Surgical appropriateness nudges: Developing behavioral science nudges to integrate appropriateness criteria into the decision making of spine surgeons.

BACKGROUND: Substantial variation exists in surgeon decision making. In response, multiple specialty societies have established criteria for the appropriate use of spine surgery. Yet few strategies exist to facilitate routine use of appropriateness criteria by surgeons. Behavioral science nudges are increasingly used to enhance decision making by clinicians. We sought to design "surgical appropriateness nudges" to support routine use of appropriateness criteria for degenerative lumbar scoliosis and spondylolisthesis. METHODS: The work reflected Stage I of the NIH Stage Model for Behavioral Intervention Development and involved an iterative, multi-method approach, emphasizing qualitative methods. Study sites included two large referral centers for spine surgery. We recruited spine surgeons from both sites for two rounds of focus groups. To produce preliminary nudge prototypes, we examined sources of variation in surgeon decision making (Focus Group 1) and synthesized existing knowledge of appropriateness criteria, behavioral science nudge frameworks, electronic tools, and the surgical workflow. We refined nudge prototypes via feedback from content experts, site leaders, and spine surgeons (Focus Group 2). Concurrently, we collected data on surgical practices and outcomes at study sites. We pilot tested the refined nudge prototypes among spine surgeons, and surveyed them about nudge applicability, acceptability, and feasibility (scale 1-5, 5 = strongly agree). RESULTS: Fifteen surgeons participated in focus groups, giving substantive input and feedback on nudge design. Refined nudge prototypes included: individualized surgeon score cards (frameworks: descriptive social norms/peer comparison/feedback), online calculators embedded in the EHR (decision aid/mapping), a multispecialty case conference (injunctive norms/social influence), and a preoperative check (reminders/ salience of information/ accountable justification). Two nudges (score cards, preop checks) incorporated data on surgeon practices and outcomes. Six surgeons pilot tested the refined nudges, and five completed the survey (83%). The overall mean score was 4.0 (standard deviation [SD] 0.5), with scores of 3.9 (SD 0.5) for applicability, 4.1 (SD 0.5) for acceptability, and 4.0 (SD 0.5), for feasibility. Conferences had the highest scores 4.3 (SD 0.6) and calculators the lowest 3.9 (SD 0.4). CONCLUSIONS: Behavioral science nudges might be a promising strategy for facilitating incorporation of appropriateness criteria into the surgical workflow of spine surgeons. Future stages in intervention development will test whether these surgical appropriateness nudges can be implemented in practice and influence surgical decision making.

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.

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.

Variations in surgical practice and short-term outcomes for degenerative lumbar scoliosis and spondylolisthesis: do surgeon training and experience matter?

For diverse procedures, sizable geographic variation exists in rates and outcomes of surgery, including for degenerative lumbar spine conditions. Little is known about how surgeon training and experience are associated with surgeon-level variations in spine surgery practice and short-term outcomes. This retrospective observational analysis characterized variations in surgical operations for degenerative lumbar scoliosis or spondylolisthesis, two common age-related conditions. The study setting was two large spine surgery centers in one region during 2017-19. Using data (International Classification of Diseases-10th edition and current procedural terminology codes) extracted from electronic health record systems, we characterized surgeon-level variations in practice (use of instrumented fusion - a more extensive procedure that involves device-related risks) and short-term postoperative outcomes (major in-hospital complications and readmissions). Next, we tested for associations between surgeon training (specialty and spine fellowship) and experience (career stage and operative volume) and use of instrumented fusion as well as outcomes. Eighty-nine surgeons performed 2481 eligible operations. For the study diagnoses, spine surgeons exhibited substantial variation in operative volume, use of instrumented fusion, and postoperative outcomes. Among surgeons above the median operative volume, use of instrumented fusion ranged from 0% to >90% for scoliosis and 9% to 100% for spondylolisthesis, while rates of major in-hospital complications ranged from 0% to 25% for scoliosis and from 0% to 14% for spondylolisthesis. For scoliosis, orthopedic surgeons were more likely than neurosurgeons to perform instrumented fusion for scoliosis [49% vs. 33%, odds ratio (OR) = 2.3, 95% confidence interval (95% CI) 1.3-4.2, P-value = .006] as were fellowship-trained surgeons (49% vs. 25%, OR = 3.0, 95% CI 1.6-5.8; P = .001). Fellowship-trained surgeons had lower readmission rates. Surgeons with higher operative volumes used instrumented fusion more often (OR = 1.1, 95% CI 1.0-1.2, P < .05 for both diagnoses) and had lower rates of major in-hospital complications (OR = 0.91, 95% CI 0.85-0.97; P = .006). Surgical practice can vary greatly for degenerative spine conditions, even within the same region and among colleagues at the same institution. Surgical specialty and subspecialty, in addition to recent operative volume, can be linked to variations in spine surgeons' practice patterns and outcomes. These findings reinforce the notion that residency and fellowship training may contribute to variation and present important opportunities to optimize surgical practice over the course of surgeons' careers. Future efforts to reduce unexplained variation in surgical practice could test interventions focused on graduate medical education. Graphical Abstract.

Minimally Invasive Transforaminal Lumbar Interbody Fusion: Strategies for Creating Lordosis with a Posterior Approach.

The purpose of this article is to review the outcomes concerning lumbar lordosis restoration after the MIS-TLIF and to present strategies to create lumbar lordosis by using this MIS posterior approach. MIS-TLIF is an effective MIS lumbar interbody fusion that can achieve lumbar lordosis restoration. Several crucial steps aid in this sagittal profile correction during the MIS-TLIF, including the appropraite prone positioning, optimizing disc space preparation, maximizing disc space height, anterior interbody cage placement, and reducing the spondylolisthesis.

Selective thoracolumbar fusion in adult spinal deformity double curves with circumferential minimally invasive surgery: 2-year minimum follow-up.

OBJECTIVE: Selection of the upper instrumented vertebra (UIV) level for adult spinal deformity (ASD) remains controversial. Although selective fusion attempts have been described for fractional curves or adolescent curves, no authors have described selective thoracolumbar fusion performance for ASD with double curves. This study evaluated the clinical impact of selective fusion constructs within the lower thoracic and/or lumbar spine on ASD with double curves. METHODS: A retrospective review was performed on an ASD (Cobb angle > 20°, sagittal vertical axis [SVA] > 50 mm, and pelvic incidence minus lumbar lordosis mismatch [PI-LL] > 10°) database consisting of 438 patients who underwent correction with circumferential minimally invasive surgery (CMIS) between 2007 and 2020. The inclusion criteria were ASD double curves (lumbar Cobb angle > 35° and thoracic Cobb angle > 30°), 4 or more levels fused, and minimum 2-year follow-up. Analyses were performed on spinopelvic data and clinical outcome scores. Complications were recorded, specifically the need for revision surgery and hardware-related complications. RESULTS: Twenty-one ASD double curve patients underwent selective correction with a mean ± SD (range) follow-up of 91 ± 43 (24-174) months. A total of 141 levels were fused with a mean of 6.7 ± 1.3 (4-8) levels. T10 was the most proximal and most common UIV (10/21 [48%]). Pelvic fixation was performed in 12 patients (57%). Significant improvements in lumbar Cobb angle, thoracic Cobb angle, coronal balance, lumbar lordosis, thoracic kyphosis, SVA, and PI-LL were achieved. The uninstrumented thoracic spine demonstrated 14.5° of mean coronal correction and a mean increase of 9.4° in kyphosis. Significant improvements in visual analog scale (VAS) and Oswestry Disability Index (ODI) scores were observed. Four patients required revision for the following reasons: 1) superficial wound infection requiring irrigation and debridement; 2) bilateral L5 pars fractures requiring L5-S1 anterior lumbar interbody fusion and pelvic fixation; 3) adjacent-segment degeneration at L5-S1 requiring anterior lumbar interbody fusion and pelvic fixation; and 4) proximal junctional kyphosis requiring revision fusion to include the entire thoracic curve. There were no instances of hardware failure such as rod breakage or screw loosening. CONCLUSIONS: Selective thoracolumbar fusion with CMIS for ASD double curves can provide significant clinical improvements. Despite limiting fusion constructs to within the lower thoracic and/or lumbar spine, significant correction can be observed in the uninstrumented thoracic curve. The rate of mechanical complications was low, and the 2-year follow-up results suggested that limited fusion constructs are viable options for ASD double curve patients.

Do peri-operative parathyroid hormone (PTH) analogues improve bone density and decrease mechanical complications in spinal deformity correction?-a minimum 2-year radiological study measuring Hounsfield units.

OBJECTIVE: To delineate whether use of a PTH analogue in the 1-year peri-operative period improves lumbar bone density. METHODS: A prospectively collected data registry of 254 patients who underwent CMIS correction of ASD (Cobb angle > 20 or SVA > 50 mm or (PI-LL) > 10) from Jan 2011 to Jan 2020 was analysed. Patients who were placed on PTH analogues for one year in conjunction with surgery were included in the study. Ultimately, 41 patients who had pre- and two-year post-operative CT scans for review were included in this study. Hounsfield units were measured off of the L1-L3 levels for all patients before and after surgery on pre-op and post-op CT scans. RESULT: The mean age of patients in this study was 70 (52-84, SD 7). Mean follow-up was 66 (24-132, SD 33) months. Twenty-three patients met criteria for severe deformity (Cobb angle > 50 degrees or SVA > 95 mm or PI/LL mismatch > 20 or PT > 30). Based off 2-year post-op CT scan, there were significant improvements in L1 Hounsfield units when comparing pre-op values (96; SD 55) to post-op values (185 SD 102); p. < 0.05. There was no screw loosening or screw pull out. There were 2 patients with PJF (4.8%). Both these patients had not completed their PTH treatment: one only took PTH for 3 months (PJF at 2-year post-op) and the other one took it only for 1 month (PJF at 1-year post-op). No increase in bone density was noted (based off of Hounsfield units) in five patients (12%) despite completion of their PTH therapy. Only one patient experienced nausea from PTH therapy. There were no other PTH related adverse events. CONCLUSION: The incidence of PTH analogues failing to increase bone density in our series was low at 12%. This study shows that PTH analogues may be a powerful adjunct for increasing bone density and may help to mitigate the risk of mechanical complications in patients undergoing deformity correction with minimally invasive techniques. Future comparative studies are warranted to confirm these latter findings and to potentially protocolize the ideal peri-operative bone health optimization strategy.

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

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

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.

Does the Global Alignment and Proportion score predict mechanical complications in circumferential minimally invasive surgery for adult spinal deformity?

OBJECTIVE: The Global Alignment and Proportion (GAP) score was developed to serve as a tool to predict mechanical complication probability in patients undergoing surgery for adult spinal deformity (ASD), serving as an aid for setting surgical goals to decrease the prevalence of mechanical complications in ASD surgery. However, it was developed using ASD patients for whom open surgical techniques were used for correction. Therefore, the purpose of this study was to assess the applicability of the score for patients undergoing circumferential minimally invasive surgery (cMIS) for correction of ASD. METHODS: Study participants were patients undergoing cMIS ASD surgery without the use of osteotomies with a minimum of four levels fused and 2 years of follow-up. Postoperative GAP scores were calculated for all patients, and the association with mechanical failure was analyzed. RESULTS: The authors identified 182 patients who underwent cMIS correction of ASD. Mechanical complications were found in 11.1% of patients with proportioned spinopelvic states, 20.5% of patients with moderately disproportioned spinopelvic states, and 18.8% of patients with severely disproportioned spinopelvic states. Analysis with a chi-square test showed a significant difference between the cMIS and original GAP study cohorts in the moderately disproportioned and severely disproportioned spinopelvic states, but not in the proportioned spinopelvic states. CONCLUSIONS: For patients stratified into proportioned, moderately disproportioned, and severely disproportioned spinopelvic states, the GAP score predicted 6%, 47%, and 95% mechanical complication rates, respectively. The mechanical complication rate in patients undergoing cMIS ASD correction did not correlate with the calculated GAP spinopelvic state.

The Benefit of Addressing Malalignment in Revision Surgery for Proximal Junctional Kyphosis Following ASD Surgery.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Understand the benefit of addressing malalignment in revision surgery for proximal junctional kyphosis (PJK). SUMMARY OF BACKGROUND DATA: PJK is a common cause of revision surgery for adult spinal deformity patients. During a revision, surgeons may elect to perform a proximal extension of the fusion, or also correct the source of the lumbopelvic mismatch. MATERIALS AND METHODS: Recurrent PJK following revision surgery was the primary outcome. Revision surgical strategy was the primary predictor (proximal extension of fusion alone compared with combined sagittal correction and proximal extension). Multivariable logistic regression determined rates of recurrent PJK between the two surgical groups with lumbopelvic surgical correction assessed through improving ideal alignment in one or more alignment criteria [Global Alignment and Proportionality (GAP), Roussouly-type, and Sagittal Age-Adjusted Score (SAAS)]. RESULTS: A total of 151 patients underwent revision surgery for PJK. PJK occurred at a rate of 43.0%, and PJF at 12.6%. Patients proportioned in GAP postrevision had lower rates of recurrent PJK [23% vs. 42%; odds ratio (OR): 0.3, 95% confidence interval (CI): 0.1-0.8, P =0.024]. Following adjusted analysis, patients who were ideally aligned in one of three criteria (Matching in SAAS and/or Roussouly matched and/or achieved GAP proportionality) had lower rates of recurrent PJK (36% vs. 53%; OR: 0.4, 95% CI: 0.1-0.9, P =0.035) and recurrent PJF (OR: 0.1, 95% CI: 0.02-0.7, P =0.015). Patients ideally aligned in two of three criteria avoid any development of PJF (0% vs. 16%, P <0.001). CONCLUSIONS: Following revision surgery for PJK, patients with persistent poor sagittal alignment showed increased rates of recurrent PJK compared with patients who had abnormal lumbopelvic alignment corrected during the revision. These findings suggest addressing the root cause of surgical failure in addition to proximal extension of the fusion may be beneficial.

Catastrophic acute failure of pelvic fixation in adult spinal deformity requiring revision surgery: a multicenter review of incidence, failure mechanisms, and risk factors.

OBJECTIVE: There are few prior reports of acute pelvic instrumentation failure in spinal deformity surgery. The objective of this study was to determine if a previously identified mechanism and rate of pelvic fixation failure were present across multiple institutions, and to determine risk factors for these types of failures. METHODS: Thirteen academic medical centers performed a retrospective review of 18 months of consecutive adult spinal fusions extending 3 or more levels, which included new pelvic screws at the time of surgery. Acute pelvic fixation failure was defined as occurring within 6 months of the index surgery and requiring surgical revision. RESULTS: Failure occurred in 37 (5%) of 779 cases and consisted of either slippage of the rods or displacement of the set screws from the screw tulip head (17 cases), screw shaft fracture (9 cases), screw loosening (9 cases), and/or resultant kyphotic fracture of the sacrum (6 cases). Revision strategies involved new pelvic fixation and/or multiple rod constructs. Six patients (16%) who underwent revision with fewer than 4 rods to the pelvis sustained a second acute failure, but no secondary failures occurred when at least 4 rods were used. In the univariate analysis, the magnitude of surgical correction was higher in the failure cohort (higher preoperative T1-pelvic angle [T1PA], presence of a 3-column osteotomy; p < 0.05). Uncorrected postoperative deformity increased failure risk (pelvic incidence-lumbar lordosis mismatch > 10°, higher postoperative T1PA; p < 0.05). Use of pelvic screws less than 8.5 mm in diameter also increased the likelihood of failure (p < 0.05). In the multivariate analysis, a larger preoperative global deformity as measured by T1PA was associated with failure, male patients were more likely to experience failure than female patients, and there was a strong association with implant manufacturer (p < 0.05). Anterior column support with an L5-S1 interbody fusion was protective against failure (p < 0.05). CONCLUSIONS: Acute catastrophic failures involved large-magnitude surgical corrections and likely resulted from high mechanical strain on the pelvic instrumentation. Patients with large corrections may benefit from anterior structural support placed at the most caudal motion segment and multiple rods connecting to more than 2 pelvic fixation points. If failure occurs, salvage with a minimum of 4 rods and 4 pelvic fixation points can be successful.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

STUDY DESIGN: Prospective randomized Food and Drug Administration investigational device exemption clinical trial. OBJECTIVE: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. SUMMARY OF BACKGROUND DATA: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. METHODS: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. RESULTS: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. CONCLUSIONS: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.

Prevalence and Modes of Posterior Hardware Failure With a Staged Protocol for Circumferential Minimally Invasive Surgical Correction of Adult Spinal Deformity: A 13-Year Experience.

BACKGROUND: One of the common complications of adult spinal deformity (ASD) correction is the failure to relieve pain. This may result from the failure of implanted hardware to provide adequate stabilization. While numerous studies exist, characterizing complications that can occur with minimally invasive correction of ASD and data regarding hardware failure in this setting are limited. OBJECTIVE: This article characterizes the rate and mode of posterior hardware failure in the setting of circumferential minimally invasive surgery (CMIS) for ASD correction. METHODS: Patients undergoing staged CMIS correction of ASD from January 2007 to September 2018 were identified. Patients with a minimum 2-year follow-up were included in the study. RESULT: A total of 263 patients (168 women and 95 men) were included in the study. The mean age of patients was 64 years (21-85, SD 13.7), and the mean length of follow-up was 90 months (24-164, SD 40.2). An average of 6 levels (3-16, SD 3.15) was fused per patient.Eight patients had a mechanical hardware failure and required revision surgery (3.04%). No catastrophic failures were noted in our series. Hardware failures were characterized as follows: 2 patients with broken screws, 5 patients with loose screws, and 1 patient who had symptomatic T12-L1 and L5-S1 nonunion with bilateral distal rod fractures, iliac set screw loosening, and proximal T12 screw loosening. Following revision surgery, all of these patients had confirmed solid fusion on computed tomography (CT) scan at their latest follow-up visit.Interestingly, 3 other patients had loosening of the set screw on their iliac bolts. Five patients had rod fractures between L5 and S1 or below S1. All 8 of these patients were asymptomatic with confirmed fusion at L5-S1 on CT scans. CONCLUSION: The prevalence of clinically significant hardware failure needing revision in our series was low at 3.04%. Symptomatic hardware prominence requiring revision was 2.3%. Specifically, rod fractures were not common (2.2%). Our study suggests that in the appropriately selected patient, CMIS to correct ASD without osteotomies may result in acceptable rates of hardware failure. Future studies should compare the results of CMIS deformity correction to a matched population of patients undergoing open deformity correction. CLINICAL RELEVANCE: This study suggests that in the appropriately selected patient, CMIS to correct ASD without osteotomies may result in acceptable rates of hardware failure.

Are Minimally Invasive Spine Surgeons or Classical Open Spine Surgeons More Consistent with Their Treatment of Adult Spinal Deformity?

OBJECTIVE: Spine surgeons have a heuristic sense of how to surgically restore alignment and address adult spinal deformity (ASD) symptoms, but consensus on the extent of treatment remains unclear. We sought to determine the variability of surgical approaches in treating ASD. METHODS: Sixteen spine surgeons were surveyed on treatment approaches in 10 select ASD cases. We repeated the survey with the same surgeons 4 weeks later, with cases ordered differently. We examined the variability in length of construct, use of interbody spacers, osteotomies, and pelvic fixation frequency. RESULTS: Treatment approaches for each case varied by surgeon, with some surgeons opting for long fusion constructs in cases for which others offered no surgery. There was no consensus among surgeons on the number of levels fused, interbody spacer use, or anterior/posterior osteotomies. Intersurgeon and intrasurgeon variability was 48% (kappa = 0.31) and 59% (kappa = 0.44) for surgeons performing minimally invasive surgery (MIS) versus 37% (kappa = 0.21) and 47% (kappa = 0.30) for those performing open surgery. In the second-round survey, 8 of 15 (53%) surgeons substantially changed the construct length, number of interbody spacers, and osteotomies in at least half the cases they previously reviewed. Surgeons performing MIS versus open surgery were less likely to extend constructs to the pelvis (42.5% vs. 67.5%; P = 0.02), but construct length was not correlated with whether a surgeon performed MIS or open surgery. CONCLUSIONS: Spinal deformity surgeons lack consensus on the optimal surgical approach for treating ASD. Classifying surgeons as performing MIS or open surgery does not mitigate this variability.

Predictive Analytics for Determining Extended Operative Time in Corrective Adult Spinal Deformity Surgery.

BACKGROUND: More sophisticated surgical techniques for correcting adult spinal deformity (ASD) have increased operative times, adding to physiologic stress on patients and increased complication incidence. This study aims to determine factors associated with operative time using a statistical learning algorithm. METHODS: Retrospective review of a prospective multicenter database containing 837 patients undergoing long spinal fusions for ASD. Conditional inference decision trees identified factors associated with skin-to-skin operative time and cutoff points at which factors have a global effect. A conditional variable-importance table was constructed based on a nonreplacement sampling set of 2000 conditional inference trees. Means comparison for the top 15 variables at their respective significant cutoffs indicated effect sizes. RESULTS: Included: 544 surgical ASD patients (mean age: 58.0 years; fusion length 11.3 levels; operative time: 378 minutes). The strongest predictor for operative time was institution/surgeon. Center/surgeons, grouped by decision tree hierarchy, a and b were, on average, 2 hours faster than center/surgeons c-f, who were 43 minutes faster than centers g-j, all P < 0.001. The next most important predictors were, in order, approach (combined vs posterior increases time by 139 minutes, P < 0.001), levels fused (<4 vs 5-9 increased time by 68 minutes, P < 0.050; 5-9 vs < 10 increased time by 47 minutes, P < 0.001), age (age <50 years increases time by 57 minutes, P < 0.001), and patient frailty (score <1.54 increases time by 65 minutes, P < 0.001). Surgical techniques, such as three-column osteotomies (35 minutes), interbody device (45 minutes), and decompression (48 minutes), also increased operative time. Both minor and major complications correlated with <66 minutes of increased operative time. Increased operative time also correlated with increased hospital length of stay (LOS), increased estimated intraoperative blood loss (EBL), and inferior 2-year Oswestry Disability Index (ODI) scores. CONCLUSIONS: Procedure location and specific surgeon are the most important factors determining operative time, accounting for operative time increases <2 hours. Surgical approach and number of levels fused were also associated with longer operative times, respectively. Extended operative time correlated with longer LOS, higher EBL, and inferior 2-y ODI outcomes. CLINICAL RELEVANCE: We further identified the poor outcomes associated with extended operative time during surgical correction of ASD, and attributed the useful predictors of time spent in the operating room, including site, surgeon, surgical approach, and the number of levels fused.

Management of severe adult spinal deformity with circumferential minimally invasive surgical strategies without posterior column osteotomies: a 13-year experience.

OBJECTIVE: To evaluate the mid- to long-term clinical outcomes of circumferential minimally invasive surgery (CMIS) without posterior column osteotomies for severe adult spine deformity (ASD) correction. METHODS: All patients with a minimum of 2-year follow-up undergoing staged CMIS correction of ASD from January 2007 to July 2018 were identified. All included patients had fusion of 3 or more interbody levels that spanned the L5-S1 junction. Only patients with severe deformity, Coronal Cobb > 50° or at least one SRS-Schwab ++ sagittal modifier (SVA > 95 mm, or PI-LL > 20, or PT > 30) were included. All complications were noted. RESULT: 136 patients met inclusion criteria; mean age of patients was 63.6 years (21-85, SD 13.7). The mean follow-up was 82.8 months (24-159, SD 36.6). The mean number of levels fused was 7 (3-16, SD 3). A total of 40 (29.4%) major complications were noted at final follow-ups: 2 (1.4%) intra-operative, 12 (8.9%) peri-operative (≤ 6 weeks from index), 26 (19.1%) post-operative (> 6 weeks from index). There was a total of 53 (40.0%) minor complications. Seven (5.1%) patients who developed radiographic proximal junctional kyphosis. Three patients (2.2%) developed proximal junctional failure. There were 8 (5.9%) cases of pseudarthrosis. Five of these occurred in patients undergoing AxiaLIF. All patients experienced improvements in patient-perceived outcomes (VAS, TIS, ODI, and SRS-22) and radiographic parameters at last follow-up when compared to pre-op (p < 0.05). CONCLUSION: Rates of complications with CMIS correction of severe ASD are lower than published rates of complications seen with open ASD correction. Specifically, the incidence of catastrophic complications is lower. Furthermore, CMIS is associated with significant improvements in clinical and functional outcomes, low rates of pseudarthrosis and proximal junctional kyphosis. Therefore, in the appropriately selected patient, CMIS may be an excellent alternative approach to addressing severe ASD.

Role of obesity in less radiographic correction and worse health-related quality-of-life outcomes following minimally invasive deformity surgery.

OBJECTIVE: Minimally invasive surgery (MIS) for adult spinal deformity (ASD) can offer deformity correction with less tissue manipulation and damage. However, the impact of obesity on clinical outcomes and radiographic correction following MIS for ASD is poorly understood. The goal of this study was to determine the role, if any, that obesity has on radiographic correction and health-related quality-of-life measures in MIS for ASD. METHODS: Data were collected from a multicenter database of MIS for ASD. This was a retrospective review of a prospectively collected database. Patient inclusion criteria were age ≥ 18 years and coronal Cobb angle ≥ 20°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, or sagittal vertical axis (SVA) > 5 cm. A group of patients with body mass index (BMI) < 30 kg/m2 was the control cohort; BMI ≥ 30 kg/m2 was used to define obesity. Obesity cohorts were categorized into BMI 30-34.99 and BMI ≥ 35. All patients had at least 1 year of follow-up. Preoperative and postoperative health-related quality-of-life measures and radiographic parameters, as well as complications, were compared via statistical analysis. RESULTS: A total of 106 patients were available for analysis (69 control, 17 in the BMI 30-34.99 group, and 20 in the BMI ≥ 35 group). The average BMI was 25.24 kg/m2 for the control group versus 32.46 kg/m2 (p < 0.001) and 39.5 kg/m2 (p < 0.001) for the obese groups. Preoperatively, the BMI 30-34.99 group had significantly more prior spine surgery (70.6% vs 42%, p = 0.04) and worse preoperative numeric rating scale leg scores (7.71 vs 5.08, p = 0.001). Postoperatively, the BMI 30-34.99 cohort had worse Oswestry Disability Index scores (33.86 vs 23.55, p = 0.028), greater improvement in numeric rating scale leg scores (-4.88 vs -2.71, p = 0.012), and worse SVA (51.34 vs 26.98, p = 0.042) at 1 year postoperatively. Preoperatively, the BMI ≥ 35 cohort had significantly worse frailty (4.5 vs 3.27, p = 0.001), Oswestry Disability Index scores (52.9 vs 44.83, p = 0.017), and T1 pelvic angle (26.82 vs 20.71, p = 0.038). Postoperatively, after controlling for differences in frailty, the BMI ≥ 35 cohort had significantly less improvement in their Scoliosis Research Society-22 outcomes questionnaire scores (0.603 vs 1.05, p = 0.025), higher SVA (64.71 vs 25.33, p = 0.015) and T1 pelvic angle (22.76 vs 15.48, p = 0.029), and less change in maximum Cobb angle (-3.93 vs -10.71, p = 0.034) at 1 year. The BMI 30-34.99 cohort had significantly more infections (11.8% vs 0%, p = 0.004). The BMI ≥ 35 cohort had significantly more implant complications (30% vs 11.8%, p = 0.014) and revision surgery within 90 days (5% vs 1.4%, p = 0.034). CONCLUSIONS: Obese patients who undergo MIS for ASD have less correction of their deformity, worse quality-of-life outcomes, more implant complications and infections, and an increased rate of revision surgery compared with their nonobese counterparts, although both groups benefit from surgery. Appropriate counseling should be provided to obese patients.