The effect of obesity, diabetes, and epidural steroid injection on regional volumetric bone mineral density measured by quantitative computed tomography in the lumbosacral spine.

PURPOSE: High body mass index (BMI) is positively correlated with bone mineral density (BMD) in healthy adults; however, the effect of BMI on regional segmental BMDs in the axial skeleton is unclear. In addition, obese patients often have glucose intolerance and patients with lumbar spine pathology commonly have a history of epidural steroid injections (ESIs). The purpose of this study is to evaluate the effect of these patient factors on regional differences in BMD measured by quantitative computed tomography (QCT) in a lumbar fusion patient cohort. METHODS: The data were obtained from a database comprised of clinical and preoperative CT data from 296 patients who underwent primary posterior lumbar spinal fusion from 2014 to 2017. QCT-vBMDs of L1 to L5, S1 body, and sacral alae were measured. Multivariate linear regression analyses were performed with setting vBMDs as the response variables. As explanatory variables, age, sex, race, current smoking, categorized BMI, diabetes, and ESI were chosen a priori. RESULTS: A total of 260 patients were included in the final analysis. Multivariate analyses demonstrated that obese and morbidly obese patients had significantly higher vBMD in the sacral alae (SA). Diabetes showed independent positive associations with vBMDs in L1, L2, and the SA. Additionally, patients with an ESI history demonstrated significantly lower vBMD in the SA. CONCLUSIONS: Our results demonstrate that obesity, diabetes, and epidural steroids affected vBMD differently by lumbosacral spine region. The vBMD of the SA appeared to be more sensitive to various patient factors than other lumbar regions.

Hyoid position as a novel predictive marker for postoperative dysphagia and dysphonia after anterior cervical discectomy and fusion.

PURPOSE: The purpose of this study is to investigate the predictive value of the hyoid horizontal positional change on the severity of dysphagia and dysphonia (PDD) after anterior cervical discectomy and fusion (ACDF) comparing pre-vertebral soft-tissue thickness (PVST). METHODS: This is a retrospective observational study with prospectively collected data at a single academic institution. ACDF patients between 2015 to 2018 who had complete self-reported PDD surveys and pre- and postoperative lateral cervical radiographs were included in the analysis. PDD was assessed utilizing the Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI). The hyoid-vertebral distance (HVD) and PVST (the averages of C2 to C7 levels (PVSTC2-7) and all operating levels (PVSTOP)) were assessed preoperatively and upon discharge. The associations among postoperative changes of HVD, PVSTs, and the 4-week HSS-DDI score were evaluated. RESULTS: Of the 268 patients with a HSS-DDI score assessment, 209 patients had complete data. In univariate analyses, HVD and PVSTC2-7 changes demonstrated significant correlations with HSS-DDI, whereas PVSTOP showed no significant association. After adjusting with sex and operating level, the changes in HVD (p = 0.019) and PVSTC2-7 (p = 0.009) showed significant associations with the HSS-DDI score and PVSTOP showed no significant association. PVSTC2-7 could not be evaluated in 12% of patients due to measurement difficulties of PVST at lower levels. CONCLUSION: We introduce a novel potential predictive marker for PDD after ACDF. Our results suggest that HVD can be utilized for the risk assessment of PDD, especially in PVST unmeasurable cases, which accounts for over 10% of ACDF patients.

Minimum Clinically Important Differences of the Hospital for Special Surgery Dysphagia and Dysphonia Inventory and Other Dysphagia Measurements in Patients Undergoing ACDF.

BACKGROUND: Postoperative dysphagia is a common complication after anterior cervical surgery, and it can be measured using patient-reported outcome measures (PROMs). The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) is a condition-specific PROM to evaluate dysphagia and dysphonia after anterior cervical discectomy and fusion (ACDF). The minimum clinically important difference (MCID) of the HSS-DDI has not, to our knowledge, been established. Other PROMs have been used to assess dysphagia (SWAL-QOL and MD Anderson Dysphagia Inventory [MDADI]) in ACDF. Currently, few studies have addressed the MCIDs of these PROMs. QUESTIONS/PURPOSES: To determine (1) the minimum detectable changes (MDC) of the HSS-DDI, SWAL-QOL, and MDADI using a distribution-based approach, and (2) the MCID of the HSS-DDI, SWAL-QOL, and MDADI, using an anchor-based approach. METHODS: We used a longitudinally maintained database that was originally established for the HSS-DDI development and validation study. In all, 323 patients who underwent elective ACDF were assessed for enrollment eligibility; 83% (268 of 323) met the inclusion criteria and completed the HSS-DDI Week 4 survey. We set six outcomes: distribution-based MDCs for the (1) HSS-DDI, (2) SWAL-QOL, (3) MDADI, in addition to anchor-based MCIDs for the (4) HSS-DDI, (5) SWAL-QOL, and (6) MDADI. The HSS-DDI consists of 31 questions and ranges 0 (worst) to 100 (normal). We used the focused SWAL-QOL, which consists of 14 selected items from the original SWAL-QOL and ranges from 0 (worst) to 100 (normal). The MDADI is a 20-item survey and ranges from 20 (worst) to 100 (normal). A distribution-based approach is used to calculate values defined as the smallest difference above the measurement error. An anchor-based approach is used to determine the MCIDs based on an external scale, called an anchor, which indicates the minimal symptom change that is considered clinically important. All 268 patients were used for the distribution-based (0.5 SD) HSS-DDI MDC analysis. The first 16% (44 of 268) of patients completed retesting of the HSS-DDI via a telephone interview and were used for another distribution-based (standard error of measurement: SEM) MDC analysis. The number of patients for the test-retest group was determined based on the previously reported minimum required sample size of reliability studies. The first 63% (169 of 268, SWAL-QOL and 168 of 268, MDADI) of patients completed two other surveys for the external validation of the HSS-DDI, and were used for the SWAL-QOL and MDADI 0.5 SD analyses. Among the patients, 86% (230 of 268) completed the Week 8 HSS-DDI survey that was used for the anchor-based HSS-DDI MCID analysis, and 56% (SWAL-QOL, 150 of 268 and MDADI, 151 of 268) of patients completed the Week 8 surveys that were used for the SWAL-QOL and MDADI MCID analyses. Subjective improvement grades from the previous assessment were used as the anchor. The MCIDs were calculated as the mean score changes among those who reported little better or greater in the improvement assessment and receiver operating characteristic (ROC) curve analyses. We adopted the higher value of these two as the MCID for each PROM. RESULTS: The distribution-based MDCs for the HSS-DDI total score, SWAL-QOL, and MDADI were 11 of 100, 9 of 100, and 8 of 80 points, respectively, using the 0.5 SD method. Using the SEM-based method, the MDC for the HSS-DDI total score was 9 of 100 points. Regarding the anchor-based MCIDs, the values calculated with the mean score change method were consistently higher than those of ROC analysis and were adopted as the MCIDs. The MCIDs were 10 for the total HSS-DDI total score, 8 for the SWAL-QOL, and 6 for the MDADI. CONCLUSIONS: Improvements of less than 10 points for the HSS-DDI score, 9 points for the SWAL-QOL, and 6 points for the MDADI are unlikely to be perceived by patients to be clinically important. Future studies on dysphagia after anterior cervical surgery should report between-group differences in light of this, rather than focusing on p values and statistical significance. LEVEL OF EVIDENCE: Level III, therapeutic study.

Prevalence of osteoporosis and osteopenia diagnosed using quantitative CT in 296 consecutive lumbar fusion patients.

OBJECTIVE: Osteoporosis is a metabolic bone disease that increases the risk for fragility fractures. Screening and diagnosis can be achieved by measuring bone mineral density (BMD) using quantitative CT tomography (QCT) in the lumbar spine. QCT-derived BMD measurements can be used to diagnose osteopenia or osteoporosis based on American College of Radiology (ACR) thresholds. Many reports exist regarding the disease prevalence in asymptomatic and disease-specific populations; however, osteoporosis/osteopenia prevalence rates in lumbar spine fusion patients without fracture have not been reported. The purpose of this study was to define osteoporosis and osteopenia prevalence in lumbar fusion patients using QCT. METHODS: A retrospective review of prospective data was performed. All patients undergoing lumbar fusion surgery who had preoperative fine-cut CT scans were eligible. QCT-derived BMD measurements were performed at L1 and L2. The L1-2 average BMD was used to classify patients as having normal findings, osteopenia, or osteoporosis based on ACR criteria. Disease prevalence was calculated. Subgroup analyses based on age, sex, ethnicity, and history of abnormal BMD were performed. Differences between categorical groups were calculated with Fisher's exact test. RESULTS: Overall, 296 consecutive patients (55.4% female) were studied. The mean age was 63 years (range 21-89 years). There were 248 (83.8%) patients with ages ≥ 50 years. No previous clinical history of abnormal BMD was seen in 212 (71.6%) patients. Osteopenia was present in 129 (43.6%) patients and osteoporosis in 44 (14.9%). There were no prevalence differences between sex or race. Patients ≥ 50 years of age had a significantly higher frequency of osteopenia/osteoporosis than those who were < 50 years of age. CONCLUSIONS: In 296 consecutive patients undergoing lumbar fusion surgery, the prevalence of osteoporosis was 14.9% and that for osteopenia was 43.6% diagnosed by QCT. This is the first report of osteoporosis disease prevalence in lumbar fusion patients without vertebral fragility fractures diagnosed by QCT.

Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS.

BACKGROUND: Nutritional status is an important prognostic factor in Amyotrophic Lateral Sclerosis (ALS). We wished to study the safety, tolerability and efficacy of nutritional counseling with or without an mHealth application to maintain or increase body weight in ALS, compared to standard care. METHODS: In this randomized open-label, standard-of-care-controlled, single-center clinical trial, we randomly assigned adults with ALS to one of three nutritional interventions: counseling by their physician or nurse ("standard care"), counseling by a registered dietitian (RD) ("in-person"), or counseling supported by a mHealth app ("mHealth"). Both intervention arms received tailored nutrition recommendations and recorded dietary intake and weight biweekly (mHealth) or monthly (in-person). The primary outcome of weight and secondary and tertiary outcomes of calorie intake, ALSFRS-R, and quality of life (QOL) were recorded at each clinic visit and analyzed in an ITT mixed model analysis. RESULTS: A total of 88 participants were enrolled of whom 78 were included in this analysis. The three arms were well-balanced except for excess males in the mHealth arm and greater weight lost at baseline in the in-person arm. Participants in the mHealth arm increased their calorie intake at month 3 to an average of 94% (95% CI: 85, 103) of recommended calories, compared to 81% (95% CI: 72, 91, p = 0.06 vs. mHealth) in the standard care arm. After 6 months, calorie intake was not different among the three arms. Overall weight was stable across all three groups. QOL scores in the mHealth arm were stable over 3 months (0.3 points, 95% CI: - 1.7, 2.2) compared to worsening in standard care (- 2.1 points, 95% CI: - 4.0, - 0.2, p = 0.09 vs. mHealth), but all scores declined by 6 months. ALSFRS-R total scores declined by an average of - 2.6 points (95% CI: - 5.1, - 0.1) over 6 months in the mHealth arm (p = 0.13 vs. standard care) compared to - 5.8 points (95% CI: - 8.2, - 3.4, p = 0.74 vs. standard care) in the in-person and - 5.2 points (95% CI: - 7.6, - 2.9) in the standard care arm. CONCLUSIONS: Nutritional counseling by a registered dietitian (with or without support by an mHealth app) is safe but did not maintain weight significantly better than standard care in ALS patients. TRIAL REGISTRATION: https://clinicaltrials.gov/ identifier NCT02418546. Registered April 16, 2015.

Risk factors for postoperative dysphagia and dysphonia following anterior cervical spine surgery: a comprehensive study utilizing the hospital for special surgery dysphagia and dysphonia inventory (HSS-DDI).

BACKGROUND CONTEXT: Postoperative dysphagia and dysphonia (PDD) are prevalent complications after anterior cervical discectomy and fusion (ACDF). Identification of risk factors for these complications is necessary for effective prevention. Recently, patient reported outcome measures (PROM) have been used to determine PDD after ACDF. The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) is a validated PROM that specifically assesses dysphagia and dysphonia after anterior cervical spine surgery. PURPOSE: To identify the perioperative risk factors for PDD utilizing the HSS-DDI. STUDY DESIGN/SETTING: Observational study of prospectively collected data at a single academic institution. PATIENT SAMPLE: Patients undergoing anterior cervical discectomy and fusion from 2015 to 2019 who enrolled in the prospective data collection. OUTCOME MEASURE: The HSS-DDI administered 4 weeks, 8 weeks, and 4-6 months after surgery. METHODS: As potential risk factors, the data on demographic factors, analgesic medications, history of psychiatric illness, preoperative sagittal alignment, surgical factors, preoperative diagnoses, and preoperative Neck Disability Index (NDI) scores were collected. Bivariate and multivariable regression analyses utilizing the Tobit model were conducted. RESULTS: 291 patients were included in the final analysis. The median HSS-DDI at 4-weeks, 8 weeks, and 4-6 months postoperatively, were 80.7, 92.7, and 98.4, respectively. Multivariable analysis demonstrated that current smoking, previous cervical spine surgery, preoperative C2-7 angle, upper level surgery, multilevel surgery, opioid use, and a high preoperative NDI score, were independent contributing factors to a low HSS-DDI score at 4-weeks follow-up. Intraoperative topical steroid use was an independent protective factor for a low HSS-DDI score. Opioid use and high NDI score remained independent factors at 4-6 months. Sub-domain analysis demonstrated that prior cervical surgery, preoperative C2-7 angle, multilevel surgery, and intraoperative topical steroid use were significant for dysphagia only. Current smoking was significant for dysphonia only. CONCLUSIONS: Our results showed that preoperative opioid use and a high preoperative NDI score are novel independent risk factors for postoperative dysphagia and dysphonia in addition to other known factors.

Regional bone mineral density differences measured by quantitative computed tomography in patients undergoing anterior cervical spine surgery.

BACKGROUND CONTEXT: Clinically, the association between bone mineral density (BMD) and surgical instrumentation efficacy is well recognized. Although several studies have quantified the BMD of the human lumbar spine, comprehensive BMD data for the cervical spine is limited. The few available studies included young and healthy patient samples, which may not represent the typical cervical fusion patient. Currently no large scale study provides detailed BMD information of the cervical and first thoracic vertebrae in patients undergoing anterior cervical spine surgery. PURPOSE: The objective of this study was to determine possible trabecular BMD variations throughout the cervical spine and first thoracic vertebra in patients undergoing anterior cervical discectomy and fusion (ACDF) and to assess the correlation between BMDs of the spinal levels C1-T1. STUDY DESIGN/SETTING: This is a retrospective case series. PATIENT SAMPLE: Patients undergoing ACDF from 2015 to 2018 at a single, academic institution with available preoperative CT imaging were included in this study. OUTCOME MEASURES: The outcome measure was BMD measured by QCT. METHODS: Patients that underwent ACDF from 2015 to 2018 at a single, academic institution were included in this study. Subjects with previous cervical instrumentation or missing/incomplete preoperative cervical spine CT imaging were excluded. Asynchronous quantitative computed tomography (QCT) measurements of the lateral masses of C1 and the C2-T1 vertebral bodies were performed. For this purpose, an elliptical region of interest that consisted exclusively of trabecular bone was selected. Any apparent sclerotic levels that might affect trabecular QCT measurements were excluded from the final analysis. Interobserver reliability of measurements was assessed by calculating the interclass correlation coefficients (ICC). Pairwise comparison of BMD was performed and correlations between the various cervical levels were evaluated. The statistical significance level was set at p<.05. RESULTS: In all, 194 patients (men, 62.9%) met inclusion criteria. The patient population was 91.2% Caucasian with a mean age of 55.9 years and mean BMI of 28.2 kg/m2. The ICC of cervical QCT measurements was excellent (ICC 0.92). The trabecular BMD was highest in the mid-cervical spine (C4) and decreased in the caudal direction (C1 average=253.3 mg/cm3, C2=276.6 mg/cm3, C3=272.2 mg/cm3, C4=283.5 mg/cm3, C5=265.1 mg/cm3, C6=235.3 mg/cm3, C7=216.8 mg/cm3, T1=184.4 mg/cm3). The BMD of C7 and T1 was significantly lower than those of all other levels. Nonetheless, significant correlations in BMD among all measured levels were observed, with a Pearson's correlation coefficient ranging from 0.507 to 0.885. CONCLUSIONS: To the authors' knowledge this is the largest study assessing trabecular BMD of the entire cervical spine and first thoracic vertebra by QCT. The patient sample consisted of patients undergoing ACDF, which adds to the clinical relevance of the findings. Knowledge of BMD variation in the cervical spine might be useful to surgeons utilizing anterior cervical spine plate and screw systems. Due to the significant variation in cervical BMD, procedures involving instrumentation at lower density caudal levels might potentially benefit from a modification in instrumentation or surgical technique to achieve results similar to more cephalad levels.

The impact of degenerative disc disease on regional volumetric bone mineral density (vBMD) measured by quantitative computed tomography.

BACKGROUND CONTEXT: It has been reported that degenerative disc disease (DDD) is associated with higher spinal bone mineral density (BMD) based on previous studies that used dual X-ray absorptiometry (DXA). However, DDD is often associated with proliferative bone changes and can lead to an overestimation of BMD measured with DXA. Trabecular volumetric BMD (vBMD) in the vertebral body measured with quantitative computed tomography (QCT) is less affected by those changes and can be a favorable alternative to DXA for patients with degenerative spinal changes. PURPOSE: The purpose of this study is to investigate the effect of DDD on regional trabecular vBMDs in the vertebral body measured by QCT. STUDY DESIGN/SETTING: Cross-sectional observational study at a single academic institution. PATIENTS SAMPLE: Consecutive patients undergoing posterior lumbar spinal fusion between 2014 and 2017 who had a routine preoperative CT scan and magnetic resonance imaging (MRI) within a 90-day interval. OUTCOME MEASURES: Regional trabecular vBMDs in the vertebral body by QCT. METHODS: QCT measurements were conducted in L1-S1 vertebral trabecular bone. Any apparent sclerotic lesions that might affect vBMD values were excluded from the region of interest. The vBMDs of each level were defined as the average vBMD of the upper and lower vertebrae. To evaluate DDD, Pfirrmann grade, Modic grade, total end plate score, and vacuum phenomenon were documented. Univariate regression analysis and multivariate analyses with a linear mixed model adjusted with individual variability of segmental vBMDs were conducted with vBMD as the response variable. RESULTS: Of 143 patients and 715 disc levels, 125 patients and 596 discs met our inclusion criteria. Mean vBMD (±standard deviation [SD]) of all levels was 119.0±39.6 mg/cm3. After adjusting for all covariates, Pfirrmann grade was not an independent contributor to vBMD, but the presence of any Modic change (type 1, ß=6.8, p≤.001; type 2, ß=6.7, p<.001; type 3, ß=43.6, p<.001), high TEPS (score 10-12, ß=14.2, p<.001), or vacuum phenomenon (ß=9.0, p<.001) was shown to be independent contributors to vBMD. CONCLUSIONS: Our results showed that the presence of certain end plate lesions (Modic changes and high TEPS) on MRI was significantly associated with increased regional QCT-vBMDs in the vertebral body, but no significant association was observed with disc nucleus pathology, unless it was associated with a vacuum phenomenon. When end plate lesions with Modic changes and high TEPS are present at the measuring level, care must be taken to interpret vBMD values, which might be overestimations even if the trabecular area appears normal.

Correlation between Urine N-Terminal Telopeptide and Fourier Transform Infrared Spectroscopy Parameters: A Preliminary Study.

N-terminal telopeptide (NTX) is a bone resorption marker that is commonly referenced in clinical practice. Bone remodeling is also associated with changes in mineral components. Fourier transform infrared spectroscopy (FTIR) is utilized in the assessment of bone material properties and some parameters are reported to have associations with bone remodeling. The aim of this cross-sectional study is to investigate the relationship between uNTX levels and FTIR parameters, utilizing prospectively collected study data for patients who underwent lumbar fusion surgery. Bone specimens were taken from iliac crest (IC) and vertebrae (V). Cortical (C) and trabecular (T) bones were separately analyzed. 22 patients (mean age 60.0 years (35.9-73.3), male : female 9 : 13) were included in the final analysis. Women showed significantly higher uNTX levels (male : female, median [range] 21.0 [11.0-39.0] : 36.0 [15.0-74.0] nM·BCE/mM, p=0.033). Among women, a significant positive correlation was observed between uNTX and mineral-to-matrix ratio in IC-C. Among men, uNTX demonstrated significant negative correlation with collagen crosslinks (XLR: ratio of mature to immature collagen crosslinks) in IC-C, V-T, and V-C. In addition, uNTX was positively correlated with acid phosphate substitution (HPO4, a parameter of new bone formation) in IC-C, IC-T, and V-C. After age adjustment, HPO4 in IC-T and V-C among men showed significant positive associations with uNTX (IC-T: p=0.018, R 2 = 0.544; V-C: p=0.007, R 2 = 0.672). We found associations between FTIR parameters and uNTX in men, but not in women. The correlations between uNTX and FTIR parameters in men might suggest a better balance of bone breakdown (uNTX) and new bone formation (FTIR parameters: XLR, HPO4) than in women.

BMI and gender increase risk of sacral fractures after multilevel instrumented spinal fusion compared with bone mineral density and pelvic parameters.

BACKGROUND CONTEXT: Sacral fractures are a rare but potentially devastating complication. Long-fusion constructs, including the sacrum, that do not extend to the pelvis may result in sacral fractures. Besides established risk factors including gender, age, and number of levels fused, body mass index (BMI), pelvic parameters, and bone mineral density (BMD) have also been proposed as potential risk factors for postoperative sacral fractures. The literature supporting this, however, is limited. PURPOSE: The aim of the present study was to assess whether preoperative pelvic parameters, BMI, or BMD of patients with sacral fracture are different compared with age, gender, and fusion level-matched non-fracture controls. STUDY DESIGN/SETTING: This is a case-control study. PATIENT SAMPLE: Patients undergoing posterior instrumented fusion at a single academic institution between 2002 and 2016 were included in the study. OUTCOME MEASURES: The outcome measure was occurrence of a postoperative sacral fracture. METHODS: Patients with sacral fractures after posterior instrumented spinal fusion, including the sacrum, were retrospectively identified and matched 2:1 with non-fracture controls based on gender, age, and number of levels fused. Patients with concurrent spinopelvic fixation or missing preoperative computed tomography (CT) imaging were excluded. Preoperative sagittal balance was assessed using lateral radiographs. Quantitative computed tomography (QCT) assessment included standard measurements at L1/L2 and additional experimental measurements of the S1 body and sacral ala. RESULTS: Twenty-one patients with sacral fracture were matched to non-fracture controls. The majority of the patients with sacral fracture was female (76.2%) and of advanced age (mean 66.4 years). Fracture and control groups were well matched with respect to gender, age, and number of levels fused. Standard measurements at L1/L2 showed no significant difference in BMD between the fracture and the control groups (109.9 mg/cm3 vs. 116.4 mg/cm3, p=.414). Similarly, there was no significant BMD differences between the groups using the experimental measurements of the S1 body (183.6 mg/cm3 vs. 176.2 mg/cm3, p=.567) and the sacral ala (8.9 mg/cm3 vs. 4.8 mg/cm3, p=.616). Mean preoperative pelvic incidence-lumbar lordosis mismatch and pelvic tilt were not significantly different between the groups. Univariate conditional logistic regression analysis revealed that the odds of experiencing a sacral fracture was approximately six times higher for obese patients compared with normal or underweight patients. After controlling for BMI in multivariate conditional logistic regression models, BMD was still not significantly associated with the odds of experiencing sacral fractures. CONCLUSIONS: To our knowledge, this is the first study to assess the association of preoperative BMD measured by QCT, pelvic parameters, and BMI with postoperative sacral fractures in a large patient cohort. Interestingly, our data do not show any difference in preoperative pelvic parameters and BMD between the groups. This is in line with previous reports that indicate only a few patients with sacral fracture after fusion surgery have clear evidence of osteoporosis. Bone mineral density as a measure of bone quantity, rather than bone quality, may not be as important in these fractures as previously thought. Obesity, however, was associated with higher odds of experiencing postoperative sacral fractures. The present study thereby challenges the widespread concept that obesity is a protective factor against fractures in the elderly. In summary, our results suggest that BMI and gender, more than pelvic parameters and BMD, are risk factors for postoperative sacral fractures.