Comparison of transforaminal and posterior lumbar interbody fusion outcomes in patients receiving a novel allograft versus rhBMP-2: a radiographic and patient-reported outcomes analysis.

OBJECTIVE: Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been demonstrated to achieve the highest rates of arthrodesis in multilevel lumbar fusion but is also associated with possible perioperative morbidity. A novel allograft (OSTEOAMP) is a differentiated allograft that retains growth factors supporting bone healing. The authors sought to compare the clinical and radiographic outcomes of rhBMP-2 and the novel allograft in lumbar interbody arthrodesis to determine if the latter may be a safer and equally effective alternative to rhBMP-2 for single- and multilevel posterior or transforaminal lumbar interbody fusion (PLIF or TLIF). METHODS: Patients who underwent single- or multilevel TLIF or PLIF using either OSTEOAMP or rhBMP-2 at the authors' institution over a 2-year period were prospectively followed for 12 months. Healthcare utilization, safety measures, patient satisfaction, physical disability (measured on the Oswestry Disability Index [ODI]), back and leg pain (on the numeric rating scale [NRS]), quality of life (on the EQ-5D scale), and return to work (RTW) were prospectively recorded. For purposes of this study, this consecutive series was retrospectively analyzed and pseudarthrosis rates were assessed at 2 years of follow-up. All patients (100%) had both 12-month patient-reported outcome follow-up and 24-month clinical and radiographic follow-up. RESULTS: One thousand one hundred fifty-four patients (654 treated with OSTEOAMP, 500 with rhBMP-2) were prospectively enrolled in the institutional registry. After propensity score matching, there were no significant baseline differences between 330 novel allograft and 330 rhBMP-2 cases. Perioperative morbidity and 90-day hospital readmission (3.3% vs 2.4%, p = 0.485) did not significantly differ between the novel allograft and the rhBMP-2 cases. At the 2-year follow-up, symptomatic pseudarthrosis requiring revision surgery occurred in 8 patients (2.4%) with OSTEOAMP and 6 patients (1.8%) with rhBMP-2 (p = 0.589). The overall fusion rate at 2 years was similar between groups (p = 0.213). Both groups showed significant and equivalent improvement in patient-reported outcome measures (PROMs) from baseline to 12-month follow-up, with no significant difference in 1-year mean NRS leg pain score (2.5 vs 2.7), ODI (25 vs 26), quality-adjusted life years (0.73 vs 0.73), satisfaction (83% vs 80%), or RTW (6.6 vs 7 weeks). CONCLUSIONS: In the authors' institutional experience, OSTEOAMP is a clinically viable substitute for rhBMP-2 for single- and multilevel lumbar fusion. This novel allograft provides clinically effective arthrodesis and improvements in PROMs comparable to rhBMP-2 with a similar safety profile. Additional indications and outcome assessment in longitudinal studies are needed to further characterize this allogeneic graft.

Does type of bone graft matter? A retrospective review of the use of biological bone grafts in patients undergoing elective 1-3 level spinal interbody fusion.

OBJECTIVE: There is a lack of strong evidence for use of expensive bone substitutes. This study compares perioperative data and patient reported quality-of-life outcomes across the varied types of bone graft extenders. The study analyzes the existing Quality and Outcomes Database and evaluates patient reported outcomes for 1-3 level lumbar fusion procedures comparing across different types of biologics bone graft. METHODS: We retrospectively analyzed a prospectively collected data registry. Bone graft implant data were collected and grouped into the following categories: (1) Autograft with basic allograft (2) Enhanced, synthetic, or cellular allograft (3) Use of BMP. Preoperative and 1 year patient reported outcomes and perioperative data from the prospective collected registry were analyzed. RESULTS: There were 384 patients included in this study. There were 168 (43.8%) patients in group 1, 133 (34.6%) patients in group 2, and 83 (21.6%) in group 3. There were no group differences in baseline or 1 year back pain, leg pain, ODI, or EQ-5D. The GLM Repeated Measures results indicate a significant difference within each of the three groups between the preoperative and postoperative measures for back pain, leg pain, ODI, and EQ-5D. The change over time was not significantly different between the groups. CONCLUSIONS: Bone graft extenders are a significant contributor to the cost of lumbar fusion. This study demonstrates no difference in preoperative, and 1 year patient reported outcomes between the three groups. There was no significant difference in rate of reoperations across the three groups.

Mental health comorbidities in workers' compensation patients and the effect on pain, disability, quality of life, and return to work after lumbar spine surgery.

OBJECTIVE: The impact of mental health comorbidities on outcomes after lumbar spine surgery in workers' compensation (WC) patients has not been robustly explored. The goal of this study was to examine the impact of mental health comorbidities on pain, disability, quality of life, and return to work after lumbar spine surgery in WC patients. METHODS: A nationwide, prospective surgical outcomes registry (National Neurosurgery Quality Outcomes Database [N2QOD]) was queried for all patients who underwent 1- to 4-level lumbar decompression and/or fusion from 2012 to 2021. Patients were stratified on the basis of compensation status into non-WC (25,507) and WC (1018) cohorts. Baseline demographic data, perioperative safety data, and patient-reported outcome measures were compared between groups. The WC cohort was further subdivided on the basis of mental health status into patients with anxiety and depression (n = 107) and those without anxiety and depression (n = 911). Propensity matching was used to generate parity between these subgroups, generating 214 patients (107 pairs) for analysis. Perioperative safety, facility utilization, 1-year patient-reported outcomes (back and leg pain, disability, and quality of life), and return to work were measured as a function of WC and mental health comorbidity status. RESULTS: A total of 26,525 patients (25,507 non-WC and 1018 WC) who underwent 1- to 4-level lumbar spine surgery were reviewed. WC patients were younger, healthier (lower American Society of Anesthesiologists class), more likely to be minorities, less educated, and more likely to smoke and had greater baseline back pain, disability, and quality of life compared to non-WC patients. The prevalence of anxiety and depression was similar between groups (11%). WC patients had worse outcomes for all measures and lower rates of return to work compared to non-WC patients. WC patients with anxiety and depression demonstrated even greater disparities in all outcomes. After propensity matching, WC patients with anxiety and depression continued to demonstrate significantly worse outcomes in comparison to WC patients without anxiety and depression. CONCLUSIONS: Disparities in outcomes after lumbar spine surgery in WC patients are exacerbated in patients with anxiety and depression. WC patients with mental health comorbidities receive the least benefit from lumbar spine surgery and may represent the most vulnerable subset of patients with spine pathology. Addressing mental health comorbidities preoperatively may represent an opportunity for valuable resource allocation and surgical optimization in the WC population.

Patent bibliometrics in spinal deformity: the first bibliometric analysis of spinal deformity's technological literature.

PURPOSE: Bibliometric analyses have gained popularity for studying scientific literature, but their application to evaluate technological literature (patents) remains unexplored. We conducted a bibliometric analysis on the top 100 most-cited patents in scoliosis surgery. METHODS: Multiple databases were queried using The Lens to identify the top 100 scoliosis surgery patents, which were selected based on forward patent citations. These patents were then categorized into 8 groups based on technological descriptors and assessed based on various factors including earliest priority date, year issued, and expiration status. RESULTS: The top 100 most-cited patents included technology underlying anterolateral tethering and distraction systems (n = 11), posterior tethering and distraction systems (n = 23), posterior segmental bone anchor and rod engagement systems (n = 29), interbody devices (n = 10), biological and electrophysiological agents for scoliosis treatment and/or improved arthrodesis (n = 8), intraoperative arthroplasty devices (n = 5), orthotic devices (n = 12), and implantable devices for non-invasive, postoperative alterations of skeletal alignment (n = 2). Seventy-five patents were expired, 21 are still active, and 4 were listed as inactive. The late 1970s and early 2000s saw increased numbers of patent filings. Demonstrated trends showed no meaningful correlation between patent rank and earliest priority date (linear trendline y = 0.2648x - 477.27; R2 = 0.0114), while a very strong correlation was found between patent rank and citations per year (power trendline y = 118.82x--0.83; R2 = 0.8983). CONCLUSION: Patent bibliometric analyses in the field of spinal deformity surgery provide a means to assess past advancements, better understand what it takes to make a difference in the field, and to potentially facilitate the development of innovative technologies in the future. The method described is a reliable and reproducible technique for evaluating technological literature in our field.

Remote cognitive behavioral therapy utilizing an in-home virtual reality toolkit (Vx Therapy) reduces pain, anxiety, and depression in patients with chronic cervical and lumbar spondylytic pain: A potential alternative to opioids in multimodal pain management.

Background Context: Virtual reality (VR) reduces pain through visual and auditory distraction without narcotic-related side effects or dependency. Cognitive behavioral therapy (CBT) improves pain-related disability and quality of life, but patient access remains a challenge. We hypothesized that in-home weekly CBT coordinated with daily use of a proprietary VR toolkit will reduce pain, anxiety, and depression for patients with non-operative chronic cervical and lumbar spondylitic pain with and without radiculopathy. Methods: A total of 145 patients with chronic spondylitic pain (63 cervical, 46 noradicular lumbar, 36 radicular lumbar) were enrolled into a guided 14-week VR+CBT program (Vx Therapy) consisting of weekly encounters with a trained therapist and 50 modules. Pain/anxiety severity scores and time to pain recurrence were recorded prospectively by patients. PROMIS measures of overall daily pain intensity, behavior, interference, anxiety, and depression were recorded at baseline and conclusion of the program. Results: A total of 52% of the 145 patients were male. The average (SD) age of the cohort was 51 (10.7) years (range: 24-76 years). Mean score for all PROMIS domains were significantly improved after 14 weeks of Vx Therapy (pain intensity 36±24 vs. 28±21, interference 39±25 vs. 24±21, behavior 35±21 vs. 25±16, anxiety 51±28 vs. 41±26, depression 58±32 vs. 48±32) for the entire cohort and each diagnosis group. Virtual reality acutely reduced pain on average by 33% (4.5±2.5 vs. 6.7±2.2, p<.05) across all 14 weeks, lasting a mean 2.8 hours after use. Duration of pain relief increased by the final vs. first month (4.5 hours vs. 2.5 hours, p<.05). Virtual reality acutely reduced anxiety on average by 46% (3.5±3 vs. 6.4±2, p<.05) across all 14 weeks lasting a mean 2.7 hours after use. The effect was similar for all 3 groups. Conclusions: Fourteen weeks of a remote CBT guided in-home VR toolkit provided effective and sustained pain, anxiety, and depression relief in patients with chronic degenerative neck/back pain with and without radiculopathy. The non-invasive, non-pharmacological nature of Vx Therapy makes it an ideal option for pain management in the post-opioid epidemic era.

Effect of workers' compensation status on pain, disability, quality of life, and return to work after anterior cervical discectomy and fusion: a 1-year propensity score-matched analysis.

OBJECTIVE: Patients with workers' compensation (WC) claims are reported to demonstrate poorer surgical outcomes after lumbar spine surgery. However, outcomes after anterior cervical discectomy and fusion (ACDF) in WC patients remain debatable. The authors aimed to compare outcomes between a propensity score-matched population of WC and non-WC patients who underwent ACDF. METHODS: Patients who underwent 1- to 4-level ACDF were retrospectively reviewed from the prospectively maintained Quality Outcomes Database (QOD). After propensity score matching, 1-year patient satisfaction, physical disability (Neck Disability Index [NDI]), pain (visual analog scale [VAS]), EQ-5D, and return to work were compared between WC and non-WC cohorts. RESULTS: A total of 9957 patients were included (9610 non-WC and 347 WC patients). Patients in the WC cohort were significantly younger (50 ± 9.1 vs 56 ± 11.4 years, p < 0.001), less educated, and were more frequently male, non-Caucasian, and active smokers (29.1% vs 18.1%, p < 0.001), with greater baseline VAS and NDI scores and poorer quality of life (p < 0.001). One-year postoperative improvements in VAS, NDI, EQ-5D, and return-to-work rates and satisfaction were all significantly worse for WC compared with non-WC patients. After adjusting for baseline differences via propensity score matching, WC versus non-WC patients continued to demonstrate worse 3- and 12-month VAS neck pain and NDI (p = 0.010), satisfaction (χ2 = 4.03, p = 0.045), and delayed return to work (9.3 vs 5.7 weeks, p < 0.001). CONCLUSIONS: WC status was associated with greater 1-year residual disability and axial pain along with delayed return to work, without any difference in quality of life despite having fewer comorbidities and being a younger population. Further studies are needed to determine the societal impact that WC claims have on healthcare delivery in the setting of ACDF.

Minimally Invasive Transforaminal Lumbar Interbody Fusion in the Ambulatory Surgery Center Versus Inpatient Setting: A 1-Year Comparative Effectiveness Analysis.

BACKGROUND: Ambulatory surgery centers (ASCs) have emerged as an alternative setting for surgical care as part of the national effort to lower health care costs. The literature regarding the safety of minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) in the ASC setting is limited to few small case series. OBJECTIVE: To assess the safety and efficacy of MIS TLIF performed in the ASC vs inpatient hospital setting. METHODS: A total of 775 patients prospectively enrolled in the Quality Outcomes Database undergoing single-level MIS TLIF at a single ASC (100) or the inpatient hospital setting (675) were compared. Propensity matching generated 200 patients for analysis (100 per cohort). Demographic data, resource utilization, patient-reported outcome measures (PROMs), and patient satisfaction were assessed. RESULTS: There were no significant differences regarding baseline demographic data, clinical history, or comorbidities after propensity matching. Only 1 patient required inpatient transfer from the ASC because of intractable pain. All other patients were discharged home within 23 hours of surgery. The rates of 90-day readmission (2.0%) and reoperation (0%) were equivalent between groups. Both groups experienced significant improvements in all PROMs (Oswestry Disability Index, EuroQol-5D, back pain, and leg pain) at 3 months that were maintained at 1 year. PROMs did not differ between groups at any time point. Patient satisfaction was similar between groups at 3 and 12 months after surgery. CONCLUSION: In carefully selected patients, MIS TLIF may be performed safely in the ASC setting with no statistically significant difference in safety or efficacy in comparison with the inpatient setting.

Anterior Cervical Discectomy and Fusion Versus Microendoscopic Posterior Cervical Foraminotomy for Unilateral Cervical Radiculopathy: A 1-Year Cost-Utility Analysis.

BACKGROUND: Anterior cervical discectomy and fusion (ACDF) and posterior cervical foraminotomy (PCF) are the most common surgical approaches for medically refractory cervical radiculopathy. Rigorous cost-effectiveness studies comparing ACDF and PCF are lacking. OBJECTIVE: To assess the cost-utility of ACDF vs PCF performed in the ambulatory surgery center setting for Medicare and privately insured patients at 1-year follow-up. METHODS: A total of 323 patients who underwent 1-level ACDF (201) or PCF (122) at a single ambulatory surgery center were compared. Propensity matching generated 110 pairs (220 patients) for analysis. Demographic data, resource utilization, patient-reported outcome measures, and quality-adjusted life-years were assessed. Direct costs (1-year resource use × unit costs based on Medicare national allowable payment amounts) and indirect costs (missed workdays × average US daily wage) were recorded. Incremental cost-effectiveness ratios were calculated. RESULTS: Perioperative safety, 90-day readmission, and 1-year reoperation rates were similar between groups. Both groups experienced significant improvements in all patient-reported outcome measures at 3 months that was maintained at 12 months. The ACDF cohort had a significantly higher preoperative Neck Disability Index and a significantly greater improvement in health-state utility (ie, quality-adjusted life-years gained) at 12 months. ACDF was associated with significantly higher total costs at 1 year for both Medicare ($11 744) and privately insured ($21 228) patients. The incremental cost-effectiveness ratio for ACDF was $184 654 and $333 774 for Medicare and privately insured patients, respectively, reflecting poor cost-utility. CONCLUSION: Single-level ACDF may not be cost-effective in comparison with PCF for surgical management of unilateral cervical radiculopathy.

Effect of workers' compensation status on pain, disability, quality of life, and return to work after lumbar spine surgery: a 1-year propensity-matched analysis.

OBJECTIVE: Workers' compensation (WC) and litigation have been shown to adversely impact prognoses in a vast range of health conditions. Low-back pain is currently the most frequent reason for WC claims. The objective of this study was to conduct the largest propensity-matched comparison of outcomes between patients with WC and non-WC status who underwent lumbar spinal decompression with and without fusion. METHODS: Complete data sets for patients who underwent 1- to 4-level lumbar spinal fusion or decompression alone were retrospectively retrieved from the Quality Outcomes Database (QOD), which included 1-year patient-reported outcomes from more than 200 hospital systems collected from 2012 to 2021. Population demographics, perioperative safety, facility utilization, patient satisfaction, disability, pain, EQ-5D quality of life, and return to work (RTW) rates were compared between cohorts for both subgroups. Statistical significance was set at p < 0.05. RESULTS: There were 29,652 patients included in the study. Laminectomy was performed in 16,939 with non-WC status and in 615 with WC, whereas fusion was performed in 11,767 with non-WC status and in 331 with WC. WC patients were more frequently male, a minority race, younger, less educated, more frequently a smoker, had a healthier American Society of Anesthesiologists grade, and with greater baseline visual analog scale (VAS) and Oswestry Disability Index (ODI) scores (p < 0.001). One-year postoperative improvements in VAS, ODI, quality-adjusted life years (QALYs), RTW rates, and satisfaction were all significantly worse for WC versus non-WC patients for both procedures. After adjusting for baseline differences via propensity matching, WC versus non-WC patients continued to demonstrate worse 3- and 12-month VAS and ODI scores, reduced 12-month QALY gain, and delayed RTW after both procedure types. CONCLUSIONS: WC status was associated with significantly greater residual disability and pain postoperatively, a lower quality of life, and delayed RTW. Utilizing resources to identify the negative influences on outcomes for WC patients may be valuable in preoperative optimization and could yield better outcomes in these patients.

Anterior Cervical Discectomy and Fusion in the Ambulatory Surgery Center Versus Inpatient Setting: One-Year Cost-Utility Analysis.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: Assess the cost-utility of anterior cervical discectomy and fusion (ACDF) performed in the ambulatory surgery center (ASC) versus inpatient hospital setting for Medicare and privately insured patients at one-year follow-up. SUMMARY OF BACKGROUND DATA: Outpatient ACDF has gained popularity due to improved safety and reduced costs. Formal cost-utility studies for ambulatory versus inpatient ACDF are lacking, precluding an accurate assessment of cost-effectiveness. MATERIALS AND METHODS: A total of 6504 patients enrolled in the Quality Outcomes Database (QOD) undergoing one-level to two-level ACDF at a single ASC (520) or the inpatient hospital setting (5984) were compared. Propensity matching generated 748 patients for analysis (374 per cohort). Demographic data, resource utilization, patient-reported outcome measures, and quality-adjusted life-years (QALYs) were assessed. Direct costs (1-year resource use×unit costs based on Medicare national allowable payment amounts) and indirect costs (missed workdays×average US daily wage) were recorded. Incremental cost-effectiveness ratios were calculated. RESULTS: Complication rates and improvements in patient-reported outcome measures and QALYs were similar between groups. Ambulatory ACDF was associated with significantly lower total costs at 1 year for Medicare ($5879.46) and privately insured ($12,873.97) patients, respectively. The incremental cost-effectiveness ratios for inpatient ACDF was $3,674,662 and $8,046,231 for Medicare and privately insured patients, respectively, reflecting unacceptably poor cost-utility. CONCLUSION: Inpatient ACDF is associated with significant increases in total costs compared to the ASC setting without a safety, outcome, or QALY benefit. The ASC setting is a dominant option from a health economy perspective for first-time one-l to two-level ACDF in select patients compared to the inpatient hospital setting.

Minimally Invasive Transforaminal Lumbar Interbody Fusion in the Ambulatory Setting with an Enhanced Recovery After Surgery Protocol.

OBJECTIVE: Enhanced Recovery After Surgery (ERAS) is a multidisciplinary approach to surgical care that aims to improve outcomes and reduce costs. Its application to spine surgery has been increasing in recent years, with a notable focus on lumbar fusion. This study describes the development, implementation, and outcomes of the first ERAS pathway for ambulatory spine surgery and the largest ambulatory minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) series to date. METHODS: A comprehensive protocol for ambulatory lumbar fusion is described, including patient selection criteria, a multimodal analgesia regimen, and discharge assessment. Consecutive patients undergoing 1- or 2-level MIS TLIF using the described protocol at a single ambulatory surgery center (ASC) over a five-year period were queried. RESULTS: A total of 215 patients underwent ambulatory MIS TLIF over the study period. There were no intraoperative or immediate postoperative complications. All but one patient (99.5%) were discharged home from the ASC. Almost three-quarters (71.2%) were discharged on the day of surgery. Thirty- and 90-day readmission rates were 1.4% and 2.8%, respectively. Only one readmission (0.5%) was for intractable back pain. There were no reoperations or mortalities within 90 days of surgery. CONCLUSIONS: MIS TLIF can be performed safely in a freestanding ambulatory surgery center with minimal perioperative and short-term morbidity. The addition of comprehensive ERAS protocols to the ambulatory setting can promote the transition of fusion procedures to this lower cost environment in an effort to provide higher value care.

Review: Patent Bibliometrics in Cranial Neurosurgery: The First Bibliometric Analysis of Neurosurgery's Technological Literature.

BACKGROUND: Bibliometric analyses of the scientific literature have grown increasingly popular in the past few decades. However, patent bibliometric studies, evaluation of technological literature, have not yet been applied in neurosurgery. OBJECTIVE: To perform a pilot patent bibliometric analysis of the top 100 most cited patents in cranial neurosurgery. METHODS: The Lens was used to query multiple databases, to select the top 100 cranial neurosurgical patents based upon forward patent citations. These were organized into 9 categories based on technological descriptors and were evaluated based on the earliest priority date, year issued, and expiration status, among others. RESULTS: The top 100 most cited patents included technology underlying 3D navigation (n = 31), pharmacology and implants (n = 20), vascular occlusion (n = 5), craniotomy closure (n = 9), focal lesioning and tissue resection (n = 8), brain and systemic cooling (n = 5), neuroendoscopy (n = 8), neuromonitoring and stimulation (6), and technologies improving surgeon performance (n = 8). Ninety-six patents were filed in the United States, 72 were expired, 19 are still active, and 9 were listed as inactive. The highest number of patents was applied for from the mid-1990s to the mid-2000s. Demonstrated trends showed no meaningful correlation between patent rank and earliest priority date (linear trendline y = 0.7107 x -1367.5; R2 = 0.0671), while a very strong correlation was found between patent rank and citations per year (power trendline y = 127.93 x -1.094; R2 = 0.8579). CONCLUSIONS: Patent bibliometrics allow evaluation of neurosurgical advancements from the past and enable subsequent development of cutting-edge technology in the future. The described method is a reproducible and reliable technique for evaluating our field's patent literature.

Defining the relative utility of lumbar spine surgery: A systematic literature review of common surgical procedures and their impact on health states.

Degenerative lumbar spondylosis is a common indication for patients undergoing spine surgery. As healthcare costs rise, measuring quality of life (QOL) gains after surgical procedures is critical in assessing value. We set out to: 1) compare baseline and postoperative EuroQol-5D (EQ-5D) scores for lumbar spine surgery and common surgical procedures to obtain post-operative quality-adjusted life year (QALY) gain, and 2) establish the relative utility of lumbar spine surgery as compared to other commonly performed surgical procedures. A systematic literature review was conducted to identify all studies reporting preoperative/baseline and postoperative EQ-5D scores for common surgical procedures. For each study, the number of patients included and baseline/preoperative and follow-up mean EQ-5D scores were recorded, and mean QALY gained for each intervention was calculated. A total of 67 studies comprising 95,014 patients were identified. Patients with lumbar spondylosis had the worst reported QOL at baseline compared to other surgical cohorts. The greatest QALY gain was seen in patients undergoing hip arthroplasty (0.38), knee arthroplasty (0.35) and lumbar spine surgery (0.32), nearly 2.5-fold greater QALY gained than for all other procedures. The low preoperative QOL, coupled with the improvements offered with surgery, highlight the utility and value of lumbar spine surgery compared to other common surgical procedures.

Early postoperative physical activity and function: a descriptive case series study of 53 patients after lumbar spine surgery.

BACKGROUND: The purpose of this prospective case series study was to compare changes in early postoperative physical activity and physical function between 6 weeks and 3 and 6 months after lumbar spine surgery. METHODS: Fifty-three patients (mean [95% confidence interval; CI] age = 59.2 [56.2, 62.3] years, 64% female) who underwent spine surgery for a degenerative lumbar condition were assessed at 6 weeks and 3- and 6-months after surgery. The outcomes were objectively-measured physical activity (accelerometry) and patient-reported and objective physical function. Physical activity was assessed using mean steps/day and time spent in moderate to vigorous physical activity (MVPA) over a week. Physical function measures included Oswestry Disability Index (ODI), 12-item Short Form Health Survey (SF-12), Timed Up and Go (TUG), and 10-Meter Walk (10 MW). We compared changes over time in physical activity and function using generalized estimating equations with robust estimator and first-order autoregressive covariance structure. Proportion of patients who engaged in meaningful physical activity (e.g., walked at least 4400 and 6000 steps/day or engaged in at least 150 min/week in MVPA) and achieved clinically meaningful changes in physical function were compared at 3 and 6 months. RESULTS: After surgery, 72% of patients initiated physical therapy (mean [95%CI] sessions =8.5 [6.6, 10.4]) between 6 weeks and 3 months. Compared to 6 weeks post-surgery, no change in steps/day or time in MVPA/week was observed at 3 or 6 months. From 21 to 23% and 9 to 11% of participants walked at least 4400 and 6000 steps/day at 3 and 6 months, respectively, while none of the participants spent at least 150 min/week in MVPA at these same time points. Significant improvements were observed on ODI, SF-12, TUG and 10 MW (p <  0.05), with over 43 to 68% and 62 to 87% achieving clinically meaningful improvements on these measures at 3 and 6 months, respectively. CONCLUSION: Limited improvement was observed in objectively-measured physical activity from 6 weeks to 6 months after spine surgery, despite moderate to large function gains. Early postoperative physical therapy interventions targeting physical activity may be needed.

Development and Validation of Cervical Prediction Models for Patient-Reported Outcomes at 1 Year After Cervical Spine Surgery for Radiculopathy and Myelopathy.

STUDY DESIGN: Retrospective analysis of prospectively collected registry data. OBJECTIVE: To develop and validate prediction models for 12-month patient-reported outcomes of disability, pain, and myelopathy in patients undergoing elective cervical spine surgery. SUMMARY OF BACKGROUND DATA: Predictive models have the potential to be utilized preoperatively to set expectations, adjust modifiable characteristics, and provide a patient-centered model of care. METHODS: This study was conducted using data from the cervical module of the Quality Outcomes Database. The outcomes of interest were disability (Neck Disability Index:), pain (Numeric Rating Scale), and modified Japanese Orthopaedic Association score for myelopathy. Multivariable proportional odds ordinal regression models were developed for patients with cervical radiculopathy and myelopathy. Patient demographic, clinical, and surgical covariates as well as baseline patient-reported outcomes scores were included in all models. The models were internally validated using bootstrap resampling to estimate the likely performance on a new sample of patients. RESULTS: Four thousand nine hundred eighty-eight patients underwent surgery for radiculopathy and 2641 patients for myelopathy. The most important predictor of poor postoperative outcomes at 12-months was the baseline Neck Disability Index score for patients with radiculopathy and modified Japanese Orthopaedic Association score for patients with myelopathy. In addition, symptom duration, workers' compensation, age, employment, and ambulatory and smoking status had a statistically significant impact on all outcomes (P < 0.001). Clinical and surgical variables contributed very little to predictive models, with posterior approach being associated with higher odds of having worse 12-month outcome scores in both the radiculopathy and myelopathy cohorts (P < 0.001). The full models overall discriminative performance ranged from 0.654 to 0.725. CONCLUSIONS: These predictive models provide individualized risk-adjusted estimates of 12-month disability, pain, and myelopathy outcomes for patients undergoing spine surgery for degenerative cervical disease. Predictive models have the potential to be used as a shared decision-making tool for evidence-based preoperative counselling. LEVEL OF EVIDENCE: 2.

Psychosocial Mechanisms of Cognitive-Behavioral-Based Physical Therapy Outcomes After Spine Surgery: Preliminary Findings From Mediation Analyses.

OBJECTIVE: Changing Behavior through Physical Therapy (CBPT), a cognitive-behavioral-based program, has been shown to improve outcomes after lumbar spine surgery in patients with a high psychosocial risk profile; however, little is known about potential mechanisms associated with CBPT treatment effects. The purpose of this study was to explore potential mediators underlying CBPT efficacy after spine surgery. METHODS: In this secondary analysis, 86 participants were enrolled in a randomized trial comparing a postoperative CBPT (n = 43) and education program (n = 43). Participants completed validated questionnaires at 6 weeks (baseline) and 3 and 6 months following surgery for back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (12-Item Short-Form Health Survey), fear of movement (Tampa Scale for Kinesiophobia), pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Parallel multiple mediation analyses using Statistical Package for the Social Sciences (SPSS) were conducted to examine whether 3- and 6-month changes in fear of movement, pain catastrophizing, and pain self-efficacy mediate treatment outcome effects at 6 months. RESULTS: Six-month changes, but not 3-month changes, in fear of movement and pain self-efficacy mediated postoperative outcomes at 6 months. Specifically, changes in fear of movement mediated the effects of CBPT treatment on disability (indirect effect = -2.0 [95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5 [95% CI = 1.2 to 6.1]). CONCLUSIONS: This study advances evidence on potential mechanisms underlying cognitive-behavioral strategies. Future work with larger samples is needed to establish whether these factors are a definitive causal mechanism. IMPACT: Fear of movement and pain self-efficacy may be important mechanisms to consider when developing and testing psychologically informed physical therapy programs.

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).

Does Neck Disability Index Correlate With 12-Month Satisfaction After Elective Surgery for Cervical Radiculopathy? Results From a National Spine Registry.

BACKGROUND: Modern healthcare reforms focus on identifying and measuring the quality and value of care. Patient satisfaction is particularly important in the management of degenerative cervical radiculopathy (DCR) since it leads to significant neck pain and disability primarily affecting the patients' quality of life. OBJECTIVE: To determine the association of baseline and 12-mo Neck Disability Index (NDI) with patient satisfaction after elective surgery for DCR. METHODS: The Quality Outcomes Database cervical module was queried for patients who underwent elective surgery for DCR. A multivariable proportional odds regression model was fitted with 12-mo satisfaction as the outcome. The covariates for this model included patients' demographics, surgical characteristics, and baseline and 12-mo patient reported outcomes (PROs). Wald-statistics were calculated to determine the relative importance of each independent variable for 12-mo patient satisfaction. RESULTS: The analysis included 2206 patients who underwent elective surgery for DCR. In multivariable analysis, after adjusting for baseline and surgery specific variables, the 12-mo NDI score showed the highest association with 12-mo satisfaction (Waldχ2-df = 99.17, 58.1% of total χ2). The level of satisfaction increases with decrease in 12-mo NDI score regardless of the baseline NDI score. CONCLUSION: Our study identifies 12-mo NDI score as a very influential driver of 12-mo patient satisfaction after surgery for DCR. In addition, there are lesser contributions from other 12-mo PROs, baseline Numeric Rating Scale for arm pain and American Society of Anesthesiologists (ASA) grade. The baseline level of disability was found to be irrelevant to patients. They seemed to only value their current level of disability, compared to baseline, in rating satisfaction with surgical outcome.

Trajectory of Improvement in Myelopathic Symptoms From 3 to 12 Months Following Surgery for Degenerative Cervical Myelopathy.

BACKGROUND: Degenerative cervical myelopathy (DCM) is a progressive disease resulting from cervical cord compression. The modified Japanese Orthopaedic Association (mJOA) is commonly used to grade myelopathic symptoms, but its persistent postoperative improvement has not been previously explored. OBJECTIVE: To utilize the Quality Outcomes Database (QOD) to evaluate the trajectory of outcomes in those operatively treated for DCM. METHODS: This study is a retrospective analysis of prospectively collected data. The QOD was queried for patients undergoing elective surgery for DCM. Patients were divided into mild (≥14), moderate (9-13), or severe (<9) categories for their baseline severity of myelopathic symptoms (mJOA scores). A parsimonious multivariable logistic regression model was fitted with 2 points improvement on mJOA from 3- to 12-mo follow-up as the outcome of interest. RESULTS: A total of 2156 patients who underwent elective surgery for DCM and had complete 3- and 12-mo follow-up were included in our analysis. Patients improved significantly from baseline to 3-mo on their mJOA scores, regardless of their baseline mJOA severity. After adjusting for the relevant preoperative characteristics, the baseline mJOA categories had significant impact on outcome of whether a patient keeps improving in mJOA score from 3 to 12 mo postsurgery. Patient with severe mJOA score at baseline had a higher likelihood of improvement in their myelopathic symptoms, compared to patients with mild mJOA score in. CONCLUSION: Most patients achieve improvement on a shorter follow-up; however, patients with severe symptoms keep on improving until after a longer follow-up. Preoperative identification of such patients helps the clinician settling realistic expectations for each follow-up timepoint.