Does Bone Morphogenetic Protein Use Reduce Pseudarthrosis Rates in Single-Level Transforaminal Lumbar Interbody Fusion Surgeries?

BACKGROUND: Recombinant human bone morphogenetic protein 2 (rhBMP-2, or BMP for short) is a popular biological product used in spine surgeries to promote fusion and avoid the morbidity associated with iliac crest autograft. BMP's effect on pseudarthrosis in transforaminal lumbar interbody fusion (TLIF) remains unknown. OBJECTIVE: To assess the rates of pseudarthrosis in single-level TLIF with and without concurrent use of BMP. METHODS: This was a retrospective cohort study conducted at a single academic institution. Adults undergoing primary single-level TLIF with a minimum of 1 year of clinical and radiographic follow-up were included. BMP use was determined by operative notes at index surgery. Non-BMP cases with iliac crest bone graft were excluded. Pseudarthrosis was determined using radiographic and clinical evaluation. Bivariate differences between groups were assessed by independent t test and χ 2 analyses, and perioperative characteristics were analyzed by multiple logistic regression. RESULTS: One hundred forty-eight single-level TLIF patients were included. The mean age was 59.3 years, and 52.0% were women. There were no demographic differences between patients who received BMP and those who did not. Pseudarthrosis rates in patients treated with BMP were 6.2% vs 7.5% in the no BMP group (P = 0.756). There was no difference in reoperation for pseudarthrosis between patients who received BMP (3.7%) vs those who did not receive BMP (7.5%, P = 0.314). Patients who underwent revision surgery for pseudarthrosis more commonly had diabetes with end-organ damage (revised 37.5% vs not revised 1.4%, P < 0.001). Multiple logistic regression analysis demonstrated no reduction in reoperation for pseudarthrosis related to BMP use (OR 0.2, 95% CI 0.1-3.7, P = 0.269). Diabetes with end-organ damage (OR 112.6,95% CI 5.7-2225.8, P = 0.002) increased the risk of reoperation for pseudarthrosis. CONCLUSIONS: BMP use did not reduce the rate of pseudarthrosis or the number of reoperations for pseudarthrosis in single-level TLIFs. Diabetes with end-organ damage was a significant risk factor for pseudarthrosis. CLINICAL RELEVANCE: BMP is frequently used "off-label" in transforaminal lumbar interbody fusion; however, little data exists to demonstrate its safety and efficacy in this procedure.

Analysis of tranexamic acid usage in adult spinal deformity patients with relative contraindications: does it increase the risk of complications?

OBJECTIVE: Complex spinal deformity surgeries may involve significant blood loss. The use of antifibrinolytic agents such as tranexamic acid (TXA) has been proven to reduce perioperative blood loss. However, for patients with a history of thromboembolic events, there is concern of increased risk when TXA is used during these surgeries. This study aimed to assess whether TXA use in patients undergoing complex spinal deformity correction surgeries increases the risk of thromboembolic complications based on preexisting thromboembolic risk factors. METHODS: Data were analyzed for adult patients who received TXA during surgical correction for spinal deformity at 21 North American centers between August 2018 and October 2022. Patients with preexisting thromboembolic events and other risk factors (history of deep venous thrombosis [DVT], pulmonary embolism [PE], myocardial infarction [MI], stroke, peripheral vascular disease, or cancer) were identified. Thromboembolic complication rates were assessed during the postoperative 90 days. Univariate and multivariate analyses were performed to assess thromboembolic outcomes in high-risk and low-risk patients who received intravenous TXA. RESULTS: Among 411 consecutive patients who underwent complex spinal deformity surgery and received TXA intraoperatively, 130 (31.6%) were considered high-risk patients. There was no significant difference in thromboembolic complications between patients with and those without preexisting thromboembolic risk factors in univariate analysis (high-risk group vs low-risk group: 8.5% vs 2.8%, p = 0.45). Specifically, there were no significant differences between groups regarding the 90-day postoperative rates of DVT (high-risk group vs low-risk group: 1.5% vs 1.4%, p = 0.98), PE (2.3% vs 1.8%, p = 0.71), acute MI (1.5% vs 0%, p = 0.19), or stroke (0.8% vs 1.1%, p > 0.99). On multivariate analysis, high-risk status was not a significant independent predictor for any of the thromboembolic complications. CONCLUSIONS: Administration of intravenous TXA during the correction procedure did not change rates of thromboembolic events, acute MI, or stroke in this cohort of adult spinal deformity surgery patients.

Are insufficient corrections a major factor in distal junctional kyphosis? A simulated analysis of cervical deformity correction using in-construct measurements.

OBJECTIVE: The present study utilized recently developed in-construct measurements in simulations of cervical deformity surgery in order to assess undercorrection and predict distal junctional kyphosis (DJK). METHODS: A retrospective review of a database of operative cervical deformity patients was analyzed for severe DJK and mild DJK. C2-lower instrumented vertebra (LIV) sagittal angle (SA) was measured postoperatively, and the correction was simulated in the preoperative radiograph in order to match the C2-LIV by using the planning software. Linear regression analysis that used C2 pelvic angle (CPA) and pelvic tilt (PT) determined the simulated PT that matched the virtual CPA. Linear regression analysis was used to determine the C2-T1 SA, C2-T4 SA, and C2-T10 SA that corresponded to DJK of 20° and cervical sagittal vertical axis (cSVA) of 40 mm. RESULTS: Sixty-nine cervical deformity patients were included. Severe and mild DJK occurred in 11 (16%) and 22 (32%) patients, respectively; 3 (4%) required DJK revision. Simulated corrections demonstrated that severe and mild DJK patients had worse alignment compared to non-DJK patients in terms of cSVA (42.5 mm vs 33.0 mm vs 23.4 mm, p < 0.001) and C2-LIV SVA (68.9 mm vs 57.3 mm vs 36.8 mm, p < 0.001). Linear regression revealed the relationships between in-construct measures (C2-T1 SA, C2-T4 SA, and C2-T10 SA), cSVA, and change in DJK (all R > 0.57, p < 0.001). A cSVA of 40 mm corresponded to C2-T4 SA of 10.4° and C2-T10 SA of 28.0°. A DJK angle change of 10° corresponded to C2-T4 SA of 5.8° and C2-T10 SA of 20.1°. CONCLUSIONS: Simulated cervical deformity corrections demonstrated that severe DJK patients have insufficient corrections compared to patients without DJK. In-construct measures assess sagittal alignment within the fusion separate from DJK and subjacent compensation. They can be useful as intraoperative tools to gauge the adequacy of cervical deformity correction.

Machine learning clustering of adult spinal deformity patients identifies four prognostic phenotypes: a multicenter prospective cohort analysis with single surgeon external validation.

BACKGROUND CONTEXT: Among adult spinal deformity (ASD) patients, heterogeneity in patient pathology, surgical expectations, baseline impairments, and frailty complicates comparisons in clinical outcomes and research. This study aims to qualitatively segment ASD patients using machine learning-based clustering on a large, multicenter, prospectively gathered ASD cohort. PURPOSE: To qualitatively segment adult spinal deformity patients using machine learning-based clustering on a large, multicenter, prospectively gathered cohort. STUDY DESIGN/SETTING: Machine learning algorithm using patients from a prospective multicenter study and a validation cohort from a retrospective single center, single surgeon cohort with complete 2-year follow up. PATIENT SAMPLE: About 805 ASD patients; 563 patients from a prospective multicenter study and 242 from a single center to be used as a validation cohort. OUTCOME MEASURES: To validate and extend the Ames-ISSG/ESSG classification using machine learning-based clustering analysis on a large, complex, multicenter, prospectively gathered ASD cohort. METHODS: We analyzed a training cohort of 563 ASD patients from a prospective multicenter study and a validation cohort of 242 ASD patients from a retrospective single center/surgeon cohort with complete two-year patient-reported outcomes (PROs) and clinical/radiographic follow-up. Using k-means clustering, a machine learning algorithm, we clustered patients based on baseline PROs, Edmonton frailty, age, surgical history, and overall health. Baseline differences in clusters identified using the training cohort were assessed using Chi-Squared and ANOVA with pairwise comparisons. To evaluate the classification system's ability to discern postoperative trajectories, a second machine learning algorithm assigned the single-center/surgeon patients to the same 4 clusters, and we compared the clusters' two-year PROs and clinical outcomes. RESULTS: K-means clustering revealed four distinct phenotypes from the multicenter training cohort based on age, frailty, and mental health: Old/Frail/Content (OFC, 27.7%), Old/Frail/Distressed (OFD, 33.2%), Old/Resilient/Content (ORC, 27.2%), and Young/Resilient/Content (YRC, 11.9%). OFC and OFD clusters had the highest frailty scores (OFC: 3.76, OFD: 4.72) and a higher proportion of patients with prior thoracolumbar fusion (OFC: 47.4%, OFD: 49.2%). ORC and YRC clusters exhibited lower frailty scores and fewest patients with prior thoracolumbar procedures (ORC: 2.10, 36.6%; YRC: 0.84, 19.4%). OFC had 69.9% of patients with global sagittal deformity and the highest T1PA (29.0), while YRC had 70.2% exhibiting coronal deformity, the highest mean coronal Cobb Angle (54.0), and the lowest T1PA (11.9). OFD and ORC had similar alignment phenotypes with intermediate values for Coronal Cobb Angle (OFD: 33.7; ORC: 40.0) and T1PA (OFD: 24.9; ORC: 24.6) between OFC (worst sagittal alignment) and YRC (worst coronal alignment). In the single surgeon validation cohort, the OFC cluster experienced the greatest increase in SRS Function scores (1.34 points, 95%CI 1.01-1.67) compared to OFD (0.5 points, 95%CI 0.245-0.755), ORC (0.7 points, 95%CI 0.415-0.985), and YRC (0.24 points, 95%CI -0.024-0.504) clusters. OFD cluster patients improved the least over 2 years. Multivariable Cox regression analysis demonstrated that the OFD cohort had significantly worse reoperation outcomes compared to other clusters (HR: 3.303, 95%CI: 1.085-8.390). CONCLUSION: Machine-learning clustering found four different ASD patient qualitative phenotypes, defined by their age, frailty, physical functioning, and mental health upon presentation, which primarily determines their ability to improve their PROs following surgery. This reaffirms that these qualitative measures must be assessed in addition to the radiographic variables when counseling ASD patients regarding their expected surgical outcomes.

Lumbar Lordosis Redistribution and Segmental Correction in Adult Spinal Deformity (ASD): Does it Matter?

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: Evaluate the impact of correcting to normative segmental lordosis values on post-operative outcomes. BACKGROUND: Restoring lumbar lordosis magnitude is crucial in adult spinal deformity surgery, but the optimal location and segmental distribution remains unclear. METHODS: Patients were grouped based on offset to normative segmental lordosis values, extracted from recent publications. Matched patients were within 10% of the cohort's mean offset, less than or over 10% were under- and over-corrected. Surgical technique, PROMs, and surgical complications were compared across groups at baseline and 2-year. RESULTS: 510 patients with an average age of 64.6, mean CCI 2.08, and average follow-up of 25 months. L4-5 was least likely to be matched (19.1%), while L4-S1 was the most likely (24.3%). More patients were overcorrected at proximal levels (T10-L2; Undercorrected, U: 32.2% vs. Matched, M: 21.7% vs. Overcorrected, O: 46.1%) and undercorrected at distal levels (L4-S1: U: 39.0% vs. M: 24.3% vs. O: 36.8%). Postoperative ODI was comparable across correction groups at all spinal levels except at L4-S1 and T10-L2/L4-S1, where overcorrected patients and matched were better than undercorrected (U: 32.1 vs. M: 25.4 vs. O: 26.5, P=0.005; U: 36.2 vs. M: 24.2 vs. O: 26.8, P=0.001; respectively). Patients overcorrected at T10-L2 experienced higher rates of proximal junctional failure (PJF) (U: 16.0% vs. M: 15.6% vs. O: 32.8%, P<0.001) and had greater posterior inclination of the upper instrumented vertebra (UIV) (U: -9.2±9.4° vs. M: -9.6±9.1° vs. O: -12.2±10.0°, P<0.001), whereas undercorrection at these levels led to higher rates of revision for implant failure (U: 14.2% vs. M: 7.3% vs. O: 6.4%, P=0.025). CONCLUSIONS: Patients undergoing fusion for adult spinal deformity suffer higher rates of PJF with overcorrection and increased rates of implant failure with undercorrection based on normative segmental lordosis. LEVEL OF EVIDENCE: IV.

Persistent Lower Extremity Compensation for Sagittal Imbalance After Surgical Correction of Complex Adult Spinal Deformity: A Radiographic Analysis of Early Impact.

BACKGROUND AND OBJECTIVES: Achieving spinopelvic realignment during adult spinal deformity (ASD) surgery does not always produce ideal outcomes. Little is known whether compensation in lower extremities (LEs) plays a role in this disassociation. The objective is to analyze lower extremity compensation after complex ASD surgery, its effect on outcomes, and whether correction can alleviate these mechanisms. METHODS: We included patients with complex ASD with 6-week data. LE parameters were as follows: sacrofemoral angle, knee flexion angle, and ankle flexion angle. Each parameter was ranked, and upper tertile was deemed compensation. Patients compensating and not compensating postoperatively were propensity score matched for body mass index, frailty, and T1 pelvic angle. Linear regression assessed correlation between LE parameters and baseline deformity, demographics, and surgical details. Multivariate analysis controlling for baseline deformity and history of total knee/hip arthroplasty evaluated outcomes. RESULTS: Two hundred and ten patients (age: 61.3 ± 14.1 years, body mass index: 27.4 ± 5.8 kg/m2, Charlson Comorbidity Index: 1.1 ± 1.6, 72% female, 22% previous total joint arthroplasty, 24% osteoporosis, levels fused: 13.1 ± 3.8) were included. At baseline, 59% were compensating in LE: 32% at hips, 39% knees, and 36% ankles. After correction, 61% were compensating at least one joint. Patients undercorrected postoperatively were less likely to relieve LE compensation (odds ratio: 0.2, P = .037). Patients compensating in LE were more often undercorrected in age-adjusted pelvic tilt, pelvic incidence, lumbar lordosis, and T1 pelvic angle and disproportioned in Global Alignment and Proportion (P < .05). Patients matched in sagittal age-adjusted score at 6 weeks but compensating in LE were more likely to develop proximal junctional kyphosis (odds ratio: 4.1, P = .009) and proximal junctional failure (8% vs 0%, P = .035) than those sagittal age-adjusted score-matched and not compensating in LE. CONCLUSION: Perioperative lower extremity compensation was a product of undercorrecting complex ASD. Even in age-adjusted realignment, compensation was associated with global undercorrection and junctional failure. Consideration of lower extremities during planning is vital to avoid adverse outcomes in perioperative course after complex ASD surgery.

Lateral lumbar interbody fusion at L4-L5 has a low rate of complications in appropriately selected patients when using a standardized surgical technique.

Aims: The aim of this study was to reassess the rate of neurological, psoas-related, and abdominal complications associated with L4-L5 lateral lumbar interbody fusion (LLIF) undertaken using a standardized preoperative assessment and surgical technique. Methods: This was a multicentre retrospective study involving consecutively enrolled patients who underwent L4-L5 LLIF by seven surgeons at seven institutions in three countries over a five-year period. The demographic details of the patients and the details of the surgery, reoperations and complications, including femoral and non-femoral neuropraxia, thigh pain, weakness of hip flexion, and abdominal complications, were analyzed. Neurological and psoas-related complications attributed to LLIF or posterior instrumentation and persistent symptoms were recorded at one year postoperatively. Results: A total of 517 patients were included in the study. Their mean age was 65.0 years (SD 10.3) and their mean BMI was 29.2 kg/m2 (SD 5.5). A mean of 1.2 levels (SD 0.6) were fused with LLIF, and a mean of 1.6 (SD 0.9) posterior levels were fused. Femoral neuropraxia occurred in six patients (1.2%), of which four (0.8%) were LLIF-related and two (0.4%) had persistent symptoms one year postoperatively. Non-femoral neuropraxia occurred in nine patients (1.8%), one (0.2%) was LLIF-related and five (1.0%) were persistent at one year. All LLIF-related neuropraxias resolved by one year. A total of 32 patients (6.2%) had thigh pain, 31 (6.0%) were LLIF-related and three (0.6%) were persistent at one year. Weakness of hip flexion occurred in 14 patients (2.7%), of which eight (1.6%) were LLIF-related and three (0.6%) were persistent at one year. No patients had bowel injury, three (0.6%) had an intraoperative vascular injury (not LLIF-related), and five (1.0%) had ileus. Reoperations occurred in five patients (1.0%) within 30 days, 37 (7.2%) within 90 days, and 41 (7.9%) within one year postoperatively. Conclusion: LLIF involving the L4-L5 disc level has a low rate of persistent neurological, psoas-related, and abdominal complications in patients with the appropriate indications and using a standardized surgical technique.

Single-Position Prone Lateral Lumbar Interbody Fusion Increases Operative Efficiency and Maintains Safety in Revision Lumbar Spinal Fusion.

STUDY DESIGN: Multi-centre retrospective cohort study. OBJECTIVE: To evaluate the feasibility and safety of the single-position prone lateral lumbar interbody fusion (LLIF) technique for revision lumbar fusion surgery. BACKGROUND CONTEXT: Prone LLIF (P-LLIF) is a novel technique allowing for placement of a lateral interbody in the prone position and allowing posterior decompression and revision of posterior instrumentation without patient repositioning. This study examines perioperative outcomes and complications of single position P-LLIF against traditional Lateral LLIF (L-LLIF) technique with patient repositioning. METHOD: A multi-centre retrospective cohort study involving patients undergoing 1 to 4 level LLIF surgery was performed at 4 institutions in the US and Australia. Patients were included if their surgery was performed via either: P-LLIF with revision posterior fusion; or L-LLIF with repositioning to prone. Demographics, perioperative outcomes, complications, and radiological outcomes were compared using independent samples t-tests and chi-squared analyses as appropriate with significance set at P <0.05. RESULTS: 101 patients undergoing revision LLIF surgery were included, of which 43 had P-LLIF and 58 had L-LLIF. Age, BMI and CCI were similar between groups. The number of posterior levels fused (2.21 P-LLIF vs. 2.66 L-LLIF, P =0.469) and number of LLIF levels (1.35 vs. 1.39, P =0.668) was similar between groups.Operative time was significantly less in the P-LLIF group (151 vs. 206 min, P =0.004). EBL was similar between groups (150mL P-LLIF vs. 182mL L-LLIF, P =0.31) and there was a trend toward reduced length of stay in the P-LLIF group (2.7 vs. 3.3d, P =0.09). No significant difference was demonstrated in complications between groups. Radiographic analysis demonstrated no significant differences in preoperative or postoperative sagittal alignment measurements. CONCLUSION: P-LLIF significantly improves operative efficiency when compared to L-LLIF for revision lumbar fusion. No increase in complications was demonstrated by P-LLIF or trade-offs in sagittal alignment restoration. LEVEL OF EVIDENCE: Level 4.

The Case for Operative Efficiency in Adult Spinal Deformity Surgery: Impact of Operative Time on Complications, Length of Stay, Alignment, Fusion Rates, and Patient-Reported Outcomes.

STUDY DESIGN: Retrospective review of prospectively collected data. OBJECTIVE: To analyze the impact of operative room (OR) time in adult spinal deformity (ASD) surgery on patient outcomes. BACKGROUND: It is currently unknown if OR time in ASD patients matched for deformity severity and surgical invasiveness is associated with patient outcomes. MATERIALS AND METHODS: ASD patients with baseline and two-year postoperative radiographic and patient-reported outcome measures (PROM) data, undergoing a posterior-only approach for long fusion (>L1-Ilium) were included. Patients were grouped into short OR time (<40th percentile: <359 min) and long OR time (>60th percentile: >421 min). Groups were matched by age, baseline deformity severity, and surgical invasiveness. Demographics, radiographic, PROM data, fusion rate, and complications were compared between groups at baseline and two years follow-up. RESULTS: In total, 270 patients were included for analysis: the mean OR time was 286 minutes in the short OR group versus 510 minutes in the long OR group ( P <0.001). Age, gender, percent of revision cases, surgical invasiveness, pelvic incidence minus lumbar lordosis, sagittal vertical axis, and pelvic tilt were comparable between groups ( P >0.05). Short OR had a slightly lower body mass index than the short OR group ( P <0.001) and decompression was more prevalent in the long OR time ( P =0.042). Patients in the long group had greater hospital length of stay ( P =0.02); blood loss ( P <0.001); proportion requiring intensive care unit ( P =0.003); higher minor complication rate ( P =0.001); with no significant differences for major complications or revision procedures ( P >0.5). Both groups had comparable radiographic fusion rates ( P =0.152) and achieved improvement in sagittal alignment measures, Oswestry disability index, and Short Form-36 ( P <0.001). CONCLUSION: Shorter OR time for ASD correction is associated with a lower minor complication rate, a lower estimated blood loss, fewer intensive care unit admissions, and a shorter hospital length of stay without sacrificing alignment correction or PROMs. Maximizing operative efficiency by minimizing OR time in ASD surgery has the potential to benefit patients, surgeons, and hospital systems.

Patient-specific Cervical Deformity Corrections With Consideration of Associated Risk: Establishment of Risk Benefit Thresholds for Invasiveness Based on Deformity and Frailty Severity.

STUDY DESIGN/SETTING: This was a retrospective cohort study. BACKGROUND: Little is known of the intersection between surgical invasiveness, cervical deformity (CD) severity, and frailty. OBJECTIVE: The aim of this study was to investigate the outcomes of CD surgery by invasiveness, frailty status, and baseline magnitude of deformity. METHODS: This study included CD patients with 1-year follow-up. Patients stratified in high deformity if severe in the following criteria: T1 slope minus cervical lordosis, McGregor's slope, C2-C7, C2-T3, and C2 slope. Frailty scores categorized patients into not frail and frail. Patients are categorized by frailty and deformity (not frail/low deformity; not frail/high deformity; frail/low deformity; frail/high deformity). Logistic regression assessed increasing invasiveness and outcomes [distal junctional failure (DJF), reoperation]. Within frailty/deformity groups, decision tree analysis assessed thresholds for an invasiveness cutoff above which experiencing a reoperation, DJF or not achieving Good Clinical Outcome was more likely. RESULTS: A total of 115 patients were included. Frailty/deformity groups: 27% not frail/low deformity, 27% not frail/high deformity, 23.5% frail/low deformity, and 22.5% frail/high deformity. Logistic regression analysis found increasing invasiveness and occurrence of DJF [odds ratio (OR): 1.03, 95% CI: 1.01-1.05, P =0.002], and invasiveness increased with deformity severity ( P <0.05). Not frail/low deformity patients more often met Optimal Outcome with an invasiveness index <63 (OR: 27.2, 95% CI: 2.7-272.8, P =0.005). An invasiveness index <54 for the frail/low deformity group led to a higher likelihood of meeting the Optimal Outcome (OR: 9.6, 95% CI: 1.5-62.2, P =0.018). For the frail/high deformity group, patients with a score <63 had a higher likelihood of achieving Optimal Outcome (OR: 4.8, 95% CI: 1.1-25.8, P =0.033). There was no significant cutoff of invasiveness for the not frail/high deformity group. CONCLUSIONS: Our study correlated increased invasiveness in CD surgery to the risk of DJF, reoperation, and poor clinical success. The thresholds derived for deformity severity and frailty may enable surgeons to individualize the invasiveness of their procedures during surgical planning to account for the heightened risk of adverse events and minimize unfavorable outcomes.

The Importance of Incorporating Proportional Alignment in Adult Cervical Deformity Corrections Relative to Regional and Global Alignment: Steps Toward Development of a Cervical-Specific Score.

STUDY DESIGN/SETTING: Retrospective single-center study. BACKGROUND: The global alignment and proportion score is widely used in adult spinal deformity surgery. However, it is not specific to the parameters used in adult cervical deformity (ACD). PURPOSE: Create a cervicothoracic alignment and proportion (CAP) score in patients with operative ACD. METHODS: Patients with ACD with 2-year data were included. Parameters consisted of relative McGregor's Slope [RMGS = (MGS × 1.5)/0.9], relative cervical lordosis [RCL = CL - thoracic kyphosis (TK)], Cervical Lordosis Distribution Index (CLDI = C2 - Apex × 100/C2 - T2), relative pelvic version (RPV = sacral slope - pelvic incidence × 0.59 + 9), and a frailty factor (greater than 0.33). Cutoff points were chosen where the cross-tabulation of parameter subgroups reached a maximal rate of meeting the Optimal Outcome. The optimal outcome was defined as meeting Good Clinical Outcome criteria without the occurrence of distal junctional failure (DJF) or reoperation. CAP was scored between 0 and 13 and categorized accordingly: ≤3 (proportioned), 4-6 (moderately disproportioned), >6 (severely disproportioned). Multivariable logistic regression analysis determined the relationship between CAP categories, overall score, and development of distal junctional kyphosis (DJK), DJF, reoperation, and Optimal Outcome by 2 years. RESULTS: One hundred five patients with operative ACD were included. Assessment of the 3-month CAP score found a mean of 5.2/13 possible points. 22.7% of patients were proportioned, 49.5% moderately disproportioned, and 27.8% severely disproportioned. DJK occurred in 34.5% and DJF in 8.7%, 20.0% underwent reoperation, and 55.7% achieved Optimal Outcome. Patients severely disproportioned in CAP had higher odds of DJK [OR: 6.0 (2.1-17.7); P =0.001], DJF [OR: 9.7 (1.8-51.8); P =0.008], reoperation [OR: 3.3 (1.9-10.6); P =0.011], and lower odds of meeting the optimal outcome [OR: 0.3 (0.1-0.7); P =0.007] by 2 years, while proportioned patients suffered zero occurrences of DJK or DJF. CONCLUSION: The regional alignment and proportion score is a method of analyzing the cervical spine relative to global alignment and demonstrates the importance of maintaining horizontal gaze, while also matching overall cervical and thoracolumbar alignment to limit complications and maximize clinical improvement.

Avoiding Pitfalls in Adult Spinal Deformity.

To avoid the high rate of complications associated with the surgical management of adult spinal deformity, it is important to recognize and avoid three major pitfalls. The first is patient selection and determining which cases are appropriately indicated. The second is optimizing modifiable medical issues that can lead to a poor outcome, such as smoking, vitamin D deficiency, nutritional status, and poor bone quality. The third is optimizing surgical factors such as defining clinically appropriate, patient-specific target alignment goals as well as using techniques to avoid proximal junctional kyphosis and proximal junctional failure. It is important to describe these three key pitfalls that are commonly seen in the treatment of patients with adult spinal deformity and to describe methods to avoid them.

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.

STUDY 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.

The ISSG-AO Complication Intervention Score, but Not Major/Minor Designation, is Correlated With Length of Stay Following Adult Spinal Deformity Surgery.

STUDY DESIGN: Retrospective review. OBJECTIVES: The International Spine Study Group-AO (ISSG-AO) Adult Spinal Deformity (ASD) Complication Classification System was developed to improve classification, reporting, and study of complications among patients undergoing ASD surgery. The ISSG-AO system classifies interventions to address complications by level of invasiveness: grade zero (none); grade 1, mild (e.g., medication change); grade 2, moderate (e.g., ICU admission); grade 3, severe (e.g., reoperation related to surgery of interest). To evaluate the efficacy of the ISSG-AO ASD Complication Classification System, we aimed to compare correlations between postoperative length of stay (LOS) and complication severity as classified by the ISSG-AO ASD and traditional major/minor complication classification systems. METHODS: Patients age ≥18 in a multicenter ASD database who sustained in-hospital complications were identified. Complications were classified with the major/minor and ISSG-AO systems and correlated with LOS using an ensemble-based machine learning algorithm (conditional random forest) and a generalized linear mixed model. RESULTS: 490 patients at 19 sites were included. 64.9% of complications were major, and 35.1% were minor. By ISSG-AO classification, 20.4%, 66.1%, 6.7%, and 6.7% were grades 0-3, respectively. ISSG-AO complication grading demonstrated significant correlation with LOS, whereas major/minor complication classification demonstrated inverse correlation with LOS. In conditional random forest analysis, ISSG-AO classification had the greatest relative importance when assessing correlations across multiple variables with LOS. CONCLUSIONS: The ISSG-AO system may help identify specific complications associated with prolonged LOS. Targeted interventions to avoid or reduce these complications may improve ASD surgical quality and resource utilization.

Post-Operative Physical Therapy Following Cervical Spine Surgery: Analysis of Patient-Reported Outcomes.

Introduction Post-operative physical therapy (PT) following anterior cervical discectomy and fusion (ACDF) surgery is often performed to improve a patient's functional ability and reduce neck pain. However, current literature evaluating the benefits of post-operative PT using patient-reported outcomes (PROs) is limited and remains inconclusive. Here we compare post-operative improvement between patients who did and did not undergo formal PT after ACDF using Patient-Reported Outcomes Measurement Information System (PROMIS) scores. Methods A retrospective observational study examining patients who underwent one- or two-level primary ACDF or cervical disc replacement (CDR) at an academic orthopedic hospital and who had PROMIS scores recorded pre-operatively and through two-year follow-up. Patients were stratified according to whether or not they attended formal postoperative PT. PROMIS scores and patient demographics were compared using the Mann-Whitney U test, Fisher's exact test, chi-square test of independence, and Student's t-test within and between cohorts. Results Two hundred and twenty patients were identified. Demographic differences between PT and no PT groups include age (PT 54.1 vs. no PT 49.5, p=0.005) and BMI (PT 28.1 vs. no PT 29.8, p=0.028). The only significant difference in post-operative PROMIS scores was in physical health scores at three months post-operatively (no PT 43.9 vs. PT 39.1, p=0.008). Physical health scores improved from baseline to one-year follow-up in both cohorts (PT +3.5, p=0.025; no PT +6.6, p=0.008). There were no significant differences when comparing improvements in physical health scores between groups at six months and one year. Conclusion In conclusion, there was no significance to support the benefits of post-operative PT as measured by PROMIS scores. No significant differences in PROMIS were observed between groups from pre-operative baseline scores to six-month and one-year follow-ups.

The impact of baseline cervical malalignment on the development of proximal junctional kyphosis following surgical correction of thoracolumbar adult spinal deformity.

OBJECTIVE: The objective of this study was to identify the effect of baseline cervical deformity (CD) on proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) in patients with adult spinal deformity (ASD). METHODS: This study was a retrospective analysis of a prospectively collected, multicenter database comprising ASD patients enrolled at 13 participating centers from 2009 to 2018. Included were ASD patients aged > 18 years with concurrent CD (C2-7 kyphosis < -15°, T1S minus cervical lordosis > 35°, C2-7 sagittal vertical axis > 4 cm, chin-brow vertical angle > 25°, McGregor's slope > 20°, or C2-T1 kyphosis > 15° across any three vertebrae) who underwent surgery. Patients were grouped according to four deformity classification schemes: Ames and Passias CD modifiers, sagittal morphotypes as described by Kim et al., and the head versus trunk balance system proposed by Mizutani et al. Mean comparison tests and multivariable binary logistic regression analyses were performed to assess the impact of these deformity classifications on PJK and PJF rates up to 3 years following surgery. RESULTS: A total of 712 patients with concurrent ASD and CD met the inclusion criteria (mean age 61.7 years, 71% female, mean BMI 28.2 kg/m2, and mean Charlson Comorbidity Index 1.90) and underwent surgery (mean number of levels fused 10.1, mean estimated blood loss 1542 mL, and mean operative time 365 minutes; 70% underwent osteotomy). By approach, 59% of the patients underwent a posterior-only approach and 41% underwent a combined approach. Overall, 277 patients (39.1%) had PJK by 1 year postoperatively, and an additional 189 patients (26.7%) developed PJK by 3 years postoperatively. Overall, 65 patients (9.2%) had PJF by 3 years postoperatively. Patients classified as having a cervicothoracic deformity morphotype had higher rates of early PJK than flat neck deformity and cervicothoracic deformity patients (p = 0.020). Compared with the head-balanced patients, trunk-balanced patients had higher rates of PJK and PJF (both p < 0.05). Examining Ames modifier severity showed that patients with moderate and severe deformity by the horizontal gaze modifier had higher rates of PJK (p < 0.001). CONCLUSIONS: In patients with concurrent cervical and thoracolumbar deformities undergoing isolated thoracolumbar correction, the use of CD classifications allows for preoperative assessment of the potential for PJK and PJF that may aid in determining the correction of extending fusion levels.

Height Gain Following Correction of Adult Spinal Deformity.

BACKGROUND: Height gain following a surgical procedure for patients with adult spinal deformity (ASD) is incompletely understood, and it is unknown if height gain correlates with patient-reported outcome measures (PROMs). METHODS: This was a retrospective cohort study of patients undergoing ASD surgery. Patients with baseline, 6-week, and subanalysis of 1-year postoperative full-body radiographic and PROM data were examined. Correlation analysis examined relationships between vertical height differences and PROMs. Regression analysis was utilized to preoperatively estimate T1-S1 and S1-ankle height changes. RESULTS: This study included 198 patients (mean age, 57 years; 69% female); 147 patients (74%) gained height. Patients with height loss, compared with those who gained height, experienced greater increases in thoracolumbar kyphosis (2.81° compared with -7.37°; p < 0.001) and thoracic kyphosis (12.96° compared with 4.42°; p = 0.003). For patients with height gain, sagittal and coronal alignment improved from baseline to postoperatively: 25° to 21° for pelvic tilt (PT), 14° to 3° for pelvic incidence - lumbar lordosis (PI-LL), and 60 mm to 17 mm for sagittal vertical axis (SVA) (all p < 0.001). The full-body mean height gain was 7.6 cm, distributed as follows: sella turcica-C2, 2.9 mm; C2-T1, 2.8 mm; T1-S1 (trunk gain), 3.8 cm; and S1-ankle (lower-extremity gain), 3.3 cm (p < 0.001). T1-S1 height gain correlated with the thoracic Cobb angle correction and the maximum Cobb angle correction (p = 0.002). S1-ankle height gain correlated with the corrections in PT, PI-LL, and SVA (p < 0.001). T1-ankle height gain correlated with the corrections in PT (p < 0.001) and SVA (p = 0.03). Trunk height gain correlated with improved Scoliosis Research Society (SRS-22r) Appearance scores (r = 0.20; p = 0.02). Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores correlated with S1-ankle height gain (r = -0.19; p = 0.03) and C2-T1 height gain (r = -0.18; p = 0.04). A 1° correction in a thoracic scoliosis Cobb angle corresponded to a 0.2-mm height gain, and a 1° correction in a thoracolumbar scoliosis Cobb angle resulted in a 0.25-mm height gain. A 1° improvement in PI-LL resulted in a 0.2-mm height gain. CONCLUSIONS: Most patients undergoing ASD surgery experienced height gain following deformity correction, with a mean full-body height gain of 7.6 cm. Height gain can be estimated preoperatively with predictive ratios, and height gain was correlated with improvements in reported SRS-22r appearance and PROMIS scores. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Use of multiple rods and proximal junctional kyphosis in adult spinal deformity surgery.

OBJECTIVE: Multiple rods are utilized in adult spinal deformity (ASD) surgery to increase construct stiffness. However, the impact of multiple rods on proximal junctional kyphosis (PJK) is not well established. This study aimed to investigate the impact of multiple rods on PJK incidence in ASD patients. METHODS: ASD patients from a prospective multicenter database with a minimum follow-up of 1 year were retrospectively reviewed. Clinical and radiographic data were collected preoperatively, at 6 weeks postoperatively, at 6 months postoperatively, at 1 year postoperatively, and at every subsequent year postoperatively. PJK was defined as a kyphotic increase of > 10° in the Cobb angle from the upper instrumented vertebra (UIV) to UIV+2 as compared with preoperative values. Demographic data, radiographic parameters, and PJK incidence were compared between the multirod and dual-rod patient cohorts. PJK-free survival analysis was performed using Cox regression to control for demographic characteristics, comorbidities, level of fusion, and radiographic parameters. RESULTS: Overall, 307/1300 (23.62%) cases utilized multiple rods. Cases with multiple rods were more likely to be revisions (68.4% vs 46.5%, p < 0.001), to be posterior only (80.7% vs 61.5%, p < 0.001), involve more levels of fusion (mean 11.73 vs 10.60, p < 0.001), and include 3-column osteotomy (42.9% vs 17.1%, p < 0.001). Patients with multiple rods also had greater preoperative pelvic retroversion (mean pelvic tilt 27.95° vs 23.58°, p < 0.001), greater thoracolumbar junction kyphosis (-15.9° vs -11.9°, p = 0.001), and more severe sagittal malalignment (C7-S1 sagittal vertical axis 99.76 mm vs 62.23 mm, p < 0.001), all of which corrected postoperatively. Patients with multiple rods had similar incidence rates of PJK (58.6% vs 58.1%) and revision surgery (13.0% vs 17.7%). The PJK-free survival analysis demonstrated equivalent PJK-free survival durations among the patients with multiple rods (HR 0.889, 95% CI 0.745-1.062, p = 0.195) after controlling for demographic and radiographic parameters. Further stratification based on implant metal type demonstrated noninferior PJK incidence rates with multiple rods in the titanium (57.1% vs 54.6%, p = 0.858), cobalt chrome (60.5% vs 58.7%, p = 0.646), and stainless steel (20% vs 63.7%, p = 0.008) cohorts. CONCLUSIONS: Multirod constructs for ASD are most frequently utilized in revision, long-level reconstructions with 3-column osteotomy. The use of multiple rods in ASD surgery does not result in an increased incidence of PJK and is not affected by rod metal type.

Calibration of a comprehensive predictive model for the development of proximal junctional kyphosis and failure in adult spinal deformity patients with consideration of contemporary goals and techniques.

OBJECTIVE: The objective of this study was to calibrate an updated predictive model incorporating novel clinical, radiographic, and prophylactic measures to assess the risk of proximal junctional kyphosis (PJK) and failure (PJF). METHODS: Operative patients with adult spinal deformity (ASD) and baseline and 2-year postoperative data were included. PJK was defined as ≥ 10° in sagittal Cobb angle between the inferior uppermost instrumented vertebra (UIV) endplate and superior endplate of the UIV + 2 vertebrae. PJF was radiographically defined as a proximal junctional sagittal Cobb angle ≥ 15° with the presence of structural failure and/or mechanical instability, or PJK with reoperation. Backstep conditional binary supervised learning models assessed baseline demographic, clinical, and surgical information to predict the occurrence of PJK and PJF. Internal cross validation of the model was performed via a 70%/30% cohort split. Conditional inference tree analysis determined thresholds at an alpha level of 0.05. RESULTS: Seven hundred seventy-nine patients with ASD (mean 59.87 ± 14.24 years, 78% female, mean BMI 27.78 ± 6.02 kg/m2, mean Charlson Comorbidity Index 1.74 ± 1.71) were included. PJK developed in 50.2% of patients, and 10.5% developed PJF by their last recorded visit. The six most significant demographic, radiographic, surgical, and postoperative predictors of PJK/PJF were baseline age ≥ 74 years, baseline sagittal age-adjusted score (SAAS) T1 pelvic angle modifier > 1, baseline SAAS pelvic tilt modifier > 0, levels fused > 10, nonuse of prophylaxis measures, and 6-week SAAS pelvic incidence minus lumbar lordosis modifier > 1 (all p < 0.015). Overall, the model was deemed significant (p < 0.001), and internally validated receiver operating characteristic analysis returned an area under the curve of 0.923, indicating robust model fit. CONCLUSIONS: PJK and PJF remain critical concerns in ASD surgery, and efforts to reduce the occurrence of PJK and PJF have resulted in the development of novel prophylactic techniques and enhanced clinical and radiographic selection criteria. This study demonstrates a validated model incorporating such techniques that may allow for the prediction of clinically significant PJK and PJF, and thus assist in optimizing patient selection, enhancing intraoperative decision making, and reducing postoperative complications in ASD surgery.