after disc replacement is registered (<1%)., Conclusions: Substantial long-term improvement can be expected after both disc replacement and MDR. The difference between groups is statistically significant in favor of surgery, but smaller than the prespecified clinically important difference of 10 ODI points that the study was designed to detect. Future research should aim to improve selection criteria for disc replacement and MDR., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: There are no previous studies evaluating risk factors for surgical site infections (SSIs) and the effectiveness of prophylactic antibiotic treatment (PAT), specifically for patients operated on for lumbar disc herniation., Method: This observational multicentre study comprises a cohort of 1,772 consecutive patients operated on for lumbar disc herniation without laminectomy or fusion at 23 different surgical units in Norway. The patients were interviewed about SSIs according to a standardised questionnaire at 3 months' follow-up., Results: Three months after surgery, 2.3% of the patients had an SSI. Only no PAT (OR = 5.3, 95% CI = 2.2-12.7, p< 0.001) and longer duration of surgery than the mean time (68 min) (OR = 2.8, 95% CI = 1.2-6.6, p = 0.02) were identified as independent risk factors for SSI. Numbers needed to have PAT to avoid one SSI was 43., Conclusions: In summary, this study clearly lends support to the use of PAT in surgery for lumbar disc herniation. Senior surgeons assisting inexperienced colleagues to avoid prolonged duration of surgery could also reduce the occurrence of SSI.