Minimally invasive versus open transforaminal lumbar interbody fusion for grade I lumbar spondylolisthesis: 5-year follow-up from the prospective multicenter Quality Outcomes Database registry.

OBJECTIVE: Minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) has been used to treat degenerative lumbar spondylolisthesis and is associated with expedited recovery, reduced operative blood loss, and shorter hospitalizations compared to those with traditional open TLIF. However, the impact of MI-TLIF on long-term patient-reported outcomes (PROs) is less clear. Here, the authors compare the outcomes of MI-TLIF to those of traditional open TLIF for grade I degenerative lumbar spondylolisthesis at 60 months postoperatively. METHODS: The authors utilized the prospective Quality Outcomes Database registry and queried for patients with grade I degenerative lumbar spondylolisthesis who had undergone single-segment surgery via an MI or open TLIF method. PROs were compared 60 months postoperatively. The primary outcome was the Oswestry Disability Index (ODI). The secondary outcomes included the numeric rating scale (NRS) for back pain (NRS-BP), NRS for leg pain (NRS-LP), EQ-5D, North American Spine Society (NASS) satisfaction, and cumulative reoperation rate. Multivariable models were constructed to assess the impact of MI-TLIF on PROs, adjusting for variables reaching p < 0.20 on univariable analyses and respective baseline PRO values. RESULTS: The study included 297 patients, 72 (24.2%) of whom had undergone MI-TLIF and 225 (75.8%) of whom had undergone open TLIF. The 60-month follow-up rates were similar for the two cohorts (86.1% vs 75.6%, respectively; p = 0.06). Patients did not differ significantly at baseline for ODI, NRS-BP, NRS-LP, or EQ-5D (p > 0.05 for all). Perioperatively, MI-TLIF was associated with less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 ml, p < 0.001) and longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 minutes, p < 0.001) but had similar lengths of hospitalizations (MI-TLIF 2.9 ± 1.8 vs open TLIF 3.3 ± 1.6 days, p = 0.08). Discharge disposition to home or home health was similar (MI-TLIF 93.1% vs open TLIF 91.1%, p = 0.60). Both cohorts improved significantly from baseline for the 60-month ODI, NRS-BP, NRS-LP, and EQ-5D (p < 0.001 for all comparisons). In adjusted analyses, MI-TLIF, compared to open TLIF, was associated with similar 60-month ODI, ODI change, odds of reaching ODI minimum clinically important difference, NRS-BP, NRS-BP change, NRS-LP, NRS-LP change, EQ-5D, EQ-5D change, and NASS satisfaction (adjusted p > 0.05 for all). The 60-month reoperation rates did not differ significantly (MI-TLIF 5.6% vs open TLIF 11.6%, p = 0.14). CONCLUSIONS: For symptomatic, single-level grade I degenerative lumbar spondylolisthesis, MI-TLIF was associated with decreased blood loss perioperatively, but there was no difference in 60-month outcomes for disability, back pain, leg pain, quality of life, or satisfaction between MI and open TLIF. There was no difference in cumulative reoperation rates between the two procedures. These results suggest that in appropriately selected patients, either procedure may be employed depending on patient and surgeon preferences.

Developing nonlinear k-nearest neighbors classification algorithms to identify patients at high risk of increased length of hospital stay following spine surgery.

OBJECTIVE: Spondylolisthesis is a common operative disease in the United States, but robust predictive models for patient outcomes remain limited. The development of models that accurately predict postoperative outcomes would be useful to help identify patients at risk of complicated postoperative courses and determine appropriate healthcare and resource utilization for patients. As such, the purpose of this study was to develop k-nearest neighbors (KNN) classification algorithms to identify patients at increased risk for extended hospital length of stay (LOS) following neurosurgical intervention for spondylolisthesis. METHODS: The Quality Outcomes Database (QOD) spondylolisthesis data set was queried for patients receiving either decompression alone or decompression plus fusion for degenerative spondylolisthesis. Preoperative and perioperative variables were queried, and Mann-Whitney U-tests were performed to identify which variables would be included in the machine learning models. Two KNN models were implemented (k = 25) with a standard training set of 60%, validation set of 20%, and testing set of 20%, one with arthrodesis status (model 1) and the other without (model 2). Feature scaling was implemented during the preprocessing stage to standardize the independent features. RESULTS: Of 608 enrolled patients, 544 met prespecified inclusion criteria. The mean age of all patients was 61.9 ± 12.1 years (± SD), and 309 (56.8%) patients were female. The model 1 KNN had an overall accuracy of 98.1%, sensitivity of 100%, specificity of 84.6%, positive predictive value (PPV) of 97.9%, and negative predictive value (NPV) of 100%. Additionally, a receiver operating characteristic (ROC) curve was plotted for model 1, showing an overall area under the curve (AUC) of 0.998. Model 2 had an overall accuracy of 99.1%, sensitivity of 100%, specificity of 92.3%, PPV of 99.0%, and NPV of 100%, with the same ROC AUC of 0.998. CONCLUSIONS: Overall, these findings demonstrate that nonlinear KNN machine learning models have incredibly high predictive value for LOS. Important predictor variables include diabetes, osteoporosis, socioeconomic quartile, duration of surgery, estimated blood loss during surgery, patient educational status, American Society of Anesthesiologists grade, BMI, insurance status, smoking status, sex, and age. These models may be considered for external validation by spine surgeons to aid in patient selection and management, resource utilization, and preoperative surgical planning.

Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry.

The Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality Outcomes Database (N2QOD), was established by the NeuroPoint Alliance (NPA) in collaboration with relevant national stakeholders and experts. The overarching goal of this project was to develop a centralized, nationally coordinated effort to allow individual surgeons and practice groups to collect, measure, and analyze practice patterns and neurosurgical outcomes. Specific objectives of this registry program were as follows: "1) to establish risk-adjusted national benchmarks for both the safety and effectiveness of neurosurgical procedures, 2) to allow practice groups and hospitals to analyze their individual morbidity and clinical outcomes in real time, 3) to generate both quality and efficiency data to support claims made to public and private payers and objectively demonstrate the value of care to other stakeholders, 4) to demonstrate the comparative effectiveness of neurosurgical and spine procedures, 5) to develop sophisticated 'risk models' to determine which subpopulations of patients are most likely to benefit from specific surgical interventions, and 6) to facilitate essential multicenter trials and other cooperative clinical studies." The NPA has launched several neurosurgical specialty modules in the QOD program in the 7 years since its inception including lumbar spine, cervical spine, and spinal deformity and cerebrovascular and intracranial tumor. The QOD Spine modules, which are the primary subject of this paper, have evolved into the largest North American spine registries yet created and have resulted in unprecedented cooperative activities within our specialty and among affiliated spine care practitioners. Herein, the authors discuss the experience of QOD Spine programs to date, with a brief description of their inception, some of the key achievements and milestones, as well as the recent transition of the spine modules to the American Spine Registry (ASR), a collaboration between the American Association of Neurological Surgeons and the American Academy of Orthopaedic Surgeons (AAOS).

Correlation of return to work with patient satisfaction after surgery for lumbar spondylolisthesis: an analysis of the Quality Outcomes Database.

OBJECTIVE: Return to work (RTW) and satisfaction are important outcome measures after surgery for degenerative spine disease. The authors queried the prospective Quality Outcomes Database (QOD) to determine if RTW correlated with patient satisfaction. METHODS: The QOD was queried for patients undergoing surgery for degenerative lumbar spondylolisthesis. The primary outcome of interest was correlation between RTW and patient satisfaction, as measured by the North American Spine Society patient satisfaction index (NASS). Secondarily, data on satisfied patients were analyzed to see what patient factors correlated with RTW. RESULTS: Of 608 total patients in the QOD spondylolisthesis data set, there were 292 patients for whom data were available on both satisfaction and RTW status. Of these, 249 (85.3%) were satisfied with surgery (NASS score 1-2), and 224 (76.7%) did RTW after surgery. Of the 68 patients who did not RTW after surgery, 49 (72.1%) were still satisfied with surgery. Of the 224 patients who did RTW, 24 (10.7%) were unsatisfied with surgery (NASS score 3-4). There were significantly more people who had an NASS score of 1 in the RTW group than in the non-RTW group (71.4% vs 42.6%, p < 0.05). Failure to RTW was associated with lower level of education, worse baseline back pain (measured with a numeric rating scale), and worse baseline disability (measured with the Oswestry Disability Index [ODI]). CONCLUSIONS: There are a substantial number of patients who are satisfied with surgery even though they did not RTW. Patients who were satisfied with surgery and did not RTW typically had worse preoperative back pain and ODI and typically did not have a college education. While RTW remains an important measure after surgery, physicians should be mindful that patients who do not RTW may still be satisfied with their outcome.

Predictive model for long-term patient satisfaction after surgery for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database.

OBJECTIVESince the enactment of the Affordable Care Act in 2010, providers and hospitals have increasingly prioritized patient-centered outcomes such as patient satisfaction in an effort to adapt the "value"-based healthcare model. In the current study, the authors queried a prospectively maintained multiinstitutional spine registry to construct a predictive model for long-term patient satisfaction among patients undergoing surgery for Meyerding grade I lumbar spondylolisthesis.METHODSThe authors queried the Quality Outcomes Database for patients undergoing surgery for grade I lumbar spondylolisthesis between July 1, 2014, and June 30, 2016. The primary outcome of interest for the current study was patient satisfaction as measured by the North American Spine Surgery patient satisfaction index, which is measured on a scale of 1-4, with 1 indicating most satisfied and 4 indicating least satisfied. In order to identify predictors of higher satisfaction, the authors fitted a multivariable proportional odds logistic regression model for ≥ 2 years of patient satisfaction after adjusting for an array of clinical and patient-specific factors. The absolute importance of each covariate in the model was computed using an importance metric defined as Wald chi-square penalized by the predictor degrees of freedom.RESULTSA total of 502 patients, out of a cohort of 608 patients (82.5%) with grade I lumbar spondylolisthesis, undergoing either 1- or 2-level decompression (22.5%, n = 113) or 1-level decompression and fusion (77.5%, n = 389), met the inclusion criteria; of these, 82.1% (n = 412) were satisfied after 2 years. On univariate analysis, satisfied patients were more likely to be employed and working (41.7%, n = 172, vs 24.4%, n = 22; overall p = 0.001), more likely to present with predominant leg pain (23.1%, n = 95, vs 11.1%, n = 10; overall p = 0.02) but more likely to present with lower Numeric Rating Scale score for leg pain (median and IQR score: 7 [5-9] vs 8 [6-9]; p = 0.05). Multivariable proportional odds logistic regression revealed that older age (OR 1.57, 95% CI 1.09-2.76; p = 0.009), preoperative active employment (OR 2.06, 95% CI 1.27-3.67; p = 0.015), and fusion surgery (OR 2.3, 95% CI 1.30-4.06; p = 0.002) were the most important predictors of achieving satisfaction with surgical outcome.CONCLUSIONSCurrent findings from a large multiinstitutional study indicate that most patients undergoing surgery for grade I lumbar spondylolisthesis achieved long-term satisfaction. Moreover, the authors found that older age, preoperative active employment, and fusion surgery are associated with higher odds of achieving satisfaction.

A comparison of minimally invasive transforaminal lumbar interbody fusion and decompression alone for degenerative lumbar spondylolisthesis.

OBJECTIVEThe optimal minimally invasive surgery (MIS) approach for grade 1 lumbar spondylolisthesis is not clearly elucidated. In this study, the authors compared the 24-month patient-reported outcomes (PROs) after MIS transforaminal lumbar interbody fusion (TLIF) and MIS decompression for degenerative lumbar spondylolisthesis.METHODSA total of 608 patients from 12 high-enrolling sites participating in the Quality Outcomes Database (QOD) lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis, of whom 143 underwent MIS (72 MIS TLIF [50.3%] and 71 MIS decompression [49.7%]). Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse plane MIS intervertebral body graft (MIS TLIF) or if there was a tubular decompression (MIS decompression). Parameters obtained at baseline through at least 24 months of follow-up were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back pain, NRS for leg pain, EuroQol-5D (EQ-5D) questionnaire, and North American Spine Society (NASS) satisfaction questionnaire. Multivariate models were constructed to adjust for patient characteristics, surgical variables, and baseline PRO values.RESULTSThe mean age of the MIS cohort was 67.1 ± 11.3 years (MIS TLIF 62.1 years vs MIS decompression 72.3 years) and consisted of 79 (55.2%) women (MIS TLIF 55.6% vs MIS decompression 54.9%). The proportion in each cohort reaching the 24-month follow-up did not differ significantly between the cohorts (MIS TLIF 83.3% and MIS decompression 84.5%, p = 0.85). MIS TLIF was associated with greater blood loss (mean 108.8 vs 33.0 ml, p < 0.001), longer operative time (mean 228.2 vs 101.8 minutes, p < 0.001), and longer length of hospitalization (mean 2.9 vs 0.7 days, p < 0.001). MIS TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, p = 0.004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 months (p < 0.001, all comparisons relative to baseline). In multivariate analyses, MIS TLIF-as opposed to MIS decompression alone-was associated with superior ODI change (ß = -7.59, 95% CI -14.96 to -0.23; p = 0.04), NRS back pain change (ß = -1.54, 95% CI -2.78 to -0.30; p = 0.02), and NASS satisfaction (OR 0.32, 95% CI 0.12-0.82; p = 0.02).CONCLUSIONSFor symptomatic, single-level degenerative spondylolisthesis, MIS TLIF was associated with a lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared with posterior MIS decompression alone. This finding may aid surgical decision-making when considering MIS for degenerative lumbar spondylolisthesis.

Does Timing of Primary Total Hip Arthroplasty Prior to or After Lumbar Spine Fusion Have an Effect on Dislocation and Revision Rates?

BACKGROUND: Patients undergoing primary total hip arthroplasty (THA) following lumbar spine fusion have an increased incidence of dislocation compared to those without prior lumbar fusion. The purpose of this study is to determine if timing of THA prior to or after lumbar fusion would have an effect on dislocation and revision incidence in patients with both hip and lumbar spine pathology. METHODS: One hundred percent Medicare inpatient claims data from 2005 to 2015 were used to compare dislocation and revision risks in patients with primary THA with pre-existing lumbar spine fusion vs THA with subsequent lumbar spine fusion within 1, 2, and 5 years after the index THA. A total of 42,300 patients met inclusion criteria, 28,668 patients of which underwent THA with pre-existing lumbar spinal fusion (LSF) and 13,632 patients who had prior THA and subsequent LSF. Patients who had THA first followed by LSF were further stratified based on the interval between index THA and subsequent LSF (1, 2, and 5 years), making 4 total groups for comparison. Multivariate cox regression analysis was performed adjusting for age, socioeconomic status, race, census region, gender, Charlson score, pre-existing conditions, discharge status, length of stay, and hospital characteristics. RESULTS: Patients with prior LSF undergoing THA had a 106% increased risk of dislocation compared to those with LSF done 5 years after THA (P < .001). Risk of revision THA was greater in the pre-existing LSF group by 43%, 41%, and 49% at 1, 2, and 5 years post THA compared to the groups with THA done first with subsequent LSF. Dislocation was the most common etiology for revision THA in all groups, but significantly higher in the prior LSF group (26.6%). CONCLUSION: Results of this study demonstrate that sequence of surgical intervention for concomitant lumbar and hip pathology requiring LSF and THA respectively significantly impacts the fate of the THA performed. Patients with prior LSF undergoing THA are at significantly higher risk of dislocation and subsequent revision compared to those with THA first followed by delayed LSF. LEVEL OF EVIDENCE: 3.

Differences in lumbar and pelvic parameters among African American, Caucasian and Asian populations.

PURPOSE: Ethnic differences in spino-pelvic parameters among a healthy population are poorly defined in the literature. The purpose of this study was to document sagittal spino-pelvic parameters in a sample of African Americans and to compare them with previously reported data for Caucasians and Asians. METHODS: African American individuals without spine pathology who had standing lateral radiographs were identified. Radiographs were measured to determine the following parameters: lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT) and sacral slope (SS). Data of adult subjects were compared with those previously published for Caucasians (n = 709) and Asians (n = 312). RESULTS: These measurements (LL, PI, PT, and SS) obtained for the 36 African American subjects aged 18 years or older [15 men and 21 women; mean age 26.6 ± 8.7 range (18-53)] The mean LL, PI, PT and SS values were 57.2°, 57.7°, 15.9° and 41.4°, respectively. A comparative analysis showed the means values for PI was greater in the African American than in Caucasian (57.7° vs. 52.6°, p = 0.007), and than in Asian (57.7° vs. 48.7°, p < 0.001). The linear regression model for the LL as a function of PI were "predict LL = 0.41 × PI + 33.7" in African American, "predict LL = 0.58 × PI + 24.3" in Caucasian, and "predict LL = 0.54 × PI + 22.0" in Asian, respectively. CONCLUSION: Significant differences in sagittal spino-pelvic parameters among races were seen. These differences should be considered when planning surgical reconstruction for spinal surgery. These slides can be retrieved under Electronic Supplementary Material.

Women fare best following surgery for degenerative lumbar spondylolisthesis: a comparison of the most and least satisfied patients utilizing data from the Quality Outcomes Database.

OBJECTIVE The American Association of Neurological Surgeons launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data, to measure the safety and quality of neurosurgical procedures, including spinal surgery. Differing results from recent randomized controlled trials have established a need to clarify the groups that would most benefit from surgery for degenerative lumbar spondylolisthesis. In the present study, the authors compared patients who were the most and the least satisfied following surgery for degenerative lumbar spondylolisthesis. METHODS This was a retrospective analysis of a prospective, national longitudinal registry including patients who had undergone surgery for grade 1 degenerative lumbar spondylolisthesis. The most and least satisfied patients were identified based on an answer of "1" and "4," respectively, on the North American Spine Society (NASS) Satisfaction Questionnaire 12 months postoperatively. Baseline demographics, clinical variables, surgical parameters, and outcomes were collected. Patient-reported outcome measures, including the Numeric Rating Scale (NRS) for back pain, NRS for leg pain, Oswestry Disability Index (ODI), and EQ-5D (the EuroQol health survey), were administered at baseline and 3 and 12 months after treatment. RESULTS Four hundred seventy-seven patients underwent surgery for grade 1 degenerative lumbar spondylolisthesis in the period from July 2014 through December 2015. Two hundred fifty-five patients (53.5%) were the most satisfied and 26 (5.5%) were the least satisfied. Compared with the most satisfied patients, the least satisfied ones more often had coronary artery disease (CAD; 26.9% vs 12.2%, p = 0.04) and had higher body mass indices (32.9 ± 6.5 vs 30.0 ± 6.0 kg/m2, p = 0.02). In the multivariate analysis, female sex (OR 2.9, p = 0.02) was associated with the most satisfaction. Notably, the American Society of Anesthesiologists (ASA) class, smoking, psychiatric comorbidity, and employment status were not significantly associated with satisfaction. Although there were no significant differences at baseline, the most satisfied patients had significantly lower NRS back and leg pain and ODI scores and a greater EQ-5D score at 3 and 12 months postoperatively (p < 0.001 for all). CONCLUSIONS This study revealed that some patient factors differ between those who report the most and those who report the least satisfaction after surgery for degenerative lumbar spondylolisthesis. Patients reporting the least satisfaction tended to have CAD or were obese. Female sex was associated with the most satisfaction when adjusting for potential covariates. These findings highlight several key factors that could aid in setting expectations for outcomes following surgery for degenerative lumbar spondylolisthesis.

Defining the minimum clinically important difference for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database.

OBJECTIVE Patient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis. METHODS The authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen's effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO. RESULTS A total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 ± 17.4 points for ODI, 0.24 ± 0.23 for EQ-5D, 4.1 ± 3.5 for NRS-LP, and 3.7 ± 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3-26.5 points for ODI, 0.04-0.3 points for EQ-5D, 0.6-4.5 points for NRS-LP, and 0.5-4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort. CONCLUSIONS The MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.

Management of Unstable Fracture-Dislocations of the Spine in Polytrauma Patients.

A multidisciplinary and systematic approach is required for the treatment of polytrauma patients with a thoracolumbar fracture-dislocation to provide timely care and prevent iatrogenic injury. Thoracolumbar fracture-dislocations frequently occur in patients who sustain a high-energy mechanism of injury; therefore, they are associated with other orthopaedic and visceral injuries that need to be identified via a systematic protocol. Orthopaedic surgeons must obtain a thorough patient history, perform an appropriate physical examination, and obtain adequate imaging studies to expeditiously treat polytrauma patients with a thoracolumbar fracture-dislocation.

Total Hip Arthroplasty in Patients With Previous Lumbar Fusion Surgery: Are There More Dislocations and Revisions?

BACKGROUND: The purpose of this study was to determine whether the risk of dislocation and/or revision following THA is increased in patients with a history of prior lumbar fusion given the alterations in dynamic pelvic motion following LSF. METHODS: A total of 62,387 patients (5% Medicare part B claims database) were identified from 1997 to 2014 with primary THA. From this group, 1809 patients (2.9%) were stratified to identify those with prior lumbar fusion within 5 years of primary THA to compare risk of dislocation and revision with those without lumbar fusion. Multivariate cox regression analysis was performed adjusting for age, socioeconomic status, race, census, region, gender, Charlson score, preexisting conditions, and type of fusion. RESULTS: Between years 2002 and 2014, there was a 293% increase in the number of patients with prior lumbar fusion undergoing THA. Prevalence of hip dislocation in patients with lumbar fusion before THA was 7.4% compared to 4.8% without fusion, P < .001. There was an 80% increase in dislocation in the fusion group at 6 months, 71% at 1 year, and 60% at 2 years. There was a 48% increased risk of failure leading to revision hip surgery in patients with fusion at 6 months, 41% at 1 year, and 47% at 2 years. Dislocation was the most common mode of failure leading to revision in both the fusion group (20.8%) and the nonfusion group (16%). CONCLUSION: Results of this study demonstrate that lumbar fusion before THA is an independent risk factor for dislocation leading to increased risk of revision THA.

Age variation in the minimum clinically important difference in SRS-22r after surgical treatment for adult spinal deformity - A single institution analysis in Japan.

BACKGROUND: The Scoliosis Research Society-22r (SRS-22r) has been shown to be reliable, valid and responsive to change in patients with adult spinal deformity (ASD) undergoing surgery. The minimum clinically important difference (MCID) quantifies a threshold value of improvement that is clinically relevant to the patient. Health-related quality of life scores depend on age. The purpose of this study was to assess MCID threshold values stratified by age for SRS-22r domains in patients with ASD undergoing surgical correction. METHODS: We identified a consecutive series of 184 Japanese ASD patients who completed the SRS-22r and Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) preoperatively and 1 year postoperatively. Effectiveness as measured on the JOABPEQ was used as the anchor to determine MCID for the Function, Pain, and Mental health domains using receiver-operating-characteristic (ROC) curve analysis. We performed MCID analysis stratified by age (<70 or ≥70). RESULTS: Mean preoperative SRS-22r Function score was 2.69 improving to 3.23 at postoperatively (p < 0.001). Mean preoperative SRS-22r Pain score was 3.04 improving to 3.78 at postoperatively (p < 0.001). Mean preoperative SRS-22r Mental health score was 2.72 improving to 3.25 at postoperatively (p < 0.001). There was a statistically difference in change in domain score between "not effective" and "effective" (p < 0.001). The ROC curve analysis methods yielded MCID values of 0.58 for Function, 0.55 for Pain, and 0.70 for Mental health domains. There was difference of MCID value for Function and Mental health domain between aged <70 and ≥70; 0.78 and 0.55 for Function; 0.70 and 0.48 for Mental health. CONCLUSION: Results of this study showed that MCID threshold values for SRS-22 Function and Mental health domains in older than 70 was lower than in younger than 70, potentially implying that older patients have lower expectation.

Clinical practice guidelines: their use, misuse, and future directions.

Evidence-based clinical practice guidelines (CPGs) have the potential to bring the best-quality evidence to orthopaedic surgeons and their patients. CPGs can improve quality by decreasing the variability in orthopaedic care, but they can also be misused through inappropriate development or application. The quality of a CPG is dependent on the strength of its evidence base, which is often deficient in orthopaedic publications. In addition, many surgeons express concern about legal liability associated with CPGs. Specific processes in CPG development and implementation can counter these potential problems. Other evidence tools, such as appropriate use criteria, also can help in the application of the proper treatment of patients by identifying those who are appropriate for specific procedures. Because payers, patients, and surgeons need access to the best evidence, CPGs will continue to be developed, and orthopaedic surgeons have the opportunity to ensure their proper development and implementation by understanding and participating in the process.

Relative benefit of TLIF versus PSF stratified by diagnostic indication.

STUDY DESIGN: Case-matched retrospective. OBJECTIVES: The purpose of this study is to compare 2-year health-related quality of life (HRQOL) outcomes of patients who underwent 1-level or 2-level posterolateral spine fusion (PSF) versus transforaminal interbody fusion (TLIF) for degenerative spondylolisthesis, disk pathology, and postdecompression instability. SUMMARY OF BACKGROUND DATA: The optimal surgical technique for patients with spondylolisthesis or other degenerative conditions has not been defined. Historically, PSF was the most common procedure, whereas in recent years TLIF has gained popularity. Although theoretical advantages for TLIF have been outlined, evidence for improved outcomes with the addition of interbody support is limited. METHODS: Patients with degenerative spondylolisthesis, with disk pathology and or postdecompression instability who underwent 1-level or 2-level TLIF and completed 2 years postoperative HRQOL measures were identified from a prospective database. These patients were then propensity-matched to a cohort of PSF patients based on age, number of surgical levels, body mass index, sex, smoking status, workers' compensation status, and preoperative outcome measures including the Oswestry Disability Index, SF-36 Physical Component Summary score, SF-36 Mental Composite Summary score, and back and leg pain scores. This produced 63 matched pairs with degenerative spondylolisthesis, 46 with disk pathology and 32 with postdecompression instability. RESULTS: All patients in both groups for each cohort reported statistically significant improvement in HRQOL scores at 2 years postoperatively compared with baseline. Improvements in the Oswestry Disability Index, SF-36 Physical Component Summary score, and back and leg pain scores within the spondylolisthesis and disk pathology subgroups were similar between patients who had a TLIF compared with those who had a PSF. The postdecompression instability subgroup was the only subgroup in which TLIF outperformed PSF for every outcome measure. CONCLUSIONS: Clinical outcome was not significantly altered with TLIF as compared with PSF in patients with spondylolisthesis or disk pathology. However, TLIF resulted in better outcomes at 2 years postoperatively in patients with postdecompression instability.

Early-term and mid-term histologic events during single-level posterolateral intertransverse process fusion with rhBMP-2/collagen carrier and a ceramic bulking agent in a nonhuman primate model: implications for bone graft preparation.

STUDY DESIGN: We used a nonhuman primate lumbar intertransverse process arthrodesis model to evaluate biological cascade of bone formation using different carrier preparation methods with a single dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) at early time points. OBJECTIVE: To examine early-term/mid-term descriptive histologic and computerized tomographic events in single-level uninstrumented posterolateral nonhuman primate spinal fusions using rhBMP-2/absorbable collagen sponge (ACS) combined with ceramic bulking agents in 3 different configurations. SUMMARY OF BACKGROUND DATA: rhBMP-2 on an ACS carrier alone leads to consistent posterolateral lumbar spine fusions in lower-order animals; however, these results have been difficult to replicate in nonhuman primates. METHODS: Twelve skeletally mature, rhesus macaque monkeys underwent single-level posterolateral arthrodesis at L4-L5. A hydroxyapatite/ß-tricalcium phosphate ceramic bulking agent in 3 formulations was used in the treatment groups (n=3). When used, rhBMP-2/ACS at 1.5 mg/cm (3.0 mg rhBMP-2) was combined with 2.5 cm of ceramic bulking agent per side. Animals were euthanized at 4 and 12 weeks postoperative. Computerized tomography scans were performed immediately postoperatively and every 4 weeks until they were euthanized. Sagittal histologic sections were evaluated for bone histogenesis and location, cellular infiltration of the graft/substitute, and bone remodeling activity. RESULTS: Significant histologic differences in the developing fusion appeared between the 3 rhBMP-2/ACS treatment groups at 4 and 12 weeks. At 4 weeks, bone formation appeared to originate at the transverse process and the intertransverse membrane. Cellular infiltration was greatest in granular ceramic groups compared with matrix ceramic group. Minimal to no residual ACS was identified at the early time point. At 12 weeks, marked ceramic remodeling was observed with continued bone formation noted in all carrier groups. CONCLUSIONS: At the early time period, histology showed that bone formation appeared to originate at the transverse processes and the intertransverse membrane, indicating that the dorsal muscle bed may not be the only location for bone formation. Histology also showed that the collagen carrier for rhBMP-2 is mostly resorbed by 4 weeks. Our results and previous literature indicate that ceramic bulking agents are needed to provide resistance to compression caused by paraspinal muscles on the fusion bed in the posterolateral environment. Histology showed that ceramic bulking agents may offer long-term scaffolding and a structure to supporting bone formation of the developing fusion mass.

Performance of the streamlined quality outcomes database web-based calculator: internal and external validation.

BACKGROUND CONTEXT: With an increasing number of web-based calculators designed to provide the probabilities of an individual achieving improvement after lumbar spine surgery, there is a need to determine the accuracy of these models. PURPOSE: To perform an internal and external validation study of the reduced Quality Outcomes Database web-based Calculator (QOD-Calc). STUDY DESIGN: Observational longitudinal cohort. PATIENT SAMPLE: Patients enrolled study-wide in Quality Outcomes Database (QOD) and patients enrolled in DaneSpine at a single institution who had elective lumbar spine surgery with baseline data to complete QOD-Calc and 12-month postoperative data. OUTCOME MEASURES: Oswestry Disability Index (ODI), Numeric Rating Scales (NRS) for back and leg pain, EuroQOL-5D (EQ-5D). METHODS: Baseline data elements were entered into QOD-Calc to determine the probability for each patient having Any Improvement and 30% Improvement in NRS leg pain, back pain, EQ-5D and ODI. These probabilities were compared with the actual 12-month postop data for each of the QOD and DaneSpine cases. Receiver-operating characteristics analyses were performed and calibration plots created to assess model performance. RESULTS: 24,755 QOD cases and 8,105 DaneSpine lumbar cases were included in the analysis. QOD-Calc had acceptable to outstanding ability (AUC: 0.694-0.874) to predict Any Improvement in the QOD cohort and moderate to acceptable ability (AUC: 0.658-0.747) to predict 30% Improvement. QOD-Calc had acceptable to exceptional ability (AUC: 0.669-0.734) to predict Any improvement and moderate to exceptional ability (AUC: 0.619-0.862) to predict 30% Improvement in the DaneSpine cohort. AUCs for the DaneSpine cohort was consistently lower that the AUCs for the QOD validation cohort. CONCLUSION: QOD-Calc performs well in predicting outcomes in a patient population that is similar to the patients that was used to develop it. Although still acceptable, model performance was slightly worse in a distinct population, despite the fact that the sample was more homogenous. Model performance may also be attributed to the low discrimination threshold, with close to 90% of cases reporting Any Improvement in outcome. Prediction models may need to be developed that are highly specific to the characteristics of the population.

Patient expectations impact patient-reported outcomes and satisfaction after lumbar fusion.

BACKGROUND CONTEXT: Prior studies suggest that patient expectations impact postoperative patient-reported outcomes (PROMs). However, no consensus exists on an appropriate expectations tool. PURPOSE: To examine the impact of patient expectations using a modified version of the Oswestry Disability Index (ODI) on clinical outcomes and patient satisfaction 1 year after lumbar fusion for degenerative pathologies. STUDY DESIGN: Prospective longitudinal cohort. PATIENT SAMPLE: Adults undergoing 1 to 2 level lumbar fusion were identified from four tertiaty spine centers. OUTCOME MEASURES: ODI, EuroQol-5D, Numeric rating scales for back and leg pain. METHODS: Preoperatively, patients completed the ODI, as well as a modified ODI reflecting their expected improvement across the 10 ODI items. For example, item 1 in the ODI asks about Pain Intensity at the moment whereas the Expectations ODI asks "One year after surgery, I expect to have…" The difference between this modified ODI score and the baseline ODI score (Baseine ODI minus Expectations ODI) was defined as the Patient Expectation Score. Patients were stratified into tertiles based on their Expectations score into High (HE), Moderate (ME), and Low (LE) Expectations and compared. RESULTS: There were 30 patients in the HE, 35 in the ME, and 26 in the LE Group, with similar demographics and surgical parameters. Patients in the HE group had worse ODI scores preoperatively (54.96 vs 41.42, p<.001) and were expecting a greater improvement in ODI (43.8 vs 13.5, p<.001). There were fewer patients in the HE group (13, 43%) who reported that they were satisfied with the results compared to either the ME (20, 71%) or LE group (22, 85%, p=.041) despite having similar ODI scores and change in ODI scores 1 year postoperatively. CONCLUSION: An expectations tool, linked to a disease-specific measure may provide the clinician with a practical method of assessing a patient's expectation of results after treatment and aid in the shared decision-making during the preoperative surgical process.

Assessment of the External Validity of Dialogue Support for Predicting Lumbar Spine Surgery Outcomes in a US Cohort.

STUDY DESIGN: External validation using prospectively collected data. OBJECTIVES: To determine the model performance of "Dialogue Support" (DS) in predicting outcomes after lumbar spine surgery. SUMMARY OF BACKGROUND DATA: To help clinicians discuss risk versus benefit with patients considering lumbar fusion surgery, DS has been made available online. As DS was created using a Swedish sample, there is a need to study how well DS performs in alternative populations. PATIENTS AND METHODS: Preoperative data from patients enrolled in the Quality Outcomes Database were entered into DS. The probability for each patient to report satisfaction, achieve success (leg pain improvement ≥3), or have no leg pain 12 months after surgery was extracted and compared with their actual 12-month postoperative data. The ability of DS to identify patients in the Quality Outcomes Database who report satisfaction, achieve success, or have no leg pain 12 months after surgery was determined using Receiver operating characteristic curve analysis, goodness-of-fit tests, and calibration plots. RESULTS: There was a significant improvement in all outcomes in 23,928 cases included in the analysis from baseline to 12 months postoperative. Most (84%) reported satisfaction, 67% achieved success, and 44% were pain-free 12 months postoperative. Receiver operating characteristic analysis showed that DS had a low ability to predict satisfaction [area under the curve (AUC) = 0.606], success (AUC = 0.546), and being pain-free (AUC = 0.578) at 12 months postoperative; poor fit for satisfaction (<0.001) and being pain-free ( P = 0.004), but acceptable fit for success ( P = 0.052). Calibration plots showed underestimation for satisfaction and success, but acceptable estimates for being pain-free. CONCLUSION: DS is not directly transferable to predict satisfaction and success after lumbar surgery in a US population. This may be due to differences in patient characteristics, weights of the variables included, or the exclusion of unknown variables associated with outcomes. Future studies to better understand and improve the transferability of these models are needed.

Risk Factors for Medial Breach During Robotic-Assisted Cortical Bone Trajectory Screw Insertion.

OBJECTIVE: We describe the incidence of, and identify the risk factors for, a medial breach of the pedicle wall during robotic-assisted cortical bone trajectory (RA-CBT) screw insertion. METHODS: We analyzed a consecutive series of adult patients who underwent RA-CBT screw placement from January 2019 to July 2022. To assess the pedicle wall medial breach, postoperative computed tomography (CT) images were analyzed. Patient demographic data and screw data were compared between patients with and without a medial breach. The Hounsfield units (HUs) on the L1 midvertebral axial CT scan was used to evaluate bone quality. RESULTS: Of 784 CBT screws in 145 patients, 30 (3.8%) had a medial breach in 23 patients (15.9%). One screw was grade 2, and the others were grade 1. Patients with a medial breach had a lower HU value compared with the patients without a medial breach (123.3 vs. 150.5; P = 0.027). A medial breach was more common in the right than left side (5.5% vs. 2.0%; P = 0.014). More than one half of the screws with a medial breach were found in the upper instrumented vertebra (UIV) compared with the middle construct or lowest instrumented vertebra (6.7% vs. 1.3% vs. 2.7%; P = 0.003). Binary logistic regression showed that low HU values, right-sided screw placement, and UIV were associated with a medial breach. No patients returned to the operating room for screw malposition. No differences were found in the clinical outcomes between patients with and without a medial breach. CONCLUSIONS: The incidence of pedicle wall medial breach was 3.8% of RA-CBT screws in the postoperative CT images. A low HU value measured in the L1 axial image, right-sided screw placement, and UIV were associated with an increased risk of medial breach for RA-CBT screw placement.