Reliability of a New Digital Tool for Photographic Analysis in Quantifying Body Asymmetry in Scoliosis.

Background: Advancements in non-ionizing methods for quantifying spinal deformities are crucial for assessing and monitoring scoliosis. In this study, we analyzed the observer variability of a newly developed digital tool for quantifying body asymmetry from clinical photographs. Methods: Prospective observational multicenter study. Initially, a digital tool was developed using image analysis software, calculating quantitative measures of body asymmetry. This tool was integrated into an online platform that exports data to a database. The tool calculated 10 parameters, including angles (shoulder height, axilla height, waist height, right and left waistline angles, and their difference) and surfaces of the left and right hemitrunks (shoulders, waists, pelvises, and total). Subsequently, an online training course on the tool was conducted for twelve observers not involved in its development (six research coordinators and six spine surgeons). Finally, 15 standardized back photographs of adolescent idiopathic scoliosis patients were selected from a multicenter image bank, representing various clinical scenarios (different age, gender, curve type, BMI, and pre- and postoperative images). The 12 observers measured the photographs at two different times with a three-week interval. For the second round, the images were randomly mixed. Inter- and intra-observer variabilities of the measurements were analyzed using intraclass correlation coefficients (ICCs), and reliability was measured by the standard error of measurement (SEM). Group comparisons were made using Student's t-test. Results: The mean inter-observer ICC for the ten measurements was 0.981, the mean intra-observer ICC was 0.937, and SEM was 0.3-1.3°. The parameter with the strongest inter- and intra-observer validity was the difference in waistline angles 0.994 and 0.974, respectively, while the highest variability was found with the waist height angle 0.963 and 0.845, respectively. No test-retest differences (p > 0.05) were observed between researchers (0.948 ± 0.04) and surgeons (0.925 ± 0.05). Conclusion: We developed a new digital tool integrated into an online platform demonstrating excellent reliability and inter- and intra-observer variabilities for quantifying body asymmetry in scoliosis patients from a simple clinical photograph. The method could be used for assessing and monitoring scoliosis and body asymmetry without radiation.

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.

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.

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.

Infections after spine instrumentation: effectiveness of short antibiotic treatment in a large multicentre cohort.

BACKGROUND AND OBJECTIVES: Available information about infection after spine instrumentation (IASI) and its management are scarce. We aimed to analyse DAIR (debridement, antibiotics and implant retention) prognosis and evaluate effectiveness of short antibiotic courses on early forms. METHODS: Multicentre retrospective study of patients with IASI managed surgically (January 2010-December 2016). Risk factors for failure were analysed by multivariate Cox regression and differences between short and long antibiotic treatment were evaluated with a propensity score-matched analysis. RESULTS: Of the 411 IASI cases, 300 (73%) presented in the first month after surgery, 48 in the second month, 22 in the third and 41 thereafter. Infections within the first 2 months (early cases) occurred mainly to older patients, with local inflammatory signs and predominance of Enterobacteriaceae, unlike those in the later periods. When managed with DAIR, prognosis of early cases was better than later ones (failure rate 10.4% versus 26.1%, respectively; P = 0.02). Risk factors for DAIR failure in early cases were female sex, Charlson Score, large fusions (>6 levels) and polymicrobial infections (adjusted HRs of 2.4, 1.3, 2.6 and 2.26, respectively). Propensity score matching proved shorter courses of antibiotics (4-6 weeks) as effective as longer courses (failure rates 11.4% and 10.5%, respectively; P = 0.870). CONCLUSIONS: IASIs within the first 2 months could be managed effectively with DAIR and shorter antibiotic courses. Clinicians should be cautious when faced with patients with comorbidities, large fusions and/or polymicrobial infections.

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.

Impact of resolved early major complications on 2-year follow-up outcome following adult spinal deformity surgery.

PURPOSE: Major complications are a concern following ASD surgery. Even when properly managed and resolved, they may still have a relevant impact on HRQL. We aimed to investigate the impact of resolved early major complications on 2-year outcome after ASD surgery. METHODS: Two groups of consecutive surgical patients were extracted from a prospective multicentre database. Major complication group (MCG) included patients with any major complication, resolved within 6 months after surgery. Patients with further major complications during follow-up were excluded. Control group (CG) included patients with no major complications over the entire follow-up. Analysis of covariance adjusting for preoperative baseline values was used to compare improvements in HRQL measures at 2 years. RESULTS: One hundred and seventy-five patients met the inclusion criteria and had complete HRQL data at 2 years (24 MCG, 151 CG). MCG patients were older and had more severe deformity and poorer baseline HRQL. There were 27 resolved major complications at 6 months needing 19 additional surgeries (18 revisions, 1 cholecystectomy). At 2 years, and after adjusting for preoperative data, outcome in MCG patients was as follows: scores were 5.98 (SE 3.03) points higher for the ODI (p = 0.05), 0.36 (SE 0.13) lower SRS-22 function (p = 0.01), 4.07 (SE 1.93) lower SF-36 PCS (p = 0.04), and 0.16 (SE 0.13) lower SRS-22 subtotal (p = 0.22). CONCLUSION: The results indicate that patients experiencing major complications after ASD surgery have significantly less functional improvement (SRS-22 function, ODI, SF-36 PCS) than their complication-free counterparts, even when complications were considered resolved, and the outcome was measured after an 18-month complication-free period. These slides can be retrieved under Electronic Supplementary Material.

Factors influencing patient satisfaction after adult scoliosis and spinal deformity surgery.

OBJECTIVE: Achieving high patient satisfaction with management is often one of the goals after adult spinal deformity (ASD) surgery. However, literature on associated factors and their correlations with patient satisfaction is limited. The aim of this study was to determine the clinical and radiographic factors independently correlated with patient satisfaction in terms of management at 2 years after surgery. METHODS: A multicenter prospective database of ASD surgery was retrospectively reviewed. The demographics, complications, health-related quality of life (HRQOL) subdomains, and radiographic parameters were examined to determine their correlation coefficients with the Scoliosis Research Society-22 questionnaire (SRS-22R) satisfaction scores at 2 years (Sat-2y score). Subsequently, factors determined to be independently associated with low satisfaction (Sat-2y score ≤ 4.0) were used to construct 2 types of multivariate models: one with 2-year data and the other with improvement (score at 2 years - score at baseline) data. RESULTS: A total of 422 patients who underwent ASD surgery (mean age 53.1 years) were enrolled. All HRQOL subdomains and several coronal and sagittal radiographic parameters had significantly improved 2 years after surgery. The Sat-2y score was strongly correlated with the SRS-22R self-image (SI)/appearance subdomain (r = 0.64), followed by moderate correlation with subdomains related to standing (r = 0.53), body pain (r = 0.49-0.55), and function (r = 0.41-0.55) at 2 years. Conversely, the correlation between radiographic or demographic parameters with Sat-2y score was weak (r < 0.4). Multivariate analysis to eliminate confounding factors revealed that a worse Oswestry Disability Index (ODI) score for standing (≥ 2 points; OR 4.48) and pain intensity (≥ 2 points; OR 2.07), SRS-22R SI/appearance subdomain (< 3 points; OR 2.70) at 2 years, and a greater sagittal vertical axis (SVA) (> 5 cm; OR 2.68) at 2 years were independent related factors for low satisfaction. According to the other model, a lower improvement in ODI for standing (< 30%; OR 2.68), SRS-22R pain (< 50%; OR 3.25) and SI/appearance (< 50%; OR 2.18) subdomains, and an inadequate restoration of the SVA from baseline (< 2 cm; OR 3.16) were associated with low satisfaction. CONCLUSIONS: Self-image, pain, standing difficulty, and sagittal alignment restoration may be useful goals in improving patient satisfaction with management at 2 years after ASD surgery. Surgeons and other medical providers have to take care of these factors to prevent low satisfaction.

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.

The Adult Deformity Surgery Complexity Index (ADSCI): a valid tool to quantify the complexity of posterior adult spinal deformity surgery and predict postoperative complications.

BACKGROUND CONTEXT: In 2008, Mirza et al. designed and validated the first and only index capable of quantifying the complexity of spine surgery. However, this index is not fully applicable to adult spinal deformity (ASD) surgery as it does not include the surgical techniques most commonly used and most strongly associated with perioperative complications in patients with ASD. PURPOSE: The objective of this study is to develop an "Adult Deformity Surgery Complexity Index" (ADSCI) to quantify objectively the complexity of the ASD posterior surgery. STUDY DESIGN/SETTING: This is an expert consensus (Delphi process) and retrospective analysis of prospectively collected data using multiple regression models. PATIENT SAMPLE: Patients were prospectively enrolled in two comparable multicenter ASD databases sharing the same inclusion criteria. OUTCOME MEASURES: The ADSCI was internally and externally validated using R2 for intraoperative bleeding and length of surgery. Receiver operating characteristics (ROC) and area under the curve (AUC) analysis was used to assess the sensitivity and specificity of ADSCI. METHODS: The development and validation of ADSCI was based on the construction and comparison of three different tools: ADSCI score was constructed by three rounds of expert consensus (ADSCI-Delphi) and two multiple regression models (ADSCI-RM-Simple and ADSCI-RM-Mixed). Their predictive capability was compared by means of R2 values in the same subrogated of surgical complexity as in the Mirza index validation: intraoperative bleeding and duration of surgery. Sensitivity and specificity were evaluated using ROC curves and AUC analysis. The external validity was also examined by evaluating its predictive capability in another multicenter ASD database of comparable patients in the United States. RESULTS: At the time of the study, the database included 1,325 patients. Four hundred seventy-five patients were eligible for the study, having been treated surgically using a posterior approach only (52.2 years standard deviation 20; 77.7% women; 85.4% American Society of Anesthesiologists I/II). Fifty-one international experts participated in the Delphi consensus process. The surgical variables selected by consensus and included in the equation were divided into actions and factors. Actions selected were number of fused segments, decompressions, interbody fusions, and cemented levels; number and type of posterior osteotomies; and use of pelvic fixation. The factors included were implant density, revision surgery, and team experience. ADSCI-RM-Mixed (regression model with Delphi formula interactions) provided the best estimates and predictive value, well above Mirza's invasiveness index. The ADSCI-RM-Mixed, with greater AUCs (>0.70), was also the most sensitive and specific for both of the dependent variables studied and for complication prediction. ADSCI-RM-Mixed obtained also the highest R2 value in the validation cohort in predicting blood loss (R2=0.34) and surgical time (R2=0.26) with effect sizes similar to those for the derivation cohort. CONCLUSIONS: The ADSCI is the first tool to be specifically developed for the preoperative assessment of the complexity of ASD surgery. This study confirms its validity, specificity, and sensitivity, and shows that it has greater predictive capability than the more generic Mirza invasiveness index. The ADSCI should be useful for quantitatively estimating the increased risk associated with more invasive surgery and adjusting for surgical case-mix when making safety comparisons in ASDS.

Impact of early unanticipated revision surgery on health-related quality of life after adult spinal deformity surgery.

BACKGROUND CONTEXT: Revision surgery represents a major event for patients undergoing adult spinal deformity (ASD) surgery. Previous reports suggest that ASD surgery has minimal or no impact on health-related-quality of life (HRQOL) outcomes. PURPOSE: The present study aims to investigate the impact of early reoperations within the first year on HRQOL and on the likelihood of reaching the minimally clinically important difference (MCID) after ASD surgery. DESIGN: This is a retrospective analysis of prospectively collected data from consecutive surgically treated adult deformity surgery patients included in a multicenter, international database. PATIENT SAMPLE: The present study included 280 patients from a multicenter international prospective database. OUTCOME MEASURE: Oswestry Disability Index (ODI), Short Form-36 (SF-36), Scoliosis Research Society-22 (SRS-22), MCID were evaluated in this work. METHODS: Consecutive surgical patients with ASD recruited prospectively in six different centers from four countries with a minimum 2-year follow-up were stratified into two groups: R (revision surgery within the first year) and NR (no revision). Health-related-quality of life (ODI, SF-36, SRS-22) was assessed and compared at 6-month, 1-year, and 2-year follow-up stages. Statistical analysis included chi-square tests, Student t tests, and linear mixed models. RESULTS: Forty-three patients (R Group) received 46 revision surgeries. Nineteen patients (41.3%) had implant-related complications, 9 patients (19.6%) had deep surgical site infections, 9 patients (19.6%) had proximal junctional kyphosis, 3 patients (6.5%) had hematoma, and 6 patients (13%) had other complications. Baseline characteristics differed between groups. At 6 months, all HRQOL scores improved in both groups, except in the SF-36 Mental Component Summary and SRS-22 mental health domain in the R Group. At 1 year, ODI and SRS-22 improvement was significantly greater in the NR Group, exceeding the reported MCID. At the 2-year follow-up, ODI, SRS-22, SF-36 MCS, and SF-36 PCS improvement was similar in both groups. However, postoperative change was only above the MCID for SF-36 PCS, ODI, and SRS-22 in the NR Group. CONCLUSIONS: Early unanticipated revision surgery has a negative impact on mental health at 6 months and reduces the chances of reaching an MCID improvement in SRS-22, SF-36 PCS, and ODI at the 2-year follow-up.

Individualized antibiotic prophylaxis reduces surgical site infections by gram-negative bacteria in instrumented spinal surgery.

PURPOSE: Surgical site infection (SSI) can be a challenging complication after posterior spinal fusion and instrumentation (PSFI). An increasing rate of SSI by gram-negative bacteria (GNB) has been observed. Current guideline recommendations have not been effective for preventing infection by these microorganisms. METHODS: Retrospective cohort study comparing two consecutive groups of patients undergoing PSFI at a single institution. Cohort A includes 236 patients, operated between January 2006 and March 2007, receiving standard preoperative antibiotic prophylaxis with cefazolin (clindamycin in allergic patients). Cohort B includes 223 patients operated between January and December 2009, receiving individualized antibiotic prophylaxis and treatment based on preoperative urine culture. Cultures were done 3-5 days before surgery in patients meeting one of the following risk criteria for urinary tract colonization: hospitalization longer than 7 days, indwelling catheter, neurogenic bladder, history of urinary incontinence, or history of recurrent urinary tract infection. RESULTS: Twenty-two (9.3%) patients in cohort A developed SSI, 68.2% due to GNB. 38 (17%) patients in cohort B were considered at risk for GNB colonization; preoperative urine culture was positive in 14 (36%). After adjusted antibiotic prophylaxis, 15 (6.27%) patients in cohort B developed SSI, 33.4% due to GNB. A statistically significant reduction in GNB SSI was seen in cohort B (Fisher's exact test, p = 0.039). CONCLUSION: Higher preoperative GNB colonization rates were found in patients with neurogenic bladder or indwelling catheters. Preoperative bacteriological screening, treatment for bacteriuria, and individualized antibiotic prophylaxis were effective for reducing GNB SSI.