Radiographic Alignment in Deformity Patients Treated With Personalized Interbody Devices: Early Experience From the COMPASS Registry.

BACKGROUND: Literature supports the need for improved techniques to achieve spinopelvic alignment and reduce complication rates in patients with adult spinal deformity (ASD). Personalized interbody devices were developed to address this need and are under evaluation in the multicenter Clinical Outcome Measures in Personalized aprevo (circle R superscript) Spine Surgery (COMPASS (TM suprascript) registry. This report presents interim COMPASS pre- and postoperative sagittal alignment results and complication rates for a subcohort of COMPASS patients diagnosed and surgically treated for spinal deformity. METHODS: COMPASS is a postmarket observational registry of patients enrolled either before or after index surgery and then followed prospectively for 24 months. Sagittal alignment was assessed with SRS-Schwab modifiers for pelvic incidence minus lumbar lordosis, pelvic tilt, and T1 pelvic angle. Summed SRS-Schwab modifiers were utilized to assign overall deformity status as mild, moderate, or severe. Complications were extracted from patient medical records. RESULTS: The study included 67 patients from 9 centers. Preoperative severe deformity was observed in 66% of patients. Index surgeries included implantation of a median of 2 personalized interbody devices by anterior, lateral, or transforaminal approaches and with a median of 8 posteriorly instrumented levels. Overall postoperative sagittal alignment improved with a significant decrease in the mean sum of SRS-Schwab modifiers that correlated strongly to improvements in pelvic incidence minus lumbar lordosis. Among 44 patients with preoperative severe overall deformity, 16 improved to moderate and 9 to mild deformity. Complications occurred for 13 patients (19.4%), including 1 mechanical complication requiring revision 9 months after surgery and none related to personalized interbody devices. CONCLUSIONS: This study demonstrates that ASD patients whose treatment included personalized interbody devices can obtain favorable postoperative alignment status comparable to published results and with no complications related to the personalized interbody devices. CLINICAL RELEVANCE: This study contributes to growing evidence that personalized interbody devices contribute to improved sagittal alignment in ASD patients by directly adjusting the orientation of adjacent vertebra.

Predictability in Achieving Target Intervertebral Lordosis Using Personalized Interbody Implants.

BACKGROUND: Lumbar lordosis distribution has become a pivotal factor in re-establishing the foundational alignment of the lumbar spine. This can directly influence overall sagittal alignment, leading to improved long-term outcomes for patients. Despite the wide availability of hyperlordotic stock cages intended to achieve optimal postoperative alignment, there is a lack of correlation between the lordotic shape of a cage and the resultant intervertebral alignment. Recently, personalized spine surgery has witnessed significant advancements, including 3D-printed personalized interbody implants, which are customized to the surgeon's treatment and alignment goals. This study evaluates the reliability of 3D-printed patient-specific interbody implants to achieve the planned postoperative intervertebral alignment. METHODS: This is a retrospective study of 217 patients with spinal deformity or degenerative conditions. Patients were included if they received 3D-printed personalized interbody implants. The desired intervertebral lordosis (IVL) angle was prescribed into the device design for each personalized interbody (IVL goal). Standing postoperative radiographs were measured, and the IVL offset was calculated as IVL achieved minus IVL goal. RESULTS: In this patient population, 365 personalized interbodies were implanted, including 145 anterior lumbar interbody fusions (ALIFs), 99 lateral lumbar interbody fusions (LLIFs), and 121 transforaminal lumbar interbody fusions. Among the 365 treated levels, IVL offset was 1.1° ± 4.4° (mean ± SD). IVL was achieved within 5° of the plan in 299 levels (81.9%). IVL offset depended on the approach of the lumbar interbody fusion and was achieved within 5° for 85.9% of LLIF, 82.6% of transforaminal lumbar interbody fusions and 78.6% of ALIFs. Ten levels (2.7%) missed the planned IVL by >10°. ALIF and LLIF levels in which the plan was missed by more than 5° tended to be overcorrected. CONCLUSIONS: This study supports the use of 3D-printed personalized interbody implants to achieve planned sagittal intervertebral alignment. CLINICAL RELEVANCE: Personalized interbody implants can consistently achieve IVL goals and potentially impact foundational lumbar alignment.

Spinal cord injury in high-risk complex adult spinal deformity surgery: review of incidence and outcomes from the Scoli-RISK-1 study.

STUDY DESIGN: Clinical case series. OBJECTIVE: To describe the cause, treatment and outcome of 6 cases of perioperative spinal cord injury (SCI) in high-risk adult deformity surgery. SETTING: Adult spinal deformity patients were enrolled in the multi-center Scoli-RISK-1 cohort study. METHODS: A total of 272 patients who underwent complex adult deformity surgery were enrolled in the prospective, multi-center Scoli-RISK-1 cohort study. Clinical follow up data were available up to a maximum of 2 years after index surgery. Cases of perioperative SCI were identified and an extensive case review was performed. RESULTS: Six individuals with SCI were identified from the Scoli-RISK-1 database (2.2%). Two cases occurred intraoperatively and four cases occurred postoperatively. The first case was an incomplete SCI due to a direct intraoperative insult and was treated postoperatively with Riluzole. The second SCI case was caused by a compression injury due to overcorrection of the deformity. Three cases of incomplete SCI occurred; one case of postoperative hematoma, one case of proximal junctional kyphosis (PJK) and one case of adjacent segment disc herniation. All cases of post-operative incomplete SCI were managed with revision decompression and resulted in excellent clinical recovery. One case of incomplete SCI resulted from infection and PJK. The patient's treatment was complicated by a delay in revision and the patient suffered persistent neurological deficits up to six weeks following the onset of SCI. CONCLUSION: Despite the low incidence in high-risk adult deformity surgeries, perioperative SCI can result in devastating consequences. Thus, appropriate postoperative care, follow up and timely management of SCI are essential.

Thoracolumbar fusions for adult lumbar deformity show superior QALY gain and lower costs compared with upper thoracic fusions.

PURPOSE: Adult spinal deformity (ASD) patients with sagittal plane deformity (N) or structural lumbar/thoraco-lumbar (TL) curves can be treated with fusions stopping at the TL junction or extending to the upper thoracic (UT) spine. This study evaluates the impact on cost/cumulative quality-adjusted life year (QALY) in patients treated with TL vs UT fusion. METHODS: ASD patients with > 4-level fusion and 2-year follow-up were included. Index and total episode-of-care costs were estimated using average itemized direct costs obtained from hospital records. Cumulative QALY gained were calculated from preoperative to 2-year postoperative change in Short Form Six-Dimension (SF-6D) scores. The TL and UT groups comprised patients with upper instrumented vertebrae (UIV) at T9-T12 and T2-T5, respectively. RESULTS: Of 566 patients with type N or L curves, mean age was 63.2 ± 12.1 years, 72% were female and 93% Caucasians. Patients in the TL group had better sagittal vertical axis (7.3 ± 6.9 vs. 9.2 ± 8.1 cm, p = 0.01), lower surgical invasiveness (- 30; p < 0.001), and shorter OR time (- 35 min; p = 0.01). Index and total costs were 20% lower in the TL than in the UT group (p < 0.001). Cost/QALY was 65% lower (492,174.6 vs. 963,391.4), and 2-year QALY gain was 40% higher, in the TL than UT group (0.15 vs. 0.10; p = 0.02). Multivariate model showed TL fusions had lower total cost (p = 0.001) and higher QALY gain (p = 0.03) than UT fusions. CONCLUSION: In Schwab type N or L curves, TL fusions showed lower 2-year cost and improved QALY gain without increased reoperation rates or length of stay than UT fusions. LEVEL OF EVIDENCE: III.

Changes in Alignment at Untreated Vertebral Levels Following Short-Segment Fusion Using Personalized Interbody Cages: Leveraging Personalized Medicine to Reduce the Risk of Reoperation.

BACKGROUND: An abnormal postoperative lordosis distribution index (LDI), which quantifies the ratio between the lordosis at L4 to S1 and the lordosis at L1 to S1, contributes to the development of adjacent segment disease and increased revision rates in patients undergoing short-segment lumbar intervertebral fusions. Incorporating preoperative spinopelvic parameters and LDI into the surgical plan for short-segment fusion is important for guiding alignment restoration and preserving normal preoperative alignment in unfused segments. This study examined changes in LDI, segmental lordosis, and lordosis of the unfused levels in patients treated with personalized interbody cage (PIC) implants. METHODS: This retrospective study evaluated radiographic measurements from 111 consecutively treated patients diagnosed with degenerative spinal conditions and treated with a short-segment fusion of L4 to L5, L5 to S1, or L4 to S1 using PIC implant(s) within 6 months of the fusion procedure. Comparisons of intervertebral lordosis for treated and untreated levels as well as LDI pre- and postoperatively were performed. RESULTS: In patients with a preoperative hypolordotic distribution (LDI < 50%), statistically significant increases were found in LDI postoperatively, approaching the normal LDI range (LDI 50%-80%). Likewise, patients with hyperlordotic distribution preoperatively (LDI > 80%) experienced a decrease in LDI postoperatively, trending toward the normal range, although the changes were not statistically significant. Intervertebral lordosis for the L5 to S1 level increased significantly following the placement of a PIC in the normal and hypolordotic LDI groups. Changes in intervertebral lordosis for L5 to S1 were not significant for patients with preoperative hyperlordotic LDI. Reciprocal changes in intervertebral lordosis at L1 to L4 were not observed in any groups. CONCLUSIONS: PIC implants may provide a benefit for patients, particularly those with hypolordotic distributions preoperatively. They have the potential to further improve patient outcomes by helping surgeons to achieve patient-specific lordosis goals, which may help to reduce the risk of adjacent segment disease and revisions in patients undergoing short-segment lumbar intervertebral fusions. CLINICAL RELEVANCE: Personalized implants can help surgeons achieve patient-specific alignment goals, potentially prevent adjacent segment disease, and reduce long-term reinterventions.

Tomographic Assessment of Fusion Rate, Implant-Endplate Contact Area, Subsidence, and Alignment With Lumbar Personalized Interbody Implants at 1-Year Follow-Up.

BACKGROUND: Incongruity between irregularly shaped vertebral endplates and the uniform surfaces of stock interbody fusion cages has been identified as contributing to cage subsidence, pseudarthrosis, and unpredictable alignment. Advances in manufacturing techniques have driven the development of personalized interbody cages (PICs) that can match individual endplate morphology and provide the exact shape and size needed to fill the disc space and achieve the planned correction. This study used computed tomography (CT) imaging to evaluate the implant-endplate contact area, fusion, subsidence, and achievement of planned alignment correction in patients receiving PIC devices. METHODS: This retrospective study included patients treated for adult spinal deformity at a single site and implanted with PIC devices at L4 to L5 or L5 to S1 for segmental stabilization and alignment correction, who received 1-year postoperative CT images as part of their standard of care. An evaluation using 3-dimensional thin-section scans was conducted. Implant-endplate contact and signs of fusion were assessed in each CT slice across both endplates. The degree of subsidence as well as measures of segmental and global lumbar alignment were also assessed. RESULTS: Fifteen patients were included in the study, with a mean age of 68.2 years. Follow-up ranged between 9 and 14 months. Twenty-six total lumbar levels were implanted; 20 with PIC devices via the anterior lumbar interbody fusion approach, 2 with stock cages via the anterior lumbar interbody fusion approach, and 4 with PIC devices via the transforaminal lumbar interbody fusion approach. CT analysis of PIC-implanted levels found an overall implant-endplate contact area ratio of 93.9%, a subsidence rate of 4.5%, a fusion rate of 100%, and satisfactory segmental and global lumbar correction compared with the preoperative plan. CONCLUSIONS: PIC implants can provide nearly complete contact with endplate surfaces regardless of the individual endplate morphology. Subsidence, fusion, and alignment assessments in this tomographic study illustrated results consistent with the benefits of a personalized interbody implant.

Effects of pelvic fixation strategies and multi-rod constructs on biomechanics of the proximal junction in long thoracolumbar posterior instrumented fusions: a finite-element analysis.

PURPOSE: To assess the effect of various pelvic fixation techniques and number of rods on biomechanics of the proximal junction of long thoracolumbar posterior instrumented fusions. METHODS: A validated spinopelvic finite-element (FE) model was instrumented with L5-S1 ALIF and one of the following 9 posterior instrumentation configurations: (A) one traditional iliac screw bilaterally ("2 Iliac/2 Rods"); (B) T10 to S1 ("Sacral Only"); (C) unilateral traditional iliac screw ("1 Iliac/2 Rods"); (D) one traditional iliac screw bilaterally with one midline accessory rod ("2 Iliac/3 rods"); (E) S2AI screws connected directly to the midline rods ("2 S2AI/2 Rods"); and two traditional iliac screws bilaterally with two lateral accessory rods connected to the main rods at varying locations (F1: T10-11, F2: T11-12, F3: T12-L1, F4: L1-2) ("4 Iliac/4 Rods"). Range of motions (ROM) at T10-S1 and T9-T10 were recorded and compared between models. The T9-T10 intradiscal pressures and stresses of the T9-10 disc's annulus in addition to the von Mises stresses of the T9 and T10 vertebral bodies were recorded and compared. RESULTS: For T10-S1 ROM, 4 iliac/4 rods had lowest ROM in flexion and extension, while 2 S2AI/2 rods showed lowest ROM in rotation. Constructs with 3 or 4 rods had lower stresses on the primary rods compared to 2-rod constructs. At the proximal adjacent disc (T9-10), 4 iliac/4 rods showed lowest ROM, lowest intradiscal pressures, and lowest annular stress in all directions (most pronounced in flexion-extension). Under flexion and extension, 4 iliac/4 rods also showed the lowest von Mises stresses on the T10 vertebral body but the highest stresses on the T9 vertebral body. CONCLUSIONS: Dual iliac screws with 4 rods across the lumbosacral junction and extending to the thoracolumbar junction demonstrated the lowest T10-S1 ROM, the lowest adjacent segment disc (T9-T10) ROM, intradiscal pressures, and annular stresses, and the lowest UIV stresses, albeit with the highest UIV + 1 stresses. Additional studies are needed to confirm whether these biomechanical findings dictate clinical outcomes and effect rates of proximal junctional kyphosis and failure.

Impact of Prior Cervical Fusion on Patients Undergoing Thoracolumbar Deformity Correction.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: Evaluate the impact of prior cervical constructs on upper instrumented vertebrae (UIV) selection and postoperative outcomes among patients undergoing thoracolumbar deformity correction. BACKGROUND: Surgical planning for adult spinal deformity (ASD) patients involves consideration of spinal alignment and existing fusion constructs. METHODS: ASD patients with (ANTERIOR or POSTERIOR) and without (NONE) prior cervical fusion who underwent thoracolumbar fusion were included. Demographics, radiographic alignment, patient-reported outcome measures (PROMs), and complications were compared. Univariate and multivariate analyses were performed on POSTERIOR patients to identify parameters predictive of UIV choice and to evaluate postoperative outcomes impacted by UIV selection. RESULTS: Among 542 patients, with 446 NONE, 72 ANTERIOR, and 24 POSTERIOR patients, mean age was 64.4 years and 432 (80%) were female. Cervical fusion patients had worse preoperative cervical and lumbosacral deformity, and PROMs (P<0.05). In the POSTERIOR cohort, preoperative LIV was frequently below the cervicothoracic junction (54%) and uncommonly (13%) connected to the thoracolumbar UIV. Multivariate analyses revealed that higher preoperative cervical SVA (coeff=-0.22, 95%CI=-0.43--0.01, P=0.038) and C2SPi (coeff=-0.72, 95%CI=-1.36--0.07, P=0.031), and lower preoperative thoracic kyphosis (coeff=0.14, 95%CI=0.01-0.28, P=0.040) and thoracolumbar lordosis (coeff=0.22, 95%CI=0.10-0.33, P=0.001) were predictive of cranial UIV. Two-year postoperatively, cervical patients continued to have worse cervical deformity and PROMs (P<0.05) but had comparable postoperative complications. Choice of thoracolumbar UIV below or above T6, as well as the number of unfused levels between constructs, did not affect patient outcomes. CONCLUSIONS: Among patients who underwent thoracolumbar deformity correction, prior cervical fusion was associated with more severe spinopelvic deformity and PROMs preoperatively. The choice of thoracolumbar UIV was strongly predicted by their baseline cervical and thoracolumbar alignment. Despite their poor preoperative condition, these patients still experienced significant improvements in their thoracolumbar alignment and PROMs after surgery, irrespective of UIV selection. LEVEL OF EVIDENCE: IV.

Personalizing adult spinal deformity surgery through multimodal artificial intelligence.

To achieve meaningful, patient-centered outcomes following adult spinal deformity (ASD) surgery, it is crucial to engage in precise preoperative planning, perform excellent intraoperative execution, and ensure careful postoperative management. The field of multimodal artificial intelligence (AI) is rapidly developing and should be integrated into the management of ASD patients. In this context, we outline the current concepts and explore future applications of AI across the ASD care continuum. Cite this article as: Azad TD, Vattipally VN, Ames CP. Personalizing adult spinal deformity surgery through multimodal artificial intelligence. Acta Orthop Traumatol Turc., 2024;58(2):80-82.

A comparative cohort study of surgical approaches for adult spinal deformity at a minimum 2-year follow-up.

STUDY DESIGN: This study was a retrospective multi-center comparative cohort study. MATERIALS AND METHODS: A retrospective institutional database of operative adult spinal deformity patients was utilized. All fusions > 5 vertebral levels and including the sacrum/pelvis were eligible for inclusion. Revisions, 3 column osteotomies, and patients with < 2-year clinical follow-up were excluded. Patients were separated into 3 groups based on surgical approach: 1) posterior spinal fusion without interbody (PSF), 2) PSF with interbody (PSF-IB), and 3) anteroposterior (AP) fusion (anterior lumbar interbody fusion or lateral lumbar interbody fusion with posterior screw fixation). Intraoperative, radiographic, and clinical outcomes, as well as complications, were compared between groups with ANOVA and χ2 tests. RESULTS: One-hundred and thirty-eight patients were included for study (PSF, n = 37; PSF-IB, n = 44; AP, n = 57). Intraoperatively, estimated blood loss was similar between groups (p = 0.171). However, the AP group had longer operative times (547.5 min) compared to PSF (385.1) and PSF-IB (370.7) (p < 0.001). Additionally, fusion length was shorter in PSF-IB (11.4) compared to AP (13.6) and PSF (12.9) (p = 0.004). There were no differences between the groups in terms of change in alignment from preoperative to 2 years postoperative. There were no differences in clinical outcomes. While postoperative complications were largely similar between groups, operative complications were higher in the AP group (31.6%) compared to the PSF (5.4%) and PSF-IB (9.1) groups (p < 0.001). CONCLUSION: While there were differences in intraoperative outcomes (operative time and fusion length), there were no differences in postoperative clinical or radiographic outcomes. AP fusion was associated with a higher rate of operative complications.

Hip Osteoarthritis in Patients Undergoing Surgery for Severe Adult Spinal Deformity: Prevalence and Impact on Spine Surgery Outcomes.

BACKGROUND: Hip osteoarthritis (OA) is common in patients with adult spinal deformity (ASD). Limited data exist on the prevalence of hip OA in patients with ASD, or on its impact on baseline and postoperative alignment and patient-reported outcome measures (PROMs). Therefore, this paper will assess the prevalence and impact of hip OA on alignment and PROMs. METHODS: Patients with ASD who underwent L1-pelvis or longer fusions were included. Two independent reviewers graded hip OA with the Kellgren-Lawrence (KL) classification and stratified it by severity into non-severe (KL grade 1 or 2) and severe (KL grade 3 or 4). Radiographic parameters and PROMs were compared among 3 patient groups: Hip-Spine (hip KL grade 3 or 4 bilaterally), Unilateral (UL)-Hip (hip KL grade 3 or 4 unilaterally), or Spine (hip KL grade 1 or 2 bilaterally). RESULTS: Of 520 patients with ASD who met inclusion criteria for an OA prevalence analysis, 34% (177 of 520) had severe bilateral hip OA and unilateral or bilateral hip arthroplasty had been performed in 8.7% (45 of 520). A subset of 165 patients had all data components and were examined: 68 Hip-Spine, 32 UL-Hip, and 65 Spine. Hip-Spine patients were older (67.9 ± 9.5 years, versus 59.6 ± 10.1 years for Spine and 65.8 ± 7.5 years for UL-Hip; p < 0.001) and had a higher frailty index (4.3 ± 2.6, versus 2.7 ± 2.0 for UL-Hip and 2.9 ± 2.0 for Spine; p < 0.001). At 1 year, the groups had similar lumbar lordosis, yet the Hip-Spine patients had a worse sagittal vertebral axis (SVA) measurement (45.9 ± 45.5 mm, versus 25.1 ± 37.1 mm for UL-Hip and 19.0 ± 39.3 mm for Spine; p = 0.001). Hip-Spine patients also had worse Veterans RAND-12 Physical Component Summary scores at baseline (25.7 ± 9.3, versus 28.7 ± 9.8 for UL-Hip and 31.3 ± 10.5 for Spine; p = 0.005) and 1 year postoperatively (34.5 ± 11.4, versus 40.3 ± 10.4 for UL-Hip and 40.1 ± 10.9 for Spine; p = 0.006). CONCLUSIONS: This study of operatively treated ASD revealed that 1 in 3 patients had severe hip OA bilaterally. Such patients with severe bilateral hip OA had worse baseline SVA and PROMs that persisted 1 year following ASD surgery, despite correction of lordosis. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Mechanisms of lumbar spine "flattening" in adult spinal deformity: defining changes in shape that occur relative to a normative population.

PURPOSE: Previous work comparing ASD to a normative population demonstrated that a large proportion of lumbar lordosis is lost proximally (L1-L4). The current study expands on these findings by collectively investigating regional angles and spinal contours. METHODS: 119 asymptomatic volunteers with full-body free-standing radiographs were used to identify age-and-PI models of each Vertebra Pelvic Angle (VPA) from L5 to T10. These formulas were then applied to a cohort of primary surgical ASD patients without coronal malalignment. Loss of lumbar lordosis (LL) was defined as the offset between age-and-PI normative value and pre-operative alignment. Spine shapes defined by VPAs were compared and analyzed using paired t-tests. RESULTS: 362 ASD patients were identified (age = 64.4 ± 13, 57.1% females). Compared to their age-and-PI normative values, patients demonstrated a significant loss in LL of 17 ± 19° in the following distribution: 14.1% had "No loss" (mean = 0.1 ± 2.3), 22.9% with 10°-loss (mean = 9.9 ± 2.9), 22.1% with 20°-loss (mean = 20.0 ± 2.8), and 29.3% with 30°-loss (mean = 33.8 ± 6.0). "No loss" patients' spine was slightly posterior to the normative shape from L4 to T10 (VPA difference of 2°), while superimposed on the normative one from S1 to L2 and became anterior at L1 in the "10°-loss" group. As LL loss increased, ASD and normative shapes offset extended caudally to L3 for the "20°-loss" group and L4 for the "30°-loss" group. CONCLUSION: As LL loss increases, the difference between ASD and normative shapes first occurs proximally and then progresses incrementally caudally. Understanding spinal contour and LL loss location may be key to achieving sustainable correction by identifying optimal and personalized postoperative shapes.

Contemporary utilization of three-column osteotomy techniques in a prospective complex spinal deformity multicenter database: implications on full-body alignment and perioperative course.

BACKGROUND: Research has focused on the increased correction from a three-column osteotomy (3CO) during adult spinal deformity (ASD) surgery. However, an in-depth analysis on the performance of a 3CO in a cohort of complex spinal deformity cases has not been described. STUDY DESIGN/SETTING: This is a retrospective study on a prospectively enrolled, complex ASD database. PURPOSE: This study aimed to determine if three-column osteotomies demonstrate superior benefit in correction of complex sagittal deformity at the cost of increased perioperative complications. METHODS: Surgical complex adult spinal deformity patients were included and grouped into thoracolumbar 3COs compared to those who did not have a 3CO (No 3CO) (remaining cohort). Rigid deformity was defined as ΔLL less than 33% from standing to supine. Severe deformity was defined as global (SVA > 70 mm) or C7-PL > 70 mm, or lumbopelvic (PI-LL > 30°). Means comparison tests assessed correction by 3CO grade/location. Multivariate analysis controlling for baseline deformity evaluated outcomes up to six weeks compared to No 3CO. RESULTS: 648 patients were included (Mean age 61 ± 14.6 years, BMI 27.55 ± 5.8 kg/m2, levels fused: 12.6 ± 3.8). 126 underwent 3CO, a 20% higher usage than historical cohorts. 3COs were older, frail, and more likely to undergo revision (OR 5.2, 95% CI [2.6-10.6]; p < .001). 3COs were more likely to present with both severe global/lumbopelvic deformity (OR 4), 62.4% being rigid. 3COs had greater use of secondary rods (OR 4st) and incurred 4 times greater risk for: massive blood loss (> 3500 mL), longer LOS, SICU admission, perioperative wound and spine-related complications, and neurologic complications when performed below L3. 3COs had similar HRQL benefit, but higher perioperative opioid use. Mean segmental correction increased by grade (G3-21; G4-24; G5-27) and was 4 × greater than low-grade osteotomies, especially below L3 (OR 12). 3COs achieved 2 × greater spinopelvic correction. Higher grades properly distributed lordosis 50% of the time except L5. Pelvic compensation and non-response were relieved more often with increasing grade, with greater correction in all lower extremity parameters (p < .01). Due to the increased rate of complications, 3COs trended toward higher perioperative cost ($42,806 vs. $40,046, p = .086). CONCLUSION: Three-column osteotomy usage in contemporary complex spinal deformities is generally limited to more disabled individuals undergoing the most severe sagittal and coronal realignment procedures. While there is an increased perioperative cost and prolongation of length of stay with usage, these techniques represent the most powerful realignment techniques available with a dramatic impact on normalization at operative levels and reciprocal changes.

Restoring L4-S1 Lordosis Shape in Severe Sagittal Deformity: Impact of Correction Techniques on Alignment and Complication Profile.

BACKGROUND: Severe sagittal plane deformity with loss of L4-S1 lordosis is disabling and can be improved through various surgical techniques. However, data are limited on the differing ability of anterior lumbar interbody fusion (ALIF), pedicle subtraction osteotomy (PSO), and transforaminal lumbar interbody fusion (TLIF) to achieve alignment goals in severely malaligned patients. METHODS: Severe adult spinal deformity patients with preoperative PI-LL >20°, L4-S1 lordosis <30°, and full body radiographs and PROMs at baseline and 6-week postoperative visit were included. Patients were grouped into ALIF (1-2 level ALIF at L4-S1), PSO (L4/L5 PSO), and TLIF (1-2 level TLIF at L4-S1). Comparative analyses were performed on demographics, radiographic spinopelvic parameters, complications, and PROMs. RESULTS: Among the 96 included patients, 40 underwent ALIF, 27 underwent PSO, and 29 underwent TLIF. At baseline, cohorts had comparable age, sex, race, Edmonton frailty scores, and radiographic spinopelvic parameters (P > 0.05). However, PSO was performed more often in revision cases (P < 0.001). Following surgery, L4-S1 lordosis correction (P = 0.001) was comparable among ALIF and PSO patients and caudal lordotic apex migration (P = 0.044) was highest among ALIF patients. PSO patients had higher intraoperative estimated blood loss (P < 0.001) and motor deficits (P = 0.049), and in-hospital ICU admission (P = 0.022) and blood products given (P = 0.004), but were otherwise comparable in terms of length of stay, blood transfusion given, and postoperative admission to rehab. Likewise, 90-day postoperative complication profiles and 6-week PROMs were comparable as well. CONCLUSIONS: ALIF can restore L4-S1 sagittal alignment as powerfully as PSO, with fewer intraoperative and in-hospital complications. When feasible, ALIF is a suitable alternative to PSO and likely superior to TLIF for correcting L4-S1 lordosis among patients with severe sagittal malalignment.

Revision Strategy for Proximal Junctional Failure: Combined Effect of Proximal Extension and Focal Correction.

STUDY DESIGN: Retrospective review of a prospectively-collected multicenter database. OBJECTIVES: The objective of this study was to determine optimal strategies in terms of focal angular correction and length of proximal extension during revision for PJF. METHODS: 134 patients requiring proximal extension for PJF were analyzed in this study. The correlation between amount of proximal junctional angle (PJA) reduction and recurrence of proximal junctional kyphosis (PJK) and/or PJF was investigated. Following stratification by the degree of PJK correction and the numbers of levels extended proximally, rates of radiographic PJK (PJA >28° & ΔPJA >22°), and recurrent surgery for PJF were reported. RESULTS: Before revision, mean PJA was 27.6° ± 14.6°. Mean number of levels extended was 6.0 ± 3.3. Average PJA reduction was 18.8° ± 18.9°. A correlation between the degree of PJA reduction and rate of recurrent PJK was observed (r = -.222). Recurrent radiographic PJK (0%) and clinical PJF (4.5%) were rare in patients undergoing extension ≥8 levels, regardless of angular correction. Patients with small reductions (<5°) and small extensions (<4 levels) experienced moderate rates of recurrent PJK (19.1%) and PJF (9.5%). Patients with large reductions (>30°) and extensions <8 levels had the highest rate of recurrent PJK (31.8%) and PJF (16.0%). CONCLUSION: While the degree of focal PJK correction must be determined by the treating surgeon based upon clinical goals, recurrent PJK may be minimized by limiting reduction to <30°. If larger PJA correction is required, more extensive proximal fusion constructs may mitigate recurrent PJK/PJF rates.

The Incremental Clinical Benefit of Adding Layers of Complexity to the Planning and Execution of Adult Spinal Deformity Corrective Surgery.

BACKGROUND AND OBJECTIVES: For patients with surgical adult spinal deformity (ASD), our understanding of alignment has evolved, especially in the last 20 years. Determination of optimal restoration of alignment and spinal shape has been increasingly studied, yet the assessment of how these alignment schematics have incrementally added benefit to outcomes remains to be evaluated. METHODS: Patients with ASD with baseline and 2-year were included, classified by 4 alignment measures: Scoliosis Research Society (SRS)-Schwab, Age-Adjusted, Roussouly, and Global Alignment and Proportion (GAP). The incremental benefits of alignment schemas were assessed in chronological order as our understanding of optimal alignment progressed. Alignment was considered improved from baseline based on SRS-Schwab 0 or decrease in severity, Age-Adjusted ideal match, Roussouly current (based on sacral slope) matching theoretical (pelvic incidence-based), and decrease in proportion. Patients separated into 4 first improving in SRS-Schwab at 2-year, second Schwab improvement and matching Age-Adjusted, third two prior with Roussouly, and fourth improvement in all four. Comparison was accomplished with means comparison tests and χ2 analyses. RESULTS: Sevenhundredthirty-two. patients met inclusion. SRS-Schwab BL: pelvic incidence-lumbar lordosis mismatch (++:32.9%), sagittal vertical axis (++: 23%), pelvic tilt (++:24.6%). 640 (87.4%) met criteria for first, 517 (70.6%) second, 176 (24%) third, and 55 (7.5%) fourth. The addition of Roussouly (third) resulted in lower rates of mechanical complications and proximal junctional kyphosis (48.3%) and higher rates of meeting minimal clinically important difference (MCID) for physical component summary and SRS-Mental (P < .05) compared with the second. Fourth compared with the third had higher rates of MCID for ODI (44.2% vs third: 28.3%, P = .011) and SRS-Appearance (70.6% vs 44.8%, P < .001). Mechanical complications and proximal junctional kyphosis were lower with the addition of Roussouly (P = .024), while the addition of GAP had higher rates of meeting MCID for SRS-22 Appearance (P = .002) and Oswestry Disability Index (P = .085). CONCLUSION: Our evaluation of the incremental benefit that alignment schemas have provided in ASD corrective surgery suggests that the addition of Roussouly provided the greatest reduction in mechanical complications, while the incorporation of GAP provided the most significant improvement in patient-reported outcomes.

Impact of Self-Reported Loss of Balance and Gait Disturbance on Outcomes following Adult Spinal Deformity Surgery.

Background: The objective of this study was to evaluate if imbalance influences complication rates, radiological outcomes, and patient-reported outcomes (PROMs) following adult spinal deformity (ASD) surgery. Methods: ASD patients with baseline and 2-year radiographic and PROMs were included. Patients were grouped according to whether they answered yes or no to a recent history of pre-operative loss of balance. The groups were propensity-matched by age, pelvic incidence-lumbar lordosis (PI-LL), and surgical invasiveness score. Results: In total, 212 patients were examined (106 in each group). Patients with gait imbalance had worse baseline PROM measures, including Oswestry disability index (45.2 vs. 36.6), SF-36 mental component score (44 vs. 51.8), and SF-36 physical component score (p < 0.001 for all). After 2 years, patients with gait imbalance had less pelvic tilt correction (-1.2 vs. -3.6°, p = 0.039) for a comparable PI-LL correction (-11.9 vs. -15.1°, p = 0.144). Gait imbalance patients had higher rates of radiographic proximal junctional kyphosis (PJK) (26.4% vs. 14.2%) and implant-related complications (47.2% vs. 34.0%). After controlling for age, baseline sagittal parameters, PI-LL correction, and comorbidities, patients with imbalance had 2.2-times-increased odds of PJK after 2 years. Conclusions: Patients with a self-reported loss of balance/unsteady gait have significantly worse PROMs and higher risk of PJK.

Factors Associated with the Maintenance of Cost-Effectiveness at 5 Years in Adult Spinal Deformity Corrective Surgery.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To evaluate factors associated with the long-term durability of cost-effectiveness (CE) in ASD patients. BACKGROUND: A substantial increase in costs associated with the surgical treatment for adult spinal deformity (ASD) has given precedence to scrutinize the value and utility it provides. METHODS: We included 327 operative ASD patients with 5-year (5 Y) follow-up. Published methods were used to determine costs based on CMS.gov definitions and were based on the average DRG reimbursement rates. Utility was calculated using quality-adjusted life-years (QALY) utilizing the Oswestry Disability Index (ODI) converted to Short-Form Six-Dimension (SF-6D), with a 3% discount applied for its decline with life expectancy. The CE threshold of $150,000 was used for primary analysis. RESULTS: Major and minor complication rates were 11% and 47% respectively, with 26% undergoing reoperation by 5 Y. The mean cost associated with surgery was $91,095±$47,003, with a utility gain of 0.091±0.086 at 1Y, QALY gained at 2 Y of 0.171±0.183, and at 5 Y of 0.42±0.43. The cost per QALY at 2 Y was $414,885, which decreased to $142,058 at 5 Y.With the threshold of $150,000 for CE, 19% met CE at 2 Y and 56% at 5 Y. In those in which revision was avoided, 87% met cumulative CE till life expectancy. Controlling analysis depicted higher baseline CCI and pelvic tilt (PT) to be the strongest predictors for not maintaining durable CE to 5 Y (CCI OR: 1.821 [1.159-2.862], P=0.009) (PT OR: 1.079 [1.007-1.155], P=0.030). CONCLUSIONS: Most patients achieved cost-effectiveness after four years postoperatively, with 56% meeting at five years postoperatively. When revision was avoided, 87% of patients met cumulative cost-effectiveness till life expectancy. Mechanical complications were predictive of failure to achieve cost-effectiveness at 2 Y, while comorbidity burden and medical complications were at 5 Y.

Scoliosis Research Society-22r and Ceiling Effects: Limited Capabilities for Precision-Medicine with Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Retrospective registry analysis. OBJECTIVE: To examine predictions of individual Scoliosis Research Society-22r (SRS-22r) questions one year after surgery for adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: A precision-medicine approach to AIS surgery will inform patients of the likelihood of achieving particular results from surgery, specifically individual responses to the SRS-22r questionnaire. METHODS: A multi-center AIS registry was queried for surgical AIS patients treated between 2002-2020. Preoperative data collected included standard demographic data, deformity descriptive data, and SRS-22r scores. Postoperative 1yr SRS-22r scores were modeled using ordinal logistic regression. . The highest probability was the most likely response. Model performance was examined by c-statistics, where c>.8 was considered excellent. Ceiling effects were measured by the proportion of patients reporting "5" to each question. RESULTS: 3251 patients contributed data to the study; mean age 14.4 (±2.2) yrs, female 2631 (81%), major thoracic coronal curve 53°, mean lumbar 41°. C-statistic values ranged from .6 (poor) to .8 (excellent) evidence of varied predictive capabilities. Q17 ("days off work/school", c = .84, ceiling achieved 75%) and Q15 ("financial difficulties", c = .86, ceiling achieved 82%) had the greatest predictive capabilities while Q11 ("pain medication", c=.73, ceiling achieved 67%), Q10 ("appearance", c=.72, ceiling achieved 35%), and Q19 ("attractive", c=.69, ceiling achieved 37%) performed poorly. CONCLUSION: Prediction of individual SRS-22r item responses perhaps most germane to AIS treatment was poor. Prediction of less relevant outcomes, where ceiling effects are present, was greater as the models chose "5" for all responses. These ceiling effects may limit discrimination and hamper efforts at personalized outcome predictions. LEVEL OF EVIDENCE: 3.

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.