Numeric Rating Scale Leg Pain Research Articles

179. Predictors of clinical outcome following surgery for lumbar spinal stenosis: a study of postoperative pain and disability trajectories

BACKGROUND CONTEXT On average, patients experience important reductions in pain and disability following surgery for degenerative lumbar spinal stenosis (LSS). However, variability in the postoperative course of symptoms suggests many patients do not fit the average symptom trajectory. PURPOSE To identify patient subgroups defined by trajectories of pain and disability following surgery for LSS and investigate the construct validity of the subgroups by evaluating meaningful differences in clinical outcomes. Identify predictors of belonging to the poor outcomes subgroup for disability, leg pain and back pain. STUDY DESIGN/SETTING Retrospective analysis of prospectively collected data. PATIENT SAMPLE Patients with LSS were recruited from 13 surgical spine centers participating in the Canadian Spine Outcomes and Research Network registry. OUTCOME MEASURES Leg and back pain numeric rating scales and the modified Oswestry disability index were measured before surgery and at 3, 12, and 24 months following surgery. METHODS Patients were fit into pain and disability trajectory subgroups with group-based trajectory modeling. Differences in the proportion of patients achieving minimum clinically important change in pain and disability (30%) and clinical success (50% reduction in disability or Oswestry score ≤22) were examined. Generalized linear mixed models adjusted for age and sex, were used to identify associations between subgroup membership and preoperative demographic, clinical history, health status and surgical factors. The subgroup with excellent outcomes was used as the reference group; associations were reported with relative risk ratios (RR). RESULTS The group-based trajectory models identified 3 unique pain trajectories each (excellent, fair and poor) for leg pain, back pain and disability. Depending on outcome 29% to 42% of patients were classified as members of an outcome trajectory subgroup that experienced little to no benefit from surgery. The construct validity of the trajectory subgroups was supported by differences in the proportion of patients meeting thresholds for minimum clinically important change and clinical success (p CONCLUSIONS The percentage of patients with poor outcomes highlights the need for better methods of treatment selection for patients with LSS. The predictors of having poor outcomes suggests it is time to look beyond pathology/surgical factors only and include mental health variables as an integral part of the surgical decision-making process in an effort to avoid patients at increased risk for surgical failure. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

66. Preop opioid use is associated with worse postop outcomes and chronic opioid use in nonrevision adult scoliosis patients: corroboration of two independent multicenter studies

BACKGROUND CONTEXT Sagittal malalignment and failed surgery are established etiologies for pain in adult spinal deformity (ASD). However, pain in primary adult scoliosis with good sagittal alignment is poorly understood. Opioids may be administered to control pain in adult scoliosis but are controversial and may negatively impact patient outcome. Evaluation of two independent ASD datasets may reduce bias and help understand the impact of preop opioid therapy on postop outcomes. PURPOSE Compare datasets from two independent ASD studies to evaluate the impact that the presence and frequency of opioid use has upon postop outcomes in adult scoliosis patients who have no prior history of spine surgery and no sagittal malalignment. STUDY DESIGN/SETTING Comparative analysis of datasets from two prospective multicenter ASD studies. PATIENT SAMPLE ASD patients with no history of prior spine surgery and no sagittal malalignment (as defined by the Scoliosis Research Society ASD Classification) enrolled into two independent multicenter databases and subsequently surgically treated for adult scoliosis OUTCOME MEASURES Scoliosis Research Society-22r questionnaire (SRS-22r), SF-36 and SF-12 Physical Component Score (PCS) and Mental Component Score (MCS), numeric rating scale (NRS) back and leg pain METHODS Adult scoliosis patients age >18 years, no history of spine surgery, and presence of thoracic, lumbar or double scoliosis (as per SRS deformity type) were identified from 2 independent prospective databases and assessed for preop non-opioid (NON) vs opioid use and amount of use (DAILY vs WEEKLY). Mixed and sagittal deformities were eliminated to reduce confounding pain impact of sagittal malalignment. Patients were treated surgically and pre- and postop demographic, radiographic data, patient-reported outcome measures and postop opioid usage were evaluated, minimum 2-year follow-up. RESULTS Database 1 (D1; 102/102 patients; mean follow up 2.1+0.2yr) and Database 2 (D2; 116/168 patients, mean follow-up 3.3 years) demonstrated similar preop demographic, depression history, smoking history and radiographic parameters for NON, DAILY and WEEKLY (p>0.05; Table). DAILY had greater preop NRS back and leg pain, and worse preop PCS and MCS than NON (p 0.05). At last follow-up, DAILY had worse postop NRS back pain (D1=4.1, D2=4.9), worse PCS (D1=38.8, D2=41.9), and worse MCS (D1=49.7, D2=45.4) than NON and WEEKLY (p CONCLUSIONS Comparison of datasets from two independent, multicenter prospective ASD studies demonstrated dataset agreement that preop opioid use and increased frequency of preop opioid use in adult scoliosis patients with no history of prior surgery and no sagittal malalignment is associated with worse postop pain, outcomes and continued opioid use. Attempts should be made, including program development, to aid in the discontinuation of preop and postop opioid usage for adult scoliosis to help improve postop outcomes. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

69. Coronal correction using the kickstand rod technique: a pilot adult scoliosis study and analysis of early outcomes and complications

BACKGROUND CONTEXT A major goal of adult spinal deformity (ASD) surgery is more harmonious spinal alignment. Sagittal alignment has been emphasized since it was demonstrated to have the greatest impact on postoperative pain and functional outcomes. However, growing evidence suggests the impact of coronal alignment has likely been underestimated. Kickstand rods are a new technique recently utilized for achieving coronal balance. The kickstand spans from the thoracolumbar junction to a 3rd iliac screw. Using the iliac wing as a base, kickstand distraction produces powerful coronal realignment forces. Limited literature exists for this novel technique, and its associated outcomes and complications after ASD surgery are unknown. PURPOSE The objective of this pilot study was to investigate early outcomes and complications after coronal correction with kickstand rods. STUDY DESIGN/SETTING Retrospective review of single-center database. PATIENT SAMPLE Consecutive ASD patients. OUTCOME MEASURES Radiographic alignment correction using standing long-cassette films (both coronal and sagittal spinopelvic measurements), back and leg pain assessed with numerical rating scale (NRS) scores (0-no pain; 10-unbearable pain), and associated complications. METHODS All ASD patients who had deformity correction using kickstand rods. Demographic, surgical, coronal- and sagittal-plane radiographic measurements, and back and leg pain NRS scores were analyzed. A kickstand rod correction classification was devised to illustrate our technique: Subtype (1a) Curve Pattern: C7PL towards major concavity and fractional convexity; Kickstand Distraction: corrects major curve onlySubtype (1b) Curve Pattern: C7PL towards major concavity with neutral/concave fractional curve; Kickstand Distraction: corrects major curve +/- simultaneous fractional correction; Subtype (2) Curve Pattern: C7PL towards major convexity; Kickstand Distraction: corrects fractional curve +/- simultaneous major correction; Subtype (3) Curve Pattern: global coronal balance with scoliosis; Kickstand distraction corrects major curve, but typically after fractional correction “shifts” the spine. RESULTS The cohort comprised 19 patients (mean age: 67±7 yrs; 79% women; 63% prior lumbar fusion) with mean follow-up 21 weeks (range: 2-72 weeks). All patients had posterior-only approach surgery with tri-iliac fixation (3rd iliac screw for the kickstand) for mean fusion length 12 levels. Kickstand correction was subtype 1a, 1b, 2, and 3 in 4 (21%), 6 (32%), 7 (37%), and 2 (9%) patients, respectively. 3-column osteotomy and lumbar TLIF were performed in 5 (26%) and 15 (79%) patients, respectively. Alignment was significantly improved (coronal balance: 8 to 1cm [p CONCLUSIONS Kickstand rod distraction can achieve significant coronal correction in ASD. Kickstand subtype 1a+b was most commonly utilized (since coronal curves with C7PL shifted to the major curve concavity are most common). Back and leg pain were significantly improved, and complications rates were reasonable. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

A Comparison of Minimally Invasive Transforaminal Lumbar Interbody Fusion and Decompression Alone for Degenerative Lumbar Spondylolisthesis

Abstract INTRODUCTION The optimal minimally invasive surgical (MIS) approach for lumbar spondylolisthesis is not clearly elucidated. This study compares patient reported outcomes (PRO) following MIS transforaminal lumbar interbody fusion (MI-TLIF) and MIS decompression for degenerative lumbar spondylolisthesis. METHODS A total of 608 patients from the Quality Outcomes Database (QOD) Lumbar Spondylolisthesis Module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis of whom 143 underwent MIS [72 MI-TLIF (50.3%) and 71 MIS decompressions (49.7%)]. Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse-plane MIS intervertebral body graft (MI-TLIF) or if there was a tubular decompression (MIS decompression). In total, 24-mo follow-up parameters were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) Back Pain, NRS Leg Pain, EuroQoL-5D (EQ-5D) Questionnaire, and North American Spine Society (NASS) Satisfaction Questionnaire. Multivariate models were constructed adjusting for baseline patient and surgical factors. RESULTS The mean age of the MIS cohort was 67.1 ± 11.3 yr (MI-TLIF 62.1 yr vs MIS decompression 72.3 yr) and consisted of 79 (55.2%) women (MI-TLIF 55.6% vs MIS decompression 54.9%). The proportions reaching 24-mo follow-up were similar (MI-TLIF 83.3% and MIS decompression 84.5%; P = .85). MI-TLIF was associated with higher blood loss (108.8 vs 33.0 mL, P < .001), longer operative times (228.2 vs 101.8 min, P < .001) and length of hospitalization (2.9 vs 0.7 d, P < .001). MI-TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, P = .004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 mo (P < .001). In multivariate analyses, MI-TLIF was associated with superior ODI change (ß = −7.59; 95% CI [−14.96 to −0.23]; P = .04), NRS back pain change (ß = −1.54; 95% CI [−2.78 to −0.30]; P = .02), and NASS satisfaction (OR = 0.32; 95% CI [0.12-0.82]; P = .02). CONCLUSION For symptomatic, single-level degenerative spondylolisthesis, MI-TLIF was associated with a 10-fold lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared to MIS decompression alone.

Predictors of the Best Outcomes Following Minimally Invasive Surgery for Grade 1 Lumbar Spondylolisthesis

Abstract INTRODUCTION The factors driving the best outcomes following minimally invasive surgery (MIS) for degenerative lumbar spondylolisthesis (DLS) are not clearly elucidated. This study investigates the factors that drive the best patient reported outcomes (PRO) following MIS for DLS. METHODS A total of 608 patients from the prospective Quality Outcomes Database (QOD) Lumbar Spondylolisthesis Registry underwent surgery for grade 1 DLS of whom 259 underwent surgery with MIS techniques [187 fusions (72.2%)]. Surgeries were classified as MIS if any of the following were involved: MIS laminectomy, MIS pedicle screws, MIS interbody grafts, or percutaneous screws. Outcomes were assessed at 24 mo postoperatively. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) Back Pain, NRS Leg Pain, EuroQoL-5D (EQ-5D) Questionnaire, and North American Spine Society (NASS) Satisfaction Questionnaire. Multivariate models were constructed adjusting for patient characteristics, presentation characteristics, surgical variables, socioeconomic characteristics, and baseline PRO values. RESULTS The mean age of the MIS cohort was 64.2 ± 11.5 yr [148 (57.1%) women and 111 (42.9%) men]. In multivariate analyses, aside from baseline PRO values, only 3 factors were significantly associated with multiple 24-mo PRO change scores: employment, age, and the addition of fusion to surgery. Employment was associated with superior postoperative ODI (ß-7.8; 95% CI [−12.9- −2.6]; P = .003), NRS back pain (ß-1.2; 95% CI [−2.1- −0.4]; P = 0.004), EQ-5D (ß0.1; 95% CI [0.01-0.1]; P = .03), and NASS satisfaction (OR = 0.27; 95% CI [0.12-0.58]; P < .001). Increasing age was associated with superior NRS leg pain (ß-0.1; 95% CI [minus;0.1- minus;0.01]; P = .03) and NASS satisfaction (OR = 0.95; 95% CI [0.92-0.99]; P = .02). The addition of a fusion was associated with superior ODI (ß-6.7; 95% CI [minus;12.7- minus;0.7]; P = .03), NRS back pain (ß-1.1; 95% CI [minus;2.1- minus;0.2]; P = .02), and NASS satisfaction (OR = 0.28; 95% CI [0.12-0.62]; P = .002). CONCLUSION Preoperative active employment, at least 4 yr of college education, and surgeries including a fusion were significant predictors of superior outcomes across the domains of disease-specific disability, back pain, leg pain, quality of life, and patient satisfaction. Increasing age was predictive of superior outcomes for leg pain and satisfaction.

Lumbar Spinal Stenosis Severity by CT or MRI Does Not Predict Response to Epidural Corticosteroid versus Lidocaine Injections.

Epidural steroid injections may offer little-to-no short-term benefit in the overall population of patients with symptomatic spinal stenosis compared with lidocaine alone. We investigated whether imaging could identify subgroups of patients who might benefit most. A secondary analysis of the Lumbar Epidural Steroid Injections for Spinal Stenosis prospective, double-blind trial was performed, and patients were randomized to receive an epidural injection of lidocaine with or without corticosteroids. Patients (n = 350) were evaluated for qualitative and quantitative MR imaging or CT measures of lumbar spinal stenosis. The primary clinical end points were the Roland-Morris Disability Questionnaire and the leg pain numeric rating scale at 3 weeks following injection. ANCOVA was used to assess the significance of interaction terms between imaging measures of spinal stenosis and injectate type on clinical improvement. There was no difference in the improvement of disability or leg pain scores at 3 weeks between patients injected with epidural lidocaine alone compared with corticosteroid and lidocaine when accounting for the primary imaging measures of qualitative spinal stenosis assessment (interaction coefficients for disability score, -0.1; 95% CI, -1.3 to 1.2; P = .90; and for the leg pain score, 0.1; 95% CI, -0.6 to 0.8; P = .81) or the quantitative minimum thecal sac cross-sectional area (interaction coefficients for disability score, 0.01; 95% CI, -0.01 to 0.03; P = .40; and for the leg pain score, 0.01; 95% CI, -0.01 to 0.03; P = .33). Imaging measures of spinal stenosis are not associated with differential clinical responses following epidural corticosteroid injection.

French-Canadian Adaptation and Validation of the Swiss Spinal Stenosis Questionnaire for Patients With Lumbar Spinal Stenosis.

An observational prospective study. The study objective was to assess the reliability and validity of the French-Canadian version (FCSSSQ) of the Swiss Spinal Stenosis questionnaire (SSSQ). The SSSQ is a validated disease-specific tool developed to assess pain, function, and satisfaction with care in patients with lumbar spinal stenosis (LSS). The French-Canadian translation and adaptation of the SSSQ was completed following a four-stage approach: (1) forward translation; (2) synthesis; (3) expert committee review; and (4) testing of the questionnaire prefinal version. Psychometric properties were subsequently determined in patients who had undergone decompressive surgery for degenerative LSS. Patients completed the SSSQ adapted version, the Numerical Rating Scale, and the Oswestry Disability Index. Test-retest reliability was assessed with weighted Kappa score and intraclass correlation coefficient. Construct validity was evaluated using the Spearman correlation coefficient and responsiveness with the mean standardized response as well as the area under the receiver operating characteristic curve (AUROC). Floor and ceiling effects and internal consistency were also evaluated. Twenty-five and 50 patients were included for the adaptation and validation processes, respectively. The test-retest reliability of the FCSSSQ total score was excellent [intraclass correlation coefficient (ICC) = 0.996; 95% confidence interval (95% CI) 0.938-0.982]. High Spearman correlation coefficients were also found between the total FCSSSQ score and the leg pain Numerical Rating Scale (NRS, 0.801), back pain NRS (0.705), and the Oswestry Disability Index (ODI, 0.825) scores. External responsiveness analysis was satisfactory with an AUROC of 0.875 (95% CI 0.744-1.0). The lowest FCSSSQ possible score was observed in five patients (10%), whereas no patients reported the highest possible score. The Cronbach α coefficient ranged from 0.810 to 0.945 indicating good to excellent internal consistency. The French-Canadian version of the SSSQ is a reliable and valid questionnaire consistent with the original English version. This new version will help French-speaking clinicians and scientists document changes in condition and treatment satisfaction in patients with LSS. 2.

Erratum. Laminectomy alone versus fusion for grade 1 lumbar spondylolisthesis in 426 patients from the prospective Quality Outcomes Database.

OBJECTIVEThe AANS launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data to measure the safety and quality of spine surgery. Registry data offer "real-world" insights into the utility of spinal fusion and decompression surgery for lumbar spondylolisthesis. Using the QOD, the authors compared the initial 12-month outcome data for patients undergoing fusion and those undergoing laminectomy alone for grade 1 degenerative lumbar spondylolisthesis.METHODSData from 12 top enrolling sites were analyzed and 426 patients undergoing elective single-level spine surgery for degenerative grade 1 lumbar spondylolisthesis were found. Baseline, 3-month, and 12-month follow-up data were collected and compared, including baseline clinical characteristics, readmission rates, reoperation rates, and PROs. The PROs included Oswestry Disability Index (ODI), back and leg pain numeric rating scale (NRS) scores, and EuroQol-5 Dimensions health survey (EQ-5D) results.RESULTSA total of 342 (80.3%) patients underwent fusion, with the remaining 84 (19.7%) undergoing decompression alone. The fusion cohort was younger (60.7 vs 69.9 years, p < 0.001), had a higher mean body mass index (31.0 vs 28.4, p < 0.001), and had a greater proportion of patients with back pain as a major component of their initial presentation (88.0% vs 60.7%, p < 0.001). There were no differences in 12-month reoperation rate (4.4% vs 6.0%, p = 0.93) and 3-month readmission rates (3.5% vs 1.2%, p = 0.45). At 12 months, both cohorts improved significantly with regard to ODI, NRS back and leg pain, and EQ-5D (p < 0.001, all comparisons). In adjusted analysis, fusion procedures were associated with superior 12-month ODI (β -4.79, 95% CI -9.28 to -0.31; p = 0.04).CONCLUSIONSSurgery for grade 1 lumbar spondylolisthesis-regardless of treatment strategy-was associated with significant improvements in disability, back and leg pain, and quality of life at 12 months. When adjusting for covariates, fusion surgery was associated with superior ODI at 12 months. Although fusion procedures were associated with a lower rate of reoperation, there was no statistically significant difference at 12 months. Further study must be undertaken to assess the durability of either surgical strategy in longer-term follow-up.

Laminectomy alone versus fusion for grade 1 lumbar spondylolisthesis in 426 patients from the prospective Quality Outcomes Database.

OBJECTIVEThe AANS launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data to measure the safety and quality of spine surgery. Registry data offer "real-world" insights into the utility of spinal fusion and decompression surgery for lumbar spondylolisthesis. Using the QOD, the authors compared the initial 12-month outcome data for patients undergoing fusion and those undergoing laminectomy alone for grade 1 degenerative lumbar spondylolisthesis.METHODSData from 12 top enrolling sites were analyzed and 426 patients undergoing elective single-level spine surgery for degenerative grade 1 lumbar spondylolisthesis were found. Baseline, 3-month, and 12-month follow-up data were collected and compared, including baseline clinical characteristics, readmission rates, reoperation rates, and PROs. The PROs included Oswestry Disability Index (ODI), back and leg pain numeric rating scale (NRS) scores, and EuroQol-5 Dimensions health survey (EQ-5D) results.RESULTSA total of 342 (80.3%) patients underwent fusion, with the remaining 84 (19.7%) undergoing decompression alone. The fusion cohort was younger (60.7 vs 69.9 years, p < 0.001), had a higher mean body mass index (31.0 vs 28.4, p < 0.001), and had a greater proportion of patients with back pain as a major component of their initial presentation (88.0% vs 60.7%, p < 0.001). There were no differences in 12-month reoperation rate (4.4% vs 6.0%, p = 0.93) and 3-month readmission rates (3.5% vs 1.2%, p = 0.45). At 12 months, both cohorts improved significantly with regard to ODI, NRS back and leg pain, and EQ-5D (p < 0.001, all comparisons). In adjusted analysis, fusion procedures were associated with superior 12-month ODI (β -4.79, 95% CI -9.28 to -0.31; p = 0.04).CONCLUSIONSSurgery for grade 1 lumbar spondylolisthesis-regardless of treatment strategy-was associated with significant improvements in disability, back and leg pain, and quality of life at 12 months. When adjusting for covariates, fusion surgery was associated with superior ODI at 12 months. Although fusion procedures were associated with a lower rate of reoperation, there was no statistically significant difference at 12 months. Further study must be undertaken to assess the durability of either surgical strategy in longer-term follow-up.

Expansive Suspension Laminoplasty Using a Spinous Process-Splitting Approach for Lumbar Spinal Stenosis: Surgical Technique and Outcomes Over 8 Years of Follow-up.

Introduction:To maximize the benefits of posterior decompression for severe multilevel lumbar spinal stenosis, we refined the expansive laminoplasty technique using a spinous process–splitting approach. This study tests the hypothesis that the surgical benefit of adequate decompression with posterior element preservation is maintained in the long term, over 8 years of follow-up.Methods:Fifty-eight patients were followed up yearly for 8 years. Eight patients having nonlumbar spine surgery or Parkinson disease were excluded. The noninferiority of the 8-year versus peak-year outcomes was tested, with margins of 5 points for the Oswestry disability index and 1 point for the numeric rating scales (NRSs).Results:In the 50 patients available for follow-up, the peak values of the mean improvements from baseline within the first 7 years were 35.8, 5.7, 5.9, and 2.8 points for the Oswestry disability index, low back pain NRS, leg pain NRS, and leg numbness NRS, respectively. The 95% lower confidence limits for the differences between the mean improvements from baseline at 8 years and the peak year were within the noninferiority margins for each scale.Conclusion:Our technique was associated with substantial improvement from baseline for each scale. The initial improvements in function and symptoms were maintained for 8 years.

Effectiveness of surgery for sciatica with disc herniation is not substantially affected by differences in surgical incidences among three countries: results from the Danish, Swedish and Norwegian spine registries

PurposeYearly 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.MethodsData 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.ResultsMean 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.ConclusionWe 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.Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.

Outcomes of Operative and Nonoperative Treatment in Patients with Adult Spinal Deformity with a Minimum 2-Year Follow-Up: A Meta-Analysis

More recent studies have focused on clinical outcomes of operative versus nonoperative treatment in patients with adult spinal deformity (ASD). However, scientific support for ASD surgery is weak. We compared outcomes of operative and nonoperative treatment of ASD with minimum 2-year follow-up in a meta-analysis. MEDLINE and EMBASE databases, from the earliest available date of indexing through May 10, 2018, were searched for studies evaluating outcomes of operative and nonoperative treatment of ASD. Two authors performed data extraction independently. Any discrepancies were resolved by consensus. Four comparative studies were identified. Postoperative back pain numeric rating scale and leg pain numeric rating scale scores were significantly lower with operative treatment compared with nonoperative treatment (P < 0.00001, weighted mean difference [WMD] =-2.76 [-3.45,-2.07] vs. P < 0.0001, WMD=-2.31 [-3.33,-1.28]). Postoperative Oswestry Disability Index and Scoliosis Research Society-22 questionnaire scores were significantly better with operative treatment compared with nonoperative treatment (P < 0.00001, WMD=-10.96 [-13.56,-8.36] vs. P < 0.00001, WMD= 0.68 [0.48, 0.87]). The complication rate of operative treatment was 17%-71.5%. Our meta-analysis showed that operative treatment has been demonstrated to significantly reduce disability and pain and to improve clinical outcomes compared with nonoperative treatment. Further large, multicenter, well-designed studies are necessary to substantiate our results.

Prognostic factors associated with best outcomes (minimal symptom state) following fusion for lumbar degenerative conditions

BACKGROUND CONTEXTPrevious studies suggest that a postoperative symptom state with Oswestry Disability Index (ODI)≤20 and pain Numeric Rating Scales (NRS)≤2 following surgery for lumbar degenerative conditions are reasonable thresholds for best outcomes in which patients will be unlikely to seek additional medical care or require additional health-care resources. PURPOSETo identify prognostic factors that predict a “best outcome,” defined as postoperative ODI≤20 and pain NRS≤2 following fusion for lumbar degenerative conditions. STUDY DESIGNLongitudinal observational cohort. PATIENT SAMPLEA total of 396 patients from a single site enrolled in the Quality Outcomes Database who underwent fusion for lumbar degenerative conditions. Outcome MeasuresOswestry Disability Index, Back and Leg Pain NRS (0–10). METHODSCollected and analyzed variables included age, sex, body mass index, American Society of Anesthesia grade, number of surgical levels, surgical time, preoperative ODI, preoperative back pain, preoperative leg pain, workmen compensation status, surgical approach, smoking status, and principal diagnosis. RESULTSA total of 74 patients (19%) reported a minimal symptom state at 1-year postoperative (ODI≤20, back pain NRS≤2, and leg pain NRS≤2) and were included in the best outcomes group. Patients in the best outcomes group were older (62 vs. 57 years, p=.001), had lower preoperative ODI (43 vs. 56, p=.000), lower preoperative back pain (6.5 vs. 7.5, p=.000). They had fewer surgical levels (1.25 vs. 1.47, p=.005) and shorter operative times [OR] times (208 vs. 241 minutes, p=.002). They were more likely to have a preoperative diagnosis of spondylolisthesis or disc herniation and less likely to have a diagnosis of adjacent segment disease or mechanical disc collapse (p=.001). Stepwise forward regression analysis revealed diagnosis (p=.023, OR=0.75), age (p=.000, OR=1.04), baseline ODI (p=.000, OR=0.96), and number of levels (p=.019, OR=0.53) as predictive variables. CONCLUSIONAchieving a minimal symptom state, defined here as a postoperative ODI≤20 and pain NRS≤2, following fusion for lumbar degenerative conditions is more likely in an older patient with a lower baseline ODI undergoing a single level lumbar fusion for spondylolisthesis.

Comparative Utility of Dynamic and Static Imaging in the Management of Lumbar Spondylolisthesis

Segmental instability traditionally is investigated with flexion and extension (F/E) radiographs. We sought to determine whether motion between upright and supine (U/S) views can serve as an alternative sensitive diagnostic tool that predicts similar outcomes. Ambispective collection of data was performed for 222 consecutive patients who underwent transforaminal lumbar interbody fusion. Patients were divided into either group 1 (≥3 mm spondylolisthesis difference between F/E radiographs) or group 2 (≥3 mm spondylolisthesis difference between U/S imaging and otherwise not meeting group 1 criteria). In total, 77 patients metall inclusion/exclusion criteria. Patients in group 1 (n= 26) and group 2 (n= 51) did not differ with respect to key demographic criteria. Average clinical follow-up for groups 1 and 2 were 31.8 and 35.6 months (P= 0.43). Average spondylolisthesis was 8.1 mm and 8.0 mm for groups 1 and 2 (P= 0.93). The incidence of facet joint hyperintensity on T2-weighted magnetic resonance imaging and average maximal facet joint widening (P > 0.2) did not differ between groups. Average F/E slip change was 5.0 mm for group 1 and average U/S slip change was 5.2 mm for group 2. For both groups, Numeric Rating Scale Back Pain and Numeric Rating Scale Leg Pain, Oswestry Disability Index v2.1a, and Short-Form 36 RAND (P < 0.02) improved significantly after surgery. Furthermore, ΔNumeric Rating Scale Back Pain, ΔNumeric Rating Scale Leg Pain, ΔOswestry Disability Index v2.1a, and ΔShort-Form 36 RAND (P > 0.2) were not significantly different between groups. No differences in outcomes were noted between patients based on either imaging criteria. These data suggest that static U/S imaging may identify a distinct group of patients who may benefit from transforaminal lumbar interbody fusion surgery.

Biportal Endoscopic Decompression of Exiting and Traversing Nerve Roots Through a Single Interlaminar Window Using a Contralateral Approach: Technical Feasibilities and Morphometric Changes of the Lumbar Canal and Foramen

Endoscopic surgery for lumbar stenosis is gaining acceptance because of the minimal muscle damage, short recovery times, reduced blood loss, and good clinical results. We report a novel technique of decompressing contralateral traversing and exiting nerve roots through a single interlaminar window, avoiding separate incision for foraminal decompression with minimal damage to facet joints and comparing morphometric changes after decompression. Between March and December 2017, 30 patients were evaluated retrospectively for clinical, radiologic, and morphometric outcomes. Patients with unilateral radiculopathy and magnetic resonance imaging (MRI) showing spinal stenosis at 2 levels (lateral recess and cranial level foraminal compression) were included. Clinical evaluation used a numerical rating scale (NRS) for leg pain and Oswestry Disability Index (ODI) scores, and radiologic evaluation used MRI. For morphometric analysis, the cross-sectional area of the intervertebral foramen (CSA-IVF), spinal canal (CSAC), and facet joint (CSA-FJ) was measured on MRI. Thirty levels were decompressed (no adverse events). NRS leg pain and ODI scores improved from 7.5±0.86 and 67.9 ± 9.7 preoperatively to 1.53 ± 0.86 and 15.7 ± 6.6 at last follow-up, respectively. CSAC improved from 99.34 ± 34.01 to 186.83 ± 41.41, indicating good canal decompression. CSA-IVF improved from 56.40 ± 19.28 to 97.60 ± 28.46, indicating good foraminal decompression. CSA-FJ improved from 231.37 ± 62.53 to 194.96 ± 50.56, indicating good foraminal decompression with less damage to facet joint. Morphometric changes were statistically significant (P < 0.05). Biportal endoscopic decompression of the lateral recess and cranial foramen through a single interlaminar window can be performed using a contralateral approach. In view of the good clinical and radiologic outcomes of patients, with notable improvements in morphometric measurements at stenosed segments, this surgical technique is worthy of further evaluation and application.

Patients with Adult Spinal Deformity with Previous Fusions Have an Equal Chance of Reaching Substantial Clinical Benefit Thresholds in Health-Related Quality of Life Measures but Do Not Reach the Same Absolute Level of Improvement

Substantial clinical benefit (SCB) represents a threshold above which patients recognize substantial improvement and represents a rational target for defining clinical success. In adult spinal deformity (ASD) surgery, previous fusions may impact outcomes after deformity correction. To investigate the impact of previous spinal fusion on the likelihood of reaching SCB thresholds for 2-year health-related quality of life (HRQOL) after ASD surgery. We conducted a retrospective review comparing baseline demographic, HRQOL, and radiographic features for patients with ASD undergoing primary versus revision procedures. The primary outcome measure was reaching SCB threshold in Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS), and back and leg pain (numeric rating scale). Secondary outcomes included absolute and change scores in ODI, PCS, and back and leg pain. In total, 332 patients achieved 2-year follow-up (228 primary; 104 revision cases). Those undergoing revision surgery had similar demographic features (age 58.3/55.9, female 80.8%/82.9%) to patients undergoing primary surgery. They had worse baseline HRQOL (ODI 48.5/41.2, PCS 29.5/33.4, back 7.5/7.0, and leg pain 4.9/4.3; P < 0.001) and radiographic deformity (sagittal vertical axis 111.4/45.1, lumbopelvic mismatch 26.7/11.0, pelvic tilt 29.5/21.0; P < 0.0001). Nevertheless, the number of patients who reached SCB for ODI (38.3/36.3%), PCS (48.5/53.4%), back (53.1/60.5%), and leg pain numeric rating scale (28.6/36.9%) did not significantly differ. Revision patients had worse 2-year HRQOL for all measures. Patients undergoing revision surgery have worse baseline HRQOL and deformity. Although they do not achieve the same absolute level of 2-year HRQOL outcome, they have a similar likelihood of reaching SCB threshold for improvement in 2-year HRQOL.

Avoidable Emergency Department Utilization Within 6 Months Following Elective Thoracolumbar Spine Surgery for Degenerative Pathologies.

Study Design:Retrospective study.Objective:To identify prevalence of, reasons for, and predictors of emergency department (ED) utilization 6 months following elective thoracolumbar spine surgery.Methods:A retrospective review of a patient database was conducted (N = 577). Visits were divided by orthopedic spinal surgeons into (1) avoidable ED visit, (2) appropriate/no visit, and (3) unrelated visit.Measures:Demographics, pain scores, patient characteristics, and surgical factors.Results:A total of 14.38% of patients made an ED visit the majority for avoidable reasons (11.43%). Avoidable ED visits were predominately attributed to pain (45.5%) and physiology-related issues (50.0%). Significant differences in the Numerical Rating Scale–leg pain (NRS-L); U = 13 931, P = .031) were found. Patients with avoidable visits had higher leg pain prior to surgery than those without an avoidable visit. Marital status was also statistically significant, χ2(2, N = 535) = 8.189, P = .017. Patients were more likely to make an avoidable postoperative ED visit if they were either single or divorced/separated compared to patients who were married. A multivariate logistic regression model including NRS-L and marital status was statistically significant, χ2(3) = 10.14, P = .017; however only explained 3.7% of the variance.Conclusion:A large percentage of elective thoracolumbar surgery patients returned to the ED within 6 months for avoidable reasons. Patients likely to make avoidable visits could not be identified prior to surgery in a clinically meaningful way. Reasons for patients returning to the ED for avoidable reasons focused on pain management and minor physiological symptoms. Enhanced presurgical education may manage postsurgical expectations helping to prevent avoidable ED visits.

Defining the minimum clinically important difference for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database.

OBJECTIVE Patient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis. METHODS The authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen's effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO. RESULTS A total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 ± 17.4 points for ODI, 0.24 ± 0.23 for EQ-5D, 4.1 ± 3.5 for NRS-LP, and 3.7 ± 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3-26.5 points for ODI, 0.04-0.3 points for EQ-5D, 0.6-4.5 points for NRS-LP, and 0.5-4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort. CONCLUSIONS The MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.

Surgery for Herniated Lumbar Disc in Daily Tobacco Smokers: A Multicenter Observational Study.

To compare clinical outcomes at 1 year following single-level lumbar microdiscectomy in daily tobacco smokers and nonsmokers. 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. 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). 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.

Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation.

Is referral for early rehabilitation after lumbar disc surgery effective and cost-effective compared to no referral? Multicentre, randomised, controlled trial, and economic evaluation with concealed allocation and intention-to-treat-analysis. Adults who underwent discectomy for a herniated lumbar disc, confirmed by magnetic resonance imaging, and signs of nerve root compression corresponding to the herniation level. Early rehabilitation (exercise therapy) for 6 to 8 weeks, versus no referral, immediately after discharge. In line with the recommended core outcome set, the co-primary outcomes were: functional status (Oswestry Disability Index); leg and back pain (numerical rating scale 0 to 10); global perceived recovery (7-point Likert scale); and general physical and mental health (SF12), assessed 3, 6, 9, 12 and 26 weeks after surgery. The outcomes for the economic evaluation were quality of life and costs, measured at 6, 12 and 26 weeks after surgery. There were no clinically relevant or statistically significant overall mean differences between rehabilitation and control for any outcome adjusted for baseline characteristics: global perceived recovery (OR 1.0, 95% CI 0.6 to 1.7), functional status (MD 1.5, 95% CI -3.6 to 6.7), leg pain (MD 0.1, 95% CI -0.7 to 0.8), back pain (MD 0.3, 95% CI -0.3 to 0.9), physical health (MD -3.5, 95% CI -11.3 to 4.3), and mental health (MD -4.1, 95% CI -9.4 to 1.3). After 26 weeks, there were no significant differences in quality-adjusted life years (MD 0.01, 95% CI -0.02 to 0.04 points) and societal costs (MD -€527, 95% CI -2846 to 1506). The maximum probability for the intervention to be cost-effective was 0.75 at a willingness-to-pay of €32 000/quality-adjusted life year. Early rehabilitation after lumbar disc surgery was neither more effective nor more cost-effective than no referral. Netherlands Trial Register NTR3156. [Oosterhuis T, Ostelo RW, van Dongen JM, Peul WC, de Boer MR, Bosmans JE, Vleggeert-Lankamp CL, Arts MP, van Tulder MW (2017) Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation. Journal of Physiotherapy 63: 144-153].