Browsing by Subject "International Spine Study Group"
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Item Open Access 1-Year Post-Operative Radiographic and Patient-Reported Outcomes following Cervical Deformity Correction are not Affected by a Short-Term Unplanned Return to the OR.(Spine, 2023-02) Fourman, Mitchell S; Lafage, Renaud; Ames, Christopher; Smith, Justin S; Passias, Peter G; Shaffrey, Christopher I; Mundis, Gregory; Protopsaltis, Themistocles; Gupta, Munish; Klineberg, Eric O; Bess, Shay; Lafage, Virginie; Kim, Han Jo; International Spine Study GroupStudy design
Retrospective analysis of a prospectively-collected multi-center database.Objective
Assess the radiographic and health-related quality of life (HRQoL) impact of a short term (<1 y) return to the OR after adult cervical spine deformity (ACSD) surgery.Summary of background data
Returns to the OR within a year of ACSD correction can be particularly devastating to these vulnerable hosts as they often involve compromise of the soft tissue envelope, neurologic deficits or hardware failure. This work sought to assess the impact of a short-term reoperation on 1-year radiographic and HRQoL outcomes.Methods
Patients operated on from 1/1/2013 to 1/1/2019 with at least 1-year of follow-up were included. The primary outcome was a short-term return to the OR. Variables of interest included patient demographics, Charlson Comorbidity Index (CCI), HRQoL measured with the Modified Japanese Orthopaedic Association (mJOA), Neck Disability Index (NDI) and EuroQuol-5D visual analogue scale (EQ-5D VAS) and radiographic outcomes, including T1-slope (TS), C2-C7 sagittal cobb angle (CL), TS-CL and cervical sagittal vertical axis (cSVA). Comparisons between those who did versus did not require a 1-year reoperation were performed using paired t-tests. A Kaplan Meier survival curve was used to estimate reoperation-free survival up to 2-years post-operatively.Results
A total of 121 patients were included in this work (age 61.9±10.1 y, BMI 28.4±6.9, CCI 1.0±1.4, 62.8% female). A 1-year unplanned return to the OR was required for 28 (23.1%) patients, of whom 19 followed-up for at least 1-year. Indications for a return to the OR were most commonly for neurologic complications (5%), infectious/wound complications (5.8%) and junctional failure (6.6%) No differences in demographics, comorbidities, pre-operative or 1-year post-operative HRQoL or radiographic outcomes were seen between operative groups.Conclusion
Reoperation <1 year after ACSD surgery did not influence 1-year radiographic outcomes or HRQoL.Item Open Access A Comparison of Three Different Positioning Techniques on Surgical Corrections and Postoperative Alignment in Cervical Spinal Deformity (CD) Surgery.(Spine, 2021-05) Morse, Kyle W; Lafage, Renaud; Passias, Peter; Ames, Christopher P; Hart, Robert; Shaffrey, Christopher I; Mundis, Gregory; Protopsaltis, Themistocles; Gupta, Munish; Klineberg, Eric; Burton, Doug; Lafage, Virginie; Kim, Han Jo; International Spine Study GroupStudy design
Retrospective review of a prospective multicenter cervical deformity database.Objective
To examine the differences in sagittal alignment correction between three positioning methods in cervical spinal deformity surgery (CD).Summary of background data
Surgical correction for CD is technically demanding and various techniques are utilized to achieve sagittal alignment objectives. The effect of different patient positioning techniques on sagittal alignment correction following CD remains unknown.Methods
Patients with sagittal deformity who underwent a posterior approach (with and without anterior approach) with an upper instrumented vertebra of C6 or above. Patients with Grade 5, 6, or 7 osteotomies were excluded. Positioning groups were Mayfield skull clamp, bivector traction, and halo ring. Preoperative lower surgical sagittal curve (C2-C7), C2-C7 sagittal vertical axis (cSVA), cervical scoliosis, T1 slope minus cervical lordosis (TS-CL), T1 slope (T1S), chin-brow vertebral angle (CBVA), C2-T3 curve, and C2-T3 SVA was assessed and compared with postoperative radiographs. Segmental changes were analyzed using the Fergusson method.Results
Eighty patients (58% female) with a mean age of 60.6 ± 10.5 years (range, 31-83) were included. The mean postoperative C2-C7 lordosis was 7.8° ± 14 and C2-C7 SVA was 34.1 mm ± 15. There were overall significant changes in cervical alignment across the entire cohort, with improvements in T1 slope (P < 0.001), C2-C7 (P < 0.001), TS-CL (P < 0.001), and cSVA (P = 0.006). There were no differences postoperatively of any radiographic parameter between positioning groups (P > 0.05). The majority of segmental lordotic correction was achieved at C4-5-6 (mean 6.9° ± 11). Additionally, patients who had bivector traction applied had had significantly more segmental correction at C7-T1-T2 compared with Mayfield and halo traction (4.2° vs. 0.3° vs. -1.7° respectively, P < 0.027).Conclusion
Postoperative cervical sagittal correction or alignment was not affected by patient position. The majority of segmental correction occurred at C4-5-6 across all positioning methods, while bivector traction had the largest corrective ability at the cervicothoracic junction.Level of Evidence: 4.Item Open Access A Novel Tool for Deformity Surgery Planning: Determining the Magnitude of Lordotic Correction Required to Achieve a Desired Sagittal Vertical Axis.(World neurosurgery, 2017-08) Goldschmidt, Ezequiel; Angriman, Federico; Agarwal, Nitin; Zhou, James; Chen, Katherine; Tempel, Zachary J; Gerszten, Peter C; Kanter, Adam S; Okonkwo, David O; Passias, Peter; Scheer, Justin; Protopsaltis, Themistocles; Lafage, Virginie; Lafage, Renaud; Schwab, Frank; Bess, Shay; Ames, Christopher; Smith, Justin S; Shaffrey, Christopher I; Miller, Emily; Jain, Amit; Neuman, Brian; Sciubba, Daniel M; Burton, Douglas; Hamilton, D Kojo; International Spine Study GroupObjective
We sought to create a model capable of predicting the magnitude of pelvic incidence-lumbar lordosis (PI-LL) correction necessary to achieve a desired change in sagittal vertical axis (SVA).Methods
A retrospective review was conducted of a prospectively maintained multicenter adult spinal deformity database collected by the International Spine Study Group between 2009 and 2014. The independent variable of interest was the degree of correction achieved in the PI-LL mismatch 6 weeks after surgery. Primary outcome was the change in global sagittal alignment 6 weeks and 1 year after surgery. We used a linear mixed-effects model to determine the extent to which corrections in the PI-LL relationship affected postoperative changes in SVA.Results
A total of 1053 adult patients were identified. Of these patients, 590 were managed surgically. Eighty-seven surgically managed patients were excluded because of incomplete or missing PI-LL measurements on follow-up; the remaining 503 patients were selected for inclusion. For each degree of improvement in the PI-LL mismatch at 6 weeks, the SVA decreased by 2.18 mm (95% confidence interval, -2.56, -1.79; P < 0.01) and 1.67 mm (95% confidence interval, -2.07, -1.27; P < 0.01) at 6 weeks and 12 months, respectively. A high SVA measurement (>50 mm) 1 year after surgery was negatively associated with health-related quality of life as measured by the Scoliosis Research Society 22 outcomes assessment.Conclusions
We describe a novel model that shows how surgical correction of the PI-LL relationship affects postoperative changes in SVA. This model may enable surgeons to determine preoperatively the amount of LL necessary to achieve a desired change in SVA.Item Open Access A Risk-Benefit Analysis of Increasing Surgical Invasiveness Relative to Frailty Status in Adult Spinal Deformity Surgery.(Spine, 2021-08) Passias, Peter G; Brown, Avery E; Bortz, Cole; Pierce, Katherine; Alas, Haddy; Ahmad, Waleed; Passfall, Lara; Kummer, Nicholas; Krol, Oscar; Lafage, Renaud; Lafage, Virginie; Burton, Douglas; Hart, Robert; Anand, Neel; Mundis, Gregory; Neuman, Brian; Line, Breton; Shaffrey, Christopher; Klineberg, Eric; Smith, Justin; Ames, Christopher; Schwab, Frank J; Bess, Shay; International Spine Study GroupStudy design
Retrospective review of a prospectively enrolled multicenter Adult Spinal Deformity (ASD) database.Objective
Investigate invasiveness and outcomes of ASD surgery by frailty state.Summary of background data
The ASD Invasiveness Index incorporates deformity-specific components to assess correction magnitude. Intersections of invasiveness, surgical outcomes, and frailty state are understudied.Methods
ASD patients with baseline and 3-year (3Y) data were included. Logistic regression analyzed the relationship between increasing invasiveness and major complications or reoperations and meeting minimal clinically important differences (MCID) for health-related quality-of-life measures at 3Y. Decision tree analysis assessed invasiveness risk-benefit cutoff points, above which experiencing complications or reoperations and not reaching MCID were higher. Significance was set to P < 0.05.Results
Overall, 195 of 322 patients were included. Baseline demographics: age 59.9 ± 14.4, 75% female, BMI 27.8 ± 6.2, mean Charlson Comorbidity Index: 1.7 ± 1.7. Surgical information: 61% osteotomy, 52% decompression, 11.0 ± 4.1 levels fused. There were 98 not frail (NF), 65 frail (F), and 30 severely frail (SF) patients. Relationships were found between increasing invasiveness and experiencing a major complication or reoperation for the entire cohort and by frailty group (all P < 0.05). Defining a favorable outcome as no major complications or reoperation and meeting MCID in any health-related quality of life at 3Y established an invasiveness cutoff of 63.9. Patients below this threshold were 1.8[1.38-2.35] (P < 0.001) times more likely to achieve favorable outcome. For NF patients, the cutoff was 79.3 (2.11[1.39-3.20] (P < 0.001), 111 for F (2.62 [1.70-4.06] (P < 0.001), and 53.3 for SF (2.35[0.78-7.13] (P = 0.13).Conclusion
Increasing invasiveness is associated with increased odds of major complications and reoperations. Risk-benefit cutoffs for successful outcomes were 79.3 for NF, 111 for F, and 53.3 for SF patients. Above these, increasing invasiveness has increasing risk of major complications or reoperations and not meeting MCID at 3Y.Level of Evidence: 3.Item Open Access A standardized nomenclature for cervical spine soft-tissue release and osteotomy for deformity correction: clinical article.(Journal of neurosurgery. Spine, 2013-09) Ames, Christopher P; Smith, Justin S; Scheer, Justin K; Shaffrey, Christopher I; Lafage, Virginie; Deviren, Vedat; Moal, Bertrand; Protopsaltis, Themistocles; Mummaneni, Praveen V; Mundis, Gregory M; Hostin, Richard; Klineberg, Eric; Burton, Douglas C; Hart, Robert; Bess, Shay; Schwab, Frank J; International Spine Study GroupObject
Cervical spine osteotomies are powerful techniques to correct rigid cervical spine deformity. Many variations exist, however, and there is no current standardized system with which to describe and classify cervical osteotomies. This complicates the ability to compare outcomes across procedures and studies. The authors' objective was to establish a universal nomenclature for cervical spine osteotomies to provide a common language among spine surgeons.Methods
A proposed nomenclature with 7 anatomical grades of increasing extent of bone/soft tissue resection and destabilization was designed. The highest grade of resection is termed the major osteotomy, and an approach modifier is used to denote the surgical approach(es), including anterior (A), posterior (P), anterior-posterior (AP), posterior-anterior (PA), anterior-posterior-anterior (APA), and posterior-anterior-posterior (PAP). For cases in which multiple grades of osteotomies were performed, the highest grade is termed the major osteotomy, and lower-grade osteotomies are termed minor osteotomies. The nomenclature was evaluated by 11 reviewers through 25 different radiographic clinical cases. The review was performed twice, separated by a minimum 1-week interval. Reliability was assessed using Fleiss kappa coefficients.Results
The average intrarater reliability was classified as "almost perfect agreement" for the major osteotomy (0.89 [range 0.60-1.00]) and approach modifier (0.99 [0.95-1.00]); it was classified as "moderate agreement" for the minor osteotomy (0.73 [range 0.41-1.00]). The average interrater reliability for the 2 readings was the following: major osteotomy, 0.87 ("almost perfect agreement"); approach modifier, 0.99 ("almost perfect agreement"); and minor osteotomy, 0.55 ("moderate agreement"). Analysis of only major osteotomy plus approach modifier yielded a classification that was "almost perfect" with an average intrarater reliability of 0.90 (0.63-1.00) and an interrater reliability of 0.88 and 0.86 for the two reviews.Conclusions
The proposed cervical spine osteotomy nomenclature provides the surgeon with a simple, standard description of the various cervical osteotomies. The reliability analysis demonstrated that this system is consistent and directly applicable. Future work will evaluate the relationship between this system and health-related quality of life metrics.Item Open Access Adult Cervical Deformity Patients Have Higher Baseline Frailty, Disability, and Comorbidities Compared With Complex Adult Thoracolumbar Deformity Patients: A Comparative Cohort Study of 616 Patients.(Global spine journal, 2023-11) Smith, Justin S; Kelly, Michael P; Buell, Thomas J; Ben-Israel, David; Diebo, Bassel; Scheer, Justin K; Line, Breton; Lafage, Virginie; Lafage, Renaud; Klineberg, Eric; Kim, Han Jo; Passias, Peter; Gum, Jeffrey L; Kebaish, Khal; Mullin, Jeffrey P; Eastlack, Robert; Daniels, Alan; Soroceanu, Alex; Mundis, Gregory; Hostin, Richard; Protopsaltis, Themistocles S; Hamilton, D Kojo; Gupta, Munish; Lewis, Stephen J; Schwab, Frank J; Lenke, Lawrence G; Shaffrey, Christopher I; Burton, Douglas; Ames, Christopher P; Bess, Shay; International Spine Study GroupStudy design
Multicenter comparative cohort.Objective
Studies have shown markedly higher rates of complications and all-cause mortality following surgery for adult cervical deformity (ACD) compared with adult thoracolumbar deformity (ATLD), though the reasons for these differences remain unclear. Our objectives were to compare baseline frailty, disability, and comorbidities between ACD and complex ATLD patients undergoing surgery.Methods
Two multicenter prospective adult spinal deformity registries were queried, one ATLD and one ACD. Baseline clinical and frailty measures were compared between the cohorts.Results
616 patients were identified (107 ACD and 509 ATLD). These groups had similar mean age (64.6 vs 60.8 years, respectively, P = .07). ACD patients were less likely to be women (51.9% vs 69.5%, P < .001) and had greater Charlson Comorbidity Index (1.5 vs .9, P < .001) and ASA grade (2.7 vs 2.4, P < .001). ACD patients had worse VR-12 Physical Component Score (PCS, 25.7 vs 29.9, P < .001) and PROMIS Physical Function Score (33.3 vs 35.3, P = .031). All frailty measures were significantly worse for ACD patients, including hand dynamometer (44.6 vs 55.6 lbs, P < .001), CSHA Clinical Frailty Score (CFS, 4.0 vs 3.2, P < .001), and Edmonton Frailty Scale (EFS, 5.15 vs 3.21, P < .001). Greater proportions of ACD patients were frail (22.9% vs 5.7%) or vulnerable (15.6% vs 10.9%) based on EFS (P < .001).Conclusions
Compared with ATLD patients, ACD patients had worse baseline characteristics on all measures assessed (comorbidities/disability/frailty). These differences may help account for greater risk of complications and all-cause mortality previously observed in ACD patients and facilitate strategies for better preoperative optimization.Item Open Access Adult Scoliosis Deformity Surgery: Comparison of Outcomes Between One Versus Two Attending Surgeons.(Spine, 2017-07) Gomez, Jaime A; Lafage, Virginie; Sciubba, Daniel M; Bess, Shay; Mundis, Gregory M; Liabaud, Barthelemy; Hanstein, Regina; Shaffrey, Christopher; Kelly, Michael; Ames, Christopher; Smith, Justin S; Passias, Peter G; Errico, Thomas; Schwab, Frank; International Spine Study GroupStudy design
Retrospective review of prospectively collected data.Objective
Assess outcomes of adult spinal deformity (ASD) surgery performed by one versus two attending surgeons.Summary of background data
ASD centers have developed two attending teams to improve efficiency; their effects on complications and outcomes have not been reported.Methods
Patients with ASD with five or more levels fused and more than 2-year follow-up were included. Estimated blood loss (EBL), length of stay (LOS), operating room (OR) time, complications, quality of life (Health Related Quality of Life), and x-rays were analyzed. Outcomes were compared between one-surgeon (1S) and two-surgeon (2S) centers. A deformity-matched cohort was analyzed.Results
A total of 188 patients in 1S and 77 in 2S group were included. 2S group patients were older and had worse deformity based on the Scoliosis Research Society-Schwab classification (P < 0.05). There were no significant differences in levels fused (P = 0.57), LOS (8.7 vs 8.9 days), OR time (445.9 vs 453.2 min), or EBL (2008 vs 1898 cm; P > 0.05). 2S patients had more three-column osteotomies (3CO; P < 0.001) and used less bone morphogenetic protein 2 (BMP-2; 79.9% vs 15.6%; P < 0.001). The 2S group had fewer intraoperative complications (1.3% vs 11.1%; P = 0.006). Postoperative (6 wk to 2 yr) complications were more frequent in the 2S group (4.8% vs 15.6%; P < 0.002). After matching for deformity, there were no differences in (9.1 vs 10.1 days), OR time (467.8 vs 508.4 min), or EBL (3045 vs 2247 cm; P = 0.217). 2S group used less BMP-2 (20.6% vs 84.8%; P < 0.001), had fewer intraoperative complications (P = 0.015) but postoperative complications due to instrumentation failure/pseudarthrosis were more frequent (P < 0.01).Conclusion
No significant differences were found in LOS, OR time, or EBL between the 1S and 2S groups, even when matching for severity of deformity. 2S group had less BMP-2 use, fewer intraoperative complications but more postoperative complications.Level of evidence
2.Item Open Access Alterations in Magnitude and Shape of Thoracic Kyphosis Following Surgical Correction for Adult Spinal Deformity.(Global spine journal, 2023-11) Lafage, Renaud; Song, Junho; Diebo, Bassel; Daniels, Alan H; Passias, Peter G; Ames, Christopher P; Bess, Shay; Eastlack, Robert; Gupta, Munish C; Hostin, Richard; Kebaish, Khaled; Kim, Han Jo; Klineberg, Eric; Mundis, Gregory M; Smith, Justin S; Shaffrey, Christopher; Schwab, Frank; Lafage, Virginie; Burton, Douglas; International Spine Study GroupStudy design
Retrospective review of prospective multicenter data.Objectives
This study aimed to investigate the shape of TK before and after fusion in ASD patients treated with long fusion.Methods
ASD patients undergoing posterior spinal fusions including at least T5 to L1 without prior fusion extending to the thoracic spine were included. Patients were categorized based on the preoperative T1-T12 kyphosis into: Hypo-TK (if < 30°), Normal-TK, and Hyper-TK (if > 70°). Regional kyphosis at T10-L1 (Distal), T5-T10 (Middle), and T1-T5 (Proximal) and their relative contributions to total kyphosis were compared between groups, and the pre-to postoperative changes were investigated using paired t test.Results
In total, 329 patients were included in this analysis (mean age: 57 ± 16 years, 79.6% female). Preoperative T1-T12 TK for the entire cohort was 40.9 ± 2° (32% Hypo-TK, 11% Hyper-TK, 57% Normal-TK). The Hypo-TK group had the smallest distal TK (5.9 vs 17.1 & 26.0), and middle TK (8.0 vs 25.3 & 45.4), but the percentage of contribution to total kyphosis was not significantly different (Distal: 24.1% vs 34.1% vs 32.8%; Middle: 46.6% vs 53.9% vs 56.8%, all P > .1). Postoperatively, T1-12 TK increased significantly (40.9 ± 2.0° vs 57.8 ± 17.6°). Each group had a decrease in distal kyphosis (Hypo-TK 2.6 ± 10.4°; Normal-TK 8.9 ± 11.5°; Hyper-TK 14.9 ± 12°, all P < .05). The middle kyphosis significantly decreased for Hyper-TK (11.8 ± 12.4) and increased for both Normal-TK and Hypo-TK (3.8 ± 11° and 14.2 ± 11°). Proximal TK increased significantly for all groups by 14-18°. Deterioration from Normal-TK to Hyper-TK postoperatively was associated with lower rate of patient satisfaction (59.6% vs 77.3%, P = .032).Conclusions
Posterior spinal fusion for ASD alters the magnitude and shape of thoracic kyphosis. While 60% of patients had a normal TK at baseline, 30% of those patients developed iatrogenic hyperkyphosis postoperatively. Patients with baseline hypokyphosis were more likely to be corrected to normal TK than hyperkyphotic patients. Future research should investigate TK restoration in ASD and its impact on clinical outcomes and complications.Item Open Access An assessment of frailty as a tool for risk stratification in adult spinal deformity surgery.(Neurosurgical focus, 2017-12) Miller, Emily K; Neuman, Brian J; Jain, Amit; Daniels, Alan H; Ailon, Tamir; Sciubba, Daniel M; Kebaish, Khaled M; Lafage, Virginie; Scheer, Justin K; Smith, Justin S; Bess, Shay; Shaffrey, Christopher I; Ames, Christopher P; International Spine Study GroupOBJECTIVE The goal of this study was to analyze the value of an adult spinal deformity frailty index (ASD-FI) in preoperative risk stratification. Preoperative risk assessment is imperative before procedures known to have high complication rates, such as ASD surgery. Frailty has been associated with risk of complications in trauma surgery, and preoperative frailty assessments could improve the accuracy of risk stratification by providing a comprehensive analysis of patient factors that contribute to an increased risk of complications. METHODS Using 40 variables, the authors calculated frailty scores with a validated method for 417 patients (enrolled between 2010 and 2014) with a minimum 2-year follow-up in an ASD database. On the basis of these scores, the authors categorized patients as not frail (NF) (< 0.3 points), frail (0.3-0.5 points), or severely frail (SF) (> 0.5 points). The correlation between frailty category and incidence of complications was analyzed. RESULTS The overall mean ASD-FI score was 0.33 (range 0.0-0.8). Compared with NF patients (n = 183), frail patients (n = 158) and SF patients (n = 109) had longer mean hospital stays (1.2 and 1.6 times longer, respectively; p < 0.001). The adjusted odds of experiencing a major intraoperative or postoperative complication were higher for frail patients (OR 2.8) and SF patients ( 4.1) compared with NF patients (p < 0.01). For frail and SF patients, respectively, the adjusted odds of developing proximal junctional kyphosis (OR 2.8 and 3.1) were higher than those for NF patients. The SF patients had higher odds of developing pseudarthrosis (OR 13.0), deep wound infection (OR 8.0), and wound dehiscence (OR 13.4) than NF patients (p < 0.05), and they had 2.1 times greater odds of reoperation (p < 0.05). CONCLUSIONS Greater patient frailty, as measured by the ASD-FI, was associated with worse outcome in many common quality and value metrics, including greater risk of major complications, proximal junctional kyphosis, pseudarthrosis, deep wound infection, wound dehiscence, reoperation, and longer hospital stay.Item Open Access Are the Arbeitsgemeinschaft Für Osteosynthesefragen (AO) Principles for Long Bone Fractures Applicable to 3-Column Osteotomy to Reduce Rod Fracture Rates?(Clinical spine surgery, 2022-06) Virk, Sohrab; Lafage, Renaud; Bess, Shay; Shaffrey, Christopher; Kim, Han J; Ames, Christopher; Burton, Doug; Gupta, Munish; Smith, Justin S; Eastlack, Robert; Klineberg, Eric; Mundis, Gregory; Schwab, Frank; Lafage, Virginie; International Spine Study GroupObjective
The aim was to determine whether applying Arbeitsgemeinschaft für Osteosynthesefragen (AO) principles for external fixation of long bone fracture to patients with a 3-column osteotomy (3CO) would be associated with reduced rod fracture (RF) rates.Summary of background data
AO dictate principles to follow when fixating long bone fractures: (1) decrease bone-rod distance; (2) increase the number of connecting rods; (3) increase the diameter of rods; (4) increase the working length of screws; (5) use multiaxial fixation. We hypothesized that applying these principles to patients undergoing a 3CO reduces the rate of RF.Methods
Patients were categorized as having RF versus no rod fracture (non-RF). Details on location and type of instrumentation were collected. Dedicated software was used to calculate the distance between osteotomy site and adjacent pedicle screws, angle between screws and the distance between the osteotomy site and rod. Classic sagittal spinopelvic parameters were evaluated.Results
The study included 170 patients (34=RF, 136=non-RF). There was no difference in age (P=0.224), sagittal vertical axis correction (P=0.287), or lumbar lordosis correction (P=0.36). There was no difference in number of screws cephalad (P=0.62) or caudal (P=0.31) to 3CO site. There was a lower rate of RF for patients with >2 rods versus 2 rods (P<0.001). Patients with multiplanar rod fixation had a lower rod fracture rate (P=0.01). For patients with only 2 rods (N=68), the non-RF cohort had adjacent screws that trended to have less angulation to each other (P=0.06) and adjacent screws that had a larger working length (P=0.03).Conclusions
A portion of AO principles can be applied to 3CO to reduce RF rates. Placing more rods around a 3CO site, placing rods in multiple planes, and placing adjacent screws with a larger working length around the 3CO site is associated with lower RF rates.Item Open Access Artificial Intelligence Models Predict Operative Versus Nonoperative Management of Patients with Adult Spinal Deformity with 86% Accuracy.(World neurosurgery, 2020-09) Durand, Wesley M; Daniels, Alan H; Hamilton, David K; Passias, Peter; Kim, Han Jo; Protopsaltis, Themistocles; LaFage, Virginie; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Klineberg, Eric; Schwab, Frank; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert; International Spine Study GroupObjective
Patients with ASD show complex and highly variable disease. The decision to manage patients operatively is largely subjective and varies based on surgeon training and experience. We sought to develop models capable of accurately discriminating between patients receiving operative versus nonoperative treatment based only on baseline radiographic and clinical data at enrollment.Methods
This study was a retrospective analysis of a multicenter consecutive cohort of patients with ASD. A total of 1503 patients were included, divided in a 70:30 split for training and testing. Patients receiving operative treatment were defined as those undergoing surgery up to 1 year after their baseline visit. Potential predictors included available demographics, past medical history, patient-reported outcome measures, and premeasured radiographic parameters from anteroposterior and lateral films. In total, 321 potential predictors were included. Random forest, elastic net regression, logistic regression, and support vector machines (SVMs) with radial and linear kernels were trained.Results
Of patients in the training and testing sets, 69.0% (n = 727) and 69.1% (n = 311), respectively, received operative management. On evaluation with the testing dataset, performance for SVM linear (area under the curve =0.910), elastic net (0.913), and SVM radial (0.914) models was excellent, and the logistic regression (0.896) and random forest (0.830) models performed very well for predicting operative management of patients with ASD. The SVM linear model showed 86% accuracy.Conclusions
This study developed models showing excellent discrimination (area under the curve >0.9) between patients receiving operative versus nonoperative management, based solely on baseline study enrollment values. Future investigations may evaluate the implementation of such models for decision support in the clinical setting.Item Open Access Assessment of a Novel Adult Cervical Deformity Frailty Index as a Component of Preoperative Risk Stratification.(World neurosurgery, 2018-01) Miller, Emily K; Ailon, Tamir; Neuman, Brian J; Klineberg, Eric O; Mundis, Gregory M; Sciubba, Daniel M; Kebaish, Khaled M; Lafage, Virginie; Scheer, Justin K; Smith, Justin S; Hamilton, D Kojo; Bess, Shay; Shaffrey, Christopher I; Ames, Christopher P; International Spine Study GroupTo determine the value of a novel adult cervical deformity frailty index (CD-FI) in preoperative risk stratification.We reviewed a prospective, multicenter database of adults with cervical spine deformity. We selected 40 variables to construct the CD-FI using a validated method. Patients were categorized as not frail (NF) (<0.2), frail (0.2-0.4), or severely frail (SF) (>0.4) according to CD-FI score. We performed multivariate logistic regression to determine the relationships between CD-FI score and incidence of complications, length of hospital stay, and discharge disposition.Of 61 patients enrolled from 2009 to 2015 with at least 1 year of follow-up, the mean CD-FI score was 0.26 (range 0.25-0.59). Seventeen patients were categorized as NF, 34 as frail, and 10 as SF. The incidence of major complications increased with greater frailty, with a gamma correlation coefficient of 0.25 (asymptotic standard error, 0.22). The odds of having a major complication were greater for frail patients (odds ratio 4.4; 95% confidence interval 0.6-32) and SF patients (odds ratio 43; 95% confidence interval 2.7-684) compared with NF patients. Greater frailty was associated with a greater incidence of medical complications and had a gamma correlation coefficient of 0.30 (asymptotic standard error, 0.26). Surgical complications, discharge disposition, and length of hospital stay did not correlate significantly with frailty.Greater frailty was associated with greater risk of major complications for patients undergoing cervical spine deformity surgery. The CD-FI may be used to improve the accuracy of preoperative risk stratification and allow for adequate patient counseling.Item Open Access Assessment of Adult Spinal Deformity Complication Timing and Impact on 2-Year Outcomes Using a Comprehensive Adult Spinal Deformity Classification System.(Spine, 2022-03) Wick, Joseph B; Le, Hai V; Lafage, Renaud; Gupta, Munish C; Hart, Robert A; Mundis, Gregory M; Bess, Shay; Burton, Douglas C; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank J; Passias, Peter G; Protopsaltis, Themistocles S; Lafage, Virginie; Klineberg, Eric O; International Spine Study GroupStudy design
Retrospective review of prospectively collected multicenter registry data.Objective
To identify rates and timing of postoperative complications in adult spinal deformity (ASD) patients, the impact of complication type and timing on health related quality of life (HRQoL) outcomes, and the impact of complication timing on readmission and reoperation rates. Better understanding of complication timing and impact on HRQoL may improve patient selection, preoperative counseling, and postoperative complication surveillance.Summary of background data
ASD is common and associated with significant disability. Surgical correction is often pursued, but is associated with high complication rates. The International Spine Study Group, AO Spinal Deformity Forum, and European Spine Study Group have developed a new complication classification system for ASD (ISSG-AO spine complications classification system).Methods
The ISSG-AO spine complications classification system was utilized to assess complications occurring over the 2-year postoperative time period amongst a multicenter, prospectively enrolled cohort of patients who underwent surgery for ASD. Kaplan-Meier survival curves were established for each complication type. Propensity score matching was performed to adjust for baseline disability and comorbidities. Associations between each complication type and HRQoL, and reoperation/readmission and complication timing, were assessed.Results
Of 584 patients meeting inclusion criteria, cardiopulmonary, gastrointestinal, infection, early adverse events, and operative complications contributed to a rapid initial decrease in complication-free survival. Implant-related, radiographic, and neurologic complications substantially decreased long-term complication-free survival. Only radiographic and implant-related complications were significantly associated with worse 2-year HRQoL outcomes. Need for readmission and/or reoperation was most frequent among those experiencing complications after postoperative day 90.Conclusion
Surgeons should recognize that long-term complications have a substantial negative impact on HRQoL, and should carefully monitor for implant-related and radiographic complications over long-term follow-up.Level of Evidence: 4.Item Open Access Assessment of Patient Outcomes and Proximal Junctional Failure Rate of Adult Spinal Deformity Patients Undergoing Caudal Extension of Previous Spinal Fusion.(World neurosurgery, 2020-04-16) Daniels, Alan H; Reid, Daniel BC; Durand, Wesley M; Line, Breton; Passias, Peter; Kim, Han Jo; Protopsaltis, Themistocles; LaFage, Virginie; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Klineberg, Eric; Schwab, Frank; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert A; International Spine Study GroupOBJECT:This case series examined patients undergoing caudal extension of prior fusion without alteration of the prior UIV to assess patient outcomes and rates of PJK/PJF. METHODS:Patients eligible for 2-year minimum follow-up undergoing caudal extension of prior fusion with unchanged UIVs were identified. These patients were evaluated for PJK/PJF, and patient reported outcomes were recorded. RESULTS:In total, 40 patients were included. Mean follow-up duration was 2.2 years (SD 0.3). Patients in this cohort had poor preoperative sagittal alignment (PI-LL 26.7°, TPA 29.0°, SVA 93.4mm) and achieved substantial sagittal correction (ΔSVA -62.2mm, ΔPI-LL -19.8°, ΔTPA -11.1°) following caudal extension surgery. At final follow-up, there was a 0% rate of PJF among patients undergoing caudal extension of previous fusion without creation of a new UIV, but 27.5% of patients experienced PJK. Patients experienced significant improvement in both ODI and SRS-22r total score at 2-years post-operatively (p<0.05). In total, 7.5% (n=3) of patients underwent further revision, at an average of 1.1 years (SD 0.54) after the surgery with unaltered UIV. All three of these patients underwent revision for rod fracture with no revisions for PJK/PJF. CONCLUSIONS:Patients undergoing caudal extension of previous fusions for sagittal alignment correction have high rates of clinical success, low revision surgery rates, and very low rates of PJF. Minimizing repetitive tissue trauma at the UIV may result in decreased PJF risk, as the PJF rate in this cohort of unaltered UIV patients is below historical PJF rates of patients undergoing sagittal balance correction.Item Open Access Assessment of Surgical Treatment Strategies for Moderate to Severe Cervical Spinal Deformity Reveals Marked Variation in Approaches, Osteotomies, and Fusion Levels.(World neurosurgery, 2016-07) Smith, Justin S; Klineberg, Eric; Shaffrey, Christopher I; Lafage, Virginie; Schwab, Frank J; Protopsaltis, Themistocles; Scheer, Justin K; Ailon, Tamir; Ramachandran, Subaraman; Daniels, Alan; Mundis, Gregory; Gupta, Munish; Hostin, Richard; Deviren, Vedat; Eastlack, Robert; Passias, Peter; Hamilton, D Kojo; Hart, Robert; Burton, Douglas C; Bess, Shay; Ames, Christopher P; International Spine Study GroupObjective
Although previous reports suggest that surgery can improve the pain and disability of cervical spinal deformity (CSD), techniques are not standardized. Our objective was to assess for consensus on recommended surgical plans for CSD treatment.Methods
Eighteen CSD cases were assembled, including a clinical vignette, cervical imaging (radiography, computed tomography/magnetic resonance imaging), and full-length standing radiography. Fourteen deformity surgeons (10 orthopedic, 4 neurosurgery) were queried regarding recommended surgical plans.Results
There was marked variation in treatment plans across all deformity types. Even for the least complex deformities (moderate midcervical apex kyphosis), there was lack of agreement on approach (50% combined anterior-posterior, 25% anterior only, 25% posterior only), number of anterior (range, 2-6) and posterior (range, 4-16) fusion levels, and types of osteotomies. As the kyphosis apex moved caudally (cervical-thoracic junction/upper thoracic spine) and for cases with chin-on-chest kyphosis, >80% of surgeons agreed on a posterior-only approach and >70% recommended a pedicle subtraction osteotomy or vertebral column resection, but the range in number of anterior (4-8) and posterior (4-27) fusion levels was exceptionally broad. Cases of cervical/cervical-thoracic scoliosis had the least agreement for approach (48% posterior only, 33% combined anterior-posterior, 17% anterior-posterior-anterior or posterior-anterior-posterior, 2% anterior only) and had broad variation in the number of anterior (2-5) and posterior (6-19) fusion levels, and recommended osteotomies (41% pedicle subtraction osteotomy/vertebral column resection).Conclusions
Among a panel of deformity surgeons, there was marked lack of consensus on recommended surgical approach, osteotomies, and fusion levels for CSD. Further study is warranted to assess whether specific surgical treatment approaches are associated with better outcomes.Item Open Access Assessment of symptomatic rod fracture after posterior instrumented fusion for adult spinal deformity.(Neurosurgery, 2012-10) Smith, Justin S; Shaffrey, Christopher I; Ames, Christopher P; Demakakos, Jason; Fu, Kai-Ming G; Keshavarzi, Sassan; Li, Carol MY; Deviren, Vedat; Schwab, Frank J; Lafage, Virginie; Bess, Shay; International Spine Study GroupBackground
Improved understanding of rod fracture (RF) in adult spinal deformity could be valuable for implant design, surgical planning, and patient counseling.Objective
To evaluate symptomatic RF after posterior instrumented fusion for adult spinal deformity.Methods
A multicenter, retrospective review of RF in adult spinal deformity was performed. Inclusion criteria were spinal deformity, age older than 18 years, and more than 5 levels posterior instrumented fusion. Rod failures were divided into early (≤12 months) and late (>12 months).Results
Of 442 patients, 6.8% had symptomatic RF. RF rates were 8.6% for titanium alloy, 7.4% for stainless steel, and 2.7% for cobalt chromium. RF incidence after pedicle subtraction osteotomy (PSO) was 15.8%. Among patients with a PSO and RF, 89% had RF at or adjacent to the PSO. Mean time to early RF (63%) was 6.4 months (range, 2-12 months). Mean time to late RF (37%) was 31.8 months (range, 14-73 months). The majority of RFs after PSO (71%) were early (mean, 10 months). Among RF cases, mean sagittal vertical axis improved from preoperative (163 mm) to postoperative (76.9 mm) measures (P<.001); however, 16 had postoperative malalignment (sagittal vertical axis>50 mm; mean, 109 mm).Conclusion
Symptomatic RF occurred in 6.8% of adult spinal deformity cases and in 15.8% of PSO patients. The rate of RF was lower with cobalt chromium than with titanium alloy or stainless steel. Early failure was most common after PSO and favored the PSO site, suggesting that RF may be caused by stress at the PSO site. Postoperative sagittal malalignment may increase the risk of RF.Item Open Access Association between preoperative cervical sagittal deformity and inferior outcomes at 2-year follow-up in patients with adult thoracolumbar deformity: analysis of 182 patients.(Journal of neurosurgery. Spine, 2016-01) Scheer, Justin K; Passias, Peter G; Sorocean, Alexandra M; Boniello, Anthony J; Mundis, Gregory M; Klineberg, Eric; Kim, Han Jo; Protopsaltis, Themistocles S; Gupta, Munish; Bess, Shay; Shaffrey, Christopher I; Schwab, Frank; Lafage, Virginie; Smith, Justin S; Ames, Christopher P; International Spine Study GroupObjective
A high prevalence of cervical deformity (CD) has been identified among adult patients with thoracolumbar spinal deformity undergoing surgical treatment. The clinical impact of this is uncertain. This study aimed to quantify the differences in patient-reported outcomes among patients with adult spinal deformity (ASD) based on presence of CD prior to treatment.Methods
A retrospective review was conducted of a multicenter prospective database of patients with ASD who underwent surgical treatment with 2-year follow-up. Patients were grouped by the presence of preoperative CD: 1) cervical positive sagittal malalignment (CPSM) C2-7 sagittal vertical axis ≥ 4 cm; 2) cervical kyphosis (CK) C2-7 angle > 0; 3) CPSM and CK (BOTH); and 4) no baseline CD (NONE). Health-related quality of life (HRQOL) scores included the Physical Component Summary and Mental Component Summary (PCS and MCS) scores of the 36-Item Short Form Health Survey (SF-36), Oswestry Disability Index (ODI), Scoliosis Research Society-22 questionnaire (SRS-22), and minimum clinically important difference (MCID) of these scores at 2 years. Standard radiographic measurements were conducted for cervical, thoracic, and thoracolumbar parameters.Results
One hundred eighty-two patients were included in this study: CPSM, 45; CK, 37; BOTH, 16; and NONE, 84. Patients with preoperative CD and those without had similar baseline thoracolumbar radiographic measurements and similar correction rates at 2 years. Patients with and without preoperative CD had similar baseline HRQOL and on average both groups experienced some HRQOL improvement. However, those with preoperative CPSM had significantly worse postoperative ODI, PCS, SRS-22 Activity, SRS-22 Appearance, SRS-22 Pain, SRS-22 Satisfaction, and SRS-22 Total score, and were less likely to meet MCID for ODI, PCS, SRS-22 Activity, and SRS-22 Pain scores with the following ORs and 95% CIs: ODI 0.19 (0.07-0.58), PCS 0.17 (0.06-0.47), SRS-22 Activity 0.23 (0.09-0.62), SRS-22 Pain 0.20 (0.08-0.53), and SRS-22 Appearance 0.34 (0.12-0.94). Preoperative CK did not have an effect on outcomes. Interestingly, despite correction of the thoracolumbar deformity, 53.3% and 51.4% of patients had persistent CPSM and persistent CK, respectively.Conclusions
Patients with thoracolumbar deformity without preoperative CD are likely to have greater improvements in HRQOL after surgery than patients with concomitant preoperative CD. Cervical positive sagittal alignment in adult patients with thoracolumbar deformity is strongly associated with inferior outcomes and failure to reach MCID at 2-year follow-up despite having similar baseline HRQOL to patients without CD. This was the first study to assess the impact of concomitant preoperative cervical malalignment in adult patients with thoracolumbar deformity. These results can help surgeons educate patients at risk for inferior outcomes and direct future research to identify an etiology and improve patient outcomes. Investigation into the etiology of the baseline cervical malalignment may be warranted in patients who present with thoracolumbar deformity.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 Benchmark Values for Construct Survival and Complications by Type of ASD Surgery.(Spine, 2024-04) Bass, Robert Daniel; Lafage, Renaud; Smith, Justin S; Ames, Christopher; Bess, Shay; Eastlack, Robert; Gupta, Munish; Hostin, Richard; Kebaish, Khaled; Kim, Han Jo; Klineberg, Eric; Mundis, Gregory; Okonkwo, David; Shaffrey, Christopher; Schwab, Frank; Lafage, Virginie; Burton, Douglas; International Spine Study GroupObjective
Provide benchmarks for the rates of complications by type of surgery performed.Study design
Prospective multicenter database.Background
We have previously examined overall construct survival and complication rates for ASD surgery. However, the relationship between type of surgery and construct survival warrants more detailed assessment.Methods
Eight surgical scenarios were defined based on the levels treated, previous fusion status (primary [P] vs. revision [R]), and 3-column osteotomy use [3CO]: Short Lumbar fusion, LT-Pelvis with 5-12 levels treated (P, R or 3CO), UT-Pelvis with 13 levels treated (P, R or 3CO), and Thoracic to Lumbar fusion without pelvic fixation, representing 92.4% of the case in the cohort. Complication rates for each type were calculated and Kaplan Meier curves with multivariate Cox regression analysis was used to evaluate the effect of the case characteristics on construct survival rate, while controlling for patient profile.Results
1073 of 1494 patients eligible for 2-year follow-up (71.8%) were captured. Survival curves for major complications (with or without reoperation), while controlling for demographics differed significantly among surgical types (P<0.001). Fusion procedures short of the pelvis had the best survival rate, while UT-Pelvis with 3CO had the worst survival rate. Longer fusions and more invasive operations were associated with lower 2-year complication-free survival, however there were no significant associations between type of surgery and renal, cardiac, infection, wound, gastrointestinal, pulmonary, implant malposition or neurologic complications (all P>0.5).Conclusion
This study suggests that there is an inherent increased risk of complication for some types of ASD surgery independent of patient profile. The results of this paper can be used to produce a surgery-adjusted benchmark for ASD surgery with regard to complications and survival. Such a tool can have very impactful applications for surgical decision making and more informed patient counseling.Item Open Access Can a Minimal Clinically Important Difference Be Achieved in Elderly Patients with Adult Spinal Deformity Who Undergo Minimally Invasive Spinal Surgery?(World neurosurgery, 2016-02) Park, Paul; Okonkwo, David O; Nguyen, Stacie; Mundis, Gregory M; Than, Khoi D; Deviren, Vedat; La Marca, Frank; Fu, Kai-Ming; Wang, Michael Y; Uribe, Juan S; Anand, Neel; Fessler, Richard; Nunley, Pierce D; Chou, Dean; Kanter, Adam S; Shaffrey, Christopher I; Akbarnia, Behrooz A; Passias, Peter G; Eastlack, Robert K; Mummaneni, Praveen V; International Spine Study GroupBackground
Older age has been considered a relative contraindication to complex spinal procedures. Minimally invasive surgery (MIS) techniques to treat patients with adult spinal deformity (ASD) have emerged with the potential benefit of decreased approach-related morbidity.Objective
To determine whether a minimal clinically important difference (MCID) could be achieved in patients ages ≥ 65 years with ASD who underwent MIS.Methods
Multicenter database of patients who underwent MIS for ASD was queried. Outcome metrics assessed were Oswestry Disability Index (ODI) and visual analog scale (VAS) scores for back and leg pain. On the basis of published reports, MCID was defined as a positive change of 12.8 ODI, 1.2 VAS back pain, and 1.6 VAS leg pain.Results
Forty-two patients were identified. Mean age was 70.3 years; 31 (73.8%) were women. Preoperatively, mean coronal curve, pelvic tilt, pelvic incidence to lumbar lordosis mismatch, and sagittal vertical axis were 35°, 24.6°, 14.2°, and 4.7 cm, respectively. Postoperatively, mean coronal curve, pelvic tilt, pelvic incidence to lumbar lordosis, and sagittal vertical axis were 18°, 25.4°, 11.9°, and 4.9 cm, respectively. A mean of 5.0 levels was treated posteriorly, and a mean of 4.0 interbody fusions was performed. Mean ODI improved from 47.1 to 25.1. Mean VAS back and leg pain scores improved from 6.8 and 5.9 to 2.7 and 2.7, respectively. Mean follow-up was 32.1 months. For ODI, 64.3% of patients achieved MCID. For VAS back and leg pain, 82.9% and 72.2%, respectively, reached MCID.Conclusions
MCID represents the threshold at which patients feel a meaningful clinical improvement has occurred. Our study results suggest that the majority of elderly patients with modest ASD can achieve MCID with MIS.