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240. Spinopelvic alignment and successful outcomes following cervical deformity correction [Meeting Abstract]

Protopsaltis, T S; Ayres, E W; Eastlack, R K; Smith, J S; Hamilton, D K; Daniels, A H; Klineberg, E O; Neuman, B J; Hart, R A; Bess, S; Shaffrey, C I; Schwab, F J; Lafage, V; Ames, C P
BACKGROUND CONTEXT: Surgical correction of cervical deformity (CD) can improve a patient's functional status, but is often associated with suboptimal radiographic and clinical outcomes. Although prior studies have demonstrated a high prevalence of thoracolumbar deformity among CD patients, correction of the cervical deformity often fails to address global malalignment, which may contribute to the high rates of treatment failure. The relationship between global alignment and successful CD correction remains unclear. PURPOSE: To investigate whether spinopelvic alignment (SPA) is associated with outcomes following CD correction STUDY DESIGN/SETTING: Retrospective review of a prospective CD database PATIENT SAMPLE: A total of 97 patients with CD. OUTCOME MEASURES: One-year cervical alignment, Neck Disability Index (NDI) scores, distal junctional kyphosis (DJK).
METHOD(S): A database of operative CD patients was analyzed. Inclusion criteria: cSVA>4cm or C2-slope>20degree. Failure was defined as: 1-year cSVA >4cm, NDI change20degree). Failed surgeries were compared with respect to pelvic angles (TPA, T10PA, C2PA), C2-pelvic tilt (CPT), and pelvic incidence (PI). Age- and PI-specific alignment targets were calculated for TPA and T10PA.
RESULT(S): A total of 97 CD patients were included (mean 62+/-11y, 62%F). At 1 year 57% had alignment failure, 39% failed to reach NDI MCID and 12% developed DJK. 66% had baseline thoracolumbar malalignment (>1 +Schwab modifier). Alignment failure was associated with worse BL cervical alignment and higher rate of DJK (16% vs 2%), all p<.05; it was not associated with achieving NDI MCID. Failed alignment patients had greater BL C2PA (21degree vs 16degree) as did patients reaching NDI MCID(21degree vs 15degree), both p<.05. BL C2PA was not associated with DJK. On average, DJK patients had a BL TPA 6degree less than optimal (vs no DJK=-0.03degree) and smaller BL T10PA (-0.2degree vs 7degree). T1PA/T10PA was not associated with alignment failure or NDI improvement. Alignment failure patients had higher BL CPT(53degree vs 36degree) and 76% with a CPT>48.5 reached NDI MCID(<48.5=56%), both p<.05. PI was not associated with any outcomes. Failed alignment was associated with worse 1y C2PA (23vs16degree, p<.05).
CONCLUSION(S): Two-thirds of CD patients had concurrent TL deformity. Patients with failed alignment had worse BL CA, but successful cervical realignment was not associated with NDI improvement. This study demonstrates that SPA is associated with radiographic and clinical outcomes following CD correction. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002161702
ISSN: 1878-1632
CID: 4052422

211. Defining a surgical invasiveness threshold for major complications following adult spinal deformity surgery [Meeting Abstract]

Neuman, B J; Harris, A B; Klineberg, E O; Hostin, R A; Protopsaltis, T S; Passias, P G; Gum, J L; Hart, R A; Kelly, M P; Daniels, A H; Ames, C P; Shaffrey, C I; Kebaish, K M
BACKGROUND CONTEXT: Risk factors have been identified for complications following adult spinal deformity (ASD) surgery; however, the risk of complications following ASD surgery in relation to the degree of surgical invasiveness is unknown. Understanding the relationship between surgical invasiveness and risk of major complications is important to patients and surgeons for estimating these risks based upon the planned surgical treatment. PURPOSE: To define a surgical invasiveness threshold that predicts increased likelihood of major complications following surgical treatment of ASD. STUDY DESIGN/SETTING: Retrospective review of a prospective multicenter database PATIENT SAMPLE: Five hundred seventy-four of 760 (76%) eligible ASD patients (>5 levels fused) were identified in a multicenter database with complete 2-year follow-up OUTCOME MEASURES: Our primary outcome was development of a major complication at any time point in the postoperative period METHODS: Surgical invasiveness was calculated according to the previously published and validated ASD Surgical and Radiographic (ASD-SR) score, which assigns point values to 13 operative and radiographic factors. Youden's index was used to identify the highest predicted probability cut-off of developing a major complication to be an ASD-SR of 90. Using this value, patients were divided into quartiles (Q1: ASD-SR 0-65; Q2: ASD-SR 66-89; Q3: ASD-SR 90-119; Q4: ASD-SR 120+). Odds of developing a major complication were analyzed after controlling for baseline frailty and radiographic deformity.
RESULT(S): Mean age of patients was 59 +/- 14 years, 79% females. Mean levels fused were 11.2 +/- 4.3. The overall risk of a major complication was 17% in Q1, 21% in Q2, 35% in Q3 and 33% in Q4 (p<0.001). Comparing the odds of a major complication by adjacent quartiles demonstrated a significant increase between Q2 and Q3 (OR 1.8, 95% CI 1.03, 2.98), while the risk of increasing invasiveness from Q1 to Q2, and Q3 to Q4 were not significant (p<0.05). Similarly, patients above an ASD-SR cutoff point of 90 (Q3/Q4) were 1.9 times more likely to have a major complication than patients with a surgical invasiveness below this threshold (Q1/Q2) (OR 1.9, 95% CI 1.3 - 2.9). There were no significant differences in the odds of having a minor complication or inpatient medical complication between invasiveness groups (all p>0.05). The mean ASD-SR scores above and below the ASD-SR threshold of 90 were 120.7 +/- 25.4 and 63.4 +/- 16.8, respectively. Example of a patient with an ASD-SR of 63 (low invasiveness): T11-Pelvis, 6 Smith-Peterson Osteotomies, -.9cm change in SVA, +1degree change in TK, + 43degree change in PT. Example of a patient with an ASD-SR of 121 (high invasiveness): T8-Pelvis, 3-column osteotomy, -2.3cm change in SVA, -5degree change in TK, +38degree change in PT.
CONCLUSION(S): ASD patients have an increased risk of major complications above an ASD-SR score of 90, while the risk of minor complications and inpatient medical complications is not significantly increased. The ASD-SR score can be used as a tool to counsel patients regarding these increased risks. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002161697
ISSN: 1878-1632
CID: 4052442

213. Adult spinal deformity patients with a decline in certain activities of daily living are likely to fail nonoperative treatment [Meeting Abstract]

Harris, A B; Neuman, B J; Hostin, R A; Soroceanu, A; Protopsaltis, T S; Passias, P G; Gum, J L; Gupta, M C; Kelly, M P; Klineberg, E O; Lafage, V; Burton, D C; Bess, S; Kebaish, K M
BACKGROUND CONTEXT: The impact of worsening activities of daily living (ADL) such as spine-related financial difficulty and attending work/school have not been studied as potential independent predictors of failing nonoperative management of adult spinal deformity (ASD). PURPOSE: To identify which specific ADLs assessed with the Scoliosis Research Society 22r (SRS-22r) can identify patients with ASD who are likely to fail nonoperative management. STUDY DESIGN/SETTING: Prospective, observational study. PATIENT SAMPLE: A total of 482 patients initially selected for nonoperative treatment of ASD patients were identified from a multicenter database. Of these, 55 (11%) had eventual crossover to operative intervention. Propensity score matching (PSM) was performed using age, gender and baseline Oswestry Disability Index (ODI) to create matched cohorts of 46 crossover (CX) and 46 noncrossover (NC) patients. OUTCOME MEASURES: Our primary outcome was crossover to operative treatment among patients who were originally intended to be treated nonoperatively.
METHOD(S): Scoliosis Research Society (SRS-22r) questionnaire was administered at baseline, 6-weeks, 6-months and both 1 and 2 years. Change in overall score, subdomains and responses to specific questions over time were classified as increasing, decreasing or unchanged in relation to baseline. Kaplan-Meier curves were produced for time to crossover among patients by change in SRS-22r domains, and compared using log-rank test. Significant was set at 0.05.
RESULT(S): NC and CX groups were similar among age, baseline ODI, and SVA (p>0.05). Patients had a mean age 55 +/- 15 years; ODI of 35 +/- 15; SVA of 3.5 +/- 5.9cm. Mean time to crossover was 1.7 +/- 1.4yrs. Decline in SRS-22r Total and Activity domains were associated with increased risk of failing nonoperative management (p=0.005, p=0.006), while decline in SRS-22r pain, appearance and mental health domains were not significantly associated with failure. Analysis of specific ADLs within the activity domain showed worsening financial hardship, level of activity and going out with friends/family to be associated with failure, while work/school activity and doing household chores were not.
CONCLUSION(S): Decline in SRS-22r Activity is the primary SRS-22r domain independently associated with failing nonoperative management of ASD. Within this domain, worsening physical activity, spine-related financial hardship and decreasing time with family/friends drive patients to undergo surgery, while the ability to perform household chores and attend work/school are not independently associated with failing nonoperative management. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002161696
ISSN: 1878-1632
CID: 4052452

214. Adult spinal deformity surgery does not prevent return to work among employed patients but more invasive surgery may delay the return [Meeting Abstract]

Neuman, B J; Harris, A B; Hostin, R A; Raad, M; Protopsaltis, T S; Ames, C P; Passias, P G; Gum, J L; Gupta, M C; Klineberg, E O; Hart, R A; Burton, D C; Bess, S; International, Spine Study Group; Kebaish, K M
BACKGROUND CONTEXT: Returning to full-time work postoperatively is important to employed adults undergoing surgical treatment of adult spinal deformity (ASD). It is important for both patients and providers to have realistic expectations of returning to work after surgery, and to understand the extent to which more invasive surgery may modify a patient's return to work. PURPOSE: Our purpose was to identify the frequency of employed ASD patients who are working full-time postoperatively, and the impact of surgical invasiveness on the percentage of patients who are working full time postoperatively at various time points. STUDY DESIGN/SETTING: Retrospective review of a prospective, multicenter database. PATIENT SAMPLE: A total of 255 ASD patients were identified in a multicenter database who were employed prior to surgery and eligible for 2-year follow-up. Of these patients, 188 (74%) had 2-year follow-up or returned to work at any point within 2 years postoperatively and were included in the final cohort. OUTCOME MEASURES: Our primary outcome was returning to full-time work following surgery.
METHOD(S): Working full-time was defined as reporting 75-100% of normal work/school activity per question 9 of the Scoliosis Research Society Version 22-revised (SRS-22r) questionnaire. Surgical invasiveness was measured according to the ASD Surgical and Radiographical (ASD-SR) invasiveness index, a tool that has been developed and validated to measure the invasiveness of ASD surgery. Patients were separated into high invasiveness (HI) or low invasiveness (LI) groups for ASD-SR scores above and below 100, respectively based on previously established invasiveness categories. Chi-squared and fisher exact test were used to compare categorical variables.
RESULT(S): Mean age of patients was 51 +/- 15 years of age, 79% females. Overall, 69% of these employed patients were working full-time preoperatively, 15% were working full-time at 6-weeks, 70% at 6 months, 83% at 1-year and 84% at 2-years. The percentage of patients working full time was significantly improved at 2-years compared to preoperatively (p<0.001). The difference in patients returning to full-time work in HI and LI groups was significantly different at 6-weeks (5% in high invasiveness vs 19% with low invasiveness, p=0.03), and this difference decreased to non-significant levels at 6-months, 1-year and 2-years (p>0.05).
CONCLUSION(S): The majority of employed adults will return to full-time work following ASD surgery. More patients are working full time at 2-years postoperatively compared to preoperatively, and patients with higher invasiveness surgery may have a delay in return-to-work in the immediate postoperative period. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002161693
ISSN: 1878-1632
CID: 4052472

222. PI and age-optimal alignment within the fusion in ASD surgery improves outcomes and minimizes mechanical failures? [Meeting Abstract]

Protopsaltis, T S; Ayres, E W; Soroceanu, A; Mundis, G M; Smith, J S; Gum, J L; Daniels, A H; Klineberg, E O; Ames, C P; Hart, R A; Bess, S; Shaffrey, C I; Schwab, F J; Lafage, V
BACKGROUND CONTEXT: Age specific alignment targets have been shown to optimize outcomes and minimizing the risks of mechanical failure like proximal junctional kyphosis (PJK). Recently, PI has been shown to be an important determinant of spinal alignment but the role of PI and age-optimal alignment has not been analyzed simultaneously with respect to PJK and clinical outcomes. Previous PJK studies have used SVA to measure over- or undercorrection, however in patients with PJK, SVA underestimates the overcorrection because of patient compensation and the PJK itself increases the SVA. The T1 Pelvic Angle (TPA) has been proposed as useful perioperative planning parameter; using the component of TPA within the fusion (T10PA) allows for measuring spinopelvic alignment separate from that of the unfused thoracic spine and any PJK that may occur postoperatively. PURPOSE: To identify age- and PI-optimal alignment targets using a component angle of TPA within the fusion to define over and under-correction and their relationship to PJK and clinical outcomes. STUDY DESIGN/SETTING: Retrospective analysis of a prospective, multicenter database PATIENT SAMPLE: Operative ASD patients OUTCOME MEASURES: SF36-PCS, PJK METHODS: A prospective database of operative ASD patients was analyzed. Patients with fusions to the pelvis and UIV above T11 were included in the PJK analysis. Alignment within the fusion was correlated with clinical outcomes and PI. SF36-PCS normative data were used to compute PI- and age-optimal alignment for each patient. Over-, under- and optimally-corrected groups were determined using intervals from optimal alignment within the fusion to define the group boundaries. The rate of severe PJK (change>20degree) was determined for each group.
RESULT(S): A total of 1052 patients met inclusion criteria. Alignment within the fusion correlated with SF36-PCS and PI. At 6 weeks, 40.7% were optimally-corrected vs 39.4% overcorrected vs 20.9% undercorrected. The overall rate of PJK was 13.6%. Overcorrected patients had the highest PJK rate (18.1%) compared with optimally (11.3%) and undercorrected (9.5%), p<.05; and overcorrected patients had a trend towards more PJK revisions (2.1% vs 1.2% vs 0%, p=.09). All groups improved in HRQL from baseline to 1 year (all p<.05) but undercorrected patients had the worst 1-year SF36-PCS offset relative to normative patients of equivalent age (-8.1) vs optimal (-6.1) and overcorrected (-4.5), p<0.05.
CONCLUSION(S): A component angle of TPA within the fusion, separate from the PJK, was used to determine age and PI-optimal alignment. Correcting ASD patients to optimal alignment within the fusion produced clinical outcome improvements with the lowest rates of PJK. This age and PI-specific approach to spinal alignment within the fusion provides ASD correction targets for surgeons that can be used intraoperatively. Future studies are warranted to verify the reliability of such intraoperative spinopelvic measurements. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002161688
ISSN: 1878-1632
CID: 4052482

257. A simpler, modified frailty index weighted by complication occurrence correlates to pain and disability for adult spinal deformity patients [Meeting Abstract]

Passias, P G; Bortz, C; Pierce, K E; Alas, H; Brown, A; Vasquez-Montes, D; Diebo, B G; Raman, T; Protopsaltis, T S; Buckland, A J; Gerling, M C; Lafage, R; Lafage, V
BACKGROUND CONTEXT: The Miller et al adult spinal deformity frailty index (ASD-FI) correlates with increased complication risk after surgery; however, its development was not rooted in clinical outcomes, and the 40 factors needed for its calculation limit the index's utility in a clinical setting. PURPOSE: Develop a simplified, weighted frailty index for ASD patients. STUDY DESIGN/SETTING: Retrospective review of prospective ASD database. PATIENT SAMPLE: A total of 50 ASD patients. OUTCOME MEASURES: Health-related quality of life questionnaires: Oswestry Disability Index (ODI), SRS-22r, pain catastrophizing scale, Numerif Rating Scale (NRS) for Leg Pain.
METHOD(S): ASD patients (scoliosis>=20degree, SVA>=5cm, PT>=25degree, or TK >=60degree) with baseline ASD-FI component factors. Component ASD-FI parameters contributing to overall ASD-FI score were assessed via Pearson correlation. Top significant, clinically relevant factors were regressed against ASD-FI score to generate the modified ASD-FI (mASD-FI). Factors comprising the mASD-FI were regressed against the incidence of medical complications; weights for mASD-FI factors were calculated from these regression coefficients via the beta/Sullivan method. Total mASD-FI score was calculated by summing weights of expressed parameters, resulting in a score ranging from 0 to 21. Linear regression correlated ASD-FI and mASD-FI scores, and previously published ASD-FI cutoffs were used to generate corresponding mASD-FI frailty cutoffs: not frail (NF,<7), frail (7-12), severely frail (SF,>12). Analysis of variance assessed the relationship between increasing frailty category and validated baseline measures of patient pain and disability.
RESULT(S): Included: 50 ASD patients (52+/-20yrs, 78% female). All the following preoperative factors correlated with ASD-FI score (all p<0.039), and combined, accounted for 85.0% (p<0.001) of the variation in ASD-FI score: BMI <18.5 kg/m2 or >30 kg/m2 (weight: 5), depression (weight: 5), difficulty climbing stairs (3), presence of >3 medical comorbidities (2), leg weakness (2), difficulty getting dressed (1), bladder incontinence (1), and patient-reported deterioration in health within the past year (1). These factors were used to calculate the overall population's mean mASD-FI score: 5.7+/-5.2. Combined, these factors comprising the mASD-FI showed a trend of predicting the incidence of medical complications (Nagelkerke R2=0.558, Cox & Snell R2=0.399, p=0.065). Overall patient breakdown by mASD-FI frailty category: NF (70%), frail (12%), SF (18%). Increasing frailty category was associated with significant impairments in validated measures of disability, including ODI score (NF: 23.4, frail: 45.0, SF: 49.3, p<0.001), SRS-22r score (NF: 3.5, frail: 2.6, SF: 2.4, p=0.001), pain catastrophizing scale score (NF: 41.9, frail: 32.4, SF: 27.6, p<0.001), and NRS Leg Pain (NF: 2.3, frail: 7.2, SF: 5.6, p=0.001).
CONCLUSION(S): This study modifies an existing ASD frailty index and proposes a weighted, shorter mASD-FI. The mASD-FI relies less on patient-reported variables, and weights component factors by their contribution to adverse outcomes. As increasing mASD-FI score is associated with inferior clinical measures of pain and disability, the mASD-FI may serve as a valuable tool for preoperative risk assessment. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002161683
ISSN: 1878-1632
CID: 4052492

253. Factors associated with chronic opioid use in preoperative opioid nonusers following adult spinal deformity surgery [Meeting Abstract]

Harris, A B; Neuman, B J; Soroceanu, A; Hostin, R A; Protopsaltis, T S; Passias, P G; Gum, J L; Gupta, M C; Daniels, A H; Shaffrey, C I; Klineberg, E O; Schwab, F J; Bess, S; Kebaish, K M
BACKGROUND CONTEXT: Chronic opioid use is an emergent public health issue in the United States. Opioids are regularly prescribed to patients with adult spinal deformity (ASD) for postoperative pain. Therefore, the potential for chronic postoperative opioid use is a significant concern for patients undergoing surgery for ASD. It is important to patients, surgeons and policymakers to understand preoperative risk factors for prolonged opioid use in ASD patients who were not using opioids regularly prior to surgery. PURPOSE: To demonstrate demographic and surgical factors associated with increased risk of chronic opioid use following surgery in ASD patients who were not regularly using opioids preoperatively. STUDY DESIGN/SETTING: Retrospective review of a multicenter database. PATIENT SAMPLE: A total of 760 ASD patients were identified in a multicenter database eligible for 2-year follow-up. Of these patients, 547 (72%) had complete baseline and 2-year responses to question 11 of the Scoliosis Research Society version 22r (SRS-22r), which allowed us to categorize patients into opioid users and non-opioid users. Of these, 251/547 patients (46%) were not using opioids regularly prior to surgery and included in our analysis. OUTCOME MEASURES: Our primary outcome was chronic postoperative opioid use, and secondary outcome was patient satisfaction.
METHOD(S): Among patients who were not using opioids regularly prior to surgery, those reporting routine opioid use at 1 or 2-year follow-up were classified as CU (chronic user), while patients reporting no opioid use at both 1 and 2 years after surgery were classified as NC (no chronic use). Odds of CU vs NC were examined in relation to factors of interest, controlling for history of previous substance use disorder and baseline radiographic deformity. Satisfaction was assessed using the satisfaction domain of the SRS-22r.
RESULT(S): Mean age of patients was 55 +/- 17 years, 78% females. Overall, patients were using opioids until 3.2 +/- 7.7 months postoperatively. A total of 176 patients (78%) were classified as NC and 51 (22%) CU. Factors associated with significantly increased odds of CU compared with NC included smoking (OR 3.44, 95% CI: 1.06 - 11.11; p=0.039), and each additional point worse on the back pain Numeric Rating Scale (NRS) (OR 1.24, 95% CI: 1.06 - 1.46; p=0.008) SRS-22r Activity domain (OR 1.99, 95% CI: 1.27 - 3.09; p=0.002) and SRS-22r Mental Health domain (OR 1.50, 95% CI: 1.06 - 2.11; p=0.022). Notable factors that were not significantly associated with chronic use included gender, C7-S1 sagittal vertical axis, prior spine surgery, elderly age, number of levels fused, 3-column osteotomy and at least one major complication (p>0.05). CU had worse SRS-22r satisfaction scores at 2 years compared with NC (4.33 +/-.93 vs 3.80 +/- 0.17, p=0.001).
CONCLUSION(S): The majority of opioid nonusers prior to ASD surgery will not become chronic users following surgery. Factors associated with chronic opioid use include smoking, higher baseline back pain, worse preoperative functional status, and worse mental health. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002161677
ISSN: 1878-1632
CID: 4052502

258. The pelvic tilt response to ASD correction depends on PI, age and alignment [Meeting Abstract]

Protopsaltis, T S; Ayres, E W; Soroceanu, A; Mundis, G M; Smith, J S; Kelly, M P; Daniels, A H; Klineberg, E O; Ames, C P; Hart, R A; Bess, S; Shaffrey, C I; Schwab, F J; Lafage, V
BACKGROUND CONTEXT: Increasing pelvic tilt (PT) is the main compensatory mechanism in sagittal spinal deformity. Traditionally PT>25degree has been considered pathologically high. Some adult spinal deformity (ASD) patients do not seem to improve their PT following ASD correction. However, the driving forces behind this lack of PT-response are not well defined. Previous studies have demonstrated a significant relationship between pelvic incidence (PI), age and alignment. PURPOSE: To investigate PT response following ASD surgery and its relationship to PI, age and alignment. STUDY DESIGN/SETTING: Retrospective review of a prospectively-collected ASD database. PATIENT SAMPLE: A total of 772 operative ASD patients with positive sagittal balance and 1-year follow up. OUTCOME MEASURES: Postoperative spinal alignment and SF36-PCS.
METHOD(S): A prospective database of operative ASD was analyzed. Patients with a baseline TPA >5degree from optimal were included. Regression models were developed to calculate optimal TPA (TPAo) and PT (PTo) for age and alignment. Similarly, the PT and TPA changes (MCIC) corresponding to the SF-36 PCS MCID were calculated. Two definitions for PT nonresponse were used: (1) Traditional: PT>25 at baseline and 1 year; (2) PT>PTo by 1 MCIC and PT change 20degree). PT responders were compared to non-responders in terms of PI and PCS offset (difference between actual and age-ideal PCS).
RESULT(S): A total of 772 patients met inclusion criteria (mean 64y, 75%F). 71% (n=548) had a pre-PT>25degree, 25% had a PI >65degree. PTo for each patient was calculated using the formula: PT=3.91-.01*Age+.101*PI+.701*TPA(R2=.82). Using the new PT definition, 45% had appropriate PT(PT=PTo) (PT>PTo: 22%).The MCIC for TPA and PT were 4.1degree and 2.9degree, respectively. At 1 year, 30% had a PT>25. 91 did not have MCIC for TPA and 34 had sPJK. Analysis of the remaining 103 nonresponders showed that 48% had a PI>65, 45% had a PT=PTo (PT>PTo: 51%). For patients with pre-PT>25 and 1 year PT>PTo (n=136), 27% had a PI>65, 26% had insufficient TPA correction, 27% had sPJK and 50% were >65y old. A total of 184 patients(24%) had a PT change 25 vs <25 groups at baseline or 1 year. Using the new PT definition, the PTPTo groups (-16.7 vs -14.8 vs -13.4, p<.05). At 1 year, among non-responders with adequate TPA correction, the PT>PTo group had worse PCS offset compared to the PT=PTo group (-9.5 vs.59, p<.05).
CONCLUSION(S): PT response in ASD surgery depends on change in spinal alignment but also age and PI and so it is patient specific. A PT within 2.9degree of optimal was considered appropriate. Nearly half of the 45% of patients traditionally considered to be PT nonresponders had an appropriate PT for age and alignment. A postoperative PT greater than optimal was associated with worse HRQL. This study's novel patient-specific method for defining PT response reveals that PT is not a one-size-fits-all parameter; it is imperative to consider the patient's PI, age and alignment. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002161674
ISSN: 1878-1632
CID: 4052512

241. Towards a cervical deformity-specific outcome instrument: use of the patient-generated index to capture the disability of cervical deformity [Meeting Abstract]

Stekas, N; Protopsaltis, T S; Ayres, E W; Mundis, G M; Smith, J S; Hamilton, D K; Klineberg, E O; Sciubba, D M; Hart, R A; Bess, S; Shaffrey, C I; Schwab, F J; Lafage, V; Ames, C P
BACKGROUND CONTEXT: Existing health outcome (HRQL) metrics fail to correlate with malalignment of the cervical spine and do not adequately capture disability from cervical deformity (CD). The purpose of this study is to introduce the cervical deformity patient generated index (PGI), where patients report their greatest difficulties related to their CD. These responses can then be used to identify the disabling features of CD that are not captured by existing HRQLs and determine items to be included in a CD specific HRQL. PURPOSE: To introduce the Cervical Deformity Patient Generated Index (PGI) to determine disabling features of CD that are appropriate for a CD specific HRQL. STUDY DESIGN/SETTING: Retrospective review of a prospective operative CD database and prospective development of a novel CD-PGI metric. PATIENT SAMPLE: A total of 139 CD patients and 12 PGI patients. OUTCOME MEASURES: Existing outcome metrics: NDI, NRS Back/Neck, mJOA, EQ5D, EQ5DVAS, and SWAL-QOL. Cervical Deformity Patient Generated Index (CD-PGI).
METHOD(S): CD patients completed the CD-PGI by describing the most important aspects of their disability. Patients wrote five things that bothered them most (Stage 1). Next patients rated the severity for each answer on a scale of 0 (max disability) to 10 (no disability) (Stage 2). Finally, patients "spent" up to 60 points on whichever responses they would like to improve (Stage 3). The PGI score was obtained by summing the product of Stage 2 and Stage 3 values for each response. PGI responses were categorized to find which aspects were most important to CD patients. A CD database was analyzed to assess whether legacy HRQLs correlate with cervical malalignment (CL, TSCL, cSVA, T1S, and C2S). Next PGI responses were analyzed to find how commonly responses were captured by existing cervical HRQL metrics: NDI, NRS Back/Neck, mJOA, EQ5D, EQ5DVAS and SWAL-QOL. Finally NDI and PGI were compared to elucidate major drivers of HRQL scores.
RESULT(S): A total of 139 CD patients (mean cSVA: 46.2mm) and 12 PGI patients (mean cSVA: 62mm) were included. PGI responses were grouped into 6 categories: Pain, Sagittal Discomfort/ROM, Horizontal Gaze/Walking Safety, Activities of Daily Living (ADL), Social Life and Hobbies and Neurologic. mJOA correlated with CL (r=0.21, p=0.01), TS-CL (r=-0.20, p=0.02), and C2S (r=-0.18, p=0.03). PGI scores did not correlate with any HRQLs. 34/60 PGI responses (57%) were found to be captured by existing HRQLs. The EQ5D addressed 53% of PGI responses compared to 43% for NDI, 3% for mJOA address and 0% for SWALQOL. PGI-Pain, -neurologic, -social life, and -ADL responses were addressed by existing HRQLs. However, only 40% horizontal gaze and 0% sagittal discomfort responses were addressed. The main drivers of NDI score were reading, pain, and recreation questions, explaining 80% of variability (r2=0.80). The main drivers of PGI were ADL, sagittal discomfort and social life, explaining 75% of variability (r2=0.75). NDI-Concentration NDI-Reading, NDI-Driving and NDI-Sleep correlated with multiple individual PGI items including PGI-ADL, -sagittal discomfort, and -social life (all r>.75, p<.05).
CONCLUSION(S): Existing HRQL do not adequately capture CD disability and do not correlate with cervical malalignment. PGI items not addressed in existing HRQLs include Sagittal Discomfort/ROM and Horizontal Gaze/Walking Safety. In addition, the most important categories driving PGI scores were found to be ADLs, Sagittal Discomfort/ROM, and Social Life/Hobbies. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2002161666
ISSN: 1878-1632
CID: 4052522

285. The impact of postoperative neurologic complications on recovery kinetics in cervical deformity surgery [Meeting Abstract]

Passias, P G; Brown, A; Diebo, B G; Lafage, R; Lafage, V; Burton, D C; Hart, R A; Kim, H J; Bess, S; Protopsaltis, T S; Sciubba, D M; Chou, D; Shaffrey, C I; Schwab, F J; Eastlack, R K; Line, B; Klineberg, E O; Smith, J S; Ames, C P
BACKGROUND CONTEXT: While corrective procedures for cervical deformity (CD) have significantly advanced, little is known what impact neurologic sequlae have on the postoperative recovery process. PURPOSE: Investigate which neurologic complications affect clinical outcomes the most following CD surgery. STUDY DESIGN/SETTING: Retrospective review of a prospective multicenter adult cervical deformity database. PATIENT SAMPLE: A total of 66 operative adult CD patients. OUTCOME MEASURES: Neurologic complication rates and Integrated Health State for the Neck Disability Index (NDI), EuroQol-5D (EQ-5D), and the Modified Japanese Orthopedic Association score (mJOA).
METHOD(S): CD patients (C2-C7 Cobb>10degree, CL>10degree, cSVA>4cm, or CBVA>25degree)>18yr with follow up surgical and HRQL data were included. Descriptive analyses assessed demographics. Neuro comps assessed were: C5 motor deficit, central neuro deficit, nerve root motor deficits, nerve sensory deficits, radiculopathy and spinal cord deficits. Neuro comps were classified as major (M) or minor, then: intra-operative, before discharge, before 30 days, before 90 days, and after 90 days. The rates of persistent neurologic deficits were assessed at 1 and 2 years. HRQL outcomes were assessed at 3M, 6M, 1Y and 2Y. Integrated health state (IHS) for the NDI, EQ5D, and mJOA were assessed using all follow up time points.
RESULT(S): A total of 66 operative CD patients were included. Baseline demo and surgery data: 61 years old, 63% female, BMI 29.7, op time 531.6 +/- 275.5, EBL 924.2 +/- 729.5, 49% posterior only approach, 18% anterior only approach, 33% combined. 34 (21%) patients experienced a total of 31 neurologic complications in the postoperative period (15M). In total, there were 7 radiculopathy, 6 motor deficits, 6 sensory deficits, 5 C5 motor deficits, 2 central neuro deficits, 2 spinal cord deficits, and 2 other. Motor deficits were the most common major complication (8), 4 of which were C5. Of the intraoperative complications, there were 3M, while 23% of patients had complications before discharge (5M). A total of 39% of neurologic complications occurred before 30 days (7M) and 71% before 90 days (12M), 16% were after 90 days (2M). A total of 12% of neuro comp patients went on to have revision surgery within 6 months, and 18% within 2 years. While normalized 6M mJOA scores were worse between neuro comp and no comp patients (1.00 +/- 0.12 vs 1.11 +/- 0.19, p=0.024), there was no significant difference in 2Y IHS for the NDI, EQ5D or mJOA (all p>0.05). When assessing individual comps, central neurologic deficits and spinal cord deficit patients had the worst outcomes at 1Y (2.6 and 1.8 times worse normalized NDI scores, p=0.04, no improvement in EQ5D, 8% decrease in EQ5D). Patients with sensory deficits had the best NDI and EQ5D outcomes at 1Y (31% decrease in NDI, 8% increase in EQ5D). One-half of neuro comp patients had persistent neurologic deficits at 1Y, and 21% at 2Y, however, there was no difference in outcomes at any time point (all p>0.05). Experiencing a nerve sensory deficit or spinal cord deficit correlated with revision surgery (r=0.241, 0.283, p<0.05).
CONCLUSION(S): A total of 21% of patients undergoing CD surgery experienced a neurologic complication, with 71% occurring within 6 months. While patients who experienced any neurologic complication had worse mJOA scores at 6M, there was no significant difference in recovery kinetics at 2Y. Of the neurologic complications, central neurologic deficits and spinal cord deficits were the most detrimental. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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EMBASE:2002161644
ISSN: 1878-1632
CID: 4052542