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.

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.

On the Defensive: Identity, Language, and Partisan Reactions to Political Scandal.

We investigated how individuals judge politicians embroiled in scandal. Drawing on social identity and realistic group conflict theory, we predicted that beyond an overall ingroup bias, partisans would be particularly forgiving of in-party politicians who denied or justified their misconduct rather than apologize for it. By insisting that they did nothing wrong, these politicians defend the public image of their party and signal their commitment to partisan goals. We find qualified support for this prediction across three experiments. Participants did not respond negatively to in-party politicians who apologized but did react more positively to those who denied or justified wrongdoing (relative to silence). These accounts worked only for in-party politicians and were more effective for those whose misconduct furthered their party's agenda or whose seat was high-status or pivotal for party goals. In intergroup contexts like politics, people may accept explanations for misconduct that they would otherwise find offensive.

Staged Versus Same-Day Surgery in Circumferential Minimally Invasive Deformity Correction.

BACKGROUND AND OBJECTIVES: We sought to compare long-term clinical and radiographic outcomes in patients who underwent staged vs same-day circumferential minimally invasive surgery (cMIS) for adult spinal deformity (ASD). METHODS: We reviewed staged and same-day cMIS ASD cases in a prospective multi-institution database to compare preoperative and 2-year clinical and radiographic parameters between cohorts. RESULTS: A total of 85 patients with a 2-year follow-up were identified (27 staged, 58 same-day). Staged patients had more extensive surgeries and greater hospital length of stay (all P < .001). There were no significant differences in preoperative or 2-year postoperative clinical metrics between cohorts. Patients in the staged cohort also had greater preoperative coronal deformity and thus experienced greater reduction in coronal deformity at 2 years (all P < .01). CONCLUSION: Patients undergoing staged or same-day cMIS correction had similar outcomes at 2 years postoperatively. Staged cMIS ASD correction may be more appropriate in patients with greater deformity, higher frailty, and who require longer, more extensive surgeries.

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.

Impact of Hip and Knee Osteoarthritis on Full Body Sagittal Alignment and Compensation for Sagittal Spinal Deformity.

STUDY DESIGN: Retrospective review of prospectively collected data. OBJECTIVE: To investigate the effect of lower extremity osteoarthritis on sagittal alignment and compensatory mechanisms in adult spinal deformity (ASD). BACKGROUND: Spine, hip, and knee pathologies often overlap in ASD patients. Limited data exists on how lower extremity osteoarthritis impacts sagittal alignment and compensatory mechanisms in ASD. PATIENTS AND METHODS: In total, 527 preoperative ASD patients with full body radiographs were included. Patients were grouped by Kellgren-Lawrence grade of bilateral hips and knees and stratified by quartile of T1-Pelvic Angle (T1PA) severity into low-, mid-, high-, and severe-T1PA. Full-body alignment and compensation were compared across quartiles. Regression analysis examined the incremental impact of hip and knee osteoarthritis severity on compensation. RESULTS: The mean T1PA for low-, mid-, high-, and severe-T1PA groups was 7.3°, 19.5°, 27.8°, and 41.6°, respectively. Mid-T1PA patients with severe hip osteoarthritis had an increased sagittal vertical axis and global sagittal alignment ( P <0.001). Increasing hip osteoarthritis severity resulted in decreased pelvic tilt ( P =0.001) and sacrofemoral angle ( P <0.001), but increased knee flexion ( P =0.012). Regression analysis revealed that with increasing T1PA, pelvic tilt correlated inversely with hip osteoarthritis and positively with knee osteoarthritis ( r2 =0.812). Hip osteoarthritis decreased compensation through sacrofemoral angle (ß-coefficient=-0.206). Knee and hip osteoarthritis contributed to greater knee flexion (ß-coefficients=0.215, 0.101; respectively). For pelvic shift, only hip osteoarthritis significantly contributed to the model (ß-coefficient=0.100). CONCLUSIONS: For the same magnitude of spinal deformity, increased hip osteoarthritis severity was associated with worse truncal and full body alignment with posterior translation of the pelvis. Patients with severe hip and knee osteoarthritis exhibited decreased hip extension and pelvic tilt but increased knee flexion. This examines sagittal alignment and compensation in ASD patients with hip and knee arthritis and may help delineate whether hip and knee flexion is due to spinal deformity compensation or lower extremity osteoarthritis.

What is the effect of preoperative depression on outcomes after minimally invasive surgery for adult spinal deformity? A prospective cohort analysis.

OBJECTIVE: Depression has been implicated with worse immediate postoperative outcomes in adult spinal deformity (ASD) correction, yet the specific impact of depression on those patients undergoing minimally invasive surgery (MIS) requires further clarity. This study aimed to evaluate the role of depression in the recovery of patients with ASD after undergoing MIS. METHODS: Patients who underwent MIS for ASD with a minimum postoperative follow-up of 1 year were included from a prospectively collected, multicenter registry. Two cohorts of patients were identified that consisted of either those affirming or denying depression on preoperative assessment. The patient-reported outcome measures (PROMs) compared included scores on the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back and leg pain, Scoliosis Research Society Outcomes Questionnaire (SRS-22), SF-36 physical component summary, SF-36 mental component summary (MCS), EQ-5D, and EQ-5D visual analog scale. RESULTS: Twenty-seven of 147 (18.4%) patients screened positive for preoperative depression. The nondepressed cohort had an average of 4.83 levels fused, and the depressed cohort had 5.56 levels fused per patient (p = 0.267). At 1-year follow-up, 10 patients still reported depression, representing a 63% decrease. Postoperatively, both cohorts demonstrated improvement in their PROMs; however, at 1-year follow-up, those without depression had statistically better outcomes based on the EQ-5D, MCS, and SRS-22 scores (p < 0.05). Patients with depression continued to experience higher NRS leg scores at 1-year follow-up (3.63 vs 2.22, p = 0.018). After controlling for covariates, the authors found that depression significantly impacted only 1-year follow-up MCS scores (ß = 8.490, p < 0.05). CONCLUSIONS: Depressed and nondepressed patients reported similar improvements after MIS surgery, except MCS scores were more likely to improve in nondepressed patients.

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.

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.

Hydrogel Augmentation of the Lumbar Intervertebral Disc: An Early Feasibility Study of a Treatment for Discogenic Low Back Pain.

PURPOSE: To assess the safety and effectiveness of intradiscal hydrogel in patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional medical management. MATERIALS AND METHODS: Twenty patients aged 22-69 years with numerical rating scale (NRS) pain of ≥4 were enrolled. All patients with CLBP resulting from DDD confirmed by imaging and discography received injections of hydrogel (Hydrafil Intervertebral Disc Augmentation; ReGelTec, Baltimore, Maryland) at 1 or 2 lumbar levels (29 levels treated) from August to December 2020. The primary safety end point was freedom from serious adverse events (SAEs). The primary performance end point was successful gel delivery into the desired disc. Patients were also assessed on the NRS as well as the Oswestry disability index (ODI). RESULTS: Nineteen patients were followed up at a mean of 131 days, and 1 patient was lost to follow-up. Preliminary results showed significant reductions in median NRS back pain from 7 (range 4-10) to 1 (range 0-8) (P <.0001) and median ODI scores from 54 (range 22-58) to 2 (range 0-58) (P <.0001) at 6 months of follow-up. There were 5 SAEs, and 4 of the 2 were determined to be associated with treatment. CONCLUSIONS: This early feasibility study showed that the hydrogel implant was safe with no persistently symptomatic SAEs, and demonstrated effectiveness with significant reduction in pain and improvement in function when used to treat painful DDD and CLBP.

Finite element analysis comparing a PEEK posterior fixation device versus pedicle screws for lumbar fusion.

BACKGROUND: Pedicle screw loosening and breakage are common causes of revision surgery after lumbar fusion. Thus, there remains a continued need for supplemental fixation options that offer immediate stability without the associated failure modes. This finite element analysis compared the biomechanical properties of a novel cortico-pedicular posterior fixation (CPPF) device with those of a conventional pedicle screw system (PSS). METHODS: The CPPF device is a polyetheretherketone strap providing circumferential cortical fixation for lumbar fusion procedures via an arcuate tunnel. Using a validated finite element model, we compared the stability and load transfer characteristics of CPPF to intact conditions under a 415 N follower load and PSS conditions under a 222 N preload. Depending on the instrumented levels, two different interbody devices were used: a lateral lumbar interbody device at L4-5 or an anterior lumbar interbody device at L5-S1. Primary outcomes included range of motion of the functional spinal units and anterior load transfer, defined as the total load through the disk and interbody device after functional motion and follower load application. RESULTS: Across all combinations of interbody devices and lumbar levels evaluated, CPPF consistently demonstrated significant reductions in flexion (ranging from 90 to 98%), extension (ranging from 88 to 94%), lateral bending (ranging from 75 to 80%), and torsion (ranging from 77 to 86%) compared to the intact spine. Stability provided by the CPPF device was comparable to PSS in all simulations (range of motion within 0.5 degrees for flexion-extension, 0.6 degrees for lateral bending, and 0.5 degrees for torsion). The total anterior load transfer was higher with CPPF versus PSS, with differences across all tested conditions ranging from 128 to 258 N during flexion, 89-323 N during extension, 135-377 N during lateral bending, 95-258 N during torsion, and 82-250 N during standing. CONCLUSION: Under the modeled conditions, cortico-pedicular fixation for supplementing anterior or lateral interbody devices between L4 and S1 resulted in comparable stability based on range of motion measures and less anterior column stress shielding based on total anterior load transfer measures compared to PSS. Clinical studies are needed to confirm these finite element analysis findings.

The Lumbosacral Fractional Curve in Adult Degenerative Scoliosis.

Spine surgeons are often faced with a profoundly difficult challenge in surgically treating adult degenerative scoliosis. Deformity correction surgery is complicated by the difficulty in offering extensive surgical corrections to the elderly, complication-prone population it commonly affects. As spine surgeons attempt to offer minimally invasive solutions to this disease process, the need for fusion of the fractional curve at L4, L5, and S1 may be discounted. A treatment strategy to identify, address, and treat the fractional curve with either open or minimally invasive techniques can lead to improved patient outcomes and decrease revision rates in this complicated pathologic process.

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.

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.

Cervical Disc Arthroplasty vs Anterior Cervical Discectomy and Fusion at 10 Years: Results From a Prospective, Randomized Clinical Trial at 3 Sites.

BACKGROUND: Over the past 20 years, multiple randomized controlled trials have shown cervical disc arthroplasty (CDA) to be safe and effective for treating 1- and 2-level degenerative disc disease (DDD). The purpose of this postmarket study is to compare 10-year outcomes between CDA and anterior cervical discectomy and fusion (ACDF) from a randomized study at 3 centers. METHODS: This study was a continuation of a randomized, prospective, multicenter clinical trial comparing CDA with the Mobi-C cervical disc (Zimmer Biomet) vs ACDF. Following completion of the 7-year US Food and Drug Administration study, 10-year follow-up was obtained from consenting patients at 3 high-enrolling centers. The clinical and radiographic endpoints collected at 10 years included composite success, Neck Disability Index, neck and arm pain, short form-12, patient satisfaction, adjacent-segment pathology, major complications, and subsequent surgery. RESULTS: A total of 155 patients were enrolled (105 CDA; 50 ACDF). Follow-up was obtained from 78.1% of patients eligible after 7 years. At 10 years, CDA demonstrated superiority to ACDF. Composite success was 62.4% in CDA and 22.2% in ACDF (P < 0.0001). The cumulative risk of subsequent surgery at 10 years was 7.2% vs 25.5% (P = .001), and the risk of adjacent-level surgery was 3.1% vs 20.5% (P = .0005) in CDA vs ACDF, respectively. The progression to radiographically significant adjacent-segment pathology at 10 years was lower in CDA vs ACDF (12.9% vs 39.3%; P = 0.006). At 10 years, patient-reported outcomes and change from baseline were generally better in CDA patients. A higher percentage of CDA patients reported they were "very satisfied" at 10 years (98.7% vs 88.9%; P = 0.05). CONCLUSIONS: In this postmarket study, CDA was superior to ACDF for treating symptomatic cervical DDD. CDA was statistically superior to ACDF for clinical success, subsequent surgery, and neurologic success. Results through 10 years demonstrate that CDA continues to be a safe and effective surgical alternative to fusion. CLINICAL RELEVANCE: The results of this study support the long-term safety and effectiveness of cervical disc arthroplasty with the Mobi-C.

Incremental benefits of circumferential minimally invasive surgery for increasingly frail patients with adult spinal deformity.

OBJECTIVE: Circumferential minimally invasive surgery (cMIS) may provide incremental benefits compared with open surgery for patients with increasing frailty status by decreasing peri- and postoperative complications. METHODS: Operative patients with adult spinal deformity (ASD) ≥ 18 years old with baseline and 2-year postoperative data were assessed. With propensity score matching, patients who underwent cMIS (cMIS group) were matched with similar patients who underwent open surgery (open group) based on baseline BMI, C7-S1 sagittal vertical axis, pelvic incidence to lumbar lordosis mismatch, and S1 pelvic tilt. The Passias modified ASD frailty index (mASD-FI) was used to determine patient frailty stratification as not frail, frail, or severely frail. Baseline and postoperative factors were assessed using two-way analysis of covariance (ANCOVA) and multivariate ANCOVA while controlling for baseline age, Charlson Comorbidity Index (CCI) score, and number of levels fused. RESULTS: After propensity score matching, 170 ASD patients (mean age 62.71 ± 13.64 years, 75.0% female, mean BMI 29.25 ± 6.60 kg/m2) were included, split evenly between the cMIS and open groups. Surgically, patients in the open group had higher numbers of posterior levels fused (p = 0.021) and were more likely to undergo three-column osteotomies (p > 0.05). Perioperatively, cMIS patients had lower intraoperative blood loss and decreased use of cell saver across frailty groups (with adjustment for baseline age, CCI score, and levels fused), as well as fewer perioperative complications (p < 0.001). Adjusted analysis also revealed that compared to open patients, increasingly frail patients in the cMIS group were also more likely to demonstrate greater improvement in 1- and 2-year postoperative scores for the Oswestry Disability Index, SRS-36 (total), EQ-5D and SF-36 (all p < 0.05). With regard to postoperative complications, increasingly frail patients in the cMIS group were also noted to experience significantly fewer complications overall (p = 0.036) and fewer major intraoperative complications (p = 0.039). The cMIS patients were also less likely to need a reoperation than their open group counterparts (p = 0.043). CONCLUSIONS: Surgery performed with a cMIS technique may offer acceptable outcomes, with diminishment of perioperative complications and mitigation of catastrophic outcomes, in increasingly frail patients who may not be candidates for surgery using traditional open techniques. However, further studies should be performed to investigate the long-term impact of less optimal alignment in this population.

Metal-Free Cortico-Pedicular Device for Supplemental Fixation in Lumbar Interbody Fusion.

OBJECTIVE: Pedicle screw fixation is a commonly utilized adjunct for lumbar interbody fusion, yet risks include screw malposition, pullout, loosening, neurovascular injury, and stress transfers leading to adjacent segment degeneration. This report describes the preclinical and initial clinical results of a minimally invasive, metal-free cortico-pedicular fixation device used for supplemental posterior fixation in lumbar interbody fusion. METHODS: Safety of arcuate tunnel creation was evaluated in cadaveric lumbar (L1-S1) specimens. A finite element analysis study evaluated clinical stability of the device to pedicular screw-rod fixation at L4-L5. Preliminary clinical results were assessed by analysis of Manufacturer and User Facility Device Experience database complications, and 6-month outcomes in 13 patients treated with the device. RESULTS: Among 35 curved drill holes in 5 lumbar specimens, no breaches of the anterior cortex were identified. The mean minimum distance from the anterior surface of the hole to the spinal canal ranged from 5.1 mm at L1-L2 to 9.8 mm at L5-S1. In the finite element analysis study, the polyetheretherketone strap provided comparable clinical stability and reduced anterior stress shielding compared to the conventional screw-rod construct. The Manufacturer and User Facility Device Experience database identified 1 device fracture with no clinical sequelae among 227 procedures. Initial clinical experience showed a 53% decrease in pain severity (P = 0.009), a 50% decrease in Oswestry Disability Index (P < 0.001), and no device-related complications. CONCLUSIONS: Cortico-pedicular fixation is a safe and reproducible procedure that may address limitations of pedicle screw fixation. Longer term clinical data in large clinical studies are recommended to confirm these promising early results.

Spinal Deformity Complexity Checklist for Minimally Invasive Surgery: Expert Consensus from the Minimally Invasive International Spine Study Group.

BACKGROUND: We developed a spinal deformity complexity checklist (SDCC) to assess the difficulty in performing a circumferential minimally invasive surgery (MIS) for adult spinal deformity. METHODS: A modified Delphi method of panel experts was used to construct an SDCC checklist of radiographic and patient-related characteristics that could affect the complexity of surgery via MIS approaches. Ten surgeons with expertise in MIS deformity surgery were queried to develop and refine the SDCC with 3 radiographic categories (x-ray, magnetic resonance imaging, computed tomography) and 1 patient-related category. Within each category, characteristics affecting MIS complexity were identified by initial roundtable discussion. Second-round discussion determined which characteristics substantially impacted complexity the most. RESULTS: Thirteen characteristics within the x-ray category were determined. Spinopelvic characteristics, endpoints of instrumentation, and prior hardware/fusion were associated with increased complexity. Vertebral body rotation-as reflected by the Nash-Moe grade-added significant complexity. Psoas anatomy and spinal stenosis added the most complexity for the 5 magnetic resonance imaging characteristics. There were 3 characteristics in the CT category with pre-exisiting fusion, being the variable most highly selected. Of the 5 patient-related characteristics, osteoporosis and BMI were found to most affect complexity. CONCLUSIONS: The SDCC is a comprehensive list of pertinent radiographic and patient-related characteristics affecting complexity level for MIS deformity surgery. The value of the SDCC is that it allows rapid assessment of key factors when determining whether MIS surgery can be performed effectively and safely. Patients with scores of 4 in any characteristic should be considered challenging to treat with MIS; open surgery may be a better alternative.

Alzheimer's Disease Clinical Trial Research Adaptation Following COVID-19 Pandemic Onset: National Sample of Alzheimer's Clinical Trial Consortium Sites.

BACKGROUND: The COVID-19 pandemic created challenges in clinical research operations that required immediate and lasting changes. OJBECTIVES: The purpose of this study was to explore adaptations to clinical trial research due to COVID-19 and develop a theoretical framework of emergent strategies related to pandemic mitigation in a national network of Alzheimer's disease clinical trial sites. DESIGN: This qualitative study used a grounded theory approach including semi-structured interviews, constant comparative methods, and multi-level, iterative coding. PARTICIPANTS: Twenty-six member sites of the Alzheimer's Clinical Trial Consortium participated with a total of 49 participants. RESULTS: Findings demonstrate processes of adaptation following COVID-19 onset including establishing safety as priority, focus on scientific preservation, accommodations (creating policies, leadership mindset, maintaining operations, and determining research procedures), and evaluation of changes throughout the course of the pandemic. Communication and maintaining integrity were vital throughout these processes. CONCLUSION: Processes of accommodation among clinical research sites during the pandemic provide critical insights and direction for future clinical trials development and emergent methods in Alzheimer's disease and other therapeutic areas.

Rates of Loosening, Failure, and Revision of Iliac Fixation in Adult Deformity Surgery.

STUDY DESIGN: Retrospective cohort review of a prospective multicenter database. OBJECTIVE: Identify rates and variations in lumbopelvic fixation failure after adult spinal deformity (ASD) correction. SUMMARY OF BACKGROUND DATA: Traditional iliac (IS) and S2-alar-iliac (S2AI) pelvic fixation methods have unique technical characteristics for their application, and result in varied bio-mechanical and anatomic impact. These differences may lead to variance in lumbopelvic fixation failure types/rates. METHODS: ASD patients undergoing correction with more than five level fusion and pelvic fixation, separated by pelvic fixation type (IS vs. S2AI). Fixation fracture or loosening assessed radiographically (Figure 1). Multivariate logistic regression, accounting for significant confounders, was used to examine differences between the two groups for screw loosening/fracture, rod fracture, and revision surgery. Level of significance set at P< 0.05. RESULTS: Four hundred eighteen of 1422 patients were included (IS = 287, S2AI = 131). The groups had similar age, body mass index (BMI), baseline comorbidities, number of levels fused (P>0.05), baseline health related quality of life measures (HRQLs) (short form survey-36, Oswestry Disability Index [ODI], Scoliosis Research Society [SRS-22], numeric rating scale [NRS] leg and back, P>0.05) and deformity (pelvic tilt [PT], pelvic incidence-lumbar lordosis [PI-LL], and sagittal vertical axis [SVA], P> 0.05). The IS group had more unilateral fixation versus S2AI (12.9% vs. 6%; P = 0.02). The overall lumbopelvic fixation failure rate was 23.74%. Pelvic fixation (13.4%) and S1 screw (2.9%) loosening was more likely with S2AI (odds ratio [OR] 2.63, P = 0.001; OR 6.05, P = 0.022). Pelvic screw (2.3%) and rod fracture (14.1%) rates similar between groups but trended toward less occurrence with S2AI (OR 0.47, P= 0.06). Revision surgery occurred in 22.7%, and in 8.5% for iliac fixation specifically, but with no differences between fixation types (P = 0.55 and P = 0.365). Pelvic fixation failure conferred worse HRQL scores (physical component score [PCS] 36.23 vs. 39.37, P= 0.04; ODI 33.81 vs. 27.93, P = 0.036), and less 2 years improvement (PCS 7.69 vs. 10.46, P = 0.028; SRS 0.83 vs. 1.03, P = 0.019; ODI 12.91 vs. 19.77, P = 0.0016). CONCLUSION: Lumbopelvic fixation failure rates were high following ASD correction, and associated with lesser clinical improvements. S2AI screws were more likely to demonstrate loosening, but less commonly associated with rod fractures at the lumbopelvic region.