Complication Rates Following Adult Spinal Deformity Surgery: Evaluation of the Category of Complication and Chronology.

OBJECTIVE: Provide benchmarks for the rates of complications by type and timing. STUDY DESIGN: Prospective multicenter database. BACKGROUND: Complication rates following adult spinal deformity (ASD) surgery have been previously reported. However, the interplay between timing and complication type warrants further analysis. METHODS: The data for this study were sourced from a prospective, multicenter ASD database. The date and type of complication were collected and classified into three severity groups (minor, major, and major leading to reoperation). Only complications occurring before the two-year visit were retained for analysis. RESULTS: Of the 1260 patients eligible for two-year follow-up, 997 (79.1%) achieved two-year follow-up. The overall complication rate was 67.4% (N=672). 247 patients (24.8%) experienced at least one complication on the day of surgery (including intraoperatively), 359 (36.0%) between postoperative day 1 and six weeks postoperatively, 271 (27.2%) between six weeks and one-year postoperatively, and finally 162 (16.3%) between one year and two years postoperatively. Using Kaplan-Meier survival analysis, the rate of remaining complication-free was estimated at different time points for different severities and types of complications. Stratification by type of complication demonstrated that most of the medical complications occurred within the first 60 days. Surgical complications presented over two distinct timeframes. Operative complications, incision-related complications, and infections occurred early (within 60 d), while implant-related and radiographic complications occurred at a constant rate over the two-year follow-up period. Neurological complications had the highest occurrence within the first 60 days but continued to increase up to the two-year visit. CONCLUSION: Only one-third of ASD patients remained complication-free by two years, and 2 of 10 patients had a complication requiring a reoperation or revision. An estimation of the timing and type of complications associated with surgical treatment may prove useful for more meaningful patient counseling and aid in assessing the cost-effectiveness of treatment. LEVEL OF EVIDENCE: 3.

Cervical Spine Research Society-Cervical Stiffness Disability Index (CSRS-CSDI): Validation of a Novel Scoring System Quantifying the Effect of Postarthrodesis Cervical Stiffness on Patient Quality of Life.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: The aim was to create and validate a novel patient-reported outcome measure (PROM) focusing on stiffness-related patient functional limitations after cervical spine fusion. SUMMARY OF BACKGROUND DATA: Cervical arthrodesis is a common treatment for myelopathy/radiculopathy, however, results in increased neck stiffness as a collateral outcome. No current PROM exists quantifying the impact of postoperative stiffness on patient function. METHODS: The Cervical Spine Research Society-Cervical Stiffness Disability Index (CSRS-CSDI) was created through a modified Delphi process. The resultant 10-item questionnaire yields a score out of 100 with higher scores indicating increased functional difficulty related to neck stiffness. Cross-sectional study of control and postoperative patients was completed for CSRS-CSDI validation. Retest reliability (intraclass correlation coefficient), internal consistency (Cronbach alpha), responsiveness (levels fused vs. CSRS-CSDI scores), and discriminatory validation (CSRS-CSDI vs. neck disability index) scores) were completed. RESULTS: Fifty-seven surgical and 24 control patients completed the questionnaire. Surgical patients underwent a variety of procedures: 11 (19%) motion preserving operations, nine (16%) subaxial 1-2 level fusions, seven (12%) subaxial 3-5 level fusions, five (9%) C1-subaxial cervical spine fusions, 20 (35%) C2-upper thoracic spine fusions, five (9%) occiput-subaxial or thoracic spine fusions. The questionnaire demonstrated high internal consistency (Cronbach alpha=0.92) and retest reliability (intraclass correlation coefficient=0.95, P <0.001). Good responsiveness validity with a significant difference between fusion cohorts was found ( P <0.001, rs =0.63). Patient CSRS-CSDI scores also correlated with neck disability index scores recorded ( P <0.001, r =0.70). CONCLUSION: This is the first study to create a PROM addressing the functional impact of cervical stiffness following surgical arthrodesis. The CSRS-CSDI was a reliable and valid measure of postoperative stiffness impact on patient function. This may prove useful in counseling patients regarding their expected outcomes with further investigation demonstrating its value in a prospective fashion.

Prioritization of realignment associated with superior clinical outcomes for surgical cervical deformity patients.

BACKGROUND: To optimize quality of life in patients with cervical deformity (CD), there may be alignment targets to be prioritized. OBJECTIVE: To prioritize the cervical parameter targets for alignment. METHODS: Included: CD patients (C2-C7 Cobb >10°°, C2-C7 lordosis [CL] >10°°, cSVA > 4 cm, or chin-brow vertical angle >25°°) with full baseline (BL) and 1-year (1Y) radiographic parameters and Neck Disability Index (NDI) scores; patients with cervical (C) or cervicothoracic (CT) Primary Driver Ames type. Patients with BL Ames classified as low CD for both parameters of cSVA (<4 cm) and T1 slope minus CL (TS-CL) (<15°°) were excluded. Patients assessed: Meeting Minimal Clinically Important Difference (MCID) for NDI (<-15 ΔNDI). Ratios of correction were found for regional parameters categorized by Primary Ames Driver (C or CT). Decision tree analysis assessed cut-offs for differences associated with meeting NDI MCID at 1Y. RESULTS: Seventy-seven CD patients (62.1 years, 64%F, 28.8 kg/m2). 41.6% met MCID for NDI. A backward linear regression model including radiographic differences as predictors from BL to 1Y for meeting MCID for NDI demonstrated an R 2= 0.820 (P = 0.032) included TS-CL, cSVA, MGS, C2SS, C2-T3 angle, C2-T3 sagittal vertical axis (SVA), CL. By primary Ames driver, 67.5% of patients were C, and 32.5% CT. Ratios of change in predictors for MCID NDI patients for C and CT were not significant between the two groups (P > 0.050). Decision tree analysis determined cut-offs for radiographic change, prioritizing in the following order: ≥42.5° C2-T3 angle, >35.4° CL, <-31.76° C2 slope, <-11.57 mm cSVA, <-2.16° MGS, >-30.8 mm C2-T3 SVA, and ≤-33.6° TS-CL. CONCLUSIONS: Certain ratios of correction of cervical parameters contribute to improving neck disability. Prioritizing these radiographic alignment parameters may help optimize patient-reported outcomes for patients undergoing CD surgery.

Prioritization of Realignment Associated With Superior Clinical Outcomes for Cervical Deformity Patients.

OBJECTIVE: To prioritize the cervical parameter targets for alignment. METHODS: Included: cervical deformity (CD) patients (C2-7 Cobb angle > 10°, cervical lordosis > 10°, cervical sagittal vertical axis [cSVA] > 4 cm, or chin-brow vertical angle > 25°) with full baseline (BL) and 1-year (1Y) radiographic parameters and Neck Disability Index (NDI) scores; patients with cervical [C] or cervicothoracic [CT] Primary Driver Ames type. Patients with BL Ames classified as low CD for both parameters of cSVA ( < 4 cm) and T1 slope minus cervical lordosis (TS-CL) ( < 15°) were excluded. Patients assessed: meeting minimum clinically important differences (MCID) for NDI ( < -15 ΔNDI). Ratios of correction were found for regional parameters categorized by primary Ames driver (C or CT). Decision tree analysis assessed cutoffs for differences associated with meeting NDI MCID at 1Y. RESULTS: Seventy-seven CD patients (mean age, 62.1 years; 64% female; body mass index, 28.8 kg/m2). Forty-one point six percent of patients met MCID for NDI. A backwards linear regression model including radiographic differences as predictors from BL to 1Y for meeting MCID for NDI demonstrated an R2 of 0.820 (p = 0.032) included TS-CL, cSVA, McGregor's slope (MGS), C2 sacral slope, C2-T3 angle, C2-T3 SVA, cervical lordosis. By primary Ames driver, 67.5% of patients were C, and 32.5% CT. Ratios of change in predictors for MCID NDI patients for C and CT were not significant between the 2 groups (p > 0.050). Decision tree analysis determined cutoffs for radiographic change, prioritizing in the following order: ≥ 42.5° C2-T3 angle, > 35.4° cervical lordosis, < -31.76° C2 slope, < -11.57-mm cSVA, < -2.16° MGS, > -30.8-mm C2-T3 SVA, and ≤ -33.6° TS-CL. CONCLUSION: Certain ratios of correction of cervical parameters contribute to improving neck disability. Prioritizing these radiographic alignment parameters may help optimize patient-reported outcomes for patients undergoing CD surgery.

Predictors of Superior Recovery Kinetics in Adult Cervical Deformity Correction: An Analysis Using a Novel Area Under the Curve Methodology.

STUDY DESIGN: Retrospective review of a prospective database. OBJECTIVE: The aim of this study was to identify demographic, surgical, and radiographic factors that predict superior recovery kinetics following cervical deformity (CD) corrective surgery. SUMMARY OF BACKGROUND DATA: Analyses of CD corrective surgery use area under the curve (AUC) to assess health-related quality of life (HRQL) metrics throughout recovery. METHODS: Outcome measures were baseline (BL) to 1-year (1Y) health-related quality of life (HRQL) (Neck Disability Index [NDI]). CD criteria were C2-7 Cobb angle >10°, coronal Cobb angle >10°, C2-C7 sagittal vertical axis (cSVA) >4 cm, TS-CL >10°, or chin-brow vertical angle >25°. AUC normalization divided BL and postoperative outcomes by BL. Normalized scores (y axis) were plotted against follow-up (x axis). AUC was calculated and divided by cumulative follow-up length to determine overall, time-adjusted recovery (Integrated Health State [IHS]). IHS NDI was stratified by quartile, uppermost 25% being "Superior" Recovery Kinetics (SRK) versus "Normal" Recovery Kinetics (NRK). BL demographic, clinical, and surgical information predicted SRK using generalized linear modeling. RESULTS: Ninety-eight patients included (62 ±â€Š10 years, 28 ±â€Š6 kg/m2, 65% females, Charlson Comorbidity Index: 0.95), 6% smokers, 31% smoking history. Surgical approach was: combined (33%), posterior (49%), anterior (18%). Posterior levels fused: 8.7, anterior: 3.6, estimated blood loss: 915.9ccs, operative time: 495 minutes. Ames BL classification: cSVA (53.2% minor deformity, 46.8% moderate), TS-CL (9.8% minor, 4.3% moderate, 85.9% marked), horizontal gaze (27.4% minor, 46.6% moderate, 26% marked). Relative to BL NDI (Mean: 47), normalized NDI decreased at 3 months (0.9 ±â€Š0.5, P = 0.260) and 1Y (0.78 ±â€Š0.41, P < 0.001). NDI IHS correlated with age (P = 0.011), sex (P = 0.042), anterior approach (P = 0.042), posterior approach (P = 0.042). Greater BL pelvic tilt (PT) (SRK: 25.6°, NRK: 17°, P = 0.002), pelvic incidence-lumbar lordosis (PI-LL) (SRK: 8.4°, NRK: -2.8°, P = 0.009), and anterior approach (SRK: 34.8%, NRK: 13.3%; P = 0.020) correlated with SRK. 69.4% met MCID for NDI (<Δ-15) and 63.3% met substantial clinical benefit for NDI (<Δ-10); 100% of SRK met both MCID and substantial clinical benefit. The predictive model for SRK included (AUC = 88.1%): BL visual analog scale (VAS) EuroQol five-dimensional descriptive system (EQ5D) (odds rario [OR] 0.96, 95% confidence interval [CI]: 0.92-0.99), BL swallow sleep score (OR: 1.04, 95% CI: 1.01-1.06), BL PT (OR: 1.12, 95% CI: 1.03-1.22), BL modified Japanese Orthopedic Association scale (mJOA) (OR: 1.5, 95% CI: 1.07-2.16), BL T4-T12, BL T10-L2, BL T12-S1, and BL L1-S1. CONCLUSION: Superior recovery kinetics following CD surgery was predicted with high accuracy using BL patient-reported (VAS EQ5D, swallow sleep, mJOA) and radiographic factors (PT, TK, T10-L2, T12-S1, L1-S1). Awareness of these factors can improve decision-making and reduce postoperative neck disability.Level of Evidence: 3.

Development of a Preoperative Adult Spinal Deformity Comorbidity Score That Correlates With Common Quality and Value Metrics: Length of Stay, Major Complications, and Patient-Reported Outcomes.

STUDY DESIGN: Retrospective review of a multicenter prospective registry. OBJECTIVES: Our goal was to develop a method to risk-stratify adult spinal deformity (ASD) patients on the basis of their accumulated health deficits. We developed a novel comorbidity score (CS) specific to patients with ASD based on their preoperative health state and investigated whether it was associated with major complications, length of hospital stay (LOS), and self-reported outcomes after ASD surgery. METHODS: We identified 273 operatively treated ASD patients with 2-year follow-up. We assessed associations between major complications and age, comorbidities, Charlson Comorbidity Index score, and Oswestry Disability Index score. Significant factors were used to construct the ASD-CS. Associations of ASD-CS with major complications, LOS, and patient-reported outcomes were analyzed. RESULTS: Major complications increased significantly with ASD-CS (P < .01). Compared with patients with ASD-CS of 0, the odds of major complications were 2.8-fold higher (P = .068) in patients with ASD-CS of 1 through 3; 4.5-fold higher (P < .01) in patients with ASD-CS of 4 through 6; and 7.5-fold higher (P < .01) in patients with ASD-CS of 7 or 8. Patients with ASD-CS of 7 or 8 had the longest mean LOS (10.7 days) and worst mean Scoliosis Research Society-22r total score at baseline; however, they experienced the greatest mean improvement (0.98 points) over 2 years. CONCLUSIONS: The ASD-CS is significantly associated with major complications, LOS, and patient-reported outcomes in operatively treated ASD patients.

Does Patient Frailty Status Influence Recovery Following Spinal Fusion for Adult Spinal Deformity?: An Analysis of Patients With 3-Year Follow-up.

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.

The Effect of Prophylactic Hypothermia on Neurophysiological and Functional Measures in the Setting of Iatrogenic Spinal Cord Impact Injury.

BACKGROUND: Iatrogenic spinal cord injury (iSCI) during spinal corrective surgery can result in devastating complications, such as paraplegia or paraparesis. Perioperatively, iSCI often occurs as a direct injury during spinal cord instrumentation placement. Currently, treatment of iSCI remains limited to posttraumatic hypothermia, which has demonstrated some value in recent clinical trials. Here we report the outcomes of preinjury hypothermia initiated preprocedurally and maintained for a considerable time after iSCI. METHODS: Twenty-six female Sprague-Dawley rats were assigned at random to either a normothermic group (36 °C) or a hypothermic group (32 °C) and then underwent a laminectomy procedure at the T8 level. Each group was further divided at random to receive a 200-kdyn force contusive spinal cord injury or a sham impact. Hypothermic rats were then rewarmed after 2 hours of hypothermic treatment. Behavioral scores, temperature profiles, weights, and somatosensory evoked potentials were obtained at baseline and at specified time points after the procedure. RESULTS: The median survival was 42 days for the iSCI hypothermic group and 11 days for the iSCI normothermic group (hazard ratio, 3.82; 95% confidence interval, 1.52-9.57). The probability of survival was significantly higher in the iSCI hypothermic group compared with the iSCI normothermic group (χ2 = 4.18; P = 0.040). The hypothermic group exhibited a higher Basso, Beattie and Bresnahan (BBB) locomotor rating scale score (17 vs. 14; P < 0.01), lower normalized latencies (1.06 ± 0.16 seconds vs. 1.34 ± 0.17 seconds; P = 0.04), and higher peak-to-peak amplitudes (0.32 ± 0.10 µV vs. 0.12 ± 0.09 µV; P = 0.005). CONCLUSIONS: The use of prophylactic hypothermia before iSCI was significantly associated with an increased survival rate, higher BBB scores, and improved neurophysiological measures.

Area Under the Curve of Somatosensory Evoked Potentials Detects Spinal Cord Injury.

PURPOSE: Intraoperative neurophysiological monitoring using somatosensory evoked potentials has been linked to a reduction in the incidence of neurological deficits during corrective surgery. Nonetheless, quantitative assessments of somatosensory evoked potential waveforms are often difficult to evaluate, because they are affected by anesthesia, injury, and noise. Here, we discuss a novel method that integrates somatosensory evoked potential signals into a single metric by calculating the area under the curve (AUC). METHODOLOGY: Thirty-two Sprague-Dawley rats underwent a laminectomy procedure and were then randomly assigned to a control group or to receive a contusive spinal cord injury ranging from 100 to 200 kilodynes. Neurophysiological testing was completed at various points perioperatively and postoperatively. Somatosensory evoked potential traces obtained were processed and the AUC metric was calculated. RESULTS: The AUC significantly decreased to 11% of its baseline value after impact and remained at 25% baseline after 1 hour for the 200-kdyn cohort. Postimpact, AUC for the control versus the 150-kdyn and 200-kdyn groups, and the 150-kdyn versus 200-kdyn groups were significantly higher (P < 0.01, P < 0.001, and P < 0.05, respectively). Across days, the only significant parameter accounting for AUC variability was impact force, P < 0.0001 (subject parameters and number of days were not significant). CONCLUSIONS: The AUC metric can detect an iatrogenic contusive spinal cord injury immediately after its occurrence. Moreover, this metric can detect different iatrogenic injury impact force levels and identify injury in the postoperative period. The AUC integrates multiple Intraoperative neurophysiological monitoring measures into a single metric and thus has the potential to help clinicians and investigators evaluate spinal cord impact injury status.

Thoracic, Lumbar, and Sacral Pedicle Screw Placement Using Stryker-Ziehm Virtual Screw Technology and Navigated Stryker Cordless Driver 3: Technical Note.

OBJECT: Utilization of pedicle screws (PS) for spine stabilization is common in spinal surgery. With reliance on visual inspection of anatomical landmarks prior to screw placement, the free-hand technique requires a high level of surgeon skill and precision. Three-dimensional (3D), computer-assisted virtual neuronavigation improves the precision of PS placement and minimization steps. METHODS: Twenty-three patients with degenerative, traumatic, or neoplastic pathologies received treatment via a novel three-step PS technique that utilizes a navigated power driver in combination with virtual screw technology. (1) Following visualization of neuroanatomy using intraoperative CT, a navigated 3-mm match stick drill bit was inserted at an anatomical entry point with a screen projection showing a virtual screw. (2) A Navigated Stryker Cordless Driver with an appropriate tap was used to access the vertebral body through a pedicle with a screen projection again showing a virtual screw. (3) A Navigated Stryker Cordless Driver with an actual screw was used with a screen projection showing the same virtual screw. One hundred and forty-four consecutive screws were inserted using this three-step, navigated driver, virtual screw technique. RESULTS: Only 1 screw needed intraoperative revision after insertion using the three-step, navigated driver, virtual PS technique. This amounts to a 0.69% revision rate. One hundred percent of patients had intraoperative CT reconstructed images taken to confirm hardware placement. CONCLUSIONS: Pedicle screw placement utilizing the Stryker-Ziehm neuronavigation virtual screw technology with a three step, navigated power drill technique is safe and effective.

Novel Angular Measures of Cervical Deformity Account for Upper Cervical Compensation and Sagittal Alignment.

STUDY DESIGN: This is a retrospective review of a prospective multicenter database. OBJECTIVE: This study introduces 2 new cervical alignment measures accounting for both cervical deformity (CD) and upper cervical compensation. SUMMARY OF BACKGROUND DATA: Current descriptions of CD like the C2-C7 sagittal vertical axis (cSVA) do not account for compensatory mechanisms such as C0-C2 lordosis and pelvic tilt, which makes surgical planning difficult. The craniocervical angle (CCA) combines the slope of McGregor's line and the inclination from C7 to the hard palate. The C2-pelvic tilt (CPT) combines C2 tilt and pelvic tilt. Like the T1 pelvic angle, CPT is less affected by lower extremity and pelvic compensation. METHODS: Novel and existing CD measures were correlated in 781 patients from a thoracolumbar deformity (TLD) database and 61 patients from a prospective CD database. CD patients were subanalyzed by region of deformity driver: cervical or cervico-thoracic junction. TLD patients were substratified according to whether or not they had CD as well, where CD was defined as cSVA>4 cm or T1 slope minus cervical lordosis mismatch (TS-CL) >20. RESULTS: TLD cohort: mean cSVA was 31.7±17.8 mm. Subanalysis of TLD patients with CD versus no-CD demonstrated significant differences in CCA (56.2 vs. 60.6, P<0.001) and CPT (32.6 vs. 19.3, P<0.001). CCA and CPT correlated with cSVA (r=-0.488/r=0.418, P<0.001) and C0-C2 lordosis (r=-0.630/r=0.289,P<0.001). CD cohort: mean cSVA was 47.3±32.2 mm. CCA and CPT correlated with cSVA (r=-0.811/r=0.657, P<0.001) and C0-C2 lordosis (r=-0.656/r=0.610, P<0.001). CD cohort subanalysis indicated that CT patients were significantly more deformed by cSVA (71.3 vs 24.0 mm, P<0.001), CCA (47.1 vs 59.1 degrees, P<0.001), and CPT (63.3 vs 43.8 degrees, P=0.002). Using linear regression analysis, cSVA of 4 cm corresponded to CCA of 53.2 degrees (r=0.5) and CPT of 48.5 degrees (r=0.4). CONCLUSIONS: CCA and CPT account for both cervical sagittal alignment and upper cervical compensation and can be utilized in assessment of cervical alignment.