A randomized trial on three different minimally invasive decompression techniques for lumbar spinal stenosis. Five years follow-up from the NORDSTEN-SST.

PURPOSE: The short-term clinical outcome for midline-preserving posterior decompression techniques was comparable. The aim of this study was to evaluate long-term clinical results after three different midline-preserving posterior decompression techniques. MATERIAL: In the NORDSTEN spinal stenosis trial (NORDSTEN-SST) 437 patients were randomized to three different midline-retaining posterior decompression techniques: Unilateral laminotomy with crossover (UL), bilateral laminotomy (BL) and spinous process osteotomy (SPO). Primary outcome was the mean change in Oswestry disability index (ODI) score at five-years follow-up. Secondary outcomes were the proportion of patients classified as success, mean change in EQ-5D, ZCQ-score, NRS-score for leg and low back pain, a seven-point Global Perceived Effect (GPE) Scale and proportion of subsequential spinal surgery. RESULTS: The number of patients that completed follow-up data after five years was 358 (82%): In the UL, BL and SPO group the numbers were 122, 119 and 117, respectively. Mean age at baseline was 66.7 (SD 8.2) years, mean BMI was 27.8 (SD 4.1), and 172/358 (48%) were female. In the UL group the mean change was -18.2 (95% CI -21.0 -5.4), in the BL group it was -19.0 (95% CI -21.9-16.1) and in the SPO it was -18.6 (95% CI -21.6-15.7) (p = 0.917). No significant differences in the secondary outcomes between the three surgical groups were found, also the subsequent spinal surgery rates were similar. CONCLUSION: There were no significant differences in patient reported outcomes and subsequent spinal surgery rates after the three different decompression techniques at five-year follow-up.

Clinical Importance of Redundant Nerve Roots in Patients with Symptomatic Lumbar Spinal Stenosis: A Secondary Analysis of NORDSTEN Spinal Stenosis Trial Data.

STUDY DESIGN: Post-hoc analysis of data from a randomized clinical trial. OBJECTIVE: To compare preoperative symptoms of patients with lumbar spinal stenosis (LSS) with and without redundant nerve roots (RNR), and to compare the change in clinical outcomes between those two groups 2 years after decompression surgery. SUMMARY OF BACKGROUND DATA: RNR are often seen on MRI in patients with spinal stenosis. Previous studies have reported that patients with RNR are older and have worse symptoms at baseline. A meta-analysis from 2018 concluded that this radiological sign could be seen as a negative predictor of outcome. High quality prospective studies are lacking. METHODS: Patient characteristics and reported pain and function scores were compared between LSS groups with (RNR+) and without RNR (RNR-) at baseline and after 2 years follow-up. Primary outcome was the mean change in the Oswestry Disability Score (ODI). Secondary outcomes included mean change in scores of the Zurich Claudication Questionnaire (ZCQ) and the numeric rating scale (NRS) for leg and back pain. RESULTS: Out of 416 patients included in the present analysis, 163 (39%) had RNR at baseline. Both groups were similar in regard to patient age, smoking habits, BMI and duration of symptoms. Both groups also showed similar pain and function scores at baseline. The RNR+ group contained a significantly higher proportion of men, patients with severe stenosis and multiple stenotic levels on MRI. At 2-year follow-up the mean change of ODI was -22.1 in the RNR+ group and -17.4 in RNR- group (mean difference 4.7 (95%CI 1.3-8.2) P=0.007). Statistically significant differences were also found for secondary outcomes ZCQ, and NRS leg and back pain favouring the RNR+ group. CONCLUSION: Patients with RNR had similar baseline characteristics and similar symptoms as patients without. RNR before surgery were associated with better clinical improvement 2 years after decompression.

Surgical versus conservative treatment for odontoid fractures in older people: an international prospective comparative study.

BACKGROUND: The optimal treatment for odontoid fractures in older people remains debated. Odontoid fractures are increasingly relevant to clinical practice due to ageing of the population. METHODS: An international prospective comparative study was conducted in fifteen European centres, involving patients aged ≥55 years with type II/III odontoid fractures. The surgeon and patient jointly decided on the applied treatment. Surgical and conservative treatments were compared. Primary outcomes were Neck Disability Index (NDI) improvement, fracture union and stability at 52 weeks. Secondary outcomes were Visual Analogue Scale neck pain, Likert patient-perceived recovery and EuroQol-5D-3L at 52 weeks. Subgroup analyses considered age, type II and displaced fractures. Multivariable regression analyses adjusted for age, gender and fracture characteristics. RESULTS: The study included 276 patients, of which 144 (52%) were treated surgically and 132 (48%) conservatively (mean (SD) age 77.3 (9.1) vs. 76.6 (9.7), P = 0.56). NDI improvement was largely similar between surgical and conservative treatments (mean (SE) -11 (2.4) vs. -14 (1.8), P = 0.08), as were union (86% vs. 78%, aOR 2.3, 95% CI 0.97-5.7) and stability (99% vs. 98%, aOR NA). NDI improvement did not differ between patients with union and persistent non-union (mean (SE) -13 (2.0) vs. -12 (2.8), P = 0.78). There was no difference for any of the secondary outcomes or subgroups. CONCLUSIONS: Clinical outcome and fracture healing at 52 weeks were similar between treatments. Clinical outcome and fracture union were not associated. Treatments should prioritize favourable clinical over radiological outcomes.

Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial.

OBJECTIVE: To assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis. DESIGN: Five year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS). SETTING: 16 public orthopaedic and neurosurgical clinics in Norway. PARTICIPANTS: Patients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level. INTERVENTIONS: Decompression surgery alone and decompression with additional instrumented fusion (1:1). MAIN OUTCOME MEASURES: The primary outcome was a 30% or more reduction in Oswestry disability index from baseline to five year follow-up. The predefined non-inferiority margin was a -15 percentage point difference in the proportion of patients who met the primary outcome. Secondary outcomes included the mean change in Oswestry disability index, Zurich claudication questionnaire, numeric rating scale for leg and back pain, and EuroQol Group 5-Dimension (EQ-5D-3L) questionnaire. RESULTS: From 12 February 2014 to 18 December 2017, 267 participants were randomly assigned to decompression alone (n=134) and decompression with instrumented fusion (n=133). Of these, 230 (88%) responded to the five year questionnaire: 121 in the decompression group and 109 in the fusion group. Mean age at baseline was 66.2 years (SD 7.6), and 69% were women. In the modified intention-to-treat analysis with multiple imputation of missing data, 84 (63%) of 133 people in the decompression alone group and 81 (63%) of 129 people in the fusion group had a at least a 30% reduction in Oswestry disability index, a difference of 0.4 percentage points. (95% confidence interval (CI) -11.2 to 11.9). The respective results of the per protocol analysis were 65 (65%) of 100 in the decompression alone group and 59 (66%) of 89 in the fusion group, a difference of -1.3 percentage points (95% CI -14.5 to 12.2). Both 95% CIs were higher than the predefined non-inferiority margin of -15%. The mean change in Oswestry disability index from baseline to five years was -17.8 in both groups (mean difference 0.02 (95% CI -3.8 to 3.9)). Results of the other secondary outcomes were in the same direction as the primary outcome. From two to five year follow-up, a new lumbar operation occurred in six (5%) of 123 people in the decompression group and 11 (10%) of 113 people in the fusion group, with a total from baseline to five years of 21 (16%) of 129 people and 23 (18%) of 125, respectively. CONCLUSIONS: In participants with degenerative spondylolisthesis, decompression alone was non-inferior to decompression with instrumented fusion five years after primary surgery. Proportions of subsequent surgeries at the index level or an adjacent lumbar level were no different between the groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT02051374.

Responsiveness of the Oswestry Disability Index and Zurich Claudication Questionnaire in patients with lumbar spinal stenosis: evaluation of surgically treated patients from the NORDSTEN study.

PURPOSE: To evaluate the responsiveness of the original low back pain specific Oswestry Disability Index (ODI) and the spinal stenosis specific Zürich Claudication Questionnaire (ZCQ), and to investigate cut-off values for clinical "success" for ODI and ZCQ in surgically treated patients with lumbar spinal stenosis (LSS). METHODS: We included 601 LSS patients (218 with, 383 without degenerative spondylolisthesis) from the NORDSTEN trials. Outcome measures included ODI and ZCQ (symptom severity and physical function scales) with three alternative response parameters: scores at follow-up, absolute and relative changes from baseline to two-year follow-up. Effect size and standardised response mean evaluated internal responsiveness. External responsiveness was assessed by the Spearman rank correlation between patient-reported global perceived effect scale (GPE) and ODI and ZCQ, and receiver operating characteristics (ROC). We evaluated which cut-off values could maximise the percentage of correctly classified patients according to the GPE-anchor "completely recovered" / "much improved" for each parameter. RESULTS: Internal and external responsiveness were high for all three indices with effect sizes, standardized response means, ROC and corresponding area under the curve > 0.8. Correlations with GPE responses were moderate (> 0.50) for absolute change and strong (> 0.67) for relative change and follow-up scores. The 30% ODI relative change cut-off correctly classified 81% of patients to "success", within a range of accurate cut-offs according to the GPE-anchor. CONCLUSION: ODI and ZCQ demonstrate comparable responsiveness in evaluating outcomes for surgically treated LSS patients. The 30% ODI threshold was consistent with treatment "success" in NORDSTEN trials. TRIAL REGISTRATION: ClinicalTrials.gov; NCT02007083 10/12/2013, NCT02051374 31/01/2014 and NCT03562936 20/06/2018.

Comparison of Patients Operated for Lumbar Spinal Stenosis With and Without Spondylolisthesis​​​​​: A Secondary Analysis of the NORDSTEN Trials.

STUDY DESIGN: Observational cohort study (secondary analysis of two randomized trials). OBJECTIVE: The aim of this study was to investigate whether function, disability, pain, and quality of life before surgery and patient-reported outcome as well as complication and reoperation rates up to 2 years after surgery differ between lumbar spinal stenosis patients with and without spondylolisthesis. SUMMARY OF BACKGROUND DATA: Lumbar spinal stenosis is a degenerative condition of the spine, which appears with or without degenerative spondylolisthesis often presenting similar signs and symptoms. MATERIALS AND METHODS: This study is a secondary analysis of two randomized trials on patients with lumbar spinal stenosis with and without spondylolisthesis conducted at 16 public Norwegian hospitals. Disability, function, back pain, leg pain, quality of life, complication, and reoperation rates up to 2 years after surgery were compared between the two cohorts. RESULTS: A total of 704 patients were included in this study, 267 patients with spondylolisthesis [median age: 67.0 yr (IQR: 61.0-72.0 yr); 68.7% female] and 437 patients without spondylolisthesis [median age: 68.0 yr (IQR: 62.0-73.0 yr); 52.9% female]. In the linear mixed-model analysis there were no significant differences in disability, function, back pain, leg pain, and quality of life scores between the two cohorts of patient with and without spondylolisthesis before surgery or at 2 years of follow-up. The complication rate was 22.9% in patients with spondylolisthesis and 12.1% in patients without spondylolisthesis ( P <0.001). There were no significant differences in reoperation rates. CONCLUSIONS: In patients with lumbar spinal stenosis the symptom burden before surgery and the clinical outcome up to 2 years after surgery were similar independently of a concomitant spondylolisthesis. LEVEL OF EVIDENCE: II.

Change in Lumbar Lordosis after Decompressive Surgery in Lumbar Spinal Stenosis Patients and Associations with Patient Related Outcomes 2 Years after Surgery. Radiological and Clinical Results from the NORDSTEN Spinal Stenosis Trial.

STUDY DESIGN: A prospective cohort study. OBJECTIVE: The aim was to investigate changes in lumbar lordosis (LL) and its association to changes in patient reported outcome measures (PROMs) after decompressive surgery for lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND: Few studies have addressed change in LL after decompression surgery for LSS in relation to outcomes. METHOD: Pre- and postoperative data from 310 patients having standing x-ray both before and 2 years after surgery were included. The patients were grouped based on the change in LL preoperatively to 2 years after surgery; group 1: <5 degrees (n=196), group 2: ≥5 <10 degrees (n=55) or group 3: ≥10 degrees (n=59) of change in LL. The changes in function, disability and pain were assessed by the Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and the Zurich claudication questionnaire (ZCQ). The three groups were compared regarding baseline variables using the ANOVA test for continuous variables and the chi-square test for categorical variables. The groups were further compared with a likelihood ratio test in relation to changes in PROMs 2 year after surgery and outcomes were adjusted for respective baseline PROMs, age, sex, smoking, BMI, Schizas and Pfirrmann scores. RESULTS: LL was significantly changed at group level 2 years after surgery with a mean difference of 2.2 (SD 9.4) degrees ( P =0.001). The three LL change groups did not show any significant differences in patient characteristics, function, disability, and pain at baseline. The two groups with a change of more than 5 degrees in LL 2 year after surgery (group 2 and 3) had significantly greater improvements in ODI ( P =0.022) and ZCQ function ( P =0.016) in the adjusted analyses, but was not significant for back and leg pain. CONCLUSION: Changed LL after decompressive surgery for LSS was associated with improved ODI and physical function.

Preoperative fatty infiltration of paraspinal muscles assessed by MRI is associated with less improvement of leg pain 2 years after surgery for lumbar spinal stenosis.

PURPOSE: Fatty infiltration (FI) of the paraspinal muscles may associate with pain and surgical complications in patients with lumbar spinal stenosis (LSS). We evaluated the prognostic influence of MRI-assessed paraspinal muscles' FI on pain or disability 2 years after surgery for LSS. METHODS: A muscle fat index (MFI) was calculated (by dividing signal intensity of psoas to multifidus and erector spinae) on preoperative axial T2-weighted MRI of patients with LSS. Pain and disability 2 years after surgery were assessed using the Oswestry disability index, the Zurich claudication questionnaire and numeric rating scales for leg and back pain. Multivariate linear and logistic regression analyses (adjusted for preoperative outcome scores, age, body mass index, sex, smoking status, grade of spinal stenosis, disc degeneration and facet joint osteoarthritis) were used to assess the associations between MFI and patient-reported clinical outcomes. In the logistic regression models, odds ratios (OR) and 95% confidence intervals (CI) were calculated for associations between the MFI and ≥ 30% improvement of the outcomes (dichotomised into yes/no). RESULTS: A total of 243 patients were evaluated (mean age 66.6 ± 8.5 years), 49% females (119). Preoperative MFI and postoperative leg pain were significantly associated, both with leg pain as continuous (coefficient - 3.20, 95% CI - 5.61, - 0.80) and dichotomised (OR 1.51, 95% CI 1.17, 1.95) scores. Associations between the MFI and the other outcome measures were not statistically significant. CONCLUSION: Preoperative FI of the paraspinal muscles on MRI showed statistically significant association with postoperative NRS leg pain but not with ODI or ZCQ.

Characteristics and demography of low energy fall injuries in patients > 60 years of age: a population-based analysis over a decade with focus on undertriage.

BACKGROUND: An increasing group of elderly patients is admitted after low energy falls. Several studies have shown that this patient group tends to be severely injured and is often undertriaged. METHODS: Patients > 60 years with low energy fall (< 1 m) as mechanism of injury were identified from the Stavanger University Hospital trauma registry. The study period was between 01.01.11 and 31.12.20. Patient and injury variables as well as clinical outcome were described. Undertriage was defined as patients with a major trauma, i.e., Injury Severity Score (ISS) > 15, without trauma team activation. Statistical analysis was performed using the Chi-squared test for categorical variables and the Mann-Whitney U test for continuous variables. RESULTS: Over the 10-year study period, 388 patients > 60 years with low energy fall as mechanism of injury were identified. Median age was 78 years (IQR 68-86), and 53% were males. The location of major injury was head injury in 41% of the patients, lower extremities in 19%, and thoracic injuries in 10%. Thirty-day mortality was 13%. Fifty percent were discharged to home, 31% to nursing home, 9% in hospital mortality, and the remaining 10% were transferred to other hospitals or rehabilitation facilities. Ninety patients had major trauma, and the undertriage was 48% (95% confidence interval, 38 to 58%). CONCLUSIONS: Patients aged > 60 years with low energy falls are dominated by head injuries, and the 30-day mortality is 13%. Patients with major trauma are undertriaged in half the cases mandating increased awareness of this patient group.

The association between lumbar lordosis preoperatively and changes in PROMs for lumbar spinal stenosis patients 2 years after spinal surgery: radiological and clinical results from the NORDSTEN-spinal stenosis trial.

BACKGROUND: Patients with lumbar spinal stenosis (LSS) sometimes have lower lumbar lordosis (LL), and the incidence of LSS correlates closely with the loss of LL. The few studies that have evaluated the association between LL and clinical outcomes after non-instrumented surgery for LSS show conflicting results. This study investigates the association between preoperative LL and changes in PROMs 2 years after decompressive surgery. METHOD: This prospective cohort study obtained preoperative and postoperative data for 401 patients from the multicenter randomized controlled spinal stenosis trial as part of the NORwegian degenerative spondylolisthesis and spinal STENosis (NORDSTEN) study. Before surgery, the radiological sagittal alignment parameter LL was measured using standing X-rays. The association between LL and 2-year postoperative changes was analyzed using the oswestry disability index (ODI), a numeric rating scale (NRS) for low back and leg pain, the Zurich claudication questionnaire (ZCQ), and the global perceived effect (GPE) score. The changes in PROMs 2 years after surgery for quintiles of lumbar lordosis were adjusted for the respective baseline PROMs: age, sex, smoking, and BMI. The Schizas index and the Pfirrmann index were used to analyze multiple regressions for changes in PROMs. RESULTS: There were no associations in the adjusted and unadjusted analyses between preoperative LL and changes in ODI, ZCQ, GPE, and NRS for back and leg pain 2 years after surgery. CONCLUSION: LL before surgery was not associated with changes in PROMs 2 years after surgery. Lumbar lordosis should not be a factor when considering decompressive surgery for LSS.

Do patients with lumbar spinal stenosis benefit from decompression of levels with adjacent moderate stenosis? A prospective cohort study from the NORDSTEN study.

BACKGROUND: Lumbar spinal stenosis (LSS) is characterized by pain that radiates to the buttocks and/or legs, aggravated by walking and relieved by forward flexion. There is poor correlation between clinical symptoms and severity of stenosis on MRI, and multilevel stenosis has not been described to present worse symptoms or treatment outcomes, compared with patients with single-level stenosis. In patients with one level with severe stenosis combined with an adjacent level with moderate stenosis, the surgeon must decide whether to decompress only the narrowest level or both, to achieve the best possible outcome. The potential benefits of performing surgery on an adjacent moderate stenosis is debated, and the scientific evidence in scarce. PURPOSE: The aim of the present study was to investigate whether patients with a level of adjacent moderate stenosis, along with an index stenosis, benefitted from a dual-level decompression (DLD) compared with a single-level decompression (SLD). Furthermore, to investigate whether DLD patients had longer duration of surgery and hospital stay, higher rates of complications and/or lower rate of reoperations compared with SLD patients. STUDY DESIGN: Prospective cohort study. PATIENT SAMPLE: We analyzed data from the Norwegian Degenerative Spondylisthesis and Spinal Stenosis study- Spinal Stenosis Trial (NORDSTEN-SST). In this randomized multicenter study, 437 patients were included, evaluating clinical outcomes of three different surgical treatment options for LSS. Patients with degenerative spondylolisthesis were excluded. METHOD: Based on preoperative MRI, the present analysis included all patients who had a moderate stenosis (defined as Schizas B or C) in addition to a predefined index stenosis (the level with the smallest cross-sectional area). We compared patients who, based on the surgeons` choice, received a dual-level decompression, with those receiving a single-level decompression. OUTCOME MEASURES: The primary outcome was mean change in the Oswestry Disability Index (ODI) score from baseline to 2-year follow up. Secondary outcomes were proportion of success (30% reduction in ODI score), the Numeric Rating Scales for back and leg pain (NRS), the EuroQol 5-dimensional questionnaire utility index (EQ-5D), the Zurich Claudication Questionnaire (ZCQ), the Global Perceived Effect (GPE)-scale, duration of surgery, duration of hospital stay, perioperative complications and reoperation rates. RESULTS: Among the 222 patients, included in the analysis, 108 underwent DLD and 114 underwent SLD. There was no difference in change scores for any of the investigated patient-reported outcomes between the groups after 2 years. However, the DLD group had longer duration of surgery and longer length of hospital stay. There was no difference in reoperation rates or perioperative complications. CONCLUSION: This study, alongside the NORDSTEN-LSS trial on patients with adjacent moderate stenosis as well as an index stenosis, showed no superior clinical effectiveness for dual-level surgery compared with single-level surgery.

Is the presence of foraminal stenosis associated with outcome in lumbar spinal stenosis patients treated with posterior microsurgical decompression.

BACKGROUND: We aim to investigate associations between preoperative radiological findings of lumbar foraminal stenosis with clinical outcomes after posterior microsurgical decompression in patients with predominantly central lumbar spinal stenosis (LSS). METHODS: The study was an additional analysis in the NORDSTEN Spinal Stenosis Trial. In total, 230 men and 207 women (mean age 66.8 (SD 8.3)) were included. All patients underwent an MRI including T1- and T2-weighted sequences. Grade of foraminal stenosis was dichotomized into none to moderate (0-1) and severe (2-3) category using Lee's classification system. The Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and numeric rating scale (NRS) for back and leg pain were collected at baseline and at 2-year follow-up. Primary outcome was a reduction of 30% or more on the ODI score. Secondary outcomes included the mean improvement on the ODI, ZCQ, and NRS scores. We performed multivariable regression analyses with the radiological variates foraminal stenosis, Pfirrmann grade, Schizas score, dural sac cross-sectional area, and the possible plausible confounders: patients' gender, age, smoking status, and BMI. RESULTS: The cohort of 437 patients presented a high degree of degenerative changes at baseline. Of 414 patients with adequate imaging of potential foraminal stenosis, 402 were labeled in the none to moderate category and 12 in the severe category. Of the patients with none to moderate foraminal stenosis, 71% achieved at least 30% improvement in ODI. Among the patients with severe foraminal stenosis, 36% achieved at least 30% improvement in ODI. A significant association between severe foraminal stenosis and less chance of reaching the target of 30% improvement in the ODI score after surgery was detected: OR 0.22 (95% CI 0.06, 0.83), p=0.03. When investigating outcome as continuous variables, a similar association between severe foraminal stenosis and less improved ODI with a mean difference of 9.28 points (95%CI 0.47, 18.09; p=0.04) was found. Significant association between severe foraminal stenosis and less improved NRS pain in the lumbar region was also detected with a mean difference of 1.89 (95% CI 0.30, 3.49; p=0.02). No significant association was suggested between severe foraminal stenosis and ZCQ or NRS leg pain. CONCLUSION: In patients operated with posterior microsurgical decompression for LSS, a preoperative severe lumbar foraminal stenosis was associated with higher proportion of patients with less than 30% improvement in ODI. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov (22.11.2013) under the identifier NCT02007083.

Surgery in degenerative spondylolisthesis: does fusion improve outcome in subgroups? A secondary analysis from a randomized trial (NORDSTEN trial).

BACKGROUND CONTEXT: Patients with spinal stenosis and degenerative spondylolisthesis are treated surgically with decompression alone or decompression with fusion. However, there is debate regarding which subgroups of patients may benefit from additional fusion. PURPOSE: To investigate possible treatment effect modifiers and prognostic variables among patients operated for spinal stenosis and degenerative spondylolisthesis. DESIGN: A secondary exploratory study using data from the Norwegian Degenerative Spondylolisthesis and Spinal Stenosis (NORDSTEN-DS) trial. Patients were randomized to decompression alone or decompression with instrumented fusion. PATIENT SAMPLE: The sample in this study consists of 267 patients from a randomized multicenter trial involving 16 hospitals in Norway. Patients were enrolled from February 12, 2014, to December 18, 2017. The study did not include patients with degenerative scoliosis, severe foraminal stenosis, multilevel spondylolisthesis, or previous surgery. OUTCOME MEASURES: The primary outcome was an improvement of ≥ 30% on the Oswestry Disability Index score (ODI) from baseline to 2-year follow-up. METHODS: When investigating possible variables that could modify the treatment effect, we analyzed the treatment arms separately. When testing for prognostic factors we analyzed the whole cohort (both treatment groups). We used univariate and multiple regression analyses. The selection of variables was done a priori, according to the published trial protocol. RESULTS: Of the 267 patients included in the trial (183 female [67%]; mean [SD] age, 66 [7.6] years), complete baseline data for the variables required for the present analysis were available for 205 of the 267 individuals. We did not find any clinical or radiological variables at baseline that modified the treatment effect. Thus, none of the commonly used criteria for selecting patients for fusion surgery influenced the chosen primary outcome in the two treatment arms. For the whole cohort, less comorbidity (American Society of Anesthesiologists Classification [ASA], OR = 4.35; 95% confidence interval (CI [1.16-16.67]) and more preoperative leg pain (OR = 1.23; CI [1.02-1.50]) were significantly associated with an improved primary outcome. CONCLUSIONS: In this study on patients with degenerative spondylolisthesis, neither previously defined instability criteria nor other pre-specified baseline variables were associated with better clinical outcome if fusion surgery was performed. None of the analyzed variables can be applied to guide the decision for fusion surgery in patients with degenerative spondylolisthesis. For both treatment groups, less comorbidity and more leg pain were associated with improved outcome 2 years after surgery. TRIAL REGISTRATION: NORDSTEN-DS ClinicalTrials.gov, NCT02051374.

Postoperative Dural Sac Cross-Sectional Area as an Association for Outcome After Surgery for Lumbar Spinal Stenosis: Clinical and Radiological Results From the NORDSTEN-Spinal Stenosis Trial.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: The aim was to investigate the association between postoperative dural sac cross-sectional area (DSCA) after decompressive surgery for lumbar spinal stenosis and clinical outcome. Furthermore, to investigate if there is a minimum threshold for how extensive a posterior decompression needs to be to achieve a satisfactory clinical result. SUMMARY OF BACKGROUND DATA: There is limited scientific evidence for how extensive lumbar decompression needs to be to obtain a good clinical outcome in patients with symptomatic lumbar spinal stenosis. MATERIALS AND METHODS: All patients were included in the Spinal Stenosis Trial of the NORwegian Degenerative spondylolisthesis and spinal STENosis (NORDSTEN)-study. The patients underwent decompression according to three different methods. DSCA measured on lumbar magnetic resonance imaging at baseline and at three months follow-up, and patient-reported outcome at baseline and at two-year follow-up were registered in a total of 393 patients. Mean age was 68 (SD: 8.3), proportion of males were 204/393 (52%), proportion of smokers were 80/393 (20%), and mean body mass index was 27.8 (SD: 4.2).The cohort was divided into quintiles based on the achieved DSCA postoperatively, the numeric, and relative increase of DSCA, and the association between the increase in DSCA and clinical outcome were evaluated. RESULTS: At baseline, the mean DSCA in the whole cohort was 51.1 mm 2 (SD: 21.1). Postoperatively the area increased to a mean area of 120.6 mm 2 (SD: 46.9). The change in Oswestry disability index in the quintile with the largest DSCA was -22.0 (95% CI: -25.6 to -18), and in the quintile with the lowest DSCA the Oswestry disability index change was -18.9 (95% CI: -22.4 to -15.3). There were only minor differences in clinical improvement for patients in the different DSCA quintiles. CONCLUSION: Less aggressive decompression performed similarly to wider decompression across multiple different patient-reported outcome measures at two years following surgery.

Ruptured Aneurysm of the Anterior Communicating Artery in a Newborn: A Case Report and Review of the Literature.

We report the case of a 3-week-old neonate who presented with massive subarachnoid and intraventricular hemorrhage from a ruptured aneurysm of the anterior communicating artery (ACommA). An attempt on endovascular treatment ended up with therapeutic closure of the parent artery. However, since further investigation revealed a disastrous supratentorial cerebral infarction as a result of the hemorrhage, active treatment was terminated and the neonate died a few days after the initial stroke. To the best of our knowledge and after reviewing available literature, this is one of only five cases of ACommA aneurysm in newborns reported to date. Bleeding from an ACommA aneurysm in a neonate thus represents an extreme clinical rarity. There are no available data comparing the efficacy and safety of microsurgical versus endovascular treatment in neonates and small infants, but the latter option may at least reduce the risk associated with open surgery and further blood loss in this age group.

Is there a weekend effect on mortality rate and outcome for moderate and severe traumatic brain injury? A population-based, observational cohort study.

Purpose: The aim of the study was to analyse patient and injury characteristics and the effects of weekend admissions on mortality rate and outcome after moderate and severe traumatic brain injuries. Methods: This is an observational cohort study based on data from a prospectively maintained regional trauma registry in South Western Norway. Patients with moderate and severe traumatic brain injury admitted between January 1st, 2004 and December 31st, 2019 were included in this study. Results: During the study period 688 patients were included in the study with similar distribution between moderate (n â€‹= â€‹318) and severe (n â€‹= â€‹370) traumatic brain injury. Mortality rate was 46% in severe and 13% in moderate traumatic brain injury. Two hundred and thirty-one (34%) patients were admitted during weekends. Patients admitted during weekends were significantly younger (median age (IQR) 32.0 (25.5-67.0) vs 47.0 (20.0-55.0), p â€‹< â€‹0.001). Pre-injury ASA 1 was significantly more common in patients admitted during weekends (n â€‹= â€‹146, 64%, p â€‹= â€‹0.001) while ASA 3 showed significance during weekdays compared to weekends (n â€‹= â€‹101, 22%, p â€‹= â€‹0.013). On binominal logistic regression analysis mortality rate was significantly higher with older age (OR 1.03, 95% CI for OR 1.02-1.04, p â€‹< â€‹0.001) and increasing TBI severity (OR 7.08, 95% CI for OR 4.67-10.73, p â€‹< â€‹0.001). Conclusions: Mortality rate and poor clinical outcome remain high in severe traumatic brain injury. While a higher number of patients are admitted during the weekend, mortality rate does not differ from weekday admissions.

Incidence, Mechanisms of Injury and Mortality of Severe Traumatic Brain Injury: An Observational Population-Based Cohort Study from New Zealand and Norway.

BACKGROUND: Comparing trauma registry data from different countries can help to identify possible differences in epidemiology, which may help to improve the care of trauma patients. METHODS: This study directly compares the incidence, mechanisms of injuries and mortality of severe TBI based on population-based data from the two national trauma registries from New Zealand and Norway. All patients prospectively registered with severe TBI in either of the national registries for the 4-year study period were included. Patient and injury variables were described and age-adjusted incidence and mortality rates were calculated. RESULTS: A total of 1378 trauma patients were identified of whom 751 (54.5%) from New Zealand and 627 (45.5%) from Norway. The patient cohort from New Zealand was significantly younger (median 32 versus 53 years; p < 0.001) and more patients from New Zealand were injured in road traffic crashes (37% versus 13%; p < 0.001). The age-adjusted incidence rate of severe TBI was 3.8 per 100,000 in New Zealand and 2.9 per 100,000 in Norway. The age-adjusted mortality rates were 1.5 per 100,000 in New Zealand and 1.2 per 100,000 in Norway. The fatality rates were 38.5% in New Zealand and 34.2% in Norway (p = 0.112). CONCLUSIONS: Road traffic crashes in younger patients were more common in New Zealand whereas falls in elderly patients were the main cause for severe TBI in Norway. The age-adjusted incidence and mortality rates of severe TBI among trauma patients are similar in New Zealand and Norway. The fatality rates of severe TBI are still considerable with more than one third of patients dying.

[A man in his fifties with pain in the head, neck and ear canal] / En mann i 50-årene med smerter i hode, nakke og øregang.

BACKGROUND: A man in his fifties, originally from a Middle Eastern country, presented with left-sided otalgia and neck pain which worsened over several months. He had pre-existing hypertension, diabetes mellitus type 2 and end stage renal disease requiring dialysis. CASE PRESENTATION: His presenting complaints started whilst on a long stay in his country of origin. Symptoms progressively worsened over the coming months while he underwent extensive medical examinations and investigations. This revealed opacifications in the mastoid cavities, raised inflammatory markers, and finally a CT scan revealed osteolytic lesions in his cervical spine. The lesions continued to progress, and his clinical condition deteriorated to the point that he required surgery. Culture was obtained through perioperative biopsies and showed growth of Aspergillus flavus. INTERPRETATION: The patient had initially received topical treatment for an assumed infectious external otitis. Later culture from his outer ear also showed growth of A. flavus, the same pathogen that was found in a biopsy from his cervical spine. He was diagnosed with cervical mycotic osteomyelitis, probably secondary to a chronic external otitis. Long term antimycotic therapy and three neurosurgical operations were required to treat the patient.

The association between preoperative MRI findings and clinical improvement in patients included in the NORDSTEN spinal stenosis trial.

PURPOSE: To investigate potential associations between preoperative MRI findings and patient reported outcome measures (PROMs) after surgery for lumbar spinal stenosis (LSS). METHODS: The NORDSTEN trial included 437 patients. We investigated the association between preoperative MRI findings such as morphological grade of stenosis (Schizas grade), quantitative grade of stenosis (dural sac cross-sectional area), disc degeneration (Pfirrmann score), facet joint tropism and fatty infiltration of the multifidus muscle, and improvement in patient reported outcome measures (PROMs) 2 years after surgery. We dichotomized each radiological parameter into a moderate or severe category. PROMs i.e., Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ) and Numeric rating scale (NRS) for back and leg pain were collected before surgery and at 2 year follow-up. In the primary analysis, we investigated the association between MRI findings and ODI score (dichotomized to ≥ 30% improvement or not). In the secondary analysis, we investigated the association between MRI findings and the mean improvement on the ODI-, ZCQ- and NRS scores. We used multivariable regression models adjusted for patients' gender, age, smoking status and BMI. RESULTS: The primary analysis showed that severe disc degeneration (Pfirrmann score 4-5) was significantly associated with less chance of achieving a 30% improvement on the ODI score (OR 0.54, 95% CI 0.34, 0.88). In the secondary analysis, we detected no clinical relevant associations. CONCLUSION: Severe disc degeneration preoperatively suggest lesser chance of achieving 30% improvement in ODI score after surgery for LSS. Other preoperative MRI findings were not associated with patient reported outcome.