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.

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.

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.

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.

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.

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.

Cervical Total Disk Replacement: Available Implant Size Matters.

STUDY DESIGN: This study was a post hoc analysis of data collected from 2 Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trials. OBJECTIVE: The purposes of this study were to: (1) measure disk space heights adjacent to the level to be treated with a total disk replacement (TDR); (2) analyze cervical disk space heights to be replaced with TDR; and (3) investigate the frequency of use of a smaller height TDR when available. SUMMARY OF BACKGROUND DATA: Cervical TDR produces outcomes noninferior or superior to anterior cervical discectomy and fusion. While the restoration of the height of a collapsed, degenerated disk is a surgical goal, there are potential problems with overdistracting the segment with an implant. METHODS: Disk heights were measured using radiographs from the 1-level Simplify Cervical Artificial Disk IDE trial, producing values for 259 levels adjacent to the treated level and 162 treated levels. The device is available in 4, 5, and 6 mm heights. The 4 mm height became available only after treatment was 13% complete in the single-level trial and was available for all of the 2-level trial. RESULTS: Measurements of 259 adjacent levels found that 55.2% of disk spaces had a height of <4 mm. Among operated levels, 82.7% were <4 mm. When a 4 mm TDR was available, it was used in 38.4% of operated levels in the 1-level trial and 54.3% of levels in the 2-level trial. CONCLUSIONS: Among nonoperated levels, 55.2% were of height <4 mm, suggesting that TDRs of greater heights may potentially overdistract the disk space. The 4 mm TDR was selected by surgeons in 49.4% of all implanted levels, suggesting a preference for smaller TDR height. Further investigation is warranted to determine if the lower height implants are related to clinical and/or radiographic outcomes. LEVEL OF EVIDENCE: Level III.

Two- and three-year outcomes of minimally invasive and hybrid correction of adult spinal deformity.

OBJECTIVE: Previous studies have demonstrated the short-term radiographic and clinical benefits of circumferential minimally invasive surgery (cMIS) and hybrid (i.e., minimally invasive anterior or lateral interbody fusion with an open posterior approach) techniques to correct adult spinal deformity (ASD). However, it is not known if these benefits are maintained over longer periods of time. This study evaluated the 2- and 3-year outcomes of cMIS and hybrid correction of ASD. METHODS: A multicenter database was retrospectively reviewed for patients undergoing cMIS or hybrid surgery for ASD. Patients were ≥ 18 years of age and had one of the following: maximum coronal Cobb angle (CC) ≥ 20°, sagittal vertical axis (SVA) > 5 cm, pelvic incidence-lumbar lordosis mismatch (PI-LL) ≥ 10°, or pelvic tilt (PT) > 20°. Radiographic parameters were evaluated at the latest follow-up. Clinical outcomes were compared at 2- and 3-year time points and adjusted for age, preoperative CC, levels operated, levels with interbody fusion, presence of L5-S1 anterior lumbar interbody fusion, and upper and lower instrumented vertebral level. RESULTS: Overall, 197 (108 cMIS, 89 hybrid) patients were included with 187 (99 cMIS, 88 hybrid) and 111 (60 cMIS, 51 hybrid) patients evaluated at 2 and 3 years, respectively. The mean (± SD) follow-up duration for cMIS (39.0 ± 13.3 months, range 22-74 months) and hybrid correction (39.9 ± 16.8 months, range 22-94 months) were similar for both cohorts. Hybrid procedures corrected the CC greater than the cMIS technique (adjusted p = 0.022). There were no significant differences in postoperative SVA, PI-LL, PT, and sacral slope (SS). At 2 years, cMIS had lower Oswestry Disability Index (ODI) scores (adjusted p < 0.001), greater ODI change as a percentage of baseline (adjusted p = 0.006), less visual analog scale (VAS) back pain (adjusted p = 0.006), and greater VAS back pain change as a percentage of baseline (adjusted p = 0.001) compared to hybrid techniques. These differences were no longer significant at 3 years. At 3 years, but not 2 years, VAS leg pain was lower for cMIS compared to hybrid techniques (adjusted p = 0.032). Those undergoing cMIS had fewer overall complications compared to hybrid techniques (adjusted p = 0.006), but a higher odds of pseudarthrosis (adjusted p = 0.039). CONCLUSIONS: In this review of a multicenter database for patients undergoing cMIS and hybrid surgery for ASD, hybrid procedures were associated with a greater CC improvement compared to cMIS techniques. cMIS was associated with superior ODI and back pain at 2 years, but this difference was no longer evident at 3 years. However, cMIS was associated with superior leg pain at 3 years. There were fewer complications following cMIS, with the exception of pseudarthrosis.

Single-Level Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Results of a Multicenter FDA IDE Trial With 24-Month Follow-up.

BACKGROUND: Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. Polyetheretherketone (PEEK) is used increasingly for spinal implants due to its mechanical properties and lack of artifacts on imaging. A TDR was designed with titanium-coated PEEK endplates and a ceramic core. The purpose of this study was to compare this TDR with anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration. METHODS: This was a prospective, nonrandomized, historically controlled, multicenter US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial. Patients received the PEEK-on-ceramic Simplify® Cervical Artificial Disc (n = 150). The historic control group included 117 propensity-matched ACDF patients from an earlier IDE trial. The primary outcome was a composite success classification at the 24-month follow-up. Outcome measures included the Neck Disability Index (NDI), neurological status, adverse events, subsequent surgery, a visual analog scale assessing neck and arm pain, and the Dysphagia Handicap Index. Radiographic assessment included flexion/extension range of motion and heterotopic ossification. Facet joints were assessed at 24 months using MRI. RESULTS: The success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%; P < .001). Mean NDI, neck pain, and arm pain scores improved significantly in both groups at all follow-up points. Mean NDI scores in the TDR group were significantly lower than ACDF scores at all follow-up points. There were no significant differences in the rates of serious adverse events. The range of motion of the TDR level had increased significantly by 3 months and remained so throughout follow-up. Facet joint assessment by MRI in the TDR group showed little change from preoperation. CONCLUSIONS: The TDR had an acceptable safety profile and a significantly greater composite success rate than ACDF. These results support that the PEEK-on-ceramic TDR is a viable alternative to ACDF for single-level symptomatic disc degeneration. CLINICAL RELEVANCE: This study found that the PEEK-on-ceramic TDR is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion. LEVEL OF EVIDENCE: 2.

The minimally invasive interbody selection algorithm for spinal deformity.

OBJECTIVE: Minimally invasive surgery (MIS) for spinal deformity uses interbody techniques for correction, indirect decompression, and arthrodesis. Selection criteria for choosing a particular interbody approach are lacking. The authors created the minimally invasive interbody selection algorithm (MIISA) to provide a framework for rational decision-making in MIS for deformity. METHODS: A retrospective data set of circumferential MIS (cMIS) for adult spinal deformity (ASD) collected over a 5-year period was analyzed by level in the lumbar spine to identify surgeon preferences and evaluate segmental lordosis outcomes. These data were used to inform a Delphi session of minimally invasive deformity surgeons from which the algorithm was created. The algorithm leads to 1 of 4 interbody approaches: anterior lumbar interbody fusion (ALIF), anterior column release (ACR), lateral lumbar interbody fusion (LLIF), and transforaminal lumbar interbody fusion (TLIF). Preoperative and 2-year postoperative radiographic parameters and clinical outcomes were compared. RESULTS: Eleven surgeons completed 100 cMISs for ASD with 338 interbody devices, with a minimum 2-year follow-up. The type of interbody approach used at each level from L1 to S1 was recorded. The MIISA was then created with substantial agreement. The surgeons generally preferred LLIF for L1-2 (91.7%), L2-3 (85.2%), and L3-4 (80.7%). ACR was most commonly performed at L3-4 (8.4%) and L2-3 (6.2%). At L4-5, LLIF (69.5%), TLIF (15.9%), and ALIF (9.8%) were most commonly utilized. TLIF and ALIF were the most selected approaches at L5-S1 (61.4% and 38.6%, respectively). Segmental lordosis at each level varied based on the approach, with greater increases reported using ALIF, especially at L4-5 (9.2°) and L5-S1 (5.3°). A substantial increase in lordosis was achieved with ACR at L2-3 (10.9°) and L3-4 (10.4°). Lateral interbody arthrodesis without the use of an ACR did not generally result in significant lordosis restoration. There were statistically significant improvements in lumbar lordosis (LL), pelvic incidence-LL mismatch, coronal Cobb angle, and Oswestry Disability Index at the 2-year follow-up. CONCLUSIONS: The use of the MIISA provides consistent guidance for surgeons who plan to perform MIS for deformity. For L1-4, the surgeons preferred lateral approaches to TLIF and reserved ACR for patients who needed the greatest increase in segmental lordosis. For L4-5, the surgeons' order of preference was LLIF, TLIF, and ALIF, but TLIF failed to demonstrate any significant lordosis restoration. At L5-S1, the surgical team typically preferred an ALIF when segmental lordosis was desired and preferred a TLIF if preoperative segmental lordosis was adequate.

Two-Year Outcomes From a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device.

BACKGROUND: Interbody fusion is a widely utilized and accepted procedure to treat advanced debilitating lumbar degenerative disc disease (DDD). Increasingly, surgeons are seeking interbody devices that are large for stability and grafting purposes but can be inserted with less invasive techniques. To achieve these contrary objectives a novel, conformable mesh interbody fusion device was designed to be placed in the disc space through a small portal and filled with bone graft in situ to a large size. This design can reduce the risk of trauma to surrounding structures while creating a large graft footprint that intimately contours to the patient's own anatomy. The purpose of this Investigational Device Exempt (IDE) trial was to evaluate the perioperative and long-term results of this novel conformable mesh interbody fusion device. METHODS: This investigation is a prospective, multicenter, single-arm, Food and Drug Administration and Institutional Review Board-approved IDE, performance goal trial. A total of 102 adults presenting with DDD at a single level between L2 and S1 and unresponsive to 6 months conservative care had instrumented lumbar interbody fusion. Validated assessment tools include 100 mm visual analog scale for pain, Oswestry Disability Index (ODI) for function, single question survey for patient satisfaction, and computed tomography (CT) scan for fusion. Patients were enrolled across 10 geographically distributed sites. Pain/ODI surveys, physical evaluations, and imaging were performed serially through 24 months. Specifically, CT was performed at 12 and, if not fused, 24 months. Independent radiologists assessed CTs for fusion. An independent committee adjudicated adverse events. Patients with complete data at 24 months were included in the analysis. RESULTS: Ninety-six (96, 94% follow-up rate) patients (57.0 ± 12.0 years, 50.0% female, Body Mass Index 30.6 ± 4.9) reported average decreased low back pain from baseline of 45.0 ± 26.6 at 6 weeks and 51.4 ± 26.2 at 24 months. Right/left leg pain reduced by 28.9 ± 36.7/37.8±32.4 at 6 weeks and 30.5±33.0/40.3 34.6 at 24 months. Mean ODI improved 17.1 ± 18.7 from baseline to 6 weeks and 32.0 ± 18.5 by 24 months. At 24 months, 91.7% of patients rated their procedure as excellent/good. Fusion rates were 97.9% (94/96) at 12 months, and 99% (95/96) at 24 months. Mean operative time, estimated blood loss, and length of stay were 2.6 ± 0.9 hours, 137 ± 217 mL, and 2.3 ± 1.2 days, respectively. No device-related serious adverse events have occurred. CONCLUSIONS: Clinically significant outcomes for pain, function, fusion, and device safety were demonstrated in this population. Substantial clinical improvements occur by 6 weeks postoperative and continue to improve to 24 months. The successful outcomes observed in this trial support use of this novel device in an instrumented lumbar interbody fusion. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: This reports substantiates that the preliminary 1-year findings published earlier for this investigation are confirmed and the fusion rates and that patient improvements reported are sustained through 2 years.