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Study Design. Retrospective cross-sectional. Objectives. To determine associations between Hounsfield units (HU) within a region of interest on computed tomography (CT) scans and dual energy X-ray absorptiometry (DEXA) measurements in children and adolescents. Summary of Background Data. HU on CT scans as a proxy for bone mineral density (BMD) is widely used in adults. However, the utility of CT as a proxy for BMD have not been evaluated in children and adolescents. Materials and Methods. Patients younger than 18 years with a lumbar spine CT scan and a DEXA within 6 months of each other were identified. A region of interest was used to measure the HU at each lumbar vertebral body on midaxial cuts. Charts were reviewed for demographics, medical comorbidities, and DEXA reports. Correlation coefficients were calculated between the mean DEXA Z-score and the HU value. Patients were also stratified by Z-score (= -1.0, between -1.0 and -2.0, and =-2.0) and matched by age, sex and body mass index (BMI) to a cohort of healthy children and compared. Results. A moderate correlation between mean DEXA Z-score and mean HU on CT was found (r2=0.42, P< 0.001). After matching for age, sex and BMI, 21 patients in each group between the ages of 4 and 17 years were analyzed. The mean HU value of the control group was 231.69. When stratified by Z-score (= -1.0, between -1.0 and -2.0, and =-2.0), the mean HU values were 244.59, 216.50, and 176.54, respectively. Patients with a Z-score of =-2.0 had a significantly lower mean HU than matched controls. Conclusions. HU on lumbar CT in children and adolescents with DEXA Z-scores <-2.0, were lower when compared with healthy matched controls. This study suggests that HU on opportunistic CT scans of the spine may be used as a reasonable proxy for BMD in the pediatric population. [ABSTRACT FROM AUTHOR]

Study Design. External validation using prospectively collected data. Objectives. To determine the model performance of "Dialogue Support" (DS) in predicting outcomes after lumbar spine surgery. Summary of Background Data. To help clinicians discuss risk versus benefit with patients considering lumbar fusion surgery, DS has been made available online. As DS was created using a Swedish sample, there is a need to study how well DS performs in alternative populations. Patients and Methods. Preoperative data from patients enrolled in the Quality Outcomes Database were entered into DS. The probability for each patient to report satisfaction, achieve success (leg pain improvement =3), or have no leg pain 12 months after surgery was extracted and compared with their actual 12-month postoperative data. The ability of DS to identify patients in the Quality Outcomes Database who report satisfaction, achieve success, or have no leg pain 12 months after surgery was determined using Receiver operating characteristic curve analysis, goodness-of-fit tests, and calibration plots. Results. There was a significant improvement in all outcomes in 23,928 cases included in the analysis from baseline to 12 months postoperative. Most (84%) reported satisfaction, 67% achieved success, and 44% were pain-free 12 months postoperative. Receiver operating characteristic analysis showed that DS had a low ability to predict satisfaction [area under the curve (AUC) = 0.606], success (AUC = 0.546), and being pain-free (AUC = 0.578) at 12 months postoperative; poor fit for satisfaction (<0.001) and being pain-free (P = 0.004), but acceptable fit for success (P = 0.052). Calibration plots showed underestimation for satisfaction and success, but acceptable estimates for being pain-free. Conclusion. DS is not directly transferable to predict satisfaction and success after lumbar surgery in a US population. This may be due to differences in patient characteristics, weights of the variables included, or the exclusion of unknown variables associated with outcomes. Future studies to better understand and improve the transferability of these models are needed. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of operative compared with nonoperative treatment at initial presentation (no prior fusion) for adult lumbar scoliosis has not, to our knowledge, been evaluated in controlled trials. The goals of this study were to evaluate the effects of operative and nonoperative treatment and to assess the benefits of these treatments to help treating physicians determine whether patients are better managed operatively or nonoperatively.Methods: Patients with adult symptomatic lumbar scoliosis (aged 40 to 80 years, with a coronal Cobb angle measurement of ≥30° and an Oswestry Disability Index [ODI] score of ≥20 or Scoliosis Research Society [SRS]-22 score of ≤4.0) from 9 North American centers were enrolled in concurrent randomized or observational cohorts to evaluate operative versus nonoperative treatment. The primary outcomes were differences in the mean change from baseline in the SRS-22 subscore and ODI at 2-year follow-up. For the randomized cohort, the initial sample-size calculation estimated that 41 patients per group (82 total) would provide 80% power with alpha equal to 0.05, anticipating 10% loss to follow-up and 20% nonadherence in the nonoperative arm. However, an interim sample-size calculation estimated that 18 patients per group would be sufficient.Results: Sixty-three patients were enrolled in the randomized cohort: 30 in the operative group and 33 in the nonoperative group. Two hundred and twenty-three patients were enrolled in the observational cohort: 112 in the operative group and 111 in the nonoperative group. The intention-to-treat analysis of the randomized cohort found that, at 2 years of follow-up, outcomes did not differ between the groups. Nonadherence was high in the randomized cohort (64% nonoperative-to-operative crossover). In the as-treated analysis of the randomized cohort, operative treatment was associated with greater improvement at the 2-year follow-up in the SRS-22 subscore (adjusted mean difference, 0.7 [95% confidence interval (CI), 0.5 to 1.0]) and in the ODI (adjusted mean difference, -16 [95% CI, -22 to -10]) (p < 0.001 for both). Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001). In an overall responder analysis, more operative patients achieved improvement meeting or exceeding the minimal clinically important difference (MCID) in the SRS-22 subscore (85.7% versus 38.7%; p < 0.001) and the ODI (77.4% versus 38.3%; p < 0.001). Thirty-four revision surgeries were performed in 24 (14%) of the operative patients.Conclusions: On the basis of as-treated and MCID analyses, if a patient with adult symptomatic lumbar scoliosis is satisfied with current spine-related health, nonoperative treatment is advised, with the understanding that improvement is unlikely. If a patient is not satisfied with current spine health and expects improvement, surgery is preferred.Level Of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Purpose: Ethnic differences in spino-pelvic parameters among a healthy population are poorly defined in the literature. The purpose of this study was to document sagittal spino-pelvic parameters in a sample of African Americans and to compare them with previously reported data for Caucasians and Asians.Methods: African American individuals without spine pathology who had standing lateral radiographs were identified. Radiographs were measured to determine the following parameters: lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT) and sacral slope (SS). Data of adult subjects were compared with those previously published for Caucasians (n = 709) and Asians (n = 312).Results: These measurements (LL, PI, PT, and SS) obtained for the 36 African American subjects aged 18 years or older [15 men and 21 women; mean age 26.6 ± 8.7 range (18-53)] The mean LL, PI, PT and SS values were 57.2°, 57.7°, 15.9° and 41.4°, respectively. A comparative analysis showed the means values for PI was greater in the African American than in Caucasian (57.7° vs. 52.6°, p = 0.007), and than in Asian (57.7° vs. 48.7°, p < 0.001). The linear regression model for the LL as a function of PI were "predict LL = 0.41 × PI + 33.7" in African American, "predict LL = 0.58 × PI + 24.3" in Caucasian, and "predict LL = 0.54 × PI + 22.0" in Asian, respectively.Conclusion: Significant differences in sagittal spino-pelvic parameters among races were seen. These differences should be considered when planning surgical reconstruction for spinal surgery. These slides can be retrieved under Electronic Supplementary Material. [ABSTRACT FROM AUTHOR]

Study Design. Retrospective chart review. Objective. To provide reference values for Hounsfield unit (HU) measured on computed tomography (CT) scans of children and adolescents. Summary of Background Data. Spine surgeons increasingly use HU on spine CT as a measure of bone mineral density (BMD). This has not been described in children and adolescents. Patients and Methods. Pediatric patients who had a spine CT between 2012 and 2022 were identified. Patients who had more than 1 comorbidity or were syndromic were excluded. Using the bone window, 3 axial images (cephalad, middle, and caudal) of each vertebra were selected. In each axial view, the HU was measured using a "region of interest" (ROI) that included the total cancellous bone area and an ROI excluding the radiolucency present in the posterior vertebral body ("total" vs. "limited"). HU values were compared between total and limited areas and between the axial images at the cephalad, middle, and caudal levels. Each age category data were estimated and stratified. Results. A total of 144 patients (79 females and 65 males) from 2 to 17 years old were included. Mean limited HU was consistently lower than total HU across all images and lumbar levels except for L1. Limited HU taken mid-vertebral body was also consistently lower than those taken cephalad or caudad. Mean limited HU across all ages including all levels was 227 ± 50 (range: 109--357). Stratifying by age showed a gradual decrease in BMD from age 2 to 10 followed by an increase. Conclusions. This is the first study to measure HU on lumbar CTs in children and adolescents. The technique of measuring BMD in adults should be modified in children by using an ROI that excludes the rarefaction present in the posterior vertebral body. Further studies are needed to evaluate the age-dependent changes in BMD seen in this study. [ABSTRACT FROM AUTHOR]

Circumferential lumbar fusions (cLFs) are becoming more common with increasing and more minimally invasive anterior access techniques. Staging allows reassessment of indirect decompression and alignment prior to the posterior approach, and optimization of OR time management. Safety of staging has been well documented in deformity surgery but has yet to be delineated in less extensive, degenerative cLFs. The purpose of this study is to compare perioperative complications and outcomes between staged versus single-anesthetic circumferential fusions in the lumbar spine. Propensity-matched comparative observational cohort. Patients who underwent cLFs for lumbar degenerative disease. In-hospital, 30-day, 90-day, and 1-year complications. From 123 patients undergoing single-anesthetic and 154 patients undergoing staged cLF, 95 patients in each group were propensity-matched based on age, sex, BMI, ASA score, smoking, revision, and number of levels. We compared perioperative, 30-day, 90-day, and 1-year complications between the two cohorts. Mean days between stages was 1.58. Single-anesthetic cLF had longer total surgery time (304 vs 240 minutes, p<.001) but shorter total PACU total time (133 vs 196 minutes, p<.001). However, there was no difference in total anesthesia time (368 vs 374 minutes, p=.661) and total EBL (357 vs 320cc, p=.313). Intraoperative complications were nine incidental durotomies in the single-anesthetic and one iliac vein injury in the staged group (9% vs 1%, p=.018). There was no difference of in-hospital (38 vs 31, p=.291), 30-day (16 vs 23, p=.281), 90-day (10 vs 15, p=.391), 1-year complications (9 vs 12, p=.644), and overall cumulative 1-year complications (54 vs 56, p=.883) between the two cohorts. There is a decrease in total surgical time and intraoperative complications during staged compared with single-anesthetic cLF with no difference in in-hospital, 30-day, 90-day, and 1-year complications between approaches. [ABSTRACT FROM AUTHOR]

Abstract: Background context: Low back pain (LBP) is a symptom, not a diagnosis. The failure to differentiate underlying diagnoses in patients complaining of LBP is one of the primary reasons that studies examining treatments for LBP have yielded inconsistent results. To design a lumbar spine registry such that the accumulated data provide applicable guidance for clinical treatment, the incorporation of a functional diagnostic matrix is critical. Purpose: To propose a clinically relevant diagnostic classification scheme, simple enough for use in clinical practice but granular enough to differentiate characteristics that impact clinical outcome. Study design: Case-based development, feasibility, and reliability testing of a classification scheme. Patient sample: Thirty case histories were compiled. Each case consisted of a brief clinical history with physical examination findings as well as pertinent radiographic images, including computed tomography scan and magnetic resonance image when available. Outcome measures: Kappa values for inter- and intrarater reliability. Methods: Thirty-six physicians were asked to provide a three-digit diagnostic code, specifying Symptoms, Structural Pathology, and Compressive Pathology for each case. The cases were then randomly rearranged and sent back to the physicians 2 weeks later for a second review. Inter- and intraobserver reliability was calculated using Randolph''s free-marginal multirater kappa. Symptoms are classified differentiating between patients with back or leg pain dominance and those with equal back and leg pain; symptoms are also divided as acute versus chronic. Additional categories denote neurogenic claudication and cauda equina. Structural Pathology includes an option for age appropriate changes. Additional options include disc pathology with and without disc space collapse; spondylolisthesis or spondylolysis without olisthesis; and regional spinal deformity, either scoliosis or kyphosis. The remaining structural categories are primary facet pathology and nonunion after attempted fusion. Compressive Pathology includes a category indicating the absence of any study on which to judge compressive pathology and a category indicating an available study, but the lack of any clinically relevant compressive pathology. Additional options are for either central compression or lateral recess/foraminal/extraforaminal compressive pathology of any etiology. There is also a category for combined central and lateral compression. The final category is recurrent compression, central, lateral, or combined compression after surgical treatment at the involved level. It is important to emphasize that the intention is only to categorize Structural and Compressive Pathology that is relevant to the patient''s symptom complex. When more than one relevant structural or compressive lesion exists, the provider should select the most clinically relevant finding. Results: The interrater agreement was substantial for Symptoms (κ=0.70) and moderate for Structural Pathology (κ=0.58) and Compressive Pathology (κ=0.53). The intrarater agreement was substantial for Symptoms (κ=0.78), Structural Pathology (κ=0.70), or Compressive Pathology (κ=0.67). Conclusions: This study demonstrates that improved diagnostic stratification of lumbar spine disorders is a feasible goal. The diagnostic coding matrix, based on clinically relevant descriptors, yielded substantial interrater consistency for symptoms, moderate interrater consistency for structural and compressive pathology, and substantial intrarater consistency for all elements. [Copyright &y& Elsevier]

Bone morphogenetic protein (BMP) is commonly used as an ICBG substitute for transforaminal lumbar interbody spine fusion (TLIF). However, multiple recent reports have raised concerns regarding a substantial incidence of perioperative radiculopathy. Also, given the serious complications reported with anterior cervical BMP use, risks related to swelling and edema with TLIF need to be clarified. As TLIF related complications with rhBMP-2 have generally been reported in small series or isolated cases, without a clear denominator, actual complication rates are largely unknown. The purpose this study is to characterize perioperative complications and complication rates in a large consecutive series of TLIF procedures with rhBMP-2. We reviewed inpatient and outpatient medical records for a consecutive series of 204 patients [113 females, 91 males, mean age 49.3 (22-79) years] who underwent TLIF using rhBMP-2 between 2003 and 2007. Complications observed within a 3-month perioperative interval were categorized as to etiology and severity. Wound problems were delineated as wound infection, hematoma/seroma or persistent drainage/superficial dehiscence. Neurologic deficits and radiculopathies were analyzed to determine the presence of a clear etiology (screw misplacement) and identify any potential relationship to rhBMP-2 usage. Complications were observed in 47 of 204 patients (21.6%) during the 3-month perioperative period. Major complications occurred in 13 patients (6.4%) and minor complications in 34 patients (16.7%). New or more severe postoperative neurologic complaints were noted in 13 patients (6.4%), 6 of whom required additional surgery. These cases included one malpositioned pedicle screw and one epidural hematoma. In four patients (2.0%), localized seroma/hematoma in the area of the foramen caused neural compression, and required revision. In one additional patient, vertebral osteolysis caused foraminal narrowing and radiculopathy, but resolved without further surgery. Persistent radiculopathy without clear etiology on imaging studies was seen in six patients. Wound related problems were seen in six patients (2.9%), distributed as wound infection (3), hematoma/seroma (1) and persistent drainage/dehiscence (2). Overall, this study demonstrates a modest complication rate for TLIF using rhBMP-2. While perioperative complications which appeared specific to BMP usage were noted, they occurred infrequently. It will be necessary to weigh this incidence of complications against the complication rate associated with ICBG harvest and any differential benefit in obtaining a solid arthrodesis. [ABSTRACT FROM AUTHOR]

The article presents a study of patients who is undergoing a lumbar fusion as a correction for a previous lumbar surgery. It looks into the rate of health related quality progress of subjects who is going through this procedure. It was found that there is a moderate improvements when used as revision for prior spine operation and a much higher levels in post decompression procedure.

The article discusses a case-control study that compared clinical outcomes after posterolateral lumbar fusion in patients receiving workers' compensation with a case-matched control group who are not on workers' compensation. Outcome measures utilized included the Oswestry Disability Index (ODI), Short Form-36 (SF-36), and back and leg pain numerical rating scales. The study found no significant differences between demographics, job classification and preoperative outcome scores in the two groups.

BACKGROUND: The value of lumbar spine arthrodesis in older patients is not well documented. As most of the literature regarding lumbar arthrodesis in older patients has focused on the prevalence of complications, the purpose of this study was to determine the clinical outcomes for older compared with younger patients undergoing lumbar arthrodesis. METHODS: We studied 224 patients who underwent a single-level posterolateral lumbar arthrodesis with an iliac crest bone graft. Outcome measures included the Oswestry Disability Index, the Medical Outcomes Study Short Form-36 and numeric rating scales for back and leg pain, as well as a radiographic assessment of fusion. Outcome measures were evaluated on the basis of the mean change and the percentage of patients reaching a minimum clinically important difference threshold. For comparison, the patients were divided into two groups: 174 patients who were younger than sixty-five years and fifty patients who were sixty-five years of age or older. RESULTS: Substantial improvements from baseline were noted in all of the clinical and health-related quality-of-life measures at the six-month, one-year, and two-year intervals. The mean improvements in the Oswestry Disability Index score at two years postoperatively were 28.5 points for the older patients and 24.5 points for the younger patients. For Short Form-36 physical component summary scores, the mean improvement from baseline was 14.2 points for the older group and 11.7 points for the younger group at two years. The older patients also demonstrated a similar or greater improvement in the numeric rating scale back and leg pain scores at all time intervals, with a significant difference in leg pain scores at two years postoperatively (10.4 points for the older patients and 6.4 points for the younger patients; p = 0.002). Perioperative complications, although an obvious concern, did not appear to adversely affect clinical and health-related quality-of-life outcomes at two years postoperatively. CONCLUSIONS: This study demonstrates a substantial benefit for patients sixty-five years of age or older with degenerative disc disease who are treated with a single-level lumbar decompression and instrumented arthrodesis, and we conclude that lumbar arthrodesis is a viable and reasonable treatment option for appropriately selected patients sixty-five years of age or older. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions to Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Abstract: Background context: Reported fusion rates for spine fusions using iliac crest bone graft (ICBG) vary between 40% and 100% because of different fusion techniques, patient comorbidity, diagnosis and assessment criteria. Purpose: We report two-year results of single-level instrumented posterolateral fusions evaluated with radiographs, fine-cut computed tomography (CT) scans with reconstructions and outcome measures. Study design/ setting: Retrospective analysis of data from a prospective multicenter randomized clinical controlled trial. Patient sample: Patients with various degenerative diagnoses enrolled in the control arm of a Food and Drug Administration (FDA)-regulated, multicenter trial of single-level decompression and posterolateral fusion for degenerative lumbar disease. Outcome measures: Short Form-36 (SF-36), Oswestry Disability Index (ODI), Numeric Rating Scales (0–20) for back, leg, and graft site pain, CT scans, anteroposterior and lateral flexion/extension radiographs. Methods: Patients enrolled in an FDA-regulated, multicenter trial at 29 sites with degenerative lumbar disease treated with single-level instrumented posterolateral fusion with ICBG were included in the analysis. Demographic and surgical data were collected. Clinical outcomes were followed using standard metrics. Fusion was assessed by independent radiologists at 6, 12, and 24 months postoperatively. Two fusion criteria were compared: anteroposterior and flexion/extension radiographs to assess motion and bridging bone, with CT scans as needed to confirm bridging bone; and CT scan assessment for bridging bone only. Results: One hundred ninety-four of 224 subjects (86.6%) completed the study. The mean operative time was 2.9 hours with a blood loss of 448.6mL. The average graft volume was 36.3mL. There were 21 (9.4%) wound infections, 18 (8.0%) incidental durotomies, 3 (1.3%) implant displacements, 2 (0.9%) malpositioned implants, and 17 (7.6%) graft-related complications. Twenty-seven patients (13.9%) required reoperation, the majority for nonunions. Fusion rates based on radiographs with selective CTs at 6, 12, and 24 months were 65.3%, 82.5%, and 89.3%, respectively. Fusion rates based on bridging bone on CT scans were 56.1%, 71.5%, 83.9%, respectively. Two-year improvement for all outcome measures was significant (p<.001)—ODI 25.3, SF-36 Physical Component Score (PCS) 12.2, back pain 7.9, and leg pain 7.1. Two years postoperatively, 60% of patients complained of graft site pain (mean pain score=8.5). Conclusion: In a large series of patients who had primary single-level instrumented posterolateral fusion with ICBG, evidence of bridging bone on fine-cut CT scans improved with time to 83.9% at 24 months. Significant improvement from baseline was noted in all clinical outcome measures at all time intervals with 75% achieving minimum clinically important difference (MCID) for ODI and 66% achieving MCID for SF-36 PCS. [Copyright &y& Elsevier]

Background: Recombinant human bone morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge has been shown to be a safe and effective replacement for iliac crest bone graft when used with a threaded fusion device in anterior lumbar interbody arthrodesis. Use of rhBMP-2 on an absorbable collagen sponge in posterolateral lumbar arthrodesis requires the addition of a bulking agent to provide resistance against compression and to serve as an osteoconductive scaffold for new bone formation.Methods: We performed a prospective, randomized, multicenter pilot study to investigate the use of rhBMP-2 on an absorbable collagen sponge combined with a ceramic-granule bulking agent as a replacement for autogenous iliac crest bone graft in single-level posterolateral lumbar arthrodesis with instrumentation. The investigational group (twenty-five patients) was treated with a 1.5 mg/mL solution of rhBMP-2 on two strips of absorbable collagen sponge (total dose of rhBMP-2, 12 mg) combined with 10 cm(3) of ceramic granules. The control group (twenty-one patients) received iliac crest bone graft. Clinical outcomes were assessed with use of well-established instruments. Radiographs were reviewed to assess consolidation of fusion.Results: Eighty-eight percent (twenty-two) of the twenty-five patients in the investigational group and 86% (eighteen) of the twenty-one patients in the control group were considered to have completed the twenty-four-month follow-up. At all follow-up intervals, there were significant improvements in the clinical outcome measures, including the Oswestry Disability Index (ODI) scores, Short Form-36 scores, and back and leg pain scores, in both groups. At twenty-four months, the improvement in the mean ODI score, as compared with the preoperative score, was 28.2 points in the investigational group and 23.0 points in the control group. By twenty-four months, 95% (eighteen) of nineteen patients in the investigational group compared with 70% (fourteen) of twenty in the control group had a radiographically documented fusion. The overall success rate was 81% (seventeen of twenty-one) in the investigational group and 55% (eleven of twenty) in the control group (p = 0.345).Conclusions: Compared with an iliac crest bone graft, the combination of an absorbable collagen sponge soaked with rhBMP-2 and ceramic granules resulted in trends toward improvements in clinical outcomes and toward a higher rate of radiographic fusion. This combination of an osteoinductive agent with an osteoconductive matrix may be an effective replacement for autograft in single-level posterolateral lumbar arthrodeses with instrumentation. [ABSTRACT FROM AUTHOR]

Background Context: Computed tomography (CT) scan has been shown to be more accurate than radiographs in evaluating anterior interbody fusion but may still over-read the extent of fusion. Purpose: To assess the reliability and accuracy of fine-cut CT scans with reconstructions in evaluating anterior lumbar interbody fusion (ALIF) with metallic cages using surgical exploration as the reference standard. Study Design: Accuracy of a diagnostic test referenced to the gold standard. Patient Sample: A total of 49 patients and 69 surgical levels. Outcome Measures: Evaluation of fine-cut CT scans for evidence of fusion with subsequent surgical exploration as the reference standard. Methods: Forty-nine patients who underwent ALIF with metallic cages over 69 levels, who had a fine-cut CT scan before revision were included. Five spine surgeons unaware of the findings on surgical exploration evaluated pre-revision CT scans, classified these as fused or not; and determined the presence of a "sentinel sign" and a "posterior sentinel sign." Kappa coefficients for interobserver reliability, sensitivity, and specificity to detect fusion were determined. Results: There were 26 males and 23 females with a mean age of 43 years. There were 27 smokers. Average time from index to revision surgery was 22 months. Interobserver kappa for classification as fused or not was 0.25 with 70% to 97% sensitivity and 28% to 85% specificity. The interobserver kappa for the sentinel sign was 0.34 with 13% to 33% sensitivity and 77% to 92% specificity. The interobserver kappa for the posterior sentinel sign was 0.23 with 33% to 87% sensitivity and 56% to 90% specificity. Conclusions: Raters generally overstated fusion with low specificities across raters and low consensus specificity. Overall accuracy of the posterior sentinel sign (74%) was higher than the sentinel sign (61%). The low kappa value indicates fair reliability. In patients with metallic interbody devices, surgeons should be cautious about interpreting the findings on fine-cut CT scans whether using a general assessment of the fusion, the sentinel sign, or the posterior sentinel sign. [ABSTRACT FROM AUTHOR]

Abstract: Background context: Although numerous studies have been published, controversy still exists regarding fusion and nonsurgical treatment for symptomatic degenerative lumbar spine conditions. Definite conclusions are difficult to draw because of differences in patient inclusion criteria, fusion technique, nonoperative treatment regimen, and clinical outcome measures used to determine success. Purpose: The objective of this study was to evaluate lumbar fusion and nonsurgical interventions for various degenerative spine disorders using the Oswestry Disability Index (ODI) as a primary outcome measure in a systematic review. A secondary objective was to determine whether there is a difference in clinical outcomes based on the specific diagnosis. Study design/setting: Systematic review. Patient sample: Patients with low back pain of at least 12 weeks duration and older than 18 years, with prospectively collected ODI scores and at least a 12-month follow-up. Outcome measures: ODI and Short Form-36 (SF-36). Methods: A MEDLINE, HealthSTAR, CINAHL, and Cochrane database search was done using the search strategy recommended by the Cochrane Back Review Group. Proceedings from annual meetings of various spine societies and reference lists from review articles and retrieved articles were evaluated for possible inclusion. Criteria for inclusion were prospective randomized clinical trials in patients with low back pain of at least 12 weeks duration and older than 18 years; with prospectively collected ODI scores and at least a 12-month follow-up. The methodological quality of the studies was assessed using the van Tulder criteria. Data extracted from each study included demographics, study design, diagnosis, baseline and change in ODI, and baseline and change in SF-36 Physical Composite Score (PCS). The data were pooled and analyzed based on the primary reported inclusion diagnosis: degenerative disc disease (DDD), chronic low back pain (CLBP), and spondylolisthesis; and treatment: fusion (unspecified, posterior, anterior, combined) and nonsurgical. Results: Twenty-five studies met the inclusion criteria. The distribution of sex and smokers was similar across diagnoses and treatments. Patients with spondylolisthesis were older than patients with DDD and CLBP. Patients with spondylolisthesis had the greatest ODI improvement followed by patients with DDD and CLBP. The three fusion types produced similar amounts of improvement in ODI. Nonsurgical patients did not improve as much but had a lower baseline ODI. Improvements in the SF-36 PCS were fairly consistent across diagnostic groups and treatment types. Conclusions: Substantial improvement can be expected in patients treated with fusion, regardless of technique, when an established indication such as spondylolisthesis or DDD exists. CLBP patients are less disabled and experience less improvement. [Copyright &y& Elsevier]

Abstract: Background context: There is mounting evidence supporting the efficacy of bone morphogenetic protein (BMP) for both anterior interbody and posterolateral lumbar fusion. However, the relative cost of BMP remains an important concern for physicians, hospitals, and payers. Purpose: The purpose of this study is to report on the perioperative costs for patients treated with rhBMP-2 as compared with an iliac crest bone graft (ICBG) supplemented with graft extenders. Study design/setting: A prospective randomized controlled trial of rhBMP-2/ACS (Infuse Bone Graft; Medtronic Sofamor Danek, Memphis, TN) versus ICBG±graft extender for lumbar spine fusion in patients over 60 years old. Patient sample: One hundred two patients over 60 years old who required a posterolateral lumbar spine fusion randomized between receiving rhBMP-2/ACS or ICBG. Outcome measures: All health-care costs over the first 3 months after surgery. Methods: As part of a prospective randomized trial of rhBMP-2/ACS versus ICBG±graft extender for lumbar spine fusion, all costs over the first 3 months after surgery were directly recorded by a dedicated coder funded by Norton Healthcare, Louisville, KY. A dedicated research nurse also followed all patients throughout their hospital stay and posthospitalization recovery to identify any adverse events or additional outpatient medical care. Results: Fifty patients received rhBMP-2/ACS and 52 underwent ICBG harvest. The mean hospital cost for the index admission was $24,736 for the rhBMP-2/ACS group and $21,138 for the ICBG group. Mean inpatient physician costs were $5,082 in the rhBMP-2/ACS group and $5,316 in the ICBG group. Costs associated with posthospital rehabilitation averaged $4,906 in the rhBMP-2/ACS group versus $6,820 in the ICBG group. Total payer expenditure for the 3-month perioperative period averaged $33,860 in the rhBMP-2/ACS group and $37,227 in the ICBG group. Conclusions: The hospital carries the cost burden associated with the utilization of rhBMP-2/ACS. In contrast, the payer in a Diagnosis-Related Group (DRG) model achieves a net savings, based primarily on the decreased payment for inpatient rehabilitation, but also on decreased hospital reimbursement, physician costs, and other outpatient services. [Copyright &y& Elsevier]

Abstract: Background context: Older patients are often advised that their age is a contraindication to lumbar fusion surgery. There is, however, limited available data to support or contradict this assertion. Although prior studies of surgical treatment for lumbar degenerative disease suggest that older patients obtain symptomatic pain relief, an evaluation of fusion outcomes based on modern Health-Related Quality of Life (HRQOL) measures is lacking. Purpose: The purpose of this study was to document clinical outcomes based on standardized HRQOL measures in patients over 65 years of age treated by lumbar decompression and fusion surgery. Design/setting: This study was a retrospective review of prospectively collected patient reported outcomes data. Patient sample: Ninety-seven consecutive patients over 65 years of age treated by lumbar decompression and fusion between 2000 and 2004 were enrolled in a prospective health status outcomes protocol. Eighty-five patients (88%) had complete data at a minimum 2-year follow-up. Outcome measures: Medical Outcomes Study Short Form 36v.2 (SF-36), Oswestry Disability Index (ODI), numeric rating scales (NRS) back and leg pain scores. Methods: Patients over 65 years of age treated by lumbar fusion were evaluated based on HRQOL measures at a minimum of 2 years postoperatively. Variables including history of prior surgery and occurrence of a perioperative complication were evaluated. A comparison group of patients 50 to 64 years of age was also analyzed. Results: In patients over 65 years old, mean improvement of 6.21 points in SF-36 Physical Composite Score and 5.75 points in SF-36 Mental Composite Score was observed. There was a mean 16.38-point improvement in ODI, 3.08-point improvement in back pain NRS, and 2.65-point improvement in leg pain NRS. SF-36 subscale scores showed improvement for all parameters except general health, where there was a small but statistically significant decline. There was no difference in outcomes at 2 years postoperatively based on the occurrence of a perioperative complication. Patients undergoing a primary lumbar surgical procedure had consistently better outcomes than patients undergoing a revision procedure. Conclusions: The results of this study support the efficacy of lumbar decompression and fusion in selected patients over 65 years of age. Occurrence of a perioperative complication did not adversely affect clinical outcome. Patients undergoing a revision procedure should be counseled with regard to the more limited benefits seen with revision surgery. [Copyright &y& Elsevier]

Study Design: Retrospective single center propensity-matched observational cohort study that included patients who underwent 1- to 3-level lumbar fusion surgery for degenerative conditions.Objective: To compare 90-day complication rates between robotic-assisted and non-robotic-assisted lumbar spinal fusions in propensity-matched cohorts.Summary Of Background Data: A recent administrative database (PearlDiver) study reported increased 30-day complications with the utilization of robotic-assisted enabling technology.Methods: Of 146 robotic-assisted cases that met inclusion criteria, 114 were successfully propensity matched to 114 patients from 214 cases who had 1 to 3 level lumbar fusion without robotic assistance based on age, sex, body mass index, smoking status, American Society of Anesthesiologist grade, number of surgical levels, primary versus revision, and surgical approach (posterior-only or anterior-posterior). We excluded tumor, trauma, infection, or deformity cases. Outcomes included surgical and medical (major/minor) complications at intraoperative, immediately postoperative, 30- and 90-day postoperative intervals, including reoperations, and readmissions within 90 days.Results: All cause intraoperative complication rates were similar between non-robotic-assisted (5.3%) and robotic-assisted groups (10.5%, P = 0.366). Immediate postoperative medical complication rate was also similar between non-robotic-assisted (6.1%) and robotic-assisted groups (1.8%, P = 0.089). Thirty-day complication rates, 90-day complication rates, reoperation rates, and readmission rates showed no difference between non-robotic-assisted and robotic-assisted groups. There was no difference between return to OR for infection between the cohorts (non-robotic-assisted: 6 [5%] vs. robotic-assisted: 1 [0.8%], P = 0.119). There was however improved length of stay (LOS) in the robotic-assisted group compared with non-robotic-assisted group (2.5 vs. 3.17 days, P = 0.018).Conclusion: In propensity-matched cohorts, patients undergoing 1- to 3-level robotic-assisted posterior lumbar fusion for degenerative conditions did not have increased 90-day complication rate, and had a shorter length of stay compared with non-robotic-assisted patients. There findings differ from a prior administrative database study as the robotic-assisted group in the current study had 0% return to OR for malpositioned screws and 0.8% return to OR for infection.Level of Evidence: 2. [ABSTRACT FROM AUTHOR]

With an increasing number of web-based calculators designed to provide the probabilities of an individual achieving improvement after lumbar spine surgery, there is a need to determine the accuracy of these models. To perform an internal and external validation study of the reduced Quality Outcomes Database web-based Calculator (QOD-Calc). Observational longitudinal cohort. Patients enrolled study-wide in Quality Outcomes Database (QOD) and patients enrolled in DaneSpine at a single institution who had elective lumbar spine surgery with baseline data to complete QOD-Calc and 12-month postoperative data. Oswestry Disability Index (ODI), Numeric Rating Scales (NRS) for back and leg pain, EuroQOL-5D (EQ-5D). Baseline data elements were entered into QOD-Calc to determine the probability for each patient having Any Improvement and 30% Improvement in NRS leg pain, back pain, EQ-5D and ODI. These probabilities were compared with the actual 12-month postop data for each of the QOD and DaneSpine cases. Receiver-operating characteristics analyses were performed and calibration plots created to assess model performance. 24,755 QOD cases and 8,105 DaneSpine lumbar cases were included in the analysis. QOD-Calc had acceptable to outstanding ability (AUC: 0.694–0.874) to predict Any Improvement in the QOD cohort and moderate to acceptable ability (AUC: 0.658–0.747) to predict 30% Improvement. QOD-Calc had acceptable to exceptional ability (AUC: 0.669–0.734) to predict Any improvement and moderate to exceptional ability (AUC: 0.619–0.862) to predict 30% Improvement in the DaneSpine cohort. AUCs for the DaneSpine cohort was consistently lower that the AUCs for the QOD validation cohort. QOD-Calc performs well in predicting outcomes in a patient population that is similar to the patients that was used to develop it. Although still acceptable, model performance was slightly worse in a distinct population, despite the fact that the sample was more homogenous. Model performance may also be attributed to the low discrimination threshold, with close to 90% of cases reporting Any Improvement in outcome. Prediction models may need to be developed that are highly specific to the characteristics of the population. [ABSTRACT FROM AUTHOR]

Study Design: A retrospective analysis of prospective, multicenter National Institute of Health clinical trial.Objective: The aim of this study was to assess the rate of neurologic complications and impact of new neurologic deficits on 1-year postoperative patient-reported outcomes (PROs).Summary Of Background Data: There are limited studies evaluating the impact of new neurologic deficits on PROs following surgery for primary presentation adult lumbar scoliosis.Methods: Patients were divided into two groups: new postoperative neurological deficit (Def) or no deficit (NoDef). Preoperative and 1-year follow-up PROs were analyzed [Scoliosis Research Society (SRS) Questionnaire, Oswestry Disability Index (ODI), Short Form-12 Physical/Mental Health Composite Scores (PCS/MCS), and back/leg pain Numerical Rating Scale (NRS)].Results: One hundred forty-one patients: 14 Def (9.9%), 127 NoDef (90.1%). No differences were observed in demographic, radiographic, or PRO data between groups preoperatively. Def group had longer surgical procedures (8.3 vs. 6.9 hours, P = 0.030), greater blood loss (2832 vs. 2606 mL, P = 0.022), and longer hospitalizations (10.6 vs. 7.8 days, P = 0.004). NoDef group reported significant improvement in all PROs from preop to 1-year postoperative. Def group only had improvement in SRS Pain (2.7 preop to 3.4 postop, P = 0.037) and self-image domains (2.7 to 3.6, p = 0.004), and NRS back pain (6.6 to 3.2, P = 0.004) scores with significant worsening of NRS leg pain (4.1 to 6.1, P = 0.045). Group comparisons of 1-year postop PROs found that Def group reported more NRS leg pain (6.1 vs. 1.7, P < 0.001) and worse outcomes than NoDef group for ODI (35.7 vs. 23.1, P = 0.016) and PCS (32.6 vs. 41.9, P = 0.007).Conclusion: We found a 9.9% rate of new neurologic deficits following surgery for symptomatic primary presentation adult lumbar scoliosis, much higher than previous studies. Most neurologic deficits improved by 1-year follow-up, but appeared to have a dramatic negative impact on PROs, with increased postoperative leg pain and greater patient-perceived pathology reported in patients experiencing neurological deficits compared with those who did not.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

Background Context: Excessive use of postoperative imaging after lumbar surgery has been documented, becoming a target for cutting costs. This must be balanced with the patient's need for information and allay their postoperative concerns.Purpose: To determine the incidence and associated costs of patient interactions with the healthcare system, outside the standard follow up routine, in the first postoperative year.Study Design: Retrospective longitudinal cohort.Patient Sample: Consecutive series of 200 patients who underwent lumbar fusions from 2018 to 2019 from a multi-surgeon single tertiary spine center.Outcome Measures: All healthcare encounters: phone calls, office and emergency department visits, and additional testing METHODS: A consecutive series of 200 patients who underwent lumbar fusions from 2018 to 2019 were identified. All non-routine healthcare encounters: phone calls, office and emergency department visits, and additional testing were collected. Direct costs for all healthcare services were determined using the Medicare Allowable rates. Indirect costs were determined using local, median income, length of office visits, and distance from the clinic to the patient's home.Results: Of 200 patients, 14 with thoracic fusion were excluded. The mean age of the 186 included patients was 58.26 years and 85 (46%) were male. Forty-seven percent (87/186) had only routine postoperative visits and 24 had revision surgery. Seventy-five patients made a total of 102 phone calls, 55 office visits, leading to 38 diagnostic studies none of which led to an additional intervention. Using Medicare Allowable rates, the mean direct cost was $776 per patient and the using a median income of $16/h the mean indirect cost was $124 per patient. There were no differences in the baseline characteristics among the patients who only had routine post-op encounters, had non-routine encounters or had a repeat surgery.Conclusions: Forty percent of the patients undergoing lumbar surgery had a healthcare encounter outside their routine follow up that did not result in additional intervention after their index operation. These potentially unnecessary encounters create additional cost and inconvenience to both the patient and healthcare system. Providing patient reassurance is important and providers should identify ways to reduce associated costs through patient education, virtual visits, or new technologies to monitor patient's postoperative progress. [ABSTRACT FROM AUTHOR]

Background Context: There are situations that require the replacement of pedicle screws. They are often exchanged when loose or broken or to accommodate a different sized rod or pedicle screw system. Traditionally, pedicle screws are replaced by up-sizing the core diameter until an interference fit is obtained. However, this method carries a risk of pedicle screw breach.Purpose: To determine if dual pitch screws, with cancellous pitch in the vertebral body and cortical pitch throughout the pedicle, allows for in-line screw revision without upsizing screw diameter.Study Design: Cadaveric biomechanical Study PATIENT SAMPLE: Not applicable OUTCOME MEASURES: Not applicable METHODS: Pedicle screws were tested in the lumbar vertebrae from eleven cadavers. Standard pitch 5.5 mm screws were inserted and loaded using a "break-in" protocol. Screws were removed and replaced with one of four screw types: 5.5 mm Standard Pitch, 5.5 mm Dual Pitch, 6.0 mm Standard Pitch, or 6.0 mm Dual Pitch. Failure testing was done using a stepwise increasing cyclic loading protocol for 100 cycles at each increasing load level. The loading consisted of a combined axial and bending load simulating the load seen by the most inferior screw.Results: Failure was consistent, with the tip of the screw displacing inferiorly into the vertebral body while simultaneously pulling out. Failure strength was lowest in the 5.5mm Standard (135.8±29.4N) followed by 6.0mm Standard (141.8±38.6N), 5.5mm Dual (158.1±53.8N), and 6.0mm Dual (173.6±52.1N, p=.023). There was no difference in the failure strength between the 5.5mm Dual and 6.0mm Standard. Lumbar level (p=.701) and donor spine (p=.062) were not associated with failure strength.Conclusions: After pedicle screw removal, screws with a larger core diameter or with a dual pitch have similar failure strengths. Dual pitch screws may allow for in-line revision of screws without upsizing screw diameter, minimizing the risk of pedicle breach or fracture.Clinical Significance: Dual pitch screws, with cancellous pitch in the vertebral body and cortical pitch through the pedicle, allows for in-line revision of pedicle screws without upsizing screw diameter; reducing the risk of pedicle breach or fracture when exchanging screws. [ABSTRACT FROM AUTHOR]

Study Design: Multicenter retrospective study.Objective: Flexion-extension radiographs are frequently used to assess motion in patients with degenerative spondylolisthesis. However, they expose patients to additional radiation and increase cost. The aim of this study is to determine if flexion-extension radiographs provide additional information not seen on upright neutral radiographs and supine magnetic resonance imaging (MRI) that may guide surgical decision making.Summary Of Background Data: Supine MRI and upright neutral radiographs are routinely performed in patients with degenerative spondylolisthesis. It is unclear whether additional flexion-extension views play a significant role in surgical planning for this patient population.Methods: From the Quality Outcomes Database, patients who had surgery for grade 1 degenerative spondylolisthesis were identified. Magnitude of slip on pre-op supine MRI, upright neutral, flexion, and extension radiographs were measured. Additional motion was defined as 3 mm or more slip difference between radiographs. For the purpose of this analysis, patients with a slip of 7 mm or more on upright neutral radiographs were assumed to require a fusion.Results: A total of 191 patients were identified. Mean age was 61.6 years (114 females, 60%). Only 31 patients (16%) had additional motion on flexion-extension views not seen on upright neutral x-rays versus supine MRI. Of these 31 patients, 19 had slips less than 7 mm on upright x-ray, generating equipoise for fusion.Conclusion: Flexion-extension radiographs may play a limited role in management of degenerative spondylolisthesis. The subset of patients for which flexion-extension views were most likely to provide value were patients with smaller slips (<7 mm) with no evidence of motion on standing radiographs versus MRI. In 90% of spondylolisthesis cases, information used for surgical planning may be ascertained by comparing motion between supine MRI and upright lateral radiographs.Level of Evidence: 3. [ABSTRACT FROM AUTHOR]

Study Design: Longitudinal cohort.Objective: To determine the cost per quality-adjusted life-year for lumbar epidural steroid injections (LESI).Summary Of Background Data: Despite being a widely performed procedure, there are few studies evaluating the cost-effectiveness of LESIs.Methods: Patients who had received LESI between June 2012 and July 2013 with EuroQOL-5D (EQ-5D) scores available before and after LESIs but before any surgical intervention were identified. Costs were calculated on the basis of the Medicare Fee Schedule multiplied by the number of LESIs received between the 2 clinic visits. Quality-adjusted life-years (QALYs) were calculated using the EQ-5D.Results: Of 421 patients who had pre-LESI EQ-5D data, 323 (77%) had post-LESI data available; 200 females, 123 males, mean age: 59.2 ± 14.2 years. Cost per LESI was $608, with most patients receiving 3 LESIs for more than 1 year (range: 1-6 yr). Mean QALY gained was 0.005. One hundred forty-five patients (45%) had a QALY gain (mean = 0.117) at a cost of $62,175 per QALY gained; 127 patients (40%) had a loss in QALY (mean = -0.120) and 51 patients (15%) had no change in QALY. Fourteen of the 145 patients who improved, and 29 of the 178 patients who did not, have medical comorbidities that precluded surgery. Thirty-two (22%) of 131 patients without medical comorbidities who improved and 57 (32%) of 149 patients without medical comorbidities who did not improve subsequently had undergone surgery (P = 0.015).Conclusion: LESI may not be cost-effective in patients with lumbar degenerative disorders. For the 145 patients who improved, cost per QALY gained was acceptable at $62,175. However, for the 178 patients with no gain or a loss in QALY, the economics are not reportable with a cost per QALY gained being theoretically infinite. Further studies are needed to identify specific patient populations who will benefit from LESI because the economic viability of LESI requires improved patient selection.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

In the future, payers may not cover unplanned 90-day emergency room (ER) visits or readmissions after elective lumbar spine surgery. Prior studies using large administrative databases lack granularity, and/or use a proxy for actual cost. We analyzed a large, single-center database to identify risk factors and subsequent costs associated with 90-day ER visits and readmissions. To identify risk factors and subsequent costs associated with 90-day ER visits and readmissions. Retrospective longitudinal cohort from a single multisurgeon, spine specialty site Patients undergoing elective lumbar spine surgeries from 2013-2017. Ninety-day ER visits and readmissions. A prospective, multisurgeon, single-center database merged with hospital administrative data was queried for elective lumbar spine surgeries from 2013-2017. Predictive models were created for 90-day ER visits and readmissions. Of 5,444 patients, 729 (13%) returned to the ER, most often for pain (144, 32%). Predictors of an ER visit were prior ER visit (pER, OR:2.4), zip code (OR:1.4) and number of chronic medical conditions (OR:1.4). 421 (8%) patients were readmitted, most frequently for wound infection (123, 2%), COPD exacerbation (24, 0.4%), and sepsis (23, 0.4%). Predictors for readmission were pER (OR:1.96), multiple chronic conditions (OR:1.69), obesity (non-obese, OR:0.49), race (African American, OR:1.43), admission status (ER admission, OR:2.29) and elevated HbA1c (OR:1.80). Average direct hospital cost for an ER visit was $1,659 and readmission was $7,322, costing the institution $5.1 million over the five-year study period. Risk factors for 90-day ER visit and readmission after elective lumbar spine surgery include medical comorbidities and socioeconomic factors. Proper patient selection, appropriate postop pain management and optimization of modifiable risk factors prior to surgery can lower the 90-day ER visits and readmissions and reduce health care costs. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]