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: 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 two 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. METHOD: 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 two 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 years [IQR 61.0-72.0]; 68.7% female) and 437 patients without spondylolisthesis (median age 68.0 years IQR 62.0-73.0]; 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 two years 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. CONCLUSION: In patients with lumbar spinal stenosis the symptom burden before surgery and the clinical outcome up to two years after surgery were similar independently of a concomitant spondylolisthesis.

The Norwegian degenerative spondylolisthesis and spinal stenosis (NORDSTEN) study: study overview, organization structure and study population.

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.

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.

Comparison of 3 Different Minimally Invasive Surgical Techniques for Lumbar Spinal Stenosis: A Randomized Clinical Trial.

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.

Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis.

BACKGROUND: In patients with lumbar spinal stenosis and degenerative spondylolisthesis, it is uncertain whether decompression surgery alone is noninferior to decompression with instrumented fusion. METHODS: We conducted an open-label, multicenter, noninferiority trial involving patients with symptomatic lumbar stenosis that had not responded to conservative management and who had single-level spondylolisthesis of 3 mm or more. Patients were randomly assigned in a 1:1 ratio to undergo decompression surgery (decompression-alone group) or decompression surgery with instrumented fusion (fusion group). The primary outcome was a reduction of at least 30% in the score on the Oswestry Disability Index (ODI; range, 0 to 100, with higher scores indicating more impairment) during the 2 years after surgery, with a noninferiority margin of -15 percentage points. Secondary outcomes included the mean change in the ODI score as well as scores on the Zurich Claudication Questionnaire, leg and back pain, the duration of surgery and length of hospital stay, and reoperation within 2 years. RESULTS: The mean age of patients was approximately 66 years. Approximately 75% of the patients had leg pain for more than a year, and more than 80% had back pain for more than a year. The mean change from baseline to 2 years in the ODI score was -20.6 in the decompression-alone group and -21.3 in the fusion group (mean difference, 0.7; 95% confidence interval [CI], -2.8 to 4.3). In the modified intention-to-treat analysis, 95 of 133 patients (71.4%) in the decompression-alone group and 94 of 129 patients (72.9%) in the fusion group had a reduction of at least 30% in the ODI score (difference, -1.4 percentage points; 95% CI, -12.2 to 9.4), showing the noninferiority of decompression alone. In the per-protocol analysis, 80 of 106 patients (75.5%) and 83 of 110 patients (75.5%), respectively, had a reduction of at least 30% in the ODI score (difference, 0.0 percentage points; 95% CI, -11.4 to 11.4), showing noninferiority. The results for the secondary outcomes were generally in the same direction as those for the primary outcome. Successful fusion was achieved with certainty in 86 of 100 patients (86.0%) who had imaging available at 2 years. Reoperation was performed in 15 of 120 patients (12.5%) in the decompression-alone group and in 11 of 121 patients (9.1%) in the fusion group. CONCLUSIONS: In this trial involving patients who underwent surgery for degenerative lumbar spondylolisthesis, most of whom had symptoms for more than a year, decompression alone was noninferior to decompression with instrumented fusion over a period of 2 years. Reoperation occurred somewhat more often in the decompression-alone group than in the fusion group. (NORDSTEN-DS ClinicalTrials.gov number, NCT02051374.).

Comparative Effectiveness of Microdecompression Alone vs Decompression Plus Instrumented Fusion in Lumbar Degenerative Spondylolisthesis.

Importance: Conflicting evidence and large practice variation are present in the surgical treatment of degenerative spondylolisthesis. More than 90% of surgical procedures in the United States include instrumented fusion compared with 50% or less in other countries. Objective: To evaluate whether the effectiveness of microdecompression alone is noninferior to decompression with instrumented fusion in a real-world setting. Design, Setting, and Participants: This multicenter comparative effectiveness study with a noninferiority design assessed prospective data from the Norwegian Registry for Spine Surgery. From September 19, 2007, to December 21, 2015, 1376 patients at 35 Norwegian orthopedic and neurosurgical departments underwent surgery for lumbar spinal stenosis with degenerative spondylolisthesis without scoliosis. After excluding patients undergoing laminectomy alone, fusion without instrumentation, or surgery in more than 2 levels and those with a former operation at the index level, 794 patients were included in the analyses, regardless of missing or incomplete follow-up data, before propensity score matching. Data were analyzed from March 20 to October 30, 2018. Exposures: Microdecompression alone or decompression with instrumented fusion. Main Outcomes and Measures: A reduction from baseline of 30% or greater in the Oswestry Disability Index at 12-month follow-up. Results: After propensity score matching, 570 patients (413 female [72%]; mean [SD] age, 64.7 [9.5] years) were included for comparison, with 285 undergoing microdecompression (mean [SD] age, 64.6 [9.8] years; 205 female [72%]) and 285 undergoing decompression with instrumented fusion (mean [SD] age, 64.8 [9.2] years; 208 female [73%]). The proportion of each type of procedure varied between departments. However, changes in outcome scores varied within patients but not between departments. The proportion of patients with improvement in the Oswestry Disability Index of at least 30% was 150 of 219 (68%) in the microdecompression group and 155 of 215 (72%) in the instrumentation group. The 95% CI (-12% to 5%) for the difference of -4% was above the predefined margin of noninferiority (-15%). Microdecompression alone was associated with shorter operation time (mean [SD], 89 [44] vs 180 [65] minutes; P < .001) and shorter hospital stay (mean [SD], 2.5 [2.4] vs 6.4 [3.0] days; P < .001). Conclusions and Relevance: Among patients with degenerative spondylolisthesis, the clinical effectiveness of microdecompression alone was noninferior to that of decompression with instrumented fusion. Microdecompression alone was also associated with shorter durations of surgery and hospital stay, supporting the suggestion that the less invasive procedure should be considered for most patients.

Comparable increases in dural sac area after three different posterior decompression techniques for lumbar spinal stenosis: radiological results from a randomized controlled trial in the NORDSTEN study.

PURPOSE: To investigate changes in dural sac area after three different posterior decompression techniques in patients undergoing surgery for lumbar spinal stenosis. Decompression of the nerve roots is the main surgical treatment for lumbar spinal stenosis. The aim of this study was to radiologically investigate three commonly used posterior decompression techniques. METHODS: The present study reports data from one of two multicenter randomized trials included in the NORDSTEN study. In the present trial, involving 437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n = 146), bilateral laminotomy (BL) (n = 142) and spinous process osteotomy (SPO) (n = 149). MRI was performed before and three months after surgery. The increase in dural sac area and Schizas grade at the most stenotic level was evaluated. Three different predefined surgical indicators of substantial decompression were used: (1) postoperative dural sac area of > 100 mm2, (2) increase in the dural sac area of at least 50% and (3) postoperative Schizas grade A or B. RESULTS: No differences between the three surgical groups were found in the mean increase in dural sac area. Mean values were 66.0 (SD 41.5) mm2 in the UL-group, 71.9 (SD 37.1) mm2 in the BL-group and 68.1 (SD 41.0) mm2 in the SPO-group (p = 0.49). No differences in the three predefined surgical outcomes between the three groups were found. CONCLUSION: For patients with lumbar spinal stenosis, the three different surgical techniques provided the same increase in dural sac area. CLINICAL TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov reference on November 22th 2013 under the identifier NCT02007083.

Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis.

BACKGROUND: Assessment of outcomes for spinal surgeries is challenging, and an ideal measurement that reflects all aspects of importance for the patients does not exist. Oswestry Disability Index (ODI), EuroQol (EQ-5D) and Numeric Rating Scales (NRS) for leg pain and for back pain are commonly used patients reported outcome measurements (PROMs). Reporting the proportion of individuals with an outcome of clinical importance is recommended. Knowledge of the ability of PROMs to identify clearly improved patients is essential. The purpose of this study was to search cut-off criteria for PROMs that best reflect an improvement considered by the patients to be of clinical importance. METHODS: The Global Perceived Effect scale was utilized to evaluate a clinically important outcome 12 months after surgery. The cut-offs for the PROMs that most accurately distinguish those who reported 'completely recovered' or 'much improved' from those who reported 'slightly improved', unchanged', 'slightly worse', 'much worse', or 'worse than ever' were estimated. For each PROM, we evaluated three candidate response parameters: the (raw) follow-up score, the (numerical) change score, and the percentage change score. RESULTS: We analysed 3859 patients with Lumbar Spinal Stenosis [(LSS); mean age 66; female gender 50%] and 617 patients with Lumbar Degenerative Spondylolisthesis [(LDS); mean age 67; 72% female gender]. The accuracy of identifying 'completely recovered' and 'much better' patients was generally high, but lower for EQ-5D than for the other PROMs. For all PROMs the accuracy was lower for the change score than for the follow-up score and the percentage change score, especially among patients with low and high PROM scores at baseline. The optimal threshold for a clinically important outcome was ≤24 for ODI, ≥0.69 for EQ-5D, ≤3 for NRS leg pain, and ≤ 4 for NRS back pain, and, for the percentage change score, ≥30% for ODI, ≥40% for NRS leg pain, and ≥ 33% for NRS back pain. The estimated cut-offs were similar for LSS and for LDS. CONCLUSION: For estimating a 'success' rate assessed by a PROM, we recommend using the follow-up score or the percentage change score. These scores reflected a clinically important outcome better than the change score.

Clinical outcome after surgery for lumbar spinal stenosis in patients with insignificant lower extremity pain. A prospective cohort study from the Norwegian registry for spine surgery.

BACKGROUND: Spinal stenosis is a clinical diagnosis in which the main symptom is pain radiating to the lower extremities, or neurogenic claudication. Radiological spinal stenosis is commonly observed in the population and it is debated whether patients with no lower extremity pain should be labelled as having spinal stenosis. However, these patients is found in the Norwegian Registry for Spine Surgery, the main object of the present study was to compare the clinical outcomes after decompressive surgery in patients with insignificant lower extremity pain, with those with more severe pain. METHODS: This study is based on data from the Norwegian Registry for Spine Surgery (NORspine). Patients who had decompressive surgery in the period from 7/1-2007 to 11/3-2013 at 31 hospitals were included. The patients was divided into four groups based on preoperative Numeric Rating Scale (NRS)-score for lower extremity pain. Patients in group 1 had insignificant pain, group 2 had mild or moderate pain, group 3 severe pain and group 4 extremely severe pain. The primary outcome was change in the Oswestry Disability Index (ODI). Successfully treated patients were defined as patients reporting at least 30% reduction of baseline ODI, and the number of successfully treated patients in each group were recorded. RESULTS: In total, 3181 patients were eligible; 154 patients in group 1; 753 in group 2; 1766 in group 3; and 528 in group 4. Group 1 had significantly less improvement from baseline in all the clinical scores 12 months after surgery compared to the other groups. However, with a mean reduction of 8 ODI points and 56% of patients showing a reduction of at least 30% in their ODI score, the proportion of patients defined as successfully treated in group 1, was not significantly different from that of other groups. CONCLUSION: This national register study shows that patients with insignificant lower extremity pain had less improvement in primary and secondary outcome parameters from baseline to follow-up compared to patients with more severe lower extremity pain.

Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial.

BACKGROUND: Fusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. The present protocol describes an ongoing study with the primary aim of comparing the outcome between decompression alone and decompression with instrumented fusion. The secondary aim is to investigate whether predictors can be used to choose the best treatment for an individual. The trial, named the NORDSTEN-DS trial, is one of three studies in the Norwegian Degenerative Spinal Stenosis (NORDSTEN) study. METHODS: The NORDSTEN-DS trial is a block-randomized, controlled, multicenter, non-inferiority study with two parallel groups. The surgeons at the 15 participating hospitals decide whether a patient is eligible or not according to the inclusion and exclusion criteria. Participating patients are randomized to either a midline preserving decompression or a decompression followed by an instrumental fusion. Primary endpoint is the percentage of patients with an improvement in Oswestry Disability Index version 2.0 of more than 30% from baseline to 2-year follow-up. Secondary outcome measurements are the Zürich Claudication Questionnaire, Numeric Rating Scale for back and leg pain, Euroqol 5 dimensions questionnaire, Global perceived effect scale, complications and several radiological parameters. Analysis and interpretation of results will also be conducted after 5 and 10 years. CONCLUSION: The NORDSTEN/DS trial has the potential to provide Level 1 evidence of whether decompression alone should be advocated as the preferred method or not. Further on the study will investigate whether predictors exist and if they can be used to make the appropriate choice for surgical treatment for this patient group. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02051374 . First Posted: January 31, 2014. Last Update Posted: February 14, 2018.

Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study).

BACKGROUND: There are several posterior decompression techniques for lumbar spinal stenosis (LSS). There is a trend towards performing less invasive surgical procedures, but no multicentre randomized controlled trials have evaluated the relative efficacy of these techniques at short and long-term. METHOD/DESIGN: A multicentre randomized controlled trial [the Spinal Stenosis Trial (SST) (part of the NORDSTEN study)] including 465 patients aged 18-80 years with neurogenic claudication or radiating pain and MRI findings indicating lumbar spinal stenosis without spondylolisthesis is performed to compare three posterior decompression techniques: unilateral laminotomy with crossover, bilateral laminotomy and spinous process osteotomy. The primary outcome is change in Oswestry Disability Index (ODI 2 years postoperatively). Secondary outcomes are change in EQ-5D, Zurich Claudication Questionnaire, and Numeric Rating Scale for leg-pain and back-pain. Also recorded were Global Perceived Effect score, complications, length of hospital stay, reoperation rate 2 years postoperatively, difference in recurrence of symptoms or postoperative instability, and MRI change in the dural sac area. Further, a 5 and 10 years follow-up is planned with the same outcome measures. DISCUSSION: Newer and less invasive techniques are increasingly favoured in surgery for LSS. This trial will compare the clinical and radiological results of three different techniques, and may contribute to better clinical decision making in the surgical treatment of LSS. TRIAL REGISTRATION: ClinicalTrials.gov reference: NCT02007083 (November 22, 2013).

The effectiveness of decompression alone compared with additional fusion for lumbar spinal stenosis with degenerative spondylolisthesis: a pragmatic comparative non-inferiority observational study from the Norwegian Registry for Spine Surgery.

PURPOSE: To evaluate the effect of adding fusion to decompression in patients operated for lumbar spinal stenosis with a concomitant lumbar degenerative spondylolisthesis. METHODS: After propensity score matching, 260 patients operated with decompression and fusion and 260 patients operated with decompression alone were compared. Primary outcome measures were leg and back pain [Numeric Rating Scale (NRS), 0-10] and Oswestry Disability Index (ODI, 0-100) at 12 months. RESULTS: At 12-month follow-up, the fusion group rated their pain significantly lower than the decompression alone group [leg pain 3.0 and 3.6, respectively, mean difference -0.6, 95 % confidence interval (CI) -1.2 to -0.05, p = 0.03 and back pain 3.3 and 3.9, respectively, mean difference -0.6, 95 % CI -1.1 to -0.1, p = 0.02]. ODI was not significantly different between the groups (21.0 versus 23.3, mean difference -2.3, 95 % CI -5.8 to 1.1, p = 0.18). Seventy-four percent of the fusion group and 63 % of the decompression alone group achieved a clinically important improvement in back pain (difference in proportion of responders = 11 %, 95 % CI 2-20 %, p = 0.01), corresponding to a number needed to treat of 9 patients (95 % CI 5-50). There was no significant difference in responder rate for leg pain (74 and 67 %, respectively, difference 7 %, 95 % CI -1 to 16 %, p = 0.09) or for ODI (67 and 59 %, respectively, difference 8 %, 95 % CI 0-18 %, p = 0.06). The duration of surgery and hospital stay was longer for the fusion group (mean difference 68 min, 95 % CI 58-78, p < 0.01 and mean difference 4.2 days, 95 % CI 3.5-4.8, p < 0.01). CONCLUSION: In the present non-inferiority study, we cannot conclude that decompression alone is as good as decompression with additional fusion. However, the small differences in the groups' effect sizes suggest that a considerable number of patients can be treated with decompression alone. A challenge in future studies will be to find the best treatment option for each patient.

[A man with progressive spastic paraparesis]. / En mann med progredierende spastisk paraparese.

BACKGROUND: Adrenomyeloneuropathy is an X-linked disease caused by defects in the ABCD1 gene, which encodes the ALD protein (a peroxisome membrane transport protein). Deficiency of the ALD protein impairs the breakdown of very long chain fatty acids (VLCFA) that subsequently accumulate. The disease can present with spastic paraplegia, adrenocortical failure, or a combination of both. Spastic paraplegia can be inherited as well as acquired and is seen relatively often in neurological practice. Precise diagnosis is important as it provides information on prognosis and treatment, and allows at-risk family members to be identified. MATERIAL AND METHODS: The case history of a man with adrenomyeloneuropathy is presented, and relevant literature concerning pathogenesis, clinical presentation and treatment of the disease was retrieved from Medline and reviewed. DISCUSSION: Adrenomyeloneuropathy is often accompanied by mild peripheral neuropathy or adrenal failure and usually presents in young men with spastic paraplegia. Female carriers may also manifest clinical symptoms. Screening for VLCFA is widely available and performed in blood samples. Specific diagnosis requires measurement of the VLCFAs; C26, C24 and C22, confirmation of absent ALD protein or the finding of a specific gene mutation. In addition to hormone replacement for adrenal failure, treatment is limited to standard spasmolytic agents and physical therapy. More specific treatments are currently being tested.