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Biologics and Minimally Invasive Approach to TLIFs: What Is the Risk of Radiculitis?

Wang, Erik; Stickley, Carolyn; Manning, Jordan; Varlotta, Christopher G; Woo, Dainn; Ayres, Ethan; Abotsi, Edem; Vasquez-Montes, Dennis; Fischer, Charla R; Stieber, Jonathan; Quirno, Martin; Protopsaltis, Themistocles S; Passias, Peter G; Buckland, Aaron J
BACKGROUND: Bone morphogenetic protein (BMP) and allograft containing mesenchymal stem cells (live cell) are popular biologic substitutes for iliac crest autograft used in transforaminal lumbar interbody fusion (TLIF). Use of these agents in the pathogenesis of postoperative radiculitis remains controversial. Recent studies have independently linked minimally invasive (MIS) TLIF with increased radiculitis risk compared to open TLIF. The purpose of this study was to assess the rate of postoperative radiculitis in open and MIS TLIF patients along with its relationship to concurrent biologic adjuvant use. METHODS: Patients ≥18 years undergoing single-level TLIF from June 2012 to December 2018 with minimum 1-year follow-up were included. Outcome measures were rate of radiculitis, intra- and postoperative complications, revision surgery; length of stay (LOS), and estimated blood loss (EBL). RESULTS:= .038, N = 336) compared to other combinations of surgical approach and biologic use. CONCLUSIONS: Neither the MIS approach nor BMP use is an independent risk factor for post-TLIF radiculitis. However, risk of radiculitis significantly increases when they are used in tandem. This should be considered when selecting biological adjuvants for MIS TLIF. LEVEL OF EVIDENCE/METHODS: 3.
PMID: 33046541
ISSN: 2211-4599
CID: 4632542

170. Radiculitis: assessing the risk of biologic use in minimally invasive transforaminal lumbar interbody fusions [Meeting Abstract]

Stickley, C; Wang, E; Ayres, E W; Maglaras, C; Fischer, C R; Stieber, J R; Quirno, M; Protopsaltis, T S; Passias, P G; Buckland, A J
BACKGROUND CONTEXT: Recombinant human bone morphogenetic protein 2 (BMP) is increasingly utilized in minimally invasive (MIS) transforaminal lumbar interbody fusions (TLIF) in order to increase rate of fusion by promoting bone growth through the induction of osteoblast differentiation, awhile reducing morbidity related to iliac crest autograft. Despite these benefits, BMP use is still controversial due to its pro-inflammatory mechanism of action and potential to cause radiculitis. PURPOSE: To assess whether BMP is a risk factor for postoperative radiculitis in TLIF. STUDY DESIGN/SETTING: Single-center retrospective cohort study. PATIENT SAMPLE: A total of 397 TLIFs from June 2012 to December 2018. OUTCOME MEASURES: Perioperative clinical characteristics, post-operative risk of radiculitis and complication, and future reoperation rates.
METHOD(S): Patients >= 18 years-old undergoing elective single-level TLIFs from 2012 to 2018 were included. Outcome measures included perioperative clinical characteristics, postoperative risk of radiculitis and complication, and future reoperation rates. Radiculitis was defined the delayed onset of radicular symptoms postoperatively in patients whom had initial resolution of radicular symptoms immediately postoperatively, in the absence of persistent neurological compression on postoperative imaging. Statistical analyses included independent t-tests and chi-square analysis. Propensity score matching was utilized to control for demographic differences between the groups. Independent predictors for post-operative radiculitis were assessed by multivariate logistic regression. Significance set at p<0.05.
RESULT(S): A total of 397 cases were included in the study (59.33 +/- 13.49 mean age, 28.98 +/- 6.29 mean BMI, 52.90% female, 2.29 +/- 1.92 average Charleston comorbidity Index). There were 223 open procedures and 174 MIS. For the entire cohort, 238 cases utilized BMP and 159 did not, with 102 MIS pairing with BMP use. The MIS TLIFs had a higher percentage of BMP use than open TLIFs (58.6% vs 25.7%, p<0.001), lower estimated blood loss (212.28 +/- 193.79 mL vs 410.91 +/- 337.98 mL, p<0.001) higher fluoroscopy dosage (52.43 +/- 48.61mGy vs 16.77 +/- 27.84mGy, p<0.001), and a lower length of stay (3.20 +/- 2.55 days vs 4.11 +/- 2.52 days, p<0.001). There were no other differences in perioperative clinical characteristics. There was a significantly higher rate of postoperative radiculitis in the MIS TLIFs compared to open (12.6% vs 6.8%, p=0.046) and use of BMP compared to no BMP (13.2% vs 6.7%, p=0.029). There was a 15.7% radiculitis rate when MIS was paired with BMP use. There were no other notable differences in complication rates or rates of reoperation. Individually, MIS had a 12.6% radiculitis rate (p=0.046) and BMP use had a 13.2% rate (p=0.029). Propensity score match controlled for the significant difference in CCI between the MIS and open groups (N=168 each). Multivariate regression indicated that MIS (p=0.314) and BMP (p=0.109) were not independent predictors individually when controlling for age, gender, and BMI. When technique was paired with biologic use the regression revealed MIS + BMP is a risk factor of post-operative radiculitis (2.265(4.753-1.079), p=0.031).
CONCLUSION(S): While BMP and MIS technique were not independent risk factors for postoperative radiculitis, there is an increased risk of radiculitis when using BMP in MIS TLIF. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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EMBASE:2007747262
ISSN: 1878-1632
CID: 4597512

Age and Gender Confound PROMIS Scores in Spine Patients With Back and Neck Pain

Jevotovsky, David S; Tishelman, Jared C; Stekas, Nicholas; Moses, Michael J; Karia, Raj J; Ayres, Ethan W; Fischer, Charla R; Buckland, Aaron J; Errico, Thomas J; Protopsaltis, Themistocles S
STUDY DESIGN/UNASSIGNED:This was a single-center retrospective review. OBJECTIVES/UNASSIGNED:To explore how age and gender affect PROMIS scores compared with traditional health-related quality of life (HRQL) in spine patients. METHODS/UNASSIGNED:Patients presenting with a primary complaint of back pain (BP) or neck pain (NP) were included. Legacy HRQLs were Oswestry Disability Index (ODI), Neck Disability Index (NDI), and Visual Analogue Scale (VAS). PROMIS Physical Function (PF), Pain Intensity (Int), and Pain Interference (Inf) were also administered to patients in a clinical setting. Patients were grouped by chief complaint, age (18-44, 45-64, 65+ years) and gender. Two parallel analyses were conducted to identify the effects of age and gender on patient-reported outcomes. Age groups were compared after propensity-score matching by VAS-pain and gender. Separately, genders were compared after propensity-score matching by age and VAS-pain. RESULTS/UNASSIGNED:= .022) but not PROMIS-Int or PROMIS-Inf. CONCLUSIONS/UNASSIGNED:Age and gender confound traditional HRQLs as well as PROMIS domains. However, PROMIS offers age and gender-specific scores, which traditional HRQLs lack.
PMID: 32875861
ISSN: 2192-5682
CID: 4583312

Complication Risk in Primary and Revision Minimally Invasive Lumbar Interbody Fusion: A Comparable Alternative to Conventional Open Techniques?

Bortz, Cole; Alas, Haddy; Segreto, Frank; Horn, Samantha R; Varlotta, Christopher; Brown, Avery E; Pierce, Katherine E; Ge, David H; Vasquez-Montes, Dennis; Lafage, Virginie; Lafage, Renaud; Fischer, Charla R; Gerling, Michael C; Protopsaltis, Themistocles S; Buckland, Aaron J; Sciubba, Daniel M; De La Garza-Ramos, Rafael; Passias, Peter G
STUDY DESIGN/UNASSIGNED:Retrospective cohort study of prospective patients undergoing minimally invasive lumbar fusion at a single academic institution. OBJECTIVE/UNASSIGNED:To assess differences in perioperative outcomes between primary and revision MIS (minimally invasive surgical) lumbar interbody fusion patients and compare with those undergoing corresponding open procedures. METHODS/UNASSIGNED:Patients ≥18 years old undergoing lumbar interbody fusion were grouped by surgical technique: MIS or open. Patients within each group were propensity score matched for comorbidities and levels fused. Patient demographics, surgical factors, and perioperative complication incidences were compared between primary and revision cases using means comparison tests, as appropriate. RESULTS/UNASSIGNED:< .05). CONCLUSIONS/UNASSIGNED:Clinical outcomes of revision MIS lumbar interbody fusion were similar to those of primary surgery. Additionally, MIS techniques were associated with less EBL, shorter LOS, and fewer perioperative complications than corresponding open revisions.
PMID: 32677572
ISSN: 2192-5682
CID: 4528572

Evaluation of Health Related Quality of Life Improvement in Patients Undergoing Spine vs Adult Reconstructive Surgery

Varlotta, Christopher; Fernandez, Laviel; Manning, Jordan; Wang, Erik; Bendo, John; Fischer, Charla; Slover, James; Schwarzkopf, Ran; Davidovitch, Roy; Zuckerman, Joseph; Bosco, Joseph; Protopsaltis, Themistocles; Buckland, Aaron J
STUDY DESIGN/METHODS:Retrospective analysis of outcomes in single-level spine and primary hip and knee arthroplasty patients. OBJECTIVE:Compare baseline and post-operative outcomes in patients undergoing spine surgery procedures with total hip arthroplasty (THA) and total knee arthroplasty (TKA) to further define outcomes in orthopedic surgery. SUMMARY OF BACKGROUND DATA/BACKGROUND:Computer-adaptive Patient Reported Outcome Information System (PROMIS) allows for standardized assessment of the Health Related Quality of Life across different disease states. METHODS:Patients who underwent spine surgery (anterior cervical discectomy and fusion, cervical disc replacement, lumbar laminectomy, microscopic lumbar discectomy, transforaminal lumbar interbody fusion or adult reconstruction surgery (THA, TKA) were grouped. Mean Charlson Comorbidity Index (CCI), Baseline (BL) and 6-month (6 M) PROMIS scores of Physical Function, Pain Interference, and Pain Intensity were determined. Paired t-tests compared differences in CCI, BL, 6 M, and change in PROMIS scores for spine and adult reconstruction procedures. RESULTS:304 spine surgery patients (Age=58.1 ± 15.6; 42.9% Female) and 347 adult reconstruction patients (Age=62.9 ± 11.8; 54.1% Female) were compared. Spine surgery groups had more disability and pain at baseline than adult reconstruction patients according to Physical Function [(21.0, 22.2, 9.07, 12.6, 10.4) vs (35.8, 35.0), respectively, p < .01], Pain Interference [(80.1, 74.1, 89.6, 92.5, 90.6) vs (64.0, 63.9), respectively, p < .01] and Pain Intensity [(53.0, 53.1, 58.3, 58.5, 56.1) vs (53.4, 53.8), respectively, p < .01]. At 6 M, spine surgery patients remained more disabled and had more pain compared to adult reconstruction patients. Over the 6-month timespan, spine patients experienced greater improvements than adult reconstruction patients in terms of Physical Function [(+8.7, +22.2, +9.7, +12.9, +12.1) vs (+5.3, +3.9), respectively, p < .01] and Pain Interference scores [(-15.4, -28.1, -14.7, -13.1, -12.3) vs (-8.3, -6.0), respectively, p < .01]. CONCLUSIONS:Spinal surgery patients had lower BL and 6 M PROMIS scores, but greater relative improvement in PROMIS scores compared to adult reconstruction patients. LEVEL OF EVIDENCE/METHODS:3.
PMID: 32576778
ISSN: 1528-1159
CID: 4524922

ODI Cannot Account for All Variation in PROMIS Scores in Patients With Thoracolumbar Disorders

Passias, Peter G; Horn, Samantha R; Segreto, Frank A; Bortz, Cole A; Pierce, Katherine E; Vasquez-Montes, Dennis; Moon, John; Varlotta, Christopher G; Raman, Tina; Frangella, Nicholas J; Stekas, Nicholas; Lafage, Renaud; Lafage, Virginie; Gerling, Michael C; Protopsaltis, Themistocles S; Buckland, Aaron J; Fischer, Charla R
Study Design/UNASSIGNED:Retrospective review of single institution. Objective/UNASSIGNED:To assess the relationship between Patient-Reported Outcomes Measurement Information System (PROMIS) and Oswestry Disability Index (ODI) scores in thoracolumbar patients. Methods/UNASSIGNED:Included: Patients ≥18 years with a thoracolumbar spine condition (spinal stenosis, disc herniation, low back pain, disc degeneration, spondylolysis). Bivariate correlations assessed the linear relationships between ODI and PROMIS (Physical Function, Pain Intensity, and Pain Interference). Correlation cutoffs assessed patients with high and low correlation between ODI and PROMIS. Linear regression predicted the relationship of ODI to PROMIS. Results/UNASSIGNED:= 0.499) of the variance in Pain Intensity score. Conclusions/UNASSIGNED:There is a large amount of variability with PROMIS that cannot be accounted for with ODI. ODI questions regarding walking, social life, and lifting ability correlate strongly with PROMIS while sitting, standing, and sleeping do not. These results reinforce the utility of PROMIS as a valid assessment for low back disability, while indicating the need for further evaluation of the factors responsible for variation between PROMIS and ODI.
PMCID:7222681
PMID: 32435558
ISSN: 2192-5682
CID: 4444482

PROMIS is superior to established outcome measures in capturing disability resulting from sagittal malalignment in patients with back pain

Stekas, Nicholas D; Johnson, Bradley; Jevotovsky, David; Moses, Michael J; Segreto, Frank; Fischer, Charla; Buckland, Aaron J; Errico, Thomas J; Protopsaltis, Themistocles S
INTRODUCTION/BACKGROUND:Patient reported outcomes measurement information system (PROMIS) is a quality of life metric that has gained increased popularity due to computer adaptive testing. Previous studies have shown that PROMIS correlates with Oswestry Disability Index (ODI) in patients with back pain and takes significantly less time to complete. However, the ability of PROMIS to capture disability from spinal malalignment relative to established metrics is unknown. The aim of the present study is to validate the correlation between ODI and PROMIS in patients with back pain, analyze correlations of PROMIS and legacy metrics to sagittal alignment, and identify major drivers of PROMIS scores and ODI in patients with back pain. METHODS:A retrospective review was conducted of a prospectively collected outcome measures database (PROMIS, ODI, VAS Back, VAS Leg, VAS Neck, and VAS Arm) of spine patients > 18 years. Inclusion criteria for the present study was a chief complaint of back pain and full length weight bearing X-rays within 30 days of health related quality of life (HRQL) completion. Demographic information, radiographic alignment, psychiatric diagnoses, and comorbidities were recorded. PROMIS metrics were correlated to legacy metrics (ODI and VAS). Next, outcome metrics were correlated with sagittal alignment variables T1 Pelvic Angle (TPA), SVA, PT, and PI-LL. Patients were grouped based on the presence of spinal deformity (defined radiographically as any one of SVA > 4 cm, PI-LL > 10°, PT > 20°) and mean HRQL scores were investigated for the adult spinal deformity (ASD) and non-ASD groups. Finally, drivers of PROMIS PF scores and ODI scores were determined using multiple stepwise regression. RESULTS: = 0.376, p < 0.001). CONCLUSIONS:In a cohort of 150 patients with back pain, PROMIS correlated strongly with legacy outcome metrics, including VAS and ODI. PROMIS PF correlated more strongly with sagittal malalignment than ODI. Additionally, patients with spinal deformity had significantly worse PROMIS PF scores but similar ODI scores as patients without ASD. Finally, sagittal alignment was found to be a significant driver of PROMIS PF scores but not ODI scores. PROMIS PF should be utilized as a disability assessment tool in patients with spinal deformity due to ease of use, strong correlations with legacy metrics, and ability to capture disability resulting from sagittal alignment.
PMID: 32152963
ISSN: 2212-1358
CID: 4348842

Prevalence of Risk Factors for Hospital-Acquired Venous Thromboembolism in Neurosurgery and Orthopedic Spine Surgery Patients

Fischer, Charla R; Wang, Erik; Steinmetz, Leah; Vasquez-Montes, Dennis; Buckland, Aaron; Bendo, John; Frempong-Boadu, Anthony; Errico, Thomas
Background/UNASSIGNED:Hospital-acquired venous thromboembolisms (HA-VTE) are a significant source of morbidity and mortality in spine surgery patients. The purpose of this study was to review HA-VTE rates at our institution and evaluate the prevalence of known risk factors in patients who developed HA-VTE among both neurosurgical and orthopedic spine surgeries. Methods/UNASSIGNED: < .05. Results/UNASSIGNED: < .001). Conclusions/UNASSIGNED:The overall HA-VTE rate at our institution was 0.94% (0.61% orthopedic, 1.87% neurosurgery). In patients who sustained VTE, neurosurgical patients had higher rates of active cancer and age >60 years, and orthopedic patients had higher EBL and rates of anterior-posterior surgery. This highlights the different patient populations between the 2 departments and the need for individualized thromboprophylaxis regimens. Level of Evidence/UNASSIGNED:4.
PMCID:7043815
PMID: 32128307
ISSN: 2211-4599
CID: 4340672

Predictors of long-term opioid dependence in transforaminal lumbar interbody fusion with a focus on pre-operative opioid usage

Hockley, Aaron; Ge, David; Vasquez-Montes, Dennis; Moawad, Mohamed A; Passias, Peter Gust; Errico, Thomas J; Buckland, Aaron J; Protopsaltis, Themistocles S; Fischer, Charla R
PURPOSE/OBJECTIVE:Predictors of long-term opioid usage in TLIF patients have not been previously explored in the literature. We examined the effect of pre-operative narcotic use in addition to other predictors of the pattern and duration of post-operative narcotic usage. METHODS:We conducted a retrospective cohort study at a single academic institution of patients undergoing a one- or two-level primary TLIF between 2014 and 2017. Total oral morphine milligram equivalents (MMEs) for inpatient use were calculated and used as the common unit of comparison. RESULTS: = 0.547, specificity 95%, sensitivity 58%) demonstrated that a psychiatric or chronic pain diagnosis (OR 3.95, p = 0.013, 95% CI 1.34-11.6), pre-operative opioid use (OR 8.65, p < 0.001, 95% CI 2.59-29.0), ASA class (OR 2.95, p = 0.025, 95% CI 1.14-7.63), and inpatient total MME (1.002, p < 0.001, 95% CI 1.001-1.003) were positive predictors of prolonged opioid use at 6-month follow-up, while inpatient muscle relaxant use (OR 0.327, p = 0.049, 95% CI 0.108-0.994) decreased the probability of prolonged opioid use. Patients in the pre-operative opioid use group had a significantly higher rate of opioid usage at 6 weeks (79% vs. 46%, p < 0.001), 3 months (51% vs. 14%, p < 0.001), and 6 months (40% vs. 5%, p < 0.001). CONCLUSIONS:Pre-operative opioid usage is associated with higher total inpatient opioid use and a significantly higher risk of long-term opiate usage at 6 months. Approximately 40% of pre-operative narcotic users will continue to consume narcotics at 6-month follow-up, compared with 5% of narcotic-naïve patients. These slides can be retrieved under Electronic Supplementary Material.
PMID: 32095906
ISSN: 1432-0932
CID: 4323262

Management of Adult Lumbar Spine Problems for General Orthopaedic Surgeons: A Practical Guide

Hoffman, Eve G; Jain, Deeptee; Radcliff, Kris; Fischer, Charla R; Hilibrand, Alan S; Razi, Afshin E
Low back pain is one of the most common reasons for physician visits, leading to high heath care costs and disability. Patients may present to primary care physicians, pain management physicians, chiropractors, physical therapists, or surgeons with these complaints. A thorough history and physical examination coupled with judicious use of advanced imaging studies will aid in determining the etiology of the pain. As most cases of low back pain are self-limited and will not develop into chronic pain, nonsurgical treatment is the mainstay. First-line treatment includes exercise, superficial heat, massage, acupuncture, or spinal manipulation. Pharmacologic treatment should be reserved for patients unresponsive to nonpharmacologic treatment and may include NSAIDs or muscle relaxants. Surgery is reserved for patients with pain nonresponsive to a full trial of nonsurgical interventions and with imaging studies which are concordant with physical examination findings.
PMID: 32017754
ISSN: 0065-6895
CID: 4300102