The use of the Core Yellow Flags Index for the assessment of psychosocial distress in patients undergoing surgery of the cervical spine.

BACKGROUND: Psychosocial distress (the presence of yellow flags) has been linked to poor outcomes in spine surgery. The Core Yellow Flags Index (CYFI), a short instrument assessing the 4 main yellow flags, was developed for use in patients undergoing lumbar spine surgery. This study evaluated its ability to predict outcome in patients undergoing cervical spine surgery. METHODS: Patients with degenerative spinal disorders (excluding myelopathy) operated in one centre, from 2015 to 2019, were asked to complete the CYFI at baseline and the Core Outcome Measures Index (COMI) at baseline and 3 and 12 months after surgery. The relationship between CYFI and COMI scores at baseline as well as the predictive ability of the CYFI on the COMI follow-up scores were tested using structural equation modelling. RESULTS: From 731 eligible patients, 547 (61.0 ± 12.5 years; 57.2% female) completed forms at all three timepoints. On a cross-sectional basis, preoperative CYFI and COMI scores were highly correlated (ß = 0.54, in men and 0.51 in women; each p < 0.001). CYFI added significantly and independently to the prediction of COMI at 3 months' FU in men (ß = 0.36) and 12 months' FU in men and women (both ß = 0.20) (all p < 0.001). CONCLUSION: The CYFI had a low to moderate but significant and independent association with cervical spine surgery outcomes. Implementing the CYFI in the preoperative workup of these patients could help refine outcome predictions and better manage patient expectations.

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.

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.

A decade of experience in over 300 surgically treated spine patients with long-term oral anticoagulation: a propensity score matched cohort study.

PURPOSE: The aim of this study was to investigate the risks and outcomes of patients with long-term oral anticoagulation (OAC) undergoing spine surgery. METHODS: All patients on long-term OAC who underwent spine surgery between 01/2005 and 06/2015 were included. Data were prospectively collected within our in-house Spine Surgery registry and retrospectively supplemented with patient chart and administrative database information. A 1:1 propensity score-matched group of patients without OAC from the same time interval served as control. Primary outcomes were post-operative bleeding, wound complications and thromboembolic events up to 90 days post-surgery. Secondary outcomes included intraoperative blood loss, length of hospital stay, death and 3-month post-operative patient-rated outcomes. RESULTS: In comparison with the control group, patients with OAC (n = 332) had a 3.4-fold (95%CI 1.3-9.0) higher risk for post-operative bleeding, whereas the risks for wound complications and thromboembolic events were comparable between groups. The higher bleeding risk was driven by a higher rate of extraspinal haematomas (3.3% vs. 0.6%; p = 0.001), while there was no difference in epidural haematomas and haematoma evacuations. Risk factors for adverse events among patients with OAC were mechanical heart valves, posterior neck surgery, blood loss > 1000 mL, age, female sex, BMI > 30 kg/m2 and post-operative PTT levels. At 3-month follow-up, most patients reported favourable outcomes with no difference between groups. CONCLUSION: Although OAC patients have a higher risk for complications after spine surgery, the risk for major events is low and patients benefit similarly from surgery.

Evaluation of "appropriate use criteria" for surgical decision-making in lumbar degenerative spondylolisthesis. A controlled, multicentre, prospective observational study.

INTRODUCTION: Selecting patients with lumbar degenerative spondylolisthesis (LDS) for surgery is difficult. Appropriate use criteria (AUC) have been developed to clarify the indications for LDS surgery but have not been evaluated in controlled studies. METHODS: This prospective, controlled, multicentre study involved 908 patients (561 surgical and 347 non-surgical controls; 69.5 ± 9.7y; 69% female), treated as per normal clinical practice. Their appropriateness for surgery was afterwards determined using the AUC. They completed the Core Outcome Measures Index (COMI) at baseline and 12 months' follow-up. Multiple regression adjusting for confounders evaluated the influence of appropriateness designation and treatment received on the 12-month COMI and achievement of MCIC (≥ 2.2-point-reduction). RESULTS: As per convention, appropriate (A) and uncertain (U) groups were combined for comparison with the inappropriate (I) group. For the adjusted 12-month COMI, the benefit of surgery relative to non-surgical care was not significantly greater for the A/U than the I group (p = 0.189). There was, however, a greater treatment effect of surgery for those with higher baseline COMI (p = 0.035). The groups' adjusted probabilities of achieving MCIC were: 83% (A/U, receiving surgery), 71% (I, receiving surgery), 50% (A/U, receiving non-surgical care), and 32% (I, receiving non-surgical care). CONCLUSIONS: A/U patients receiving surgery had the highest chances of achieving MCIC, but the AUC were not able to identify which patients had a greater treatment effect of surgery relative to non-surgical care. The identification of other characteristics that predict a greater treatment effect of surgery, in addition to baseline COMI, is required to improve decision-making.

Cross-cultural adaptation, validation and establishment of the minimal clinically important change score of the European Portuguese core outcome measures index in patients with lumbar degenerative spine disease.

PURPOSE: The core outcome measures index (COMI) for the back is a questionnaire that evaluates five domains and has been translated into several languages and validated for different populations. We aimed to translate, cross-culturally adapt and validate it in European Portuguese for use in patients with degenerative lumbar disease. Additionally, we aimed to establish the minimal clinically important change score (MCIC). METHODS: The translation and cultural adaptation were done according to published guidelines. Patients awaiting surgery at a neurosurgical center completed the COMI, Oswestry Disability Index (ODI), EQ-5D questionnaires and a pain visual analog scale (VAS). To evaluate COMI's reproducibility, patients completed the questionnaire twice within two weeks, preoperatively, in addition to answering a transition question. The MCIC was determined by analysis of postoperative changes in total COMI score, using the anchor method, with a question ascertaining surgical outcome as perceived by the patient. RESULTS: The first set of questionnaires was answered by 108 patients and the second, by 98 patients. COMI's construct validity was confirmed by demonstrating the hypothesized correlation between each domain's score (Spearman Rho > 0.4) and the corresponding questionnaire score (ODI, EQ-5D and VAS) and through adequate correlation (Spearman > 0.6) between COMI's total score and ODI and EQ-5D total scores. Intraclass correlation coefficients between each domain and COMI's total score were > 0.8. The MCIC was calculated as 2.1. CONCLUSION: The cross-culturally adapted COMI questionnaire is a valid clinical assessment tool for European Portuguese-speaking patients with degenerative lumbar disease, with an MCIC of 2.1 points.

Patient-reported outcomes 1 and 2 years after transforaminal thoracic interbody fusion (TTIF).

STUDY DESIGN: Retrospective Cohort Study with prospectively collected data. PURPOSE: Transforaminal interbody fusion was initially designed for the lumbar spine. A similar approach was later introduced for the thoracic spine (TTIF). Here we report the surgical technique and the Core Outcome Measures Index (COMI) at 1-year and 2-year follow-ups, as well as the sagittal radiographic kyphosis correction of TTIF, achieved at 1 year and the latest follow-up. METHODS: All TTIF procedures from 2012 to 2020 were included. COMI scores were collected preoperatively and at 1- and 2-year follow-ups. The sagittal angle between the upper and lower endplates at the segment where TTIF was performed was measured on preoperative, 1-year postoperative, and last available radiographs. RESULTS: Seventy-nine TTIF procedures were performed for 64 patients (36% males; mean age 67.5 (SD 15.3) years). COMI score reduced from a mean value of 8.1 (SD 1.4) preoperatively to 4.7 (SD 2.7) at 1-year follow-up and 4.7 (SD 2.7) at 2-year follow-up. The mean correction of segmental kyphosis was 10.8 (SD 7.3, p < 0.0001) degrees at 1-year follow-up and 9.3 (SD 7.0, p < 0.0001) degrees at the final follow-up 3.4 (SD 1.4) years after the operation. Kaplan-Meier analysis for reoperations showed a 5-year survival of 91% (95% CI 0.795-1) for primary TTIF operations and survival of 77% (95% CI 0.651-0.899) for TTIFs performed after earlier fusion operations. CONCLUSIONS: TTIF is a feasible procedure in the thoracic spine. Kyphosis correction of approximately 10° was maintained at 1-year and final follow-up. Over 69% at 1-year and 61% at 2-year follow-up achieved MCID for COMI.

Far Lateral Lumbar Decompression Using the Far-Lateral Approach: Patient Reported Outcome is Associated with the Involved Vertebral Level and Coronal Segmental Angle.

STUDY DESIGN: Single centre retrospective study of prospectively collected data. OBJECTIVE: Analyse factors associated with patient reported outcome after far lateral decompression surgery (FLDS) for lumbar nerve root compression using the far-lateral approach. SUMMARY OF BACKGROUND DATA: To date, no studies have investigated the influence of vertebral level, coronal segmental Cobb angle, and the nature of the compressive tissue (hard/soft) on patient reported outcome following FLDS. METHODS: Patients who had undergone FLDS between 2005 and 2020 were included. Coronal segmental angle (CSCA) was measured on preoperative, posteroanterior radiographs. Primary outcome measure was the Core Outcome Measures Index (COMI) score at 2 years' follow-up (2Y-FU). Patients who had undergone microsurgical decompression using a midline approach (MID) served as a comparator group. RESULTS: There were 148 FLDS and 463 MID patients. In both groups there was a significant improvement in COMI score from preoperative to 2Y-FU (P<0.0001), with greater improvement in patients treated at higher vertebral levels than in those treated at L5/S1 (P=0.014). Baseline COMI, ASA grade, BMI, and low back pain as the "chief complaint" all had a significant association with the 2-year COMI score. The nature of compressive tissue showed no association with COMI score at 2Y-FU. In the FLDS group, there was a statistically significant correlation between the preoperative CSCA and change in COMI score preoperatively to 2Y-FU (P<0.001). The association was retained in multiple regression analysis controlling for confounders. A one-degree increase in CSCA was associated with a 0.35-point worse COMI score at 2Y-FU (P=0.003). CONCLUSION: Treatment of far lateral nerve root compression showed overall good patient reported outcome, but with less improvement with advanced coronal segmental angulation. Modified approaches and techniques might be preferable for the level L5/S1.

Evaluation of the Clinical and Radiographic Degenerative Spondylolisthesis (CARDS) classification system as a guide to surgical technique selection.

BACKGROUND CONTEXT: The role of fusion in degenerative spondylolisthesis (DS) is controversial. The Clinical and Radiographic Degenerative Spondylolisthesis (CARDS) classification system was developed to assist surgeons in surgical technique selection based on individual patient characteristics. This system has not been clinically validated as a guide to surgical technique selection. PURPOSE: The purpose of this study was to determine if outcomes vary with different surgical techniques across the CARDS categories. STUDY DESIGN/SETTING: Prospective cohort study performed at one Swiss and one American spine center. PATIENT SAMPLE: Five hundred eight patients with DS undergoing surgical treatment. OUTCOME MEASURES: Core Outcomes Measure Index (COMI) at 3 months and 12 months postoperatively. METHODS: Patients undergoing surgery for DS were enrolled at 2 institutions and classified according to the CARDS system using dynamic radiographs. The Core Outcome Measure Index (COMI) was completed preoperatively, and 3 and 12 months postoperatively. Surgical technique was classified as uninstrumented (decompression alone or decompression with uninstrumented fusion) or instrumented (decompression with pedicle screw instrumentation with or without interbody fusion). Unadjusted analyses and mixed effect models compared COMI scores between the two surgery technique groups (uninstrumented vs instrumented), stratified by CARDS category over time. Reoperation rates were also compared between the surgery technique groups stratified by CARDS category. Partial funding was given through NASS grant for clinical research. RESULTS: Five hundred five out of 508 patients enrolled in the study had sufficient data to be classified according to CARDS. Seven percent were classified as CARDS A, 28% as CARDS B, 48% as CARDS C, and 17% as CARDS D (CARDS A most "stable," CARDS D least "stable"). One hundred and thirty-three patients (26%) underwent decompression alone, 30 (6%) underwent decompression and uninstrumented fusion, 42 (8%) underwent decompression and posterolateral instrumented fusion, and 303 (60%) underwent decompression with posterolateral and interbody instrumented fusion. Patients in the least "stable" categories tended to be less likely to be treated with an uninstrumented technique (CARDS D 19% vs 32% for the other categories, p=.10). There were no significant differences in 3 or 12-month COMI scores between surgical technique groups stratified by CARDS category in the unadjusted or adjusted analyses. In the unadjusted analyses, there was a trend towards less improvement in 12-month COMI change score in the CARDS D patients in the uninstrumented group compared to the instrumented group (-2.7 vs -4.1, p=.10). Reoperation rates were not significantly different between the surgical technique groups stratified by CARDS category. CONCLUSIONS: In general, outcomes for uninstrumented and instrumented surgical techniques were similar across the CARDS categories. Surgeons likely took factors included in CARDS into account during surgical technique selection. This resulted in a low number of CARDS D (n=15) patients being treated with uninstrumented techniques, which limited the statistical power of this analysis. As such, this study does not validate CARDS as a useful classification system for surgical technique selection in DS.

Cross-cultural adaptation and validation of the Traditional Chinese version of the Core Outcome Measures Index in patients with low back pain.

PURPOSE: This study aimed to carry out a cross-cultural adaptation of the Core Outcome Measures Index (COMI) for use in Traditional Chinese-speaking patients with low back pain (LBP) and to investigate its psychometric properties. METHODS: A total of 224 patients with LBP > 6 weeks who visited our spine center from May 2018 to May 2019 were included in the study. Patients completed a booklet of questionnaires including the following: (1) pain Numeric Rating Scale, (2) Oswestry Disability Index, (3) Roland-Morris Disability Questionnaire, (4) EuroQol-five dimension (EQ-5D), and (5) COMI. Patients were sent a second booklet (also containing a transition question to indicate any change in condition) to be completed again within one month after the first. Fifty-two patients did not receive any intervening treatment (group 1), while the other 172 patients received medical treatment (group 2) between the two questionnaires. RESULTS: The intraclass correlation coefficient (ICC) for the COMI summary score was 0.94 (95% CI 0.89-0.97); the standard error of measurement (SEM) was 0.41 and the minimum detectable change (MDC) score was 1.14. The COMI summary scores showed a low floor effect (1.8%) and ceiling effect (0.4%). All COMI item scores demonstrated the hypothesized correlations with their corresponding full-length questionnaires except for the pain item (correlation stronger than hypothesized). Standardized response means (SRM) for the COMI items in the treated group were between 0.58 and 1.30. Regarding the ability of the COMI change score to differentiate between good and poor outcomes, the area under the receiver operating characteristic (AUROC) curve was 0.77 [standard error (SE) 0.07, 95% confidence interval (CI) 0.68-0.84] and the minimal clinically important change (MCIC) score was ≥ 1.85 points. CONCLUSION: The Traditional Chinese COMI represents a practical and reliable tool for the assessment of Traditional Chinese-speaking patients with back problems.

Does loss to follow-up lead to an overestimation of treatment success? Findings from a spine surgery registry of over 15,000 patients.

PURPOSE: Patient-reported outcome measures (PROMs) are integral to the assessment of treatment success, but loss to follow-up (attrition) may lead to bias in the results reported. We sought to evaluate the extent, nature and implications of attrition in a long-established, single-centre spine registry. METHODS: The registry contained the data of 15,264 consecutive spine surgery patients. PROMs included the Core Outcome Measures Index (COMI) and a rating of the Global Treatment Outcome (GTO) and Satisfaction with Care. Baseline characteristics associated with returning a 12-month PROM (= "responder") were analysed (logistic regression). The 3-month outcomes of 12-month responders versus 12-month non-responders were compared (ANOVA and Chi-square). RESULTS: In total, 14,758/15,264 (97%) patients (60 ± 17y; 46% men) had consented to the use of their registry data for research. Preoperative, 3-month post-operative and 12-month post-operative PROMs were returned by 91, 90 and 86%, respectively. Factors associated with being a 12-month responder included: greater age, born in the country of the study, no private/semi-private insurance, better baseline status (lower COMI score), fewer previous surgeries, less comorbidity and no perioperative medical complications. 12-month non-responders had shown significantly worse outcomes in their 3-month PROMs than had 12-month responders (respectively, 66% vs 80% good GTO ("treatment helped/helped a lot"); 77% vs 88% satisfied/very satisfied; and 49% vs 63% achieved MCIC on COMI). CONCLUSION: Although attrition in this cohort was relatively low, 12-month non-responders displayed distinctive characteristics and their early outcomes were significantly worse than those of 12-month responders. If loss to follow-up is not addressed, treatment success will likely be overestimated, with erroneously optimistic results being reported.

Association between sagittal alignment and loads at the adjacent segment in the fused spine: a combined clinical and musculoskeletal modeling study of 205 patients with adult spinal deformity.

PURPOSE: Sagittal malalignment is a risk factor for mechanical complications after surgery for adult spinal deformity (ASD). Spinal loads, modulated by sagittal alignment, may explain this relationship. The aims of this study were to investigate the relationships between: (1) postoperative changes in loads at the proximal segment and realignment, and (2) absolute postoperative loads and postoperative alignment measures. METHODS: A previously validated musculoskeletal model of the whole spine was applied to study a clinical sample of 205 patients with ASD. Based on clinical and radiographic data, pre-and postoperative patient-specific alignments were simulated to predict loads at the proximal segment adjacent to the spinal fusion. RESULTS: Weak-to-moderate associations were found between pre-to-postop changes in lumbar lordosis, LL (r = - 0.23, r = - 0.43; p < 0.001), global tilt, GT (r = 0.26, r = 0.38; p < 0.001) and the Global Alignment and Proportion score, GAP (r = 0.26, r = 0.37; p < 0.001), and changes in compressive and shear forces at the proximal segment. GAP score parameters, thoracic kyphosis measurements and the slope of upper instrumented vertebra were associated with changes in shear. In patients with T10-pelvis fusion, moderate-to-strong associations were found between postoperative sagittal alignment measures and compressive and shear loads, with GT showing the strongest correlations (r = 0.75, r = 0.73, p < 0.001). CONCLUSIONS: Spinal loads were estimated for patient-specific full spinal alignment profiles in a large cohort of patients with ASD pre-and postoperatively. Loads on the proximal segments were greater in association with sagittal malalignment and malorientation of proximal vertebra. Future work should explore whether they provide a causative mechanism explaining the associated risk of proximal junction complications.

Factors associated with an increased risk of developing postoperative symptomatic lumbar spondylolisthesis after decompression surgery: an explorative two-centre international cohort study.

PURPOSE: Symptomatic lumbar spinal stenosis can be treated with decompression surgery. A recent review reported that, after decompression surgery, 1.6-32.0% of patients develop postoperative symptomatic spondylolisthesis and may therefore be indicated for lumbar fusion surgery. The latter can be more challenging due to the altered anatomy and scar tissue. It remains unclear why some patients get recurrent neurological complaints due to postoperative symptomatic spondylolisthesis, though some associations have been suggested. This study explores the association between key demographic, biological and radiological factors and postoperative symptomatic spondylolisthesis after lumbar decompression. METHODS: This retrospective cohort study included patients who had undergone lumbar spinal decompression surgery between January 2014 and December 2016 at one of two Spine Centres in the Netherlands or Switzerland and had a follow-up of two years. Patient characteristics, details of the surgical procedure and recurrent neurological complaints were retrieved from patient files. Preoperative MRI scans and conventional radiograms (CRs) of the lumbar spine were evaluated for multiple morphological characteristics. Postoperative spondylolisthesis was evaluated on postoperative MRI scans. For variables assessed on a whole patient basis, patients with and without postoperative symptomatic spondylolisthesis were compared. For variables assessed on the basis of the operated segment(s), surgical levels that did or did not develop postoperative spondylolisthesis were compared. Univariable and multivariable logistic regression analyses were used to identify associations with postoperative symptomatic spondylolisthesis. RESULTS: Seven hundred and sixteen patients with 1094 surgical levels were included in the analyses. (In total, 300 patients had undergone multilevel surgery.) ICCs for intraobserver and interobserver reliability of CR and MRI variables ranged between 0.81 and 0.99 and 0.67 and 0.97, respectively. In total, 66 of 716 included patients suffered from postoperative symptomatic spondylolisthesis (9.2%). Multivariable regression analyses of patient-basis variables showed that being female [odds ratio (OR) 1.2, 95%CI 1.07-3.09] was associated with postoperative symptomatic spondylolisthesis. Higher BMI (OR 0.93, 95%CI 0.88-0.99) was associated with a lower probability of having postoperative symptomatic spondylolisthesis. Multivariable regression analyses of surgical level-basis variables showed that levels with preoperative spondylolisthesis (OR 17.30, 95%CI 10.27-29.07) and the level of surgery, most importantly level L4L5 compared with levels L1L3 (OR 2.80, 95%CI 0.78-10.08), were associated with postoperative symptomatic spondylolisthesis; greater facet joint angles (i.e. less sagittal-oriented facets) were associated with a lower probability of postoperative symptomatic spondylolisthesis (OR 0.97, 95%CI 0.95-0.99). CONCLUSION: Being female was associated with a higher probability of having postoperative symptomatic spondylolisthesis, while having a higher BMI was associated with a lower probability. When looking at factors related to postoperative symptomatic spondylolisthesis at the surgical level, preoperative spondylolisthesis, more sagittal orientated facet angles and surgical level (most significantly level L4L5 compared to levels L1L3) showed significant associations. These associations could be used as a basis for devising patient selection criteria, stratifying patients or performing subgroup analyses in future studies regarding decompression surgery with or without fusion.

External validation of the deep learning system "SpineNet" for grading radiological features of degeneration on MRIs of the lumbar spine.

BACKGROUND: Magnetic resonance imaging (MRI) is used to detect degenerative changes of the lumbar spine. SpineNet (SN), a computer vision-based system, performs an automated analysis of degenerative features in MRI scans aiming to provide high accuracy, consistency and objectivity. This study evaluated SN's ratings compared with those of an expert radiologist. METHOD: MRIs of 882 patients (mean age, 72 ± 8.8 years) with degenerative spinal disorders from two previous trials carried out in our spine center between 2011 and 2019, were analyzed by an expert radiologist. Lumbar segments (L1/2-L5/S1) were graded for Pfirrmann Grades (PG), Spondylolisthesis (SL) and Central Canal Stenosis (CCS). SN's analysis for the equivalent parameters was generated. Agreement between methods was analyzed using kappa (κ), Spearman correlation (ρ) and Lin's concordance correlation (ρc) coefficients and class average accuracy (CAA). RESULTS: 4410 lumbar segments were analyzed. κ statistics showed moderate to substantial agreement in PG between the radiologist and SN depending on spinal level (range κ 0.63-0.77, all levels together 0.72; range CAA 45-68%, all levels 55%), slight to substantial agreement for SL (range κ 0.07-0.60, all levels 0.63; range CAA 47-57%, all levels 56%) and CCS (range κ 0.17-0.57, all levels 0.60; range CAA 35-41%, all levels 43%). SN tended to record more pathological features in PG than did the radiologist whereas the contrary was the case for CCS. SL showed an even distribution between methods. CONCLUSION: SN is a robust and reliable tool with the ability to grade degenerative features such as PG, SL or CCS in lumbar MRIs with moderate to substantial agreement compared to the current gold-standard, the radiologist. It is a valuable alternative for analyzing MRIs from large cohorts for diagnostic and research purposes.

FUSE-ML: development and external validation of a clinical prediction model for mid-term outcomes after lumbar spinal fusion for degenerative disease.

BACKGROUND: Indications and outcomes in lumbar spinal fusion for degenerative disease are notoriously heterogenous. Selected subsets of patients show remarkable benefit. However, their objective identification is often difficult. Decision-making may be improved with reliable prediction of long-term outcomes for each individual patient, improving patient selection and avoiding ineffective procedures. METHODS: Clinical prediction models for long-term functional impairment [Oswestry Disability Index (ODI) or Core Outcome Measures Index (COMI)], back pain, and leg pain after lumbar fusion for degenerative disease were developed. Achievement of the minimum clinically important difference at 12 months postoperatively was defined as a reduction from baseline of at least 15 points for ODI, 2.2 points for COMI, or 2 points for pain severity. RESULTS: Models were developed and integrated into a web-app ( https://neurosurgery.shinyapps.io/fuseml/ ) based on a multinational cohort [N = 817; 42.7% male; mean (SD) age: 61.19 (12.36) years]. At external validation [N = 298; 35.6% male; mean (SD) age: 59.73 (12.64) years], areas under the curves for functional impairment [0.67, 95% confidence interval (CI): 0.59-0.74], back pain (0.72, 95%CI: 0.64-0.79), and leg pain (0.64, 95%CI: 0.54-0.73) demonstrated moderate ability to identify patients who are likely to benefit from surgery. Models demonstrated fair calibration of the predicted probabilities. CONCLUSIONS: Outcomes after lumbar spinal fusion for degenerative disease remain difficult to predict. Although assistive clinical prediction models can help in quantifying potential benefits of surgery and the externally validated FUSE-ML tool may aid in individualized risk-benefit estimation, truly impacting clinical practice in the era of "personalized medicine" necessitates more robust tools in this patient population.

Management and outcome of spinal implant-associated surgical site infections in patients with posterior instrumentation: analysis of 176 cases.

PURPOSE: The management of implant-associated surgical site infections (SSI) in patients with posterior instrumentation is challenging. Evidence regarding the most appropriate treatment and the need for removal of implants is equivocal. We sought to evaluate the management and outcome of such patients at our institution. METHODS: We searched our prospectively documented databases for eligible patients with posterior spinal instrumentation, excluding the cervical spine (January 2008-June 2018). Patient files were reviewed, demographic data and treatment details were recorded. Patient-reported outcome (PRO) was assessed with the Core Outcome Measures Index (COMI) preoperatively and postoperatively at 3 and 12 months. RESULTS: A total of 170 patients underwent 210 revisions for 176 SSIs. Two-thirds presented within four weeks (105/176, 59.7%, median 22.5d, 7d-11.1y). The most common pathogens were Staphylococcus aureus (n = 79/210, 37.6%) and Staphylococcus epidermidis (n = 56/210, 26.7%). Debridement and implant retention was performed in 135/210 (64.3%) revisions and partial replacement in 62/210 (29.5%). In 28/176 SSI (15.9%), persistent infection required multiple revisions (≤ 4). Surgery was followed by intravenous and oral antimicrobial treatment (10-12w). In 139/176 SSIs (79%) with ≥ 1y follow-up, infection was cured in 115/139 (82.7%); relapse occurred in 9 (relapse rate: 5.1%). Two patients (1.4%) died. COMI decreased significantly (8.2 ± 1.5 vs. 4.8 ± 2.9, p < 0.0001) over 12 months. 72.7% of patients were (very) satisfied with their care. CONCLUSION: Patients with SSI after posterior (thoraco-)lumbo(-sacral) instrumentation can be successfully treated in most cases with surgical and specific antibiotic treatment. An interdisciplinary approach is recommended. Loose implants should be replaced. In some cases, multiple revisions may be necessary. Patient outcomes were satisfactory.

Development of a model to predict the probability of incurring a complication during spine surgery.

PURPOSE: Predictive models in spine surgery are of use in shared decision-making. This study sought to develop multivariable models to predict the probability of general and surgical perioperative complications of spinal surgery for lumbar degenerative diseases. METHODS: Data came from EUROSPINE's Spine Tango Registry (1.2012-12.2017). Separate prediction models were built for surgical and general complications. Potential predictors included age, gender, previous spine surgery, additional pathology, BMI, smoking status, morbidity, prophylaxis, technology used, and the modified Mirza invasiveness index score. Complete case multiple logistic regression was used. Discrimination was assessed using area under the receiver operating characteristic curve (AUC) with 95% confidence intervals (CI). Plots were used to assess the calibration of the models. RESULTS: Overall, 23'714/68'111 patients (54.6%) were available for complete case analysis: 763 (3.2%) had a general complication, with ASA score being strongly predictive (ASA-2 OR 1.6, 95% CI 1.20-2.12; ASA-3 OR 2.98, 95% CI 2.19-4.07; ASA-4 OR 5.62, 95% CI 3.04-10.41), while 2534 (10.7%) had a surgical complication, with previous surgery at the same level being an important predictor (OR 1.9, 95%CI 1.71-2.12). Respectively, model AUCs were 0.74 (95% CI, 0.72-0.76) and 0.64 (95% CI, 0.62-0.65), and calibration was good up to predicted probabilities of 0.30 and 0.25, respectively. CONCLUSION: We developed two models to predict complications associated with spinal surgery. Surgical complications were predicted with less discriminative ability than general complications. Reoperation at the same level was strongly predictive of surgical complications and a higher ASA score, of general complications. A web-based prediction tool was developed at https://sst.webauthor.com/go/fx/run.cfm?fx=SSTCalculator .

Association between the appropriateness of surgery, according to appropriate use criteria, and patient-rated outcomes after surgery for lumbar degenerative spondylolisthesis.

INTRODUCTION: Treatment failures in spine surgery are often attributable to poor patient selection and the application of inappropriate treatment. We used published appropriate use criteria (AUC) to evaluate the appropriateness of surgery in a large group of patients operated for lumbar degenerative spondylolisthesis (LDS) and to evaluate its association with outcome. METHODS: This was a retrospective analysis of prospectively collected outcome data from patients operated in our Spine Centre, 2005-2012. Appropriateness of surgery was judged based on the AUC. Patients had completed the multidimensional Core Outcome Measures Index (COMI) before surgery and at 3 months' and 1, 2 and 5 years' follow-up (FU). RESULTS: In total, 448 patients (69.8 ± 9.6 years; 323 (72%) women) were eligible for inclusion and the AUC could be applied in 393 (88%) of these. Surgery was considered appropriate (A) in 234 (59%) of the patients, uncertain/equivocal (U) in 90 (23%) and inappropriate (I) in 69 (18%). A/U patients had significantly (p < 0.05) greater improvements in COMI than I patients at each FU time point. The minimal clinically important change (MCIC) score for COMI was reached by 82% A, 76% U and 54% I patients at 1-year FU (p < 0.001, I vs A and U); the odds of achieving MCIC were 3-4 times greater in A/U patients than in I patients. CONCLUSIONS: The results suggest a relationship between appropriateness of surgery for LDS and the improvements in COMI score after surgery. The findings require confirmation in prospective studies that also include a control group of non-operated patients.

Validation of a surgical invasiveness index in patients with lumbar spinal disorders registered in the Spine Tango registry.

INTRODUCTION: Being able to quantify the invasiveness of a surgical procedure is important to weigh up its associated risks, since invasiveness governs the blood loss, operative time and likelihood of complications. Mirza et al. (Spine (Phila Pa 1976) 33:2651-2661, 2008) published an invasiveness index for spinal surgery. We evaluated the validity of a modified version of the Mirza invasiveness index (mMII), adapted for use with registry data. METHODS: A cross-sectional analysis was performed with data acquired from the Spine Tango registry including 21,634 patients. The mMII was calculated as the sum of six possible interventions on each vertebral level: decompression, fusion and stabilization either on anterior or posterior structures. The association between the mMII and blood loss, operative time and complications was evaluated using multiple regression, adjusting for possible confounders. RESULTS: The mean (± SD) mMII was 3.9 ± 5.0 (range 0-40). A 1-point increase in the mMII was associated with an additional blood loss of 12.8% (95% CI 12.6-13.0; p < 0.001) and an increase of operative time of 10.4 min (95% CI 10.20-10.53; p < 0.001). The R2 for the blood loss model was of 43% and for operative time, 47%. The mean mMII was significantly (p < 0.001) higher in patients with surgical complications (4.5 ± 5.6) and general medical complications (6.5 ± 7.0) compared to those without (3.8 ± 4.9). Our results were comparable to those reported in the original publication of Mirza et al. CONCLUSION: The mMII appeared to be a valid measure of surgical invasiveness in our study population. It can be used in predictor models and to adjust for surgical case-mix when comparing outcomes in different studies or different hospitals/surgeons in a registry.