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 outcome after treatment of thoracolumbar spinal stenosis in adults with achondroplasia.

PURPOSE: To describe the complications and the outcome of patients with achondroplasia undergoing thoracolumbar spinal surgery. METHODS: Retrospective analysis of prospectively collected data of all patients with achondroplasia undergoing surgery within the years 1992-2021 at the thoracic and/or lumbar spine. The outcome was measured by analyzing the surgical complications and revisions. The patient-rated outcome was assessed with the COMI score from 2005 onwards. RESULTS: A total of 15 patients were included in this study undergoing a total of 31 surgeries at 79 thoracolumbar levels. 12/31 surgeries had intraoperative complications consisting of 11 dural tears and one excessive intraoperative bleeding. 4/18 revision surgeries were conducted due to post-decompression hyperkyphosis. The COMI score decreased from 7.5 IQR 1.4 (range 7.1-9.8) preoperatively to 5.3 IQR 4.1 (2.5-7.5) after 2 years (p = 0.046). CONCLUSION: Patients with achondroplasia, the most common skeletal dysplasia condition with short-limb dwarfism, are burdened with a congenitally narrow spinal canal and are commonly in need of spinal surgery. However, surgery in these patients is often associated with complications, namely dural tears and post-decompression kyphosis. Despite these complications, patients benefit from surgical treatment at a follow-up of 2 years after surgery.

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.

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.

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.

Revision surgery for incomplete resection or recurrence of cervical spine chordoma: a consecutive case series of 24 patients.

PURPOSE: Chordomas are rare tumors with an annual incidence of approximately one per million. Chordomas rarely metastasize but show a high local recurrence rate. Therefore, these patients present a major clinical challenge, and there is a paucity of the literature regarding the outcome after revision surgery of cervical spine chordomas. Available studies suggest a significantly worse outcome in revision scenarios. The purpose of this study is to analyze the survival rate, and complications of patients that underwent revision surgery for local recurrence or incomplete resection of chordoma at the craniocervical junction or at the cervical spine. METHODS: 24 consecutive patients that underwent revision surgery for cervical spine chordoma remnants or recurrence at a single center were reviewed retrospectively. We analyzed patient-specific surgical treatment strategies, complications, and outcome. Kaplan-Meier estimator was used to analyze five-year overall survival. RESULTS: Gross total resection was achieved in 17 cases. Seven patients developed dehiscence of the pharyngeal wall, being the most common long-term complication. No instability was observed. Postoperatively, four patients received proton beam radiotherapy and 12 patients had combined photon and proton beam radiotherapy. The five-year overall survival rate was 72.6%. CONCLUSION: With thorough preoperative planning, appropriate surgical techniques, and the addition of adjuvant radiotherapy, results similar to those in primary surgery can be achieved.

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.

Development of the "Core Yellow Flags Index" (CYFI) as a brief instrument for the assessment of key psychological factors in patients undergoing spine surgery.

BACKGROUND: Depression, anxiety, catastrophising, and fear-avoidance beliefs are key "yellow flags" (YFs) that predict a poor outcome in back patients. Most surgeons acknowledge the importance of YFs but have difficulty assessing them due to the complexity of the instruments used for their measurement and time constraints during consultations. We performed a secondary analysis of existing questionnaire data to develop a brief tool to enable the systematic evaluation of YFs and then tested it in clinical practice. METHODS: The following questionnaire datasets were available from a total of 932 secondary/tertiary care patients (61 ± 16 years; 51% female): pain catastrophising (N = 347); ZUNG depression (N = 453); Hospital Anxiety and Depression Scale (anxiety subscale) (N = 308); fear-avoidance beliefs (N = 761). The single item that best represented the full-scale score was identified, to form the 4-item "Core Yellow Flags Index" (CYFI). 2422 patients (64 ± 16 years; 54% female) completed CYFI and a Core Outcome Measures Index (COMI) before lumbar spine surgery, and a COMI 3 and 12 months later (FU). RESULTS: The item-total correlation for each item with its full-length questionnaire was: 0.77 (catastrophising), 0.67 (depression), 0.69 (anxiety), 0.68 (fear-avoidance beliefs). Cronbach's α for the CYFI was 0.79. Structural equation modelling showed CYFI uniquely explained variance (p < 0.001) in COMI at both the 3- and 12-month FUs (ß = 0.11 (women), 0.24 (men); and ß = 0.13 (women), ß = 0.14 (men), respectively). CONCLUSION: The 4-item CYFI proved to be a simple, practicable tool for routinely assessing key psychological attributes in spine surgery patients and made a relevant contribution in predicting postoperative outcome. CYFI's items were similar to those in the "STarT Back screening tool" used in primary care to triage patients into treatment pathways, further substantiating its validity. Wider use of CYFI may help improve the accuracy of predictive models derived using spine registry data.

Anterior instrumented fusion for adolescent idiopathic scoliosis.

Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spine consisting of a lateral curvature, apical vertebral rotation, and an impairment of the sagittal profile. Surgical options include anterior and posterior approaches. Anterior instrumented fusion is suitable in Lenke type 1 and 5 curves. It supplies excellent results in coronal plane correction and is superior in the restoration of the sagittal profile and apical derotation. Fusion is shorter compared to posterior correction, and the complication rate is low. Pulmonary function is impaired postoperatively but recovers within a few years.

Back Pain and Its Change After Surgery in Adolescents and Young Adults With Idiopathic Scoliosis.

STUDY DESIGN: A retrospective analysis of prospectively collected data from patients aged 12-30 years, operated for AIS in our hospital from 2005 to 2014 and registered in our local patient outcomes database linked to EUROSPSINE's Spine Tango Registry. OBJECTIVES: To investigate whether in patients with AIS and notable back pain surgery is associated with significant pain relief and whether age influences outcome. SUMMARY OF BACKGROUND DATA: Few studies have investigated the association between adolescent idiopathic scoliosis and back pain and the influence of age on the relief of back pain after surgical correction of the deformity. METHODS: Preoperatively and up to two years' postoperatively, patients completed the Core Outcome Measures Index, which includes two 0-10 scales for back pain and leg/buttock pain. A score of 4/10 or more is considered "relevant pain." RESULTS: We identified 85 patients with AIS (74 (87%) females) in the database; 60 were aged 12-18 years (mean 15.5 ± 1.7 years) and 25 were 19-30 years (mean 22.5 ± 3.1 years). There were no significant differences (p > .05) between the age groups for coronal Cobb angles of the main curves or Lenke curve types, and these curves showed no correlation with pain intensity (p > .05). Back pain was correlated with age (r = 0.31, p = .004). Preoperatively, 42% patients had a back pain score of ≥4/10 (52% in adults, 38% in adolescents). Just 8% patients had a leg pain score of ≥4/10 (16% in adults, 5% in adolescents). Those with notable back pain showed a significant (p < .0001) improvement two years after surgery. However, 24% of patients with no back pain at baseline showed a worsening of pain by 2 (out of 10) points or more two years postoperatively. There was no significant difference in the extent of improvement in older and younger patients (p = .22). CONCLUSION: In patients undergoing surgery for correction of AIS, back pain is correlated with age. In those with relevant back pain at baseline, surgery is associated with a statistically significant and clinically relevant reduction of pain 24 months later, in skeletally mature young adults and adolescents alike. LEVEL OF EVIDENCE: Level III.

Correction to: Surgical growth guidance with non-fused anchoring segments in early-onset scoliosis.

The preoperative X-ray presented in Figure 1 of the original publication erroneously was not the latest radiographic image taken before the index surgery at the age of 3 years.

Surgical growth guidance with non-fused anchoring segments in early-onset scoliosis.

PURPOSE: Surgical treatment of early-onset scoliosis (EOS) requires a balance between maintained curve correction and the capacity for spinal and thoracic growth. Spinal fusion creates irreversible conditions that prevent the implementation of further treatment methods. Our hypothesis was that non-fused anchors in growth guidance show a comparable outcome as the technique described in the literature, which involves spondylodesis of the anchoring segments. METHODS: This retrospective study analysed 148 surgeries in 22 EOS patients (11 female, 11 male) over a 15-year period. Patients underwent surgery with non-fused anchors and growth guidance techniques. Scoliosis, kyphosis, growth and anchoring segments were measured. For the latter, a new measuring technique was developed. Complications were recorded and classified. RESULTS: The mean Cobb angle reduced from 73.5 ± 24.4° to 28.4 ± 16.2° (60.2 ± 22.9%, p < 0.001) at the last follow-up. Spinal growth T1-S1 and T1-T12 were 41.1 ± 23.3 mm and 24.9 ± 16.6 mm (p < 0.001), respectively. Growth at the cranial and caudal anchoring segment was 1.5 mm/segment/year and 1.9 mm/segment/year, respectively. A total of 63 complications were documented in 20 patients, with 40 requiring unplanned revision surgery. Definitive spondylodesis was performed in three patients. CONCLUSION: Patients demonstrated a significant spinal growth including the anchoring segments. A comparable correction in Cobb angle and the type of complications was noted, although the rate of device-related complications was higher. No permanent impairment was reported. The rate of device-related complications is acceptable and outweighed by the significant degree of growth preservation and more flexible and individualised treatment strategy for patients with EOS. These slides can be retrieved under Electronic Supplementary Material.

Outcome of L5 radiculopathy after reduction and instrumented transforaminal lumbar interbody fusion of high-grade L5-S1 isthmic spondylolisthesis and the role of intraoperative neurophysiological monitoring.

PURPOSE: To evaluate the incidence and course of iatrogenic L5 radiculopathy after reduction and instrumented fusion of high-grade L5-S1 isthmic spondylolisthesis and the role of intraoperative neurophysiological monitoring (IONM). METHODS: Consecutive patients treated for high-grade spondylolisthesis with IONM from 2005 to 2013 were screened for eligibility. Prospectively collected clinical and surgical data as well as radiographic outcomes were analyzed retrospectively. Patients completed the multidimensional Core Outcome Measures Index (COMI) before and at 3, 12, and 24 months after surgery. RESULTS: Seventeen patients were included, with a mean age of 26.3 (±9.5) years. Mean preoperative L5-S1 slip was 72% (±21%) and was reduced to 19% (±13%) postoperatively. Mean loss of reduction at last follow-up [mean 19 months (±14, range 3-48 months)] was 3% (±4.3%). Rate of new L5 radiculopathy with motor deficit (L5MD) after surgery was 29% (five patients). Four patients fully recovered after 3 months, one patient was lost to neurologic follow-up. IONM sensitivity and specificity for postoperative L5MD was 20 and 100%, respectively. COMI, back pain and leg pain scores showed significant (p < 0.001) improvements at 3 months postoperatively, which were retained up to 24 months postoperatively. CONCLUSIONS: Transient L5 radiculopathy after reduction and instrumented fusion of high-grade spondylolisthesis is frequent. With IONM the risk of irreversible L5 radiculopathy is minimal. If IONM signal changes recover, full clinical recovery is expected within 3 months. Overall, patient-reported outcome of reduction and instrumented fusion of high-grade spondylolisthesis showed clinically important improvement.

What level of pain are patients happy to live with after surgery for lumbar degenerative disorders?

BACKGROUND CONTEXT: A new approach to the interpretation of treatment success comprises the reporting of the proportion of patients whose symptoms have reduced to an acceptable level, ie, who have reached a satisfactory state. PURPOSE: We sought to evaluate the acceptable level of pain in patients after surgery for painful degenerative lumbar disorders. DESIGN: This is a cross-sectional study of outcome data, 12 months postoperatively. PATIENT SAMPLE: The sample includes 6,943 patients registered in our in-house Spine Outcomes Registry, nested within the EUROSPINE "Spine Tango" registry, undergoing surgery for degenerative disorders of the lumbar spine (disc herniation [DH; N=1,608], spinal stenosis [SS; N=1,782], degenerative spondylolisthesis [DS; N=1,000], degenerative deformity [DegDef; N=612], and degenerative disc or segment disease [DegSeg; N=473], and 1,468 degenerative but no specific category). OUTCOME MEASURES: The Core Outcome Measures Index (COMI) was the outcome measure. The specific items used for this analysis were the two 0 to 10 graphic rating scales for back and leg pain and the symptom-specific well-being (SSWB) item "if you had to spend the rest of your life with the symptoms you have now, how would you feel about it?", with a 5-point response scale from "very satisfied" to "very dissatisfied." METHODS: The COMI was completed before and at 3, 12, and 24 months after surgery. Answers on the SSWB were dichotomized and used as the external criterion in receiver operating characteristics (ROC) analysis to derive the cutoff score for pain (the higher of back and leg pain) indicating being at least "somewhat satisfied" with the symptom state 12 months postoperatively. Sensitivity analyses were carried out for various subgroups (sex, age, pathology, comorbidity status, smoking status, preoperative pain level, previous surgery, type of health insurance, and time of follow-up [3 and 24 months]). The study was funded by the Schulthess Klinik Research Funds; there were no potential conflict of interest-associated biases for any of the authors. RESULTS: Of 6,943 patients, 6,248 (90%) returned a 12-month questionnaire, of which 47% reported being at least somewhat satisfied with their symptom state (52% [DH], 45% [SS], 53% [DS], 44% [DegDef], 45% [DegSeg], and 44% [others]). The areas under the curve for the ROCs were 0.89 to 0.91 for the different pathologies, indicating a good ability of the pain score to discriminate between being in a satisfactory state or not. The cutoff indicating a satisfactory symptom state was ≤2 points for DH (sensitivity: 76%; specificity: 88%) and ≤3 points for all other pathologies (sensitivity: 79%-84%; specificity 81%-85%). The sensitivity analyses revealed ≤3 points to be the most common cutoff for the various subgroups. CONCLUSIONS: Most spine interventions decrease pain but rarely do they totally eliminate it. Reporting of the percent of patients achieving a pain score equivalent to the "acceptable symptom state" may represent a more stringent target for denoting surgical success in the treatment of painful spinal disorders. For DH, this is ≤2, and for other degenerative pathologies it is ≤3.

Patient-Rated Outcomes of Lumbar Fusion in Patients With Degenerative Disease of the Lumbar Spine: Does Age Matter?

STUDY DESIGN: Single-center retrospective study of prospectively collected data, nested within the Eurospine Spine Tango data acquisition system. OBJECTIVE: The aim of this study was to assess the patient-rated outcome and complication rates associated with lumbar fusion procedures in three different age groups. SUMMARY OF BACKGROUND DATA: There is a general reluctance to consider spinal fusion procedures in elderly patients due to the increased likelihood of complications. METHODS: Before and at 3, 12, and 24 months after surgery, patients completed the multidimensional Core Outcome Measures Index. At the 3-, 12-, and 24-month follow-ups, they also rated the Global Treatment Outcome and their satisfaction with care. Patients were divided into three age groups: younger (≥50 years <65 years; n = 317), older (≥65 years <80 years; n = 350), and geriatric (≥80 years; n = 40). RESULTS: A total of 707 consecutive patients were included. The preoperative comorbidity status differed significantly (P < 0.0001) between the age groups, with the highest scores in the geriatric group. Medical complications during surgery were lower in the younger age group (7%) than in the older (13.4%; P = 0.006) and geriatric groups (17.5%; P = 0.007); surgical complications tended to be higher in the elderly group (younger, 6.3%; older, 6.0%; geriatric, 15.0%; P = 0.09). There were no significant group differences (P > 0.05) for the scores on any of the Core Outcome Measures Index domains, Global Treatment Outcome, or patient-rated satisfaction at either 3-, 12-, and 24-months of follow-up. CONCLUSION: Despite greater comorbidity and complication rates in geriatric patients, the patient-rated outcome was as good in the elderly as it was in younger age groups up to 2 years after surgery. These data indicate that geriatric age needs careful consideration of associated risks but is not per se a contraindication for fusion for lumbar degenerative disease. LEVEL OF EVIDENCE: 4.

Could less be more when assessing patient-rated outcome in spinal stenosis?

STUDY DESIGN: Longitudinal study of the measurement properties of a brief outcome instrument. OBJECTIVE: In patients undergoing surgery for lumbar spinal stenosis, we compared the responsiveness of the Core Outcome Measures Index (COMI) with that of the condition-specific Swiss Spinal Stenosis Measure (SSM), an instrument developed to assess patients with neurogenic claudication. SUMMARY OF BACKGROUND DATA: The COMI is a validated multidimensional questionnaire for assessing the key outcomes of importance to patients with back problems. Being brief, it is associated with minimal respondent burden and high completion rates. However, for a given pathology, intuitively it may be expected to be less responsive than a condition-specific instrument. METHODS: A total of 91 patients (73±8 yr; 53% males) completed the following questionnaires before surgery: COMI, SSM, Roland Morris Disability Questionnaire, back trouble "Feeling Thermometer," pain numeric rating scale, EuroQoL-visual analogue scale. Twelve months postoperatively, 78/91 (86%) completed all the questionnaires again; they also rated the "global treatment outcome" (GTO; rated 1-5) and SSM "satisfaction with treatment result" (SSM-sat; rated 1-4), which were used as external criteria of treatment success. RESULTS: Scores for the external criteria of success (GTO/SSM-sat) correlated with the change scores (baseline to 12 mo) in COMI (r=0.57) and SSM (r=0.54) to a similar extent. Using receiver operating characteristics, with GTO or SSM-sat dichotomized as external criterion, the area under the curve was similar for the COMI change score (0.86-0.90) and the SSM (sub)scales (0.80-0.90). CONCLUSION: With either SSM-sat or GTO serving as the external criterion, COMI was as responsive as the SSM. The COMI is well able to detect important change in lumbar spinal stenosis and has the added benefit of reducing the response burden for the patient and facilitating outcome comparisons with other spinal pathologies. LEVEL OF EVIDENCE: 2.