Browsing by Author "Mummaneni, Praveen"
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Item Open Access At What Point Should the Thoracolumbar Region Be Addressed in Patients Undergoing Corrective Cervical Deformity Surgery?(Spine, 2021-10) Passias, Peter G; Pierce, Katherine E; Naessig, Sara; Ahmad, Waleed; Passfall, Lara; Lafage, Renaud; Lafage, Virginie; Kim, Han Jo; Daniels, Alan; Eastlack, Robert; Klineberg, Eric; Line, Breton; Mummaneni, Praveen; Hart, Robert; Burton, Douglas; Bess, Shay; Schwab, Frank; Shaffrey, Christopher; Smith, Justin S; Ames, Christopher P; International Spine Study GroupStudy design
Retrospective cohort study.Objective
The aim of this study was to investigate the impact of cervical to thoracolumbar ratios on poor outcomes in cervical deformity (CD) corrective surgery.Summary of background data
Consideration of distal regional and global alignment is a critical determinant of outcomes in CD surgery. For operative CD patients, it is unknown whether certain thoracolumbar parameters play a significant role in poor outcomes and whether addressing such parameters is warranted.Methods
Included: surgical CD patients (C2-C7 Cobb >10°, cervical lordosis [CL] >10°, C2-C7 sagittal vertical axis (cSVA) >4 cm, or chin-brow vertical angle >25°) with baseline and 1-year data. Patients were assessed for ratios of preop cervical and global parameters including: C2 Slope/T1 slope, T1 slope minus C2-C7 lordosis (TS-CL)/mismatch between pelvic incidence and lumbar lordosis (PI-LL), cSVA/sagittal vertical axis (SVA). Deformity classification ratios of cervical (Ames-ISSG) to spinopelvic (SRS-Schwab) were investigated: cSVA modifier/SVA modifier, TS-CL modifier/PI-LL modifier. Cervical to thoracic ratios included C2-C7 lordosis/T4-T12 kyphosis. Correlations assessed the relationship between ratios and poor outcomes (major complication, reoperation, distal junctional kyphosis (DJK), or failure to meet minimal clinically important difference [MCID]). Decision tree analysis through multiple iterations of multivariate regressions assessed cut-offs for ratios for acquiring suboptimal outcomes.Results
A total of 110 CD patients were included (61.5 years, 66% F, 28.8 kg/m2). Mean preoperative radiographic ratios calculated: C2 slope/T1 slope of 1.56, TS-CL/PI-LL of 11.1, cSVA/SVA of 5.4, CL/thoracic kyphosis (TK) of 0.26. Ames-ISSG and SRS-Schwab modifier ratios: cSVA/SVA of 0.1 and TS-CL/PI-LL of 0.35. Pearson correlations demonstrated a relationship between major complications and baseline TS-CL/PI-LL, Ames TS-CL/Schwab PI-LL modifiers, and the CL/TK ratios (P < 0.050). Reoperation had significant correlation with TS-CL/PI-LL and cSVA/SVA ratios. Postoperative DJK correlated with C2 slope/T1 slope and CL/TK ratios. Not meeting MCID for Neck Disability Index (NDI) correlated with CL/TK ratio and not meeting MCID for EQ5D correlated with Ames TS-CL/Schwab PI-LL.Conclusion
Consideration of cervical to global alignment is a critical determinant of outcomes in CD corrective surgery. Key ratios of cervical to global alignment correlate with suboptimal clinical outcomes. A larger cervical lordosis to TK predicted postoperative complication, DJK, and not meeting MCID for NDI.Level of Evidence: 4.Item Open Access Correlation of the Modified Japanese Orthopedic Association With Functional and Quality-of-Life Outcomes After Surgery for Degenerative Cervical Myelopathy: A Quality Outcomes Database Study.(Neurosurgery, 2022-12) Yee, Timothy J; Upadhyaya, Cheerag; Coric, Domagoj; Potts, Eric A; Bisson, Erica F; Turner, Jay; Knightly, Jack J; Fu, Kai-Ming; Foley, Kevin T; Tumialan, Luis; Shaffrey, Mark E; Bydon, Mohamad; Mummaneni, Praveen; Chou, Dean; Chan, Andrew; Meyer, Scott; Asher, Anthony L; Shaffrey, Christopher; Gottfried, Oren N; Than, Khoi D; Wang, Michael Y; Buchholz, Avery L; Haid, Regis; Park, Paul; Park, PaulBackground
The modified Japanese Orthopedic Association (mJOA) score is a widely used and validated metric for assessing severity of myelopathy. Its relationship to functional and quality-of-life outcomes after surgery has not been fully described.Objective
To quantify the association of the mJOA with the Neck Disability Index (NDI) and EuroQol-5 Dimension (EQ-5D) after surgery for degenerative cervical myelopathy.Methods
The cervical module of the prospectively enrolled Quality Outcomes Database was queried retrospectively for adult patients who underwent single-stage degenerative cervical myelopathy surgery. The mJOA score, NDI, and EQ-5D were assessed preoperatively and 3 and 12 months postoperatively. Improvement in mJOA was used as the independent variable in univariate and multivariable linear and logistic regression models.Results
Across 14 centers, 1121 patients were identified, mean age 60.6 ± 11.8 years, and 52.5% male. Anterior-only operations were performed in 772 patients (68.9%). By univariate linear regression, improvements in mJOA were associated with improvements in NDI and EQ-5D at 3 and 12 months postoperatively (all P < .0001) and with improvements in the 10 NDI items individually. These findings were similar in multivariable regression incorporating potential confounders. The Pearson correlation coefficients for changes in mJOA with changes in NDI were -0.31 and -0.38 at 3 and 12 months postoperatively. The Pearson correlation coefficients for changes in mJOA with changes in EQ-5D were 0.29 and 0.34 at 3 and 12 months.Conclusion
Improvements in mJOA correlated weakly with improvements in NDI and EQ-5D, suggesting that changes in mJOA may not be a suitable proxy for functional and quality-of-life outcomes.Item Open Access Does Patient Frailty Status Influence Recovery Following Spinal Fusion for Adult Spinal Deformity?: An Analysis of Patients With 3-Year Follow-up.(Spine, 2020-04) Pierce, Katherine E; Passias, Peter G; Alas, Haddy; Brown, Avery E; Bortz, Cole A; Lafage, Renaud; Lafage, Virginie; Ames, Christopher; Burton, Douglas C; Hart, Robert; Hamilton, Kojo; Kelly, Michael; Hostin, Richard; Bess, Shay; Klineberg, Eric; Line, Breton; Shaffrey, Christopher; Mummaneni, Praveen; Smith, Justin S; Schwab, Frank A; International Spine Study Group (ISSG)Study design
Retrospective review of a prospective database.Objective
The aim of this study was to evaluate postop clinical recovery among adult spinal deformity (ASD) patients between frailty states undergoing primary procedures SUMMARY OF BACKGROUND DATA.: Frailty severity may be an important determinant for impaired recovery after corrective surgery.Methods
It included ASD patients with health-related quality of life (HRQLs) at baseline (BL), 1 year (1Y), and 3 years (3Y). Patients stratified by frailty by ASD-frailty index scale 0-1(no frailty: <0.3 [NF], mild: 0.3-0.5 [MF], severe: >0.5 [SF]). Demographics, alignment, and SRS-Schwab modifiers were assessed with χ/paired t tests to compare HRQLs: Scoliosis Research Society 22-question Questionnaire (SRS-22), Numeric Rating Scale (NRS) Back/Leg Pain, Oswestry Disability Index (ODI). Area-under-the-curve (AUC) method generated normalized HRQL scores at baseline (BL) and f/u intervals (1Y, 3Y). AUC was calculated for each f/u, and total area was divided by cumulative f/u, generating one number describing recovery (Integrated Health State [IHS]).Results
A total of 191 patients were included (59 years, 80% females). Breakdown of patients by frailty status: 43.6% NF, 40.8% MF, 15.6% SF. SF patients were older (P = 0.003), >body mass index (P = 0.002). MF and SF were significantly (P < 0.001) more malaligned at BL: pelvic tilt (NF: 21.6°; MF: 27.3°; SF: 22.1°), pelvic incidence and lumbar lordosis (7.4°, 21.2°, 19.7°), sagittal vertical axis (31 mm, 87 mm, 82 mm). By SRS-Schwab, NF were mostly minor (40%), and MF and SF markedly deformed (64%, 57%). Frailty groups exhibited BL to 3Y improvement in SRS-22, ODI, NRS Back/Leg (P < 0.001). After HRQL normalization, SF had improvement in SRS-22 at year 1 and year 3 (P < 0.001), and NRS Back at 1Y. 3Y IHS showed a significant difference in SRS-22 (NF: 1.2 vs. MF: 1.32 vs. SF: 1.69, P < 0.001) and NRS Back Pain (NF: 0.52, MF: 0.66, SF: 0.6, P = 0.025) between frailty groups. SF had more complications (79%). SF/marked deformity had larger invasiveness score (112) compared to MF/moderate deformity (86.2). Controlling for baseline deformity and invasiveness, SF showed more improvement in SRS-22 IHS (NF: 1.21, MF: 1.32, SF: 1.66, P < 0.001).Conclusion
Although all frailty groups exhibited improved postop disability/pain scores, SF patients recovered better in SRS-22 and NRS Back. Despite SF patients having more complications and larger invasiveness scores, they had overall better patient-reported outcomes, signifying that with frailty severity, patients have more room for improvement postop compared to BL quality of life.Level of evidence
3.Item Open Access Effect of Modified Japanese Orthopedic Association Severity Classifications on Satisfaction With Outcomes 12 Months After Elective Surgery for Cervical Spine Myelopathy.(Spine, 2019-06) Asher, Anthony L; Devin, Clinton J; Weisenthal, Benjamin M; Pennings, Jacquelyn; Khan, Inamullah; Archer, Kristin R; Sivaganesan, Ahilan; Chotai, Silky; Bydon, Mohamad; Nian, Hui; Harrell, Frank E; McGirt, Matthew J; Mummaneni, Praveen; Bisson, Erica F; Shaffrey, Christopher; Foley, Kevin T; for QOD Vanguard SitesStudy design
This study retrospectively analyzes prospectively collected data.Objective
Here, we aim to determine the influence of preoperative and 12-month modified Japanese Orthopedic Association (mJOA) on satisfaction and understand the change in mJOA severity classification after surgical management of degenerative cervical myelopathy (DCM).Summary of background data
DCM is a progressive degenerative spine disease resulting from cervical cord compression. The natural progression of DCM is variable; some patients experience periods of stability, while others rapidly deteriorate following disease onset. The mJOA is commonly used to grade and categorize myelopathy symptoms, but its association with postoperative satisfaction has not been previously explored.Methods
The quality and outcomes database (QOD) was queried for patients undergoing elective surgery for DCM. Patients were divided into mild (≥14), moderate (9 to 13), or severe (<9) categories on the mJOA scores. A McNemar-Bowker test was used to assess whether a significant proportion of patients changed mJOA category between preoperative and 12 months postoperative. A multivariable proportional odds ordinal logistic regression model was fitted with 12-month satisfaction as the outcome of interest.Results
We identified 1963 patients who underwent elective surgery for DCM and completed 12-months follow-ups. Comparing mJOA severity level preoperatively and at 12 months revealed that 55% remained in the same category, 37% improved, and 7% moved to a worse category. After adjusting for baseline and surgery-specific variables, the 12-month mJOA category had the highest impact on patient satisfaction (P < 0.001).Conclusion
Patient satisfaction is an indispensable tool for measuring quality of care after spine surgery. In this sample, 12-month mJOA category, regardless of preop mJOA, was significantly correlated with satisfaction. Given these findings, it is important to advise patients of the probability that surgery will change their mJOA severity classification and the changes required to achieve postoperative satisfaction.Level of evidence
3.Item Open Access Have We Made Advancements in Optimizing Surgical Outcomes and Enhancing Recovery for Patients With High-Risk Adult Spinal Deformity Over Time?(Oper Neurosurg (Hagerstown), 2024-11-04) Passias, Peter G; Passfall, Lara; Tretiakov, Peter S; Das, Ankita; Onafowokan, Oluwatobi O; Smith, Justin S; Lafage, Virginie; Lafage, Renaud; Line, Breton; Gum, Jeffrey; Kebaish, Khaled M; Than, Khoi D; Mundis, Gregory; Hostin, Richard; Gupta, Munish; Eastlack, Robert K; Chou, Dean; Forman, Alexa; Diebo, Bassel; Daniels, Alan H; Protopsaltis, Themistocles; Hamilton, D Kojo; Soroceanu, Alex; Pinteric, Raymarla; Mummaneni, Praveen; Kim, Han Jo; Anand, Neel; Ames, Christopher P; Hart, Robert; Burton, Douglas; Schwab, Frank J; Shaffrey, Christopher; Klineberg, Eric O; Bess, Shay; International Spine Study GroupBACKGROUND AND OBJECTIVES: The spectrum of patients requiring adult spinal deformity (ASD) surgery is highly variable in baseline (BL) risk such as age, frailty, and deformity severity. Although improvements have been realized in ASD surgery over the past decade, it is unknown whether these carry over to high-risk patients. We aim to determine temporal differences in outcomes at 2 years after ASD surgery in patients stratified by BL risk. METHODS: Patients ≥18 years with complete pre- (BL) and 2-year (2Y) postoperative data from 2009 to 2018 were categorized as having undergone surgery from 2009 to 2013 [early] or from 2014 to 2018 [late]. High-risk [HR] patients met ≥2 of the criteria: (1) ++ BL pelvic incidence and lumbar lordosis or SVA by Scoliosis Research Society (SRS)-Schwab criteria, (2) elderly [≥70 years], (3) severe BL frailty, (4) high Charlson comorbidity index, (5) undergoing 3-column osteotomy, and (6) fusion of >12 levels, or >7 levels for elderly patients. Demographics, clinical outcomes, radiographic alignment targets, and complication rates were assessed by time period for high-risk patients. RESULTS: Of the 725 patients included, 52% (n = 377) were identified as HR. 47% (n = 338) had surgery pre-2014 [early], and 53% (n = 387) underwent surgery in 2014 or later [late]. There was a higher proportion of HR patients in Late group (56% vs 48%). Analysis by early/late status showed no significant differences in achieving improved radiographic alignment by SRS-Schwab, age-adjusted alignment goals, or global alignment and proportion proportionality by 2Y (all P > .05). Late/HR patients had significantly less poor clinical outcomes per SRS and Oswestry Disability Index (both P < .01). Late/HR patients had fewer complications (63% vs 74%, P = .025), reoperations (17% vs 30%, P = .002), and surgical infections (0.9% vs 4.3%, P = .031). Late/HR patients had lower rates of early proximal junctional kyphosis (10% vs 17%, P = .041) and proximal junctional failure (11% vs 22%, P = .003). CONCLUSION: Despite operating on more high-risk patients between 2014 and 2018, surgeons effectively reduced rates of complications, mechanical failures, and reoperations, while simultaneously improving health-related quality of life.Item Open Access Highest Achievable Outcomes for Patients Undergoing Cervical Deformity Corrective Surgery by Frailty.(Neurosurgery, 2022-11) Passias, Peter G; Kummer, Nicholas; Williamson, Tyler K; Williamson, Tyler K; Moattari, Kevin; Lafage, Virginie; Lafage, Renaud; Kim, Han Jo; Daniels, Alan H; Gum, Jeffrey L; Diebo, Bassel G; Protopsaltis, Themistocles S; Mundis, Gregory M; Eastlack, Robert K; Soroceanu, Alexandra; Scheer, Justin K; Hamilton, D Kojo; Klineberg, Eric O; Line, Breton; Hart, Robert A; Burton, Douglas C; Mummaneni, Praveen; Chou, Dean; Park, Paul; Schwab, Frank J; Shaffrey, Christopher I; Bess, Shay; Ames, Christopher P; Smith, Justin S; International Spine Study GroupBackground
Frailty is influential in determining operative outcomes, including complications, in patients with cervical deformity (CD).Objective
To assess whether frailty status limits the highest achievable outcomes of patients with CD.Methods
Adult patients with CD with 2-year (2Y) data included. Frailty stratification: not frail (NF) <0.2, frail (F) 0.2 to 0.4, and severely frail (SF) >0.4. Analysis of covariance established estimated marginal means based on age, invasiveness, and baseline deformity, for improvement, deterioration, or maintenance in Neck Disability Index (NDI), Modified Japanese Orthopaedic Association (mJOA), and Numerical Rating Scale Neck Pain.Results
One hundred twenty-six patients with CD included 29 NF, 83 F, and 14 SF. The NF group had the highest rates of deterioration and lowest rates of improvement in cervical Sagittal Vertical Axis and horizontal gaze modifiers. Two-year improvements in NDI by frailty: NF: -11.2, F: -16.9, and SF: -14.6 ( P = .524). The top quartile of NF patients also had the lowest 1-year (1Y) NDI (7.0) compared with F (11.0) and SF (40.5). Between 1Y and 2Y, 7.9% of patients deteriorated in NDI, 71.1% maintained, and 21.1% improved. Between 1Y and 2Y, SF had the highest rate of improvement (42%), while NF had the highest rate of deterioration (18.5%).Conclusion
Although frail patients improved more often by 1Y, SF patients achieve most of their clinical improvement between 1 and 2Y. Frailty is associated with factors such as osteoporosis, poor alignment, neurological status, sarcopenia, and other medical comorbidities. Similarly, clinical outcomes can be affected by many factors (fusion status, number of pain generators within treated levels, integrity of soft tissues and bone, and deformity correction). Although accounting for such factors will ultimately determine whether frailty alone is an independent risk factor, these preliminary findings may suggest that frailty status affects the clinical outcomes and improvement after CD surgery.Item Open Access Introduction: Adult spinal deformity: pathophysiology and corrective measures.(Neurosurgical focus, 2014-05) Kanter, Adam S; Shaffrey, Christopher I; Mummaneni, Praveen; Wang, Michael Y; Uribe, Juan SItem Open Access Minimally Invasive Surgery for Mild-to-Moderate Adult Spinal Deformities: Impact on Intensive Care Unit and Hospital Stay.(World neurosurgery, 2019-07) Chou, Dean; Mundis, Gregory; Wang, Michael; Fu, Kai-Ming; Shaffrey, Christopher; Okonkwo, David; Kanter, Adam; Eastlack, Robert; Nguyen, Stacie; Deviren, Vedat; Uribe, Juan; Fessler, Richard; Nunley, Pierce; Anand, Neel; Park, Paul; Mummaneni, Praveen; International Spine Study GroupObjective
To compare circumferential minimally invasive (cMIS) versus open surgeries for mild-to-moderate adult spinal deformity (ASD) with regard to intensive care unit (ICU) and hospital lengths of stay (LOS).Methods
A retrospective review of 2 multicenter ASD databases with 426 ASD (sagittal vertical axis <6 cm) surgery patients with 4 or more fusion levels and 2-year follow-up was conducted. ICU stay, LOS, and estimated blood loss (EBL) were compared between open and cMIS surgeries.Results
Propensity matching resulted in 88 patients (44 cMIS, 44 open). cMIS were older (61 vs. 53 years, P = 0.005). Mean levels fused were 6.5 in cMIS and 7.1 in open (P = 0.368). Preoperative lordosis was higher in open than in cMIS (42.7° vs. 40.9°, P = 0.016), and preoperative visual analog score back pain was greater in open than in cMIS (7 vs. 6.2, P = 0.033). Preoperative and postoperative spinopelvic parameters and coronal Cobb angles were not different. EBL was 534 cc in cMIS and 1211 cc in open (P < 0.001). Transfusions were less in cMIS (27.3% vs. 70.5%, P < 0.001). ICU stay was 0.6 days for cMIS and 1.2 days for open (P = 0.009). Hospital LOS was 7.9 days for cMIS versus 9.6 for open (P = 0.804).Conclusions
For patients with mild-to-moderate ASD, cMIS surgery had a significantly lower EBL and shorter ICU stay. Major and minor complication rates were lower in cMIS patients than open patients. Overall LOS was shorter in cMIS patients, but did not reach statistical significance.Item Open Access Postoperative C5 Palsy after Anterior or Posterior Decompression for Degenerative Cervical Myelopathy: A Subgroup Analysis of the Multicenter, Prospective, Randomized, Phase III, CSM-Protect Clinical Trial.(Spine, 2024-10) Bak, Alex B; Moghaddamjou, Ali; Alvi, Mohammed; Ahn, Henry; Farhadi, H Francis; Shaffrey, Christopher I; Nassr, Ahmad; Mummaneni, Praveen; Arnold, Paul M; Jacobs, W Bradley; Riew, K Daniel; Kelly, Michael; Brodke, Darrel S; Vaccaro, Alexander R; Hilibrand, Alan S; Wilson, Jason; Harrop, James S; Yoon, S Tim; Kim, Kee D; Fourney, Daryl R; Santaguida, Carlo; Massicotte, Eric M; Kopjar, Branko; Fehlings, Michael GStudy design
Retrospective cohort study of prospectively accrued data.Objective
To evaluate a large, prospective, multicentre dataset of surgically treated degenerative cervical myelopathy (DCM) cases on the contemporary risk of C5 palsy with surgical approach.Summary of background data
The influence of surgical technique on postoperative C5 palsy after decompression for DCM is intensely debated. Comprehensive, covariate-adjusted analyses are needed using contemporary data.Methods
Patients with moderate to severe DCM were prospectively enrolled in the multicenter, randomized, Phase III CSM-Protect clinical trial and underwent either anterior or posterior decompression between Jan 31, 2012 and May 16, 2017. The primary outcome was the incidence of postoperative C5 palsy, defined as the onset of muscle weakness by at least one grade in manual muscle test at the C5 myotome with slight or absent sensory disruption after cervical surgery. Two comparative cohorts were made based on the anterior or posterior surgical approach. Multivariate hierarchical mixed-effects logistic regression was used to estimate odds ratios (OR) with 95% confidence intervals (CI) for C5 palsy.Results
A total of 283 patients were included, and 53.4% underwent posterior decompression. The total incidence of postoperative C5 palsy was 7.4% and was significantly higher in patients who underwent posterior decompression compared with anterior decompression (11.26% vs. 3.03%, P =0.008). After multivariable regression, the posterior approach was independently associated with greater than four times the likelihood of postoperative C5 palsy ( P =0.017). Rates of C5 palsy recovery were comparable between the two surgical approaches.Conclusion
The odds of postoperative C5 palsy are significantly higher after posterior decompression compared to anterior decompression for DCM. This may influence surgical decision-making when there is equipoise in deciding between anterior and posterior treatment options for DCM.Level of evidence
Therapeutic Level-II.Item Open Access Predictors of Hospital Readmission and Surgical Site Infection in the United States, Denmark, and Japan: Is Risk Stratification a Universal Language?(Spine, 2017-09) Glassman, Steven; Carreon, Leah Y; Andersen, Mikkel; Asher, Anthony; Eiskjær, Soren; Gehrchen, Martin; Imagama, Shiro; Ishii, Ken; Kaito, Takahashi; Matsuyama, Yukihiro; Moridaira, Hiroshi; Mummaneni, Praveen; Shaffrey, Christopher; Matsumoto, MorioStudy design
Retrospective review of three spine surgery databases.Objectives
The purpose of the present study is to determine whether predictors of hospital readmission and surgical site infection (SSI) after lumbar fusion will be the same in United States, Denmark, and Japan.Summary of background data
Because clinical decision making becomes more data driven, risk stratification will be crucial to minimize complications. Spine surgeons worldwide face this issue, leading to parallel efforts to address risk stratification. This raises the question as to whether pooled data would be valuable and whether models generated in one country would be applicable to other populations.Methods
Predictors of SSI and 30-day readmission from three prospective databases (National Neurosurgery Quality and Outcomes Database [N2QOD] N = 2653, DaneSpine N = 1993, Japan Multicenter Spine Database [JAMSD] N = 3798) were determined and compared to identify common or divergent predictive risks.Results
Predictive variables differed in the three databases, for both readmission and SSI. Factors predictive for hospital readmission were American Society of Anesthesiologists (ASA) grade in N2QOD (P = 0.013, odds ratio [OR] 2.08), fusion levels in DaneSpine (P = 0.005, OR 1.67), and sex in JAMSD (P = 0.001, OR = 2.81). Associated differences in demographics and procedural factors included mean ASA grade (N2QOD = 2.45, JAMSD = 1.72) and fusion levels (N2QOD = 1.39, DaneSpine = 1.52, JAMSD = 1.34). For SSI, sex (P = 0.000, OR = 3.30), diabetes (P = 0.000, OR = 2.90), and length of stay (P = 0.000, OR = 1.02) were predictive in JAMSD. No predictors were identified in N2QOD or DaneSpine.Conclusion
Predictors of SSI and hospital readmission differ in the United States, Denmark, and Japan, suggesting that risk stratification models may need to be population specific or adjusted. Some differences in measured parameters exist in the three databases analyzed; however, patient and procedure selection also appear to differ and may limit the ability to directly pool data from different regions. Therefore, risk stratification models developed in one country may not be directly applicable to other countries.Level of evidence
2.Item Open Access Re-operation After Long-Segment Fusions for Adult Spinal Deformity: The Impact of Extending the Construct Below the Lumbar Spine.(Neurosurgery, 2018-02) Witiw, Christopher D; Fessler, Richard G; Nguyen, Stacie; Mummaneni, Praveen; Anand, Neel; Blaskiewicz, Donald; Uribe, Juan; Wang, Michael Y; Kanter, Adam S; Okonkwo, David; Park, Paul; Deviren, Vedat; Akbarnia, Behrooz A; Eastlack, Robert K; Shaffrey, Christopher; Mundis, Gregory MBackground
Deciding where to end a long-segment fusion for adult spinal deformity (ASD) may be a challenge, particularly in the absence of an abnormality at L5/S1. Some suggest prophylactic extension of the construct to the sacrum and/or ilium (S/I) to protect against distal junctional failure, while others support terminating in the lower lumbar spine to preserve motion.Objective
To compare the risk of re-operation after long-segment fusions for ASD that ends at L4 or L5 (L4/5) vs S/I.Methods
A multicenter database of patients treated for ASD by circumferential minimally invasive surgery or hybrid surgical technique was screened for individuals with long fusions (≥4 vertebral levels) ending at L4 or below and with at least 2 yr of follow-up. Multivariate regression modeling was used to compare surgical morbidity between the L4/5 and S/I groups, and Cox proportional hazard modeling was used to compare risk of re-operation.Results
There were 45 subjects with fusion to L4/5 and 71 to S/I. Over a 32-mo median follow-up, 41 re-operations were performed; 6 were for distal junctional failure. In those with normal or mild degeneration at L5/S1, fusion to S/I afforded no significant change in re-operative risk (hazard ratio = 1.18 [95% confidence interval: 0.53-2.62], P = .682). In those undergoing circumferential minimally invasive surgery correction, fusion to S/I was associated with significantly greater blood loss (499.6 cc, P < .001) and surgical time (97.5 min, P = .04).Conclusion
In the setting of a normal or mildly degenerated L5/S1 disc space, fusion to the sacrum/ilium did not significantly change the risk of requiring a re-operation after a long-segment fusion for ASD.Item Open Access Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial.(JAMA network open, 2024-06) Fehlings, Michael G; Pedro, Karlo M; Alvi, Mohammed Ali; Badhiwala, Jetan H; Ahn, Henry; Farhadi, H Francis; Shaffrey, Christopher I; Nassr, Ahmad; Mummaneni, Praveen; Arnold, Paul M; Jacobs, W Bradley; Riew, K Daniel; Kelly, Michael; Brodke, Darrel S; Vaccaro, Alexander R; Hilibrand, Alan S; Wilson, Jason; Harrop, James S; Yoon, S Tim; Kim, Kee D; Fourney, Daryl R; Santaguida, Carlo; Massicotte, Eric M; Huang, PengImportance
The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery.Objective
To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM.Design, setting, and participants
This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023.Intervention
Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery.Main outcomes and measures
The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE).Results
Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007).Conclusions and relevance
In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.Item Open Access Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.(The Lancet. Neurology, 2021-02) Fehlings, Michael G; Badhiwala, Jetan H; Ahn, Henry; Farhadi, H Francis; Shaffrey, Christopher I; Nassr, Ahmad; Mummaneni, Praveen; Arnold, Paul M; Jacobs, W Bradley; Riew, K Daniel; Kelly, Michael; Brodke, Darrel S; Vaccaro, Alexander R; Hilibrand, Alan S; Wilson, Jason; Harrop, James S; Yoon, S Tim; Kim, Kee D; Fourney, Daryl R; Santaguida, Carlo; Massicotte, Eric M; Kopjar, BrankoBackground
Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy.Methods
This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18-80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8-14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov, NCT01257828.Findings
From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference -0·38 points (-0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications.Interpretation
In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study.Funding
AOSpine North America.Item Open Access The Additional Economic Burden of Frailty in Adult Cervical Deformity Patients Undergoing Surgical Intervention.(Spine, 2022-10) Passias, Peter G; Kummer, Nicholas A; Williamson, Tyler K; Ahmad, Waleed; Lebovic, Jordan; Lafage, Virginie; Lafage, Renaud; Kim, Han Jo; Daniels, Alan H; Gum, Jeffrey L; Diebo, Bassel G; Gupta, Munish C; Soroceanu, Alexandra; Scheer, Justin K; Hamilton, D Kojo; Klineberg, Eric O; Line, Breton; Schoenfeld, Andrew J; Hart, Robert A; Burton, Douglas C; Eastlack, Robert K; Mundis, Gregory M; Mummaneni, Praveen; Chou, Dean; Park, Paul; Schwab, Frank J; Shaffrey, Christopher I; Bess, Shay; Ames, Christopher P; Smith, Justin S; International Spine Study GroupSummary of background data
The influence of frailty on economic burden following corrective surgery for the adult cervical deformity (CD) is understudied and may provide valuable insights for preoperative planning.Objective
To assess the influence of baseline frailty status on the economic burden of CD surgery.Study design
Retrospective cohort.Materials and methods
CD patients with frailty scores and baseline and two-year Neck Disability Index data were included. Frailty score was categorized patients by modified CD frailty index into not frail (NF) and frail (F). Analysis of covariance was used to estimate marginal means adjusting for age, sex, surgical approach, and baseline sacral slope, T1 slope minus cervical lordosis, C2-C7 angle, C2-C7 sagittal vertical axis. Costs were derived from PearlDiver registry data. Reimbursement consisted of a standardized estimate using regression analysis of Medicare payscales for services within a 30-day window including length of stay and death. This data is representative of the national average Medicare cost differentiated by complication/comorbidity outcome, surgical approach, and revision status. Cost per quality-adjusted life-year (QALY) at two years was calculated for NF and F patients.Results
There were 126 patients included. There were 68 NF patients and 58 classified as F. Frailty groups did not differ by overall complications, instance of distal junctional kyphosis, or reoperations (all P >0.05). These groups had similar rates of radiographic and clinical improvement by two years. NF and F had similar overall cost ($36,731.03 vs. $37,356.75, P =0.793), resulting in equivocal costs per QALYs for both patients at two years ($90,113.79 vs. $80,866.66, P =0.097).Conclusion
F and NF patients experienced similar complication rates and upfront costs, with equivocal utility gained, leading to comparative cost-effectiveness with NF patients based on cost per QALYs at two years. Surgical correction for CD is an economical healthcare investment for F patients when accounting for anticipated utility gained and cost-effectiveness following the procedure.Level of evidence
III.Item Unknown The Evolution of Enhanced Recovery After Surgery: Assessing the Clinical Benefits of Developments Within Enhanced Recovery After Surgery Protocols in Adult Cervical Deformity Surgery.(Clinical spine surgery, 2024-05) Passias, Peter G; Tretiakov, Peter S; Onafowokan, Oluwatobi O; Galetta, Matthew; Lorentz, Nathan; Mir, Jamshaid M; Das, Ankita; Dave, Pooja; Lafage, Renaud; Yee, Timothy; Diebo, Bassel; Vira, Shaleen; Jankowski, Pawel P; Hockley, Aaron; Daniels, Alan; Schoenfeld, Andrew J; Mummaneni, Praveen; Paulino, Carl B; Lafage, VirginieStudy design
Retrospective cohort.Objective
To investigate the impact of evolving Enhanced Recovery After Surgery (ERAS) protocols on outcomes after cervical deformity (CD) surgery.Background
ERAS can help accelerate patient recovery and assist hospitals in maximizing the incentives of bundled payment models while maintaining high-quality patient care. However, there remains a paucity of literature assessing how developments have impacted outcomes after adult CD surgery.Methods
Patients with operative CD 18 years or older with pre-baseline and 2 years (2Y) postoperative data, who underwent ERAS protocols, were stratified by increasing implantation of ERAS components: (1) early (multimodal pain program), (2) intermediate (early protocol + paraspinal blocks, early ambulation), and (3) late (early/intermediate protocols + comprehensive prehabilitation). Differences in demographics, clinical outcomes, radiographic alignment targets, perioperative factors, and complication rates were assessed through Bonferroni-adjusted means comparison analysis.Results
A total of 131 patients were included (59.4 ± 11.7 y, 45% females, 28.8 ± 6.0 kg/m 2 ). Of these patients, 38.9% were considered "early," 36.6% were "intermediate," and 24.4% were "late." Perioperatively, rates of intraoperative complications were lower in the late group ( P = 0.036). Postoperatively, discharge disposition differed significantly between cohorts, with late patients more likely to be discharged to home versus early or intermediate cohorts [χ 2 (2) = 37.973, P < 0.001]. In terms of postoperative disability recovery, intermediate and late patients demonstrated incrementally improved 6 W modified Japanese Orthopedic Association scores ( P = 0.004), and late patients maintained significantly higher mean Euro-QOL 5-Dimension Questionnaire and modified Japanese Orthopedic Association scores by 1 year ( P < 0.001, P = 0.026). By 2Y, cohorts demonstrated incrementally increasing SWAL-QOL scores (all domains P < 0.028) domain scores versus early or intermediate cohorts. By 2Y, incrementally decreasing reoperation was observed in early versus intermediate versus late cohorts ( P = 0.034).Conclusions
The present study demonstrates that patients enrolled in an evolving ERAS program demonstrate incremental improvement in preoperative optimization and candidate selection, greater likelihood of discharge to home, decreased postoperative disability and dysphasia burden, and decreased likelihood of intraoperative complications and reoperation rates.Item Unknown The Health Impact of Symptomatic Adult Spinal Deformity: Comparison of Deformity Types to United States Population Norms and Chronic Diseases.(Spine, 2016-02) Bess, Shay; Line, Breton; Fu, Kai-Ming; McCarthy, Ian; Lafage, Virgine; Schwab, Frank; Shaffrey, Christopher; Ames, Christopher; Akbarnia, Behrooz; Jo, Han; Kelly, Michael; Burton, Douglas; Hart, Robert; Klineberg, Eric; Kebaish, Khaled; Hostin, Richard; Mundis, Gregory; Mummaneni, Praveen; Smith, Justin S; International Spine Study GroupA retrospective analysis of a prospective, multicenter database.The aim of this study was to evaluate the health impact of symptomatic adult spinal deformity (SASD) by comparing Standard Form Version 2 (SF-36) scores for SASD with United States normative and chronic disease values.Recent data have identified radiographic parameters correlating with poor health-related quality of life for SASD. Disability comparisons between SASD patients and patients with chronic diseases may provide further insight to the disease burden caused by SASD.Consecutive SASD patients, with no history of spine surgery, were enrolled into a multicenter database and evaluated for type and severity of spinal deformity. Baseline SF-36 physical component summary (PCS) and mental component summary (MCS) values for SASD patients were compared with reported U.S. normative and chronic disease SF-36 scores. SF-36 scores were reported as normative-based scores (NBS) and evaluated for minimally clinical important difference (MCID).Between 2008 and 2011, 497 SASD patients were prospectively enrolled and evaluated. Mean PCS for all SASD was lower than U.S. total population (ASD = 40.9; US = 50; P < 0.05). Generational decline in PCS for SASD patients with no other reported comorbidities was more rapid than U.S. norms (P < 0.05). PCS worsened with lumbar scoliosis and increasing sagittal vertical axis (SVA). PCS scores for patients with isolated thoracic scoliosis were similar to values reported by individuals with chronic back pain (45.5 vs 45.7, respectively; P > 0.05), whereas patients with lumbar scoliosis combined with severe sagittal malalignment (SVA >10 cm) demonstrated worse PCS scores than values reported by patients with limited use of arms and legs (24.7 vs 29.1, respectively; P < 0.05).SASD is a heterogeneous condition that, depending upon the type and severity of the deformity, can have a debilitating impact on health often exceeding the disability of more recognized chronic diseases. Health care providers must be aware of the types of SASD that correlate with disability to facilitate appropriate diagnosis, treatment, and research efforts.3.Item Unknown The National Neurosurgery Quality and Outcomes Database (N2QOD): a collaborative North American outcomes registry to advance value-based spine care.(Spine, 2014-10) Asher, Anthony L; Speroff, Ted; Dittus, Robert S; Parker, Scott L; Davies, Jason M; Selden, Nathan; Nian, Hui; Glassman, Steven; Mummaneni, Praveen; Shaffrey, Christopher; Watridge, Clarence; Cheng, Joseph S; McGirt, Mathew JStudy design
National Prospective Observational Registry.Objective
Describe our preliminary experience with the National Neurosurgery Quality and Outcomes Database (NQOD), a national collaborative registry of quality and outcomes reporting after low back surgery.Summary of background data
All major health care stakeholders are now requiring objective data regarding the value of medical services. Surgical therapies for spinal disorders have faced particular scrutiny in recent value-based discussions, in large part due to the dramatic growth in the cost and application of these procedures. Reliable data are fundamental to understanding the value of delivered health care. Clinical registries are increasingly used to provide such data.Methods
The NQOD is a prospective observational registry designed to establish risk-adjusted expected morbidity and 1-year outcomes for the most common lumbar surgical procedures performed by spine surgeons; provide practice groups and hospitals immediate infrastructure for analyzing their 30-day morbidity and mortality and 3- and 12-month quality data in real-time; generate surgeon-, practice-, and specialty-specific quality and efficacy data; and generate nationwide quality and effectiveness data on specific surgical treatments.Results
In its first 2 years of operation, the NQOD has proven to be a robust data collection platform that has helped demonstrate the objective quality of surgical interventions for medically refractory disorders of the lumbar spine. Lumbar spine surgery was found to be safe and effective at the group mean level in routine practice. Subgroups of patients did not report improvement using validated outcome measures. Substantial variation in treatment response was observed among individual patients.Conclusion
The NQOD is now positioned to determine the combined contribution of patient variables to specific clinical and patient-reported outcomes. These analyses will ultimately facilitate shared decision making and encourage efficient allocation of health care resources, thus significantly advancing the value paradigm in spine care.Level of evidence
3.