The Impact of Unplanned Reoperation Following Adult Spinal Deformity Surgery: A Prospective Longitudinal Cohort Study with 5-Year Follow-up.

BACKGROUND: The long-term impact of reoperations following adult spinal deformity (ASD) surgery is still poorly understood. Our aim was to identify the relationship between unplanned reoperation and health-related quality of life (HRQoL) gain at 2 and 5 years of follow-up. METHODS: We included patients enrolled in a prospective ASD database who underwent surgery ≥5 years prior to the start of the study and who had 2 years of follow-up data. Adverse events (AEs) leading to an unplanned reoperation, the time of reoperation occurrence, invasiveness (blood loss, surgical time, hospital stay), and AE resolution were assessed. HRQoL was measured with use of the Oswestry Disability Index, Scoliosis Research Society-22, and Short Form-36. Linear models controlling for baseline data and index surgery characteristics were utilized to assess the relationships between HRQoL gain at 2 and 5-year follow-up and the number and invasiveness of reoperations. The association between 5-year HRQoL gain and the time of occurrence of the unplanned reoperation and that between 5-year HRQoL gain and AE resolution were also investigated. RESULTS: Of 361 eligible patients, 316 (87.5%) with 2-year follow-up data met the inclusion criteria and 258 (71.5%) had 5-year follow-up data. At the 2-year follow-up, 96 patients (30.4%) had a total of 165 unplanned reoperations (1.72 per patient). At the 5-year follow-up, 73 patients (28.3%) had a total of 117 unplanned reoperations (1.60 per patient). The most common cause of reoperations was mechanical complications (64.9%), followed by surgical site infections (15.7%). At the 5-year follow-up, the AE that led to reoperation was resolved in 67 patients (91.8%). Reoperation invasiveness was not associated with 5-year HRQoL scores. The number of reoperations was associated with lesser HRQoL gain at 5 years for all HRQoL measures. The mean associated reduction in HRQoL gain per unplanned reoperation was 41% (range, 19% to 66%). Reoperations resulting in no resolution of the AE or resolution with sequelae had a greater impact on 5-year follow-up HRQoL scores than reoperations resulting in resolution of the AE. CONCLUSIONS: A postoperative, unplanned reoperation following ASD surgery was associated with lesser gain in HRQoL at 5 years of follow-up. The association did not diminish over time and was affected by the number, but not the magnitude, of reoperations. Resolution of the associated AE reduced the impact of the unplanned reoperation. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Influence of smoking on patient-reported outcome measures (PROMs) in patients undergoing surgery for adult spinal deformity: a propensity score-matched analysis.

PURPOSE: The purpose of this study was to determine the isolated influence of smoking in patient-reported outcome measures (PROMs) for adult spinal deformity (ASD) surgery excluding known tobacco-related complications. METHODS: Retrospective analysis of a prospective multicenter ASD database. Patients operated on ASD with 2 year post-operative follow-up were included. Former smokers (non-active smokers) and patients developing mechanical or infectious complications were excluded. Changes of PROMs over time were analyzed using mixed models for repeated measures (MMRM). Propensity score matching (PSM) (1:1 ratio, caliper 0.10) was performed without replacement using optimum algorithm, tolerance ≤ 0.001, and estimated with 95% confidence interval (CI). PROMS in both groups were compared by paired t test or Wilcoxon signed-rank test. RESULTS: 692 out of 1246 surgical patients met our inclusion criteria. 153 smokers were matched with 153 non-smokers according to age, BMI, number of fused levels, and global tilt. After PSM both groups were homogeneous regarding baseline parameters, surgical data, and complications (mechanical complications and infection excluded). Smokers had worse baseline results for SRS-total, SRS-pain COMI-back, and ODI; smokers also showed worse 2-year outcomes for SRS-total, SRS-function, SRS-pain, SRS-self-image, and ODI. However, no differences between the two groups were found in the improvement from baseline to 2-year follow-up or in the timing of this improvement (MMRM). The proportion of patients reaching the minimal clinically important difference (MCID) after surgery was similar in the two groups, but the proportion of patients reaching patient acceptable symptom state (PASS) was significantly lower in smokers for SRS-Subtotal, SRS-function, and SRS-image. CONCLUSION: Even in the absence of smoking-related complications, smokers had worse PROMs at baseline and 2 years after surgery with less patients achieving PASS, but similar degrees on improvement compared to non-smokers. The proportion achieving MCID was also similar between the two cohorts.

Translation, Adaptation, and Validation of a Spanish Version of the Japanese Orthopaedic Association Cervical Myelopathy Questionnaire.

STUDY DESIGN: Translation and psychometric testing of a questionnaire. OBJECTIVE: Translation, adaptation, and validation of the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) to the Spanish language. SUMMARY OF BACKGROUND DATA: Degenerative cervical myelopathy (DCM) has a clear impact on quality of life (QoL). The JOACMEQ is a self-administered questionnaire used to assess DCM-related disability and its impact on QoL. It is compound of five domains: Cervical Function, Upper Extremity Function, Lower Extremity Function, Blader Function, and QoL. Despite its increasing use, the JOACMEQ has not yet been translated and validated for Spanish-speaking patients. METHODS: A total of 180 patients completed the Spanish version. Of these, 145 (80%) had DCM (mean age: 62.53; SD: 9.92), while 35 had neck pain without DCM (age: 52.71; SD: 10.29). The psychometric properties measured were construct validity, internal consistency, reproducibility, concurrent validity, and discriminatory ability. RESULTS: We recruited 145 patients with DCM (mean age: 62.5) and 35 with cervical pain (mean age: 52.7). After factor analysis, our data showed very strong construct validity, with questions strongly loaded and clustered for five factors. Internal consistency proved high (Cronbach's α coefficient of 0.912). The intraclass correlation coefficient showed very good reproducibility for all domain (intraclass correlation coefficient range between 0.85 and 0.95). A high correlation between the JOACMEQ QoL domain and neck disability index was also found (Spearman's ρ=-0.847, P <0.01) confirming concurrent validity. The receiver operating characteristic curves proved to be significant in the upper (area under the curve=0.65, P =0.006) and lower (area under the curve=0.661, P =0.003) extremities, confirming discriminatory ability. CONCLUSIONS: Our proposed Spanish version of the JOACMEQ retains the psychometric characteristics of the original JOACMEQ and could prove useful for the evaluation of patients with DCM in Spanish-speaking countries.

Cost Benefit of Implementation of Risk Stratification Models for Adult Spinal Deformity Surgery.

STUDY DESIGN/SETTING: Retrospective cohort study. OBJECTIVE: Assess the extent to which defined risk factors of adverse events are drivers of cost-utility in spinal deformity (ASD) surgery. METHODS: ASD patients with 2-year (2Y) data were included. Tertiles were used to define high degrees of frailty, sagittal deformity, blood loss, and surgical time. Cost was calculated using the Pearl Diver registry and cost-utility at 2Y was compared between cohorts based on the number of risk factors present. Statistically significant differences in cost-utility by number of baseline risk factors were determined using ANOVA, followed by a generalized linear model, adjusting for clinical site and surgeon, to assess the effects of increasing risk score on overall cost-utility. RESULTS: By 2 years, 31% experienced a major complication and 23% underwent reoperation. Patients with ≤2 risk factors had significantly less major complications. Patients with 2 risk factors improved the most from baseline to 2Y in ODI. Average cost increased by $8234 per risk factor (R2 = .981). Cost-per-QALY at 2Y increased by $122,650 per risk factor (R2 = .794). Adjusted generalized linear model demonstrated a significant trend between increasing risk score and increasing cost-utility (r2 = .408, P < .001). CONCLUSIONS: The number of defined patient-specific and surgical risk factors, especially those with greater than two, were associated with increased index surgical costs and diminished cost-utility. Efforts to optimize patient physiology and minimize surgical risk would likely reduce healthcare expenditures and improve the overall cost-utility profile for ASD interventions.Level of evidence: III.

Future Data Points to Implement in Adult Spinal Deformity Assessment for Artificial Intelligence Modeling Prediction: The Importance of the Biological Dimension.

Adult spinal deformity (ASD) surgery is still associated with high surgical risks. Machine learning algorithms applied to multicenter databases have been created to predict outcomes and complications, optimize patient selection, and improve overall results. However, the multiple data points currently used to create these models allow for 70% of accuracy in prediction. We need to find new variables that can capture the spectrum of probability that is escaping from our control. These proposed variables are based on patients' biological dimensions, such as frailty, sarcopenia, muscle and bone (tissue) sampling, serological assessment of cellular senescence, and circulating biomarkers that can measure epigenetics, inflammaging, and -omics. Many of these variables are proven to be modifiable and could be improved with proper nutrition, toxin avoidance, endurance exercise, and even surgery. The purpose of this manuscript is to describe the different future data points that can be implemented in ASD assessment to improve modeling prediction, allow monitoring their response to prerehabilitation programs, and improve patient counseling.

Cutibacterium spp. Infections after Instrumented Spine Surgery Have a Good Prognosis Regardless of Rifampin Use: A Cross-Sectional Study.

Infection after spinal instrumentation (IASI) by Cutibacterium spp. is being more frequently reported. The aim of this study was to analyse the incidence, risk factors, clinical characteristics, and outcome of a Cutibacterium spp. IASI (CG) compared with non-Cutibacterium IASI (NCG) infections, with an additional focus on the role of rifampin in the treatment. All patients from a multicentre, retrospective, observational study with a confirmed IASI between January 2010 and December 2016 were divided into two groups: (CG and NCG) IASI. Baseline, medical, surgical, infection treatment, and follow-up data were compared for both groups. In total, 411 patients were included: 27 CG and 384 NCG. The CG patients were significantly younger. They had a longer median time to diagnosis (23 vs. 13 days) (p = 0.025), although 55.6% debuted within the first month after surgery. Cutibacterium patients were more likely to have the implant removed (29.6% vs. 12.8%; p = 0.014) and received shorter antibiotic regimens (p = 0.014). In 33% of Cutibacterium cases, rifampin was added to the baseline therapy. None of the 27 infections resulted in treatment failure during follow-up regardless of rifampin use. Cutibacterium spp. is associated with a younger age and may cause both early and late IASIs. In our experience, the use of rifampin to improve the outcome in the treatment of a Cutibacterium spp. IASI is not relevant since, in our series, none of the cases had therapeutic failure regardless of the use of rifampin.

Revision surgery following long lumbopelvic constructs for adult spinal deformity: prospective experience from two dedicated databases.

PURPOSE: Pan Lumbar Arthodesis (PLA) are often required for Adult Spinal Deformity (ASD) correction, reducing significantly the compensatory capacity in case of postoperative sagittal malalignment. Few papers have investigated outcomes and complications in this vulnerable subset of patients. The objective of this study was to assess revision surgery rate for PLA in ASD, its risk factors and impact on clinical outcomes. METHODS: Retrospective multicenter review of prospective ASD data from 7 hospitals covering Europe and Asia. ASD patients included in two prospective databases having a posterior instrumentation spanning the whole lumbar region with more than 2-years of follow-up were reviewed. Demographic, surgical, radiographic parameters and Health-Related Quality of Life (HRQoL) scores were analyzed. Univariate and multivariate regression models analyzed risk factors for revision surgery as well as surgical outcomes. Patients with Early versus Late and PJK versus Non-PJK mechanical complications were also compared. RESULTS: Out of 1359 ASD patients included in the database 589 (43%) had a PLA and 357 reached 2-years mark. They were analyzed and compared to non-PLA patients. Average age was 67 and 82% were females. 100 Patients (28.1%) needed 114 revision surgeries (75.4% for mechanical failures). Revised patients were more likely to have a nerve system disorder, higher BMI and worst immediate postoperative alignment (as measured by GAP Parameters). These risk factors were also associated with earlier mechanical complications and PJK. Deformity and HRQoL parameters were comparable at baseline. Non-revised patients had significantly better clinical outcomes at 2-years (SRS 22 scores, ODI, Back pain). Multivariate analysis could identify nerve system disorder (OR 4.8; CI 1.8-12.6; p = 0.001), postoperative sagittal alignment (GAP Score) and high BMI (OR 1.07; CI 1.01-1.13; p = 0.004) as independent risk factors for revisions. CONCLUSIONS: Revision surgery due to mechanical failures is relatively common after PLA leading to worse clinical outcomes. Prevention strategies should focus on individualized restoration of sagittal alignment and better weight control to decrease stress on these rigid constructs in non-compliant spines. Nerve system disorders independently increase revision risk in PLA. LEVEL OF EVIDENCE II: Prognosis.

A 5-year follow-up of the effect of corrective surgery in young adults with idiopathic scoliosis.

PURPOSE: The purpose of this study was to determine mid-long-term outcomes (5 years) following surgery for young adult idiopathic scoliosis (YAdIS). METHODS: This is a retrospective review of a prospective, multicenter adult deformity database including patients operated on idiopathic scoliosis by a single posterior approach, age at surgery between 19 and 29 (considered young adults), and 5-year follow-up. Demographic, radiographic and PROMS were analyzed preoperatively, at 2 years and at final follow-up. RESULTS: Forty-two patients were included. Mean preoperative major curve angle was 59.65 ± 18.94. Main coronal curve initial correction was 56.38%, with 6% loss at 5 years. From baseline to 5 years after surgery, there was improvement in all PROMs (P < 0.004)-especially self-image-, except NRS-leg pain. This improvement was present at 6 months for all PROMs except for functional outcomes (SRS-Function and ODI) in which the improvement took place between 6 months and 2 years. In the 2- to 5-year follow-up period, no significant changes were seen in any PROMs. The percentage of patients reaching MCID from baseline at 5 years was: 75% for SRS-image, 45% for SRS-pain, 47.5% for SRS-function, 51.3% for SRS-mental, 42.5% for SRS-total and 15.4% for ODI. Patients reaching PASS at 5 years were: 88.1% for SRS-image, 81% for SRS-pain, 92.9% for SRS-function, 57.1% for SRS-mental, 88.1% for SRS-total, 92.7% for ODI and 69% for NRS pain. 11 minor and 4 major complications were identified. CONCLUSION: YAdIS surgery resulted in an early and significant improvement in PROMs, especially for self-image, significantly reaching MCID and PASS thresholds. These results were maintained during long-term (5-year) follow-up.

Myelopathy disability index: establishing criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy.

PURPOSE: To find the cut-off values in the Myelopathy Disability Index (MDI) that will allow us to classify the severity of Degenerative Cervical Myelopathy (DCM) into mild, moderate and severe. METHODS: Cross-sectional study with prospective data collection, with a total of 64 patients diagnosed with Degenerative Cervical Myelopathy (DCM). Anthropometric, diagnostic, neurological, functional and quality of life variables were collected. A Receiver Operating Curve (ROC) was performed. The cut-off points were validated by comparing the functional status of patients in the 3 groups and their Nurick scores. RESULTS: Sixty-four patients (23 women) with a mean age of 61.97 (SD 11.57) participated in this study. The majority of patients were Nurick I (28.13%) and Nurick II (32.81%). The medium MDI was 7.36 (SD 6.66) and the mJOA was 14.08 (SD 2.57). The mild-moderate cut-off value was between 4 and 5, with an Area Under the Curve (AUC) of 0.805, sensitivity of 0.853 and specificity of 0.6. For moderate-severe, the cut-off value obtained was between 7 and 8, with an AUC of 0.862, sensitivity of 0.857 and specificity of 0.684. Patients with greater severity had significantly lower functionality, with a P-value of 0.004 in the 30 Metre Walking Test and 0.005 in the Nine-Hole Peg Test. Established severity groups were also significantly related to the different categories of the Nurick score (P-value = 0.000). CONCLUSION: MDI values between 0 and 4 correspond to mild DCM, between 5 and 7 would be moderate DCM and from 8 to 30 indicate severe DCM.

Combined anterior-posterior versus all-posterior approaches for adult spinal deformity correction: a matched control study.

PURPOSE: Anterior approaches are gaining popularity for adult spinal deformity (ASD) surgeries especially with the introduction of hyperlordotic cages and improvement in MIS techniques. Combined Approaches provide powerful segmental sagittal correction potential and increase the surface area available for fusion in ASD surgery, both of which would improve overall. This is the first study directly comparing surgical outcomes between combined anterior-posterior approaches and all-posterior approach in a matched ASD population. METHODS: This is a retrospective matched control cohort analysis with substitution using a multicenter prospectively collected ASD data of patients with > 2 year FU. Matching criteria include: age, American Society of Anesthesiologists Score, Lumbar Cobb angle, sagittal deformity (Global tilt) and ODI. RESULTS: In total, 1024 ASD patients were available for analysis. 29 Combined Approaches patients met inclusion criteria, and only 22 could be matched (1:2 ratio). Preoperative non-matched demographical, clinical, surgical and radiological parameters were comparable between both groups. Combined approaches had longer surgeries (548 mns vs 283) with more blood loss (2850 ml vs 1471) and needed longer ICU stays (74 h vs 27). Despite added morbidity, they had comparable complication rates but with significantly less readmissions (9.1% vs 38.1%) and reoperations (18.2% vs 43.2%) at 2 years. Combined Approaches achieved more individualised and harmonious deformity correction initially. At the 2 years control, Combined Approaches patients reported better outcomes as measured by COMI and SRS scores. This trend was maintained at 3 years. CONCLUSION: Despite an increased initial surgical invasiveness, combined approaches seem to achieve more harmonious correction with superior sagittal deformity control; they need fewer revisions and have improved long-term functional outcomes when compared to all-posterior approaches for ASD deformity correction.

Surgeons' risk perception in ASD surgery: The value of objective risk assessment on decision making and patient counselling.

BACKGROUND: Surgeons often rely on their intuition, experience and published data for surgical decision making and informed consent. Literature provides average values that do not allow for individualized assessments. Accurate validated machine learning (ML) risk calculators for adult spinal deformity (ASD) patients, based on 10 year multicentric prospective data, are currently available. The objective of this study is to assess surgeon ASD risk perception and compare it to validated risk calculator estimates. METHODS: Nine ASD complete (demographics, HRQL, radiology, surgical plan) preoperative cases were distributed online to 100 surgeons from 22 countries. Surgeons were asked to determine the risk of major complications and reoperations at 72 h, 90 d and 2 years postop, using a 0-100% risk scale. The same preoperative parameters circulated to surgeons were used to obtain ML risk calculator estimates. Concordance between surgeons' responses was analyzed using intraclass correlation coefficients (ICC) (poor < 0.5/excellent > 0.85). Distance between surgeons' and risk calculator predictions was assessed using the mean index of agreement (MIA) (poor < 0.5/excellent > 0.85). RESULTS: Thirty-nine surgeons (74.4% with > 10 years' experience), from 12 countries answered the survey. Surgeons' risk perception concordance was very low and heterogeneous. ICC ranged from 0.104 (reintervention risk at 72 h) to 0.316 (reintervention risk at 2 years). Distance between calculator and surgeon prediction was very large. MIA ranged from 0.122 to 0.416. Surgeons tended to overestimate the risk of major complications and reintervention in the first 72 h and underestimated the same risks at 2 years postop. CONCLUSIONS: This study shows that expert surgeon ASD risk perception is heterogeneous and highly discordant. Available validated ML ASD risk calculators can enable surgeons to provide more accurate and objective prognosis to adjust patient expectations, in real time, at the point of care.

A Modified Self-Growing Rod Technique for Treatment of Early-Onset Scoliosis.

Surgical treatment of early-onset scoliosis (EOS) remains challenging as no definitive surgical technique has emerged as the single best option in this varied patient population1-3. Although the available surgical techniques may differ substantially, they all share the same goals of achieving and maintaining deformity correction, allowing physiological spinal growth, and reducing the number of operations and complications. Herein, we present a modified self-growing rod technique that represents a valid alternative to the existing surgical procedures for EOS. Description: The patient is positioned prone on a radiolucent table, and the spine is prepared and draped in a standard fashion. A posterior midline skin incision is made from the upper to the lower instrumented level. Subperiosteal exposure of the spine is carried out, ensuring that capsules of the facet joints are spared. Pedicle screws are inserted bilaterally at the cranial and caudal ends of the instrumentation. Fixation with pedicle screws of at least 3 levels at the top and bottom end is usually advised; in nonambulatory patients with pelvic obliquity, caudal fixation can be extended to the pelvis with bilateral iliac screws. Sublaminar wires are positioned bilaterally at every level between the cranial and caudal ends of the instrumentation and are passed as medially as possible to avoid damage to the facet joints. Four 5-mm cobalt-chromium rods are cut, contoured, and inserted at each end of the construct. Ipsilateral rods are secured with use of sublaminar wires, making sure that they overlap over a sufficient length to allow for the remaining spinal growth. Correction of the deformity is achieved with use of a combination of cantilever maneuvers and apical translation by progressive and sequential tightening of the sublaminar wires. The wound is closed in layers over a subfascial drain. The patient is allowed free mobilization after surgery. No postoperative brace is required. Alternatives: Nonoperative alternative treatment for EOS includes serial cast immobilization and bracing4. Alternative surgical treatments include traditional growing rods5, magnetically controlled growing rods6, the vertical expandable prosthetic titanium rib-expansion technique7, and the Shilla technique8. The use of compression-based systems (i.e., staples or tether)9 or early limited fusion has also been reported by other authors. Rationale: The main advantage of our technique is that it relies on physiological spinal growth and does not require surgery or external devices for rod lengthening, which is particularly beneficial in frail patients with a neuromuscular disease in whom repeated surgery is not advised. Segmental fixation by sublaminar wires allows good control of the deformity apex during growth. Concerns regarding early fusion of the spine have not been confirmed in our mid-term follow-up study10. Expected Outcomes: This technique allows correction of the deformity and continuous spinal growth in the years following surgery. At 6.0 years postoperatively, the average main curve correction was reported to be 61% and the average pelvic obliquity correction was 69%. The spine was reported to lengthen an average of 40.9 mm (range, 14.0 to 84.0 mm) immediately postoperatively, and the T1-S1 segment was reported to continue growing at 10.5 mm/year (range, 3.6 to 16.5 mm/year) thereafter10. The most common complication is rod breakage at the thoracolumbar junction, which seems to be more common in patients with idiopathic or cerebral palsy EOS and during the pubertal growth spurt10. Important Tips: Subperiosteal exposure of the spine should be carried out, making sure to preserve facet joints in the unfused area of the spine.Achieve segmental fixation with use of sublaminar wires at every level and pedicle screws at the top and bottom ends of the instrumentation.If pelvic imbalance is present and the patient is nonambulatory, pelvic fixation with iliac screws is advised.First round correction of the deformity is achieved with a cantilever technique; correction fine-tuning can be performed by tightening sublaminar wires.Consider utilizing thicker rods in cases of idiopathic or cerebral palsy EOS. Acronyms and Abbreviations: EOS = early-onset scoliosisAP = anteroposteriorEV = end vertebraSSEP = somatosensory evoked potentialsMEP = motor evoked potentialsPJK = proximal junctional kyphosisSMA = spinal muscular atrophyCP = cerebral palsyPACU = post-anesthesia care unit.

The dynamics of satisfaction in surgical and non-surgical adult spinal deformity patients.

PURPOSE: For adult spinal deformity (ASD) patients receiving operative (op) and non-operative (non-op) treatment, the relationship between HRQoL measures, complications and self-reported satisfaction remains unclear. The objective of this analysis is to study nonlinear association dynamics between ASD patient satisfaction, HRQoL, and complications over a two-year follow-up period. METHODS: From a prospective multicenter international adult spinal deformity database, all patients with 2-year follow-up data on satisfaction (21st question of SRS-22r) were identified and included. A total of 12 LOESS (local polynomial fit) regressions were performed between patient satisfaction (SRS22 item 21) and HRQoL measures (ODI, SF36PCS and SRS22 subtotal) interacting with surgery at baseline, 6 months and 1 and 2 years of follow-up. RESULTS: A total of 856 patients (527 op and 329 non-op) were included. At baseline, satisfaction was lower for patients scheduled for surgery even when HRQL was similar to those elected for conservative treatment. The nonlinear correlations showed that for similar PROMs, op patients reached higher satisfaction levels during follow-up, especially at six months. In fact, at six months operated patients with a deterioration of their initial PROMs had some improvement in their satisfaction, which could not be further observed at the end of follow-up. CONCLUSIONS: Satisfaction does not correlate well with other PROMs, and it might be subject to other external factors not directly related to treatment. Even if patient satisfaction is important in evaluating well-being and patient's experience with medical care, it should not be considered as an isolated proxy to measure quality of treatment.

Development and Validation of a Multidomain Surgical Complication Classification System for Adult Spinal Deformity.

STUDY DESIGN: Prospective analysis of example cases. OBJECTIVE: The aim of this study was to analyze the accuracy and repeatability of a new comprehensive classification system for capturing complications data in adult spinal deformity. SUMMARY OF BACKGROUND DATA: Complications are common in adult spinal deformity surgery. However, no consensus exists on the definition or classification of complications in adult spinal deformity surgery. The lack of consensus significantly limits understanding of complications' effects on outcomes in surgery for adult spinal deformity. METHODS: Using a Delphi method, members of the International Spine Study Group, AO Spine, and the European Spine Study Group collaborated to develop an adult spinal deformity classification system. The multidomain classification system accounts for medical complications (cancer, cardiopulmonary, central nervous system, gastrointestinal, infectious, musculoskeletal, renal) and surgical complications (implant complications, radiographic complications, neurologic events, intraoperative events, and wound complications). Seventeen individuals ("event readers"), including spine surgeons, trainees, and research coordinators, used the new classification system two separate times to analyze complications in ten example cases. The accuracy and repeatability of the classification system were subsequently calculated based on the providers' responses for the example cases. RESULTS: The 10 example cases included 22 complications. Nearly 95% of complications were captured by >95% of the event readers. The system demonstrated good repeatability of 86.9% between the first and second set of responses provided by event readers. CONCLUSION: The ISSG-AO Multi-Domain Spinal Deformity Complication Classification System for Adult Spinal Deformity demonstrated good accuracy and repeatability among both surgeons and research coordinators in capturing complications in adult spinal deformity surgery. The ISSG-AO system may be applied to help better understand the impact of complications on outcomes and costs in adult spinal deformity surgery.Level of Evidence: 5.

Mid-term results of a modified self-growing rod technique for the treatment of early-onset scoliosis.

AIMS: To report the mid-term results of a modified self-growing rod (SGR) technique for the treatment of idiopathic and neuromuscular early-onset scoliosis (EOS). METHODS: We carried out a retrospective analysis of 16 consecutive patients with EOS treated with an SGR construct at a single hospital between September 2008 and December 2014. General demographics and deformity variables (i.e. major Cobb angle, T1 to T12 length, T1 to S1 length, pelvic obliquity, shoulder obliquity, and C7 plumb line) were recorded preoperatively, and postoperatively at yearly follow-up. Complications and revision procedures were also recorded. Only patients with a minimum follow-up of five years after surgery were included. RESULTS: A total of 16 patients were included. Six patients had an idiopathic EOS while ten patients had a neuromuscular or syndromic EOS (seven spinal muscular atrophy (SMA) and three with cerebral palsy or a syndrome). Their mean ages at surgery were 7.1 years (SD 2.2) and 13.3 years (SD 2.6) respectively at final follow-up. The mean preoperative Cobb angle of the major curve was 66.1° (SD 8.5°) and had improved to 25.5° (SD 9.9°) at final follow-up. The T1 to S1 length increased from 289.7 mm (SD 24.9) before surgery to 330.6 mm (SD 30.4) immediately after surgery. The mean T1 to S1 and T1 to T12 growth after surgery were 64.1 mm (SD 19.9) and 47.4 mm (SD 18.8), respectively, thus accounting for a mean T1 to S1 and T1 to T12 spinal growth after surgery of 10.5 mm/year (SD 3.7) and 7.8 mm/year (SD 3.3), respectively. A total of six patients (five idiopathic EOS, one cerebral palsy EOS) had broken rods during their growth spurt but were uneventfully revised with a fusion procedure. No other complications were noted. CONCLUSION: Our data show that SGR is a safe and effective technique for the treatment of EOS in nonambulatory hypotonic patients with a neuromuscular condition. Significant spinal growth can be expected after surgery and is comparable to other published techniques for EOS. While satisfactory correction of the deformity can be achieved and maintained with this technique, a high rate of rod breakage was seen in patients with an idiopathic or cerebral palsy EOS. Cite this article: Bone Joint J 2020;102-B(11):1560-1566.

Development and validation of risk stratification models for adult spinal deformity surgery.

OBJECTIVE: Adult spinal deformity (ASD) surgery has a high rate of major complications (MCs). Public information about adverse outcomes is currently limited to registry average estimates. The object of this study was to assess the incidence of adverse events after ASD surgery, and to develop and validate a prognostic tool for the time-to-event risk of MC, hospital readmission (RA), and unplanned reoperation (RO). METHODS: Two models per outcome, created with a random survival forest algorithm, were trained in an 80% random split and tested in the remaining 20%. Two independent prospective multicenter ASD databases, originating from the European continent and the United States, were queried, merged, and analyzed. ASD patients surgically treated by 57 surgeons at 23 sites in 5 countries in the period from 2008 to 2016 were included in the analysis. RESULTS: The final sample consisted of 1612 ASD patients: mean (standard deviation) age 56.7 (17.4) years, 76.6% women, 10.4 (4.3) fused vertebral levels, 55.1% of patients with pelvic fixation, 2047.9 observation-years. Kaplan-Meier estimates showed that 12.1% of patients had at least one MC at 10 days after surgery; 21.5%, at 90 days; and 36%, at 2 years. Discrimination, measured as the concordance statistic, was up to 71.7% (95% CI 68%-75%) in the development sample for the postoperative complications model. Surgical invasiveness, age, magnitude of deformity, and frailty were the strongest predictors of MCs. Individual cumulative risk estimates at 2 years ranged from 3.9% to 74.1% for MCs, from 3.17% to 44.2% for RAs, and from 2.67% to 51.9% for ROs. CONCLUSIONS: The creation of accurate prognostic models for the occurrence and timing of MCs, RAs, and ROs following ASD surgery is possible. The presented variability in patient risk profiles alongside the discrimination and calibration of the models highlights the potential benefits of obtaining time-to-event risk estimates for patients and clinicians.

Acute spinal implant infection treated with debridement: does extended antibiotic treatment improve the prognosis?

The study aims to determine whether 8 weeks of antibiotics is non-inferior to 12 weeks in patients with acute deep spinal implant infection (SII). In the retrospective study of all SII cases (2009-2016), patients aged ≥ 15 years with microbiologically confirmed SII treated with debridement and implant retention were included. Whenever possible, tailored antibiotic treatment was used: rifampin/linezolid in gram-positive and quinolones in gram-negative infection. Patients were divided into short treatment course (8 weeks, ST group) and extended treatment (12 weeks, ET group). Primary outcome measure was percentage of cures at 1-year follow-up. One-hundred-twenty-four patients considered, 48 excluded based on the above criteria, leaving 76 patients, 28 ST and 48 ET. There were no differences in patient age, comorbidities, underlying pathologies, infection location, or surgery characteristics between groups. Surgery-to-debridement time was similar (18.5-day ST vs. 19-day ET; P = 0.96). Sixteen SII cases (21.1%) occurred with bloodstream infection. Pathogens found were Enterobacteriaceae (35, 46.1%), Staphylococcus aureus (29, 38.2%), coagulase-negative staphylococci (12, 15.8%), Pseudomonas aeruginosa (12, 15.8%), and Enterococcus faecalis (7, 9.2%). Twenty seven (35.5%) had polymicrobial infection. E. faecalis was more frequent in the ST group (7, 25% vs. 0; P < 0.001), and P. aeruginosa in ET (1, 3.6% vs. 11, 22.9%; P = 0.05). Five patients died of causes unrelated to SII. At 1-year follow-up, cure rates (21/26 ST, 80.8% vs. 39/45 ET, 86.7%; P = 0.52) and recurrences (2/26, 7.7% vs. 2/45, 4.4%; P = 0.62) were similar. Eight-week antimicrobial courses were not inferior to 12 weeks in patients with acute deep SII treated with prompt debridement, proper wound healing, and optimized antibiotics.

30-Day unplanned surgery in cervical spondylotic myelopathy surgically treated: a single-center experience.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Analyze the rate and risk factors associated with Unplanned Surgeries (US) during the first 30 days in patients treated for cervical spondylotic myelopathy. BACKGROUND: US are often regarded as a potentially useful quality of care indicator. METHODS: We defined US as any, non-planned, surgical procedure as a complication after "index" surgery. Demographic data, comorbidities, ASA, smoking status, surgical details and postoperative complications were collected. We conducted a subjective outcome test using the Global Outcome Score (GOS). To assess risk factors, a bivariate analysis was performed using T Student or Chi-square. Risk is shown as odds ratio (OR) with 95% confidence interval (CI). Multivariable logistic regression models with bootstrap resampling procedure were performed. RESULTS: The study included 303 patients (200 men) with mean age of 57.7 years (27-86) and mean follow-up of 75.35 months (16-126 m). 63.3% patients were ASA 1 or 2 and 41.9% were smokers. 77.9% of patients had some comorbidity. Anterior approach surgeries were 65.7%. Perioperative complications: 29% medical, 8.9% intraoperative and 3% implant related. US rate was 2.6%. Causes for revision were postoperative infection or deep hematomas. After bivariate analysis, the risk factors associated were diabetes mellitus (OR 2.6; 95% CI 1-5.5) and intraoperative complications (OR 6.5, 95% CI 1-40). The presence of US does not have influence in satisfaction using GOS score. CONCLUSIONS: Our US rate was 2.6%, similar to the literature. Diabetics and patients suffering an intraoperative complication are more likely to need an early reinterventions (OR 2.2 and 6.5, respectively). US did not alter the patient's outcomes. These slides can be retrieved under Electronic Supplementary Material.

The impact of deep surgical site infection on surgical outcomes after posterior adult spinal deformity surgery: a matched control study.

PURPOSE: The impact of deep surgical site infection (SSI) on surgical outcomes after adult spinal deformity (ASD) surgery is still unclear. We aimed to study the morbidity of SSI in ASD and its impact on deformity correction and functional outcome. METHODS: Prospective multicenter matched-cohort study including consecutively enrolled ASD patients. Patients developing SSI were matched to similar controls in terms of age, gender, ASA, primary or revision, extent of fusion, and use of tri-columnar osteotomies. Preoperative parameters, surgical variables, and complications were recorded. Deformity parameters and Health Related Quality of Life (HRQoL) scores were obtained preoperatively and at 6, 12, and 24 months. Independent t test and Fischer's exact test were used for comparisons. RESULTS: 444 surgical ASD patients with more than 2 years of follow-up were identified. 20 sustained an acute SSI and 60 controls were accordingly matched. No differences were observed between groups in preoperative radiological and HRQoL variables confirming comparable groups. SSI patients had longer hospital stay and more mechanical complications including proximal junctional kyphosis. Infection was associated with more unrelated complications and revisions. Deformity correction was maintained equally at the different time intervals. One death was related to SSI. SSI patients had worse overall HRQoL status at 1 year and were less likely to experience improvement. However, no significant differences were recorded thereafter. CONCLUSION: SSI significantly affects the first postoperative year after posterior ASD surgery. It is associated with more complications, unrelated revisions, and worst quality of life. However it's negative impact seems to be diluted by the second postoperative year as differences in HRQoL scores between the two groups decrease. These slides can be retrieved under Electronic Supplementary material.