Impact of Depression and Anxiety on Patient Reported Outcomes Measures after Lumbar Fusion.

BACKGROUND: Depression and anxiety are common in patients undergoing spinal surgery and might negatively impact outcomes. This study investigates the possible effect of these diagnoses on patient reported outcomes following lumbar fusion. METHODS: Retrospective review of a registry containing prospectively collected data of lumbar fusion procedures at a single institution was performed from May 23, 2012 to June 15, 2022. Patients with a minimum of two year follow-up were included. Demographic information, diagnoses, medications, patient-reported outcomes measures (PROMs), and complications data at preoperative, three months, six months, 1 year, and two years postoperative were collected. Statistical analysis was performed using Student's t-tests, χ2, binomial correlation, odds ratios, logistic regression, and mean clinically important difference. RESULTS: A total of 156 patients were included (60 males, 96 females) with mean age 62.6 ± 11.1 years at surgery. Thirty-nine (25%) had depression and/or anxiety (DA). Baseline Oswestry Disability Index (ODI) and EuroQol Group 5D questionnaire (EQ5D) scores were significantly worse in the DA cohort compared to controls (ODI 51.1 ± 18.3 vs. 42.9 ± 15.8; P = 0.010, EQ5D 0.46 ± 0.21 vs. 0.57 ± 0.21; P = 0.005). Both cohorts experienced similar relative improvement at two years (delta ODI -18.2 ± 27.9 vs. -17.8 ± 22.1; P = 0.924, EQ5D 6.8 ± 33.8 vs. 8.1 ± 32.9; P = 0.830). Absolute outcome scores were worse in the DA cohort at all intervals. DA were not independently predictive of changes in PROMs (delta ODI mean difference 4.49, r2 = 0.36, P = 0.924). CONCLUSIONS: The present study showed similar improvement in PROMs following lumbar fusion for patients with anxiety and depression compared to healthy controls. These data suggest these patients are no less likely to benefit from appropriately planned lumbar fusion.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

STUDY DESIGN: Prospective randomized Food and Drug Administration investigational device exemption clinical trial. OBJECTIVE: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. SUMMARY OF BACKGROUND DATA: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. METHODS: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. RESULTS: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. CONCLUSIONS: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.

Implementation of a spine triage program and its effect on outpatient radiology utilization.

OBJECTIVE: Clinical care pathways designed to triage spinal disorders have been shown to reduce wait times and improve patient satisfaction. The goal of this study was to perform an analysis of outpatient radiology costs before and after the implementation of a spine care triage pathway. METHODS: All imaging orders and surgical procedures were captured in a prospective spine registry for patients referred to the department of neurosurgery within a single academic center between July 1, 2017, and November 3, 2020. A spine triage algorithm was developed and implemented January 1, 2018. Healthcare utilization was recorded for 1 year after the first appointment in the department of neurosurgery. Imaging costs were estimated using publicly available data from the Centers for Medicare and Medicaid Services. Statistical analysis consisted of an independent sample t-test or randomization test for continuous variables and a chi-square test for categorical variables. RESULTS: A total of 3854 patients were included in this study. The mean age was 60 years (50.8% female) and 89.8% had undergone advanced imaging before being referred to the department of neurosurgery. In total, 12.6% of patients were referred with a specific surgical diagnosis (i.e., spinal stenosis, lumbar spondylolisthesis, etc.). During the pretriage phase 1810 patients were enrolled, and there were 2044 patients enrolled after the triage algorithm was implemented. Advanced imaging (CT or MRI) was ordered more frequently by providers before the triage program was initiated, with imaging ordered in 34% (617/1810) of patients pretriage versus 14.8% (302/2044) after the triage pathway was implemented (p < 0.001). The authors calculated a significant reduction in cost associated with reduced radiology utilization. Before triage, the cost of radiology utilization was $85,475/1000 patients compared with $40,107/1000 patients afterward (p < 0.001). The triage program did not change the utilization of surgery (14.6% before, 13.6% after). CONCLUSIONS: Among patients treated after a spinal triage program was implemented in a single neurosurgery department, there was a substantial reduction in the use of advanced imaging and a 50% reduction in cost associated with outpatient radiology utilization. The triage program did not change the rate of spine surgery being performed.

Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis.

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS: The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS: A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4-5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°). CONCLUSIONS: This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

Age, body mass index, and osteoporosis are more predictive than imaging for adjacent-segment reoperation after lumbar fusion.

BACKGROUND: Adjacent-segment disease (ASD) is a well-described long-term complication after lumbar fusion. There is a lack of consensus about the risk factors for development of ASD, but identifying them could improve surgical outcomes. Our goal was to analyze the effect of patient characteristics and radiographic parameters on the development of symptomatic ASD requiring revision surgery after posterior lumbar fusion. METHODS: In this retrospective cohort study, we identified patients who underwent lumbar fusion surgery and revision surgery from May 2012 to November 2018 using an institutional lumbar fusion registry. Patients having both pre- and post-operative upright radiographs were included in the study. Revision surgeries for which the index operation was performed at an outside hospital were excluded from analysis. Univariate analysis was conducted on candidate variables, and variables with P< 0.2 were selected for multivariate logistic regression. RESULTS: Of the 106 patients identified, 21 required reoperation (29 months average follow-up). Age >65 years (OR 4.14, 95% CI 1.46-11.76, P= 0.008), body mass index (BMI) >34 (OR 1.13, 95% CI 1.04-1.23, P = 0.004), and osteoporosis (OR 14, 95% CI 1.38-142.42, P = 0.03) were independent predictors of reoperation in the multivariate analysis. Increased facet diastasis at fusion levels (OR 0.60, 95% CI 0.42-0.85, P = 0.004) was associated with reduced reoperation rates. Change in segmental LL at the index operation level, rostral and caudal facet diastasis, vacuum discs, and T2 hyperintensity in the facets were not predictors of reoperation. CONCLUSION: Age >65, BMI >34, and osteoporosis were independent predictors of adjacent-segment reoperation after lumbar spinal fusion.

Spine Instrumented Surgery on a Budget-Tools for Lowering Cost Without Changing Outcome.

STUDY DESIGN: Review article. OBJECTIVES: There have been substantial increases in the utilization of complex spinal surgery in the last 20 years. Spinal instrumented surgery is associated with high costs as well as significant variation in approach and care. The objective of this manuscript is to identify and review drivers of instrumented spine surgery cost and explain how surgeons can reduce costs without compromising outcome. METHODS: A literature search was conducted using PubMed. The literature review returned 217 citations. 27 publications were found to meet the inclusion criteria. The relevant literature on drivers of spine instrumented surgery cost is reviewed. RESULTS: The drivers of cost in instrumented spine surgery are varied and include implant costs, complications, readmissions, facility-based costs, surgeon-driven preferences, and patient comorbidities. Each major cost driver represents an opportunity for potential reductions in cost. With high resource utilization and often uncertain outcomes, spinal surgery has been heavily scrutinized by payers and hospital systems, with efforts to reduce costs and standardize surgical approach and care pathways. CONCLUSIONS: Education about cost and commitment to standardization would be useful strategies to reduce cost without compromising patient-reported outcomes after instrumented spinal fusion.

Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.

Importance: Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results. Objective: To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year. Design, Setting, and Participants: Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020. Interventions: Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion. Main Outcomes and Measures: The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score. Results: Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%). Conclusions and Relevance: Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach. Trial Registration: ClinicalTrials.gov Identifier: NCT02076113.

Opioid Use, Risk Factors, and Outcome in Lumbar Fusion Surgery.

OBJECTIVE: Inappropriate opioid use resulted in 68% of all U.S. drug overdoses in 2017-nearly 75% of all opioid deaths-costing $80 billion per year. It is imperative to understand the impact of opioid use on outcome from surgery for lower back pain disorders. METHODS: A retrospective review of lumbar spinal fusion registry data at a single center from 2015-2018 was performed. A novel algorithm was used to extract opioid utilization from the electronic health record. Number of levels fused, fusion type, and minimally invasive surgery status were collected from the registry, as were depression status, European Quality of Life 5 level score, and Oswestry Disability Index at 6 months to 1 year postoperatively. RESULTS: We included 294 patients (mean age 62 years, 48% male). Patients younger than 65 years trended toward more opioid use before surgery and significantly higher opioid use after surgery (P < 0.0001). Depression trended toward increasing opioid use after surgery (P = 0.08). Fusions of 4 or more levels were associated with overall greater opioid use after surgery (P = 0.03). Higher rate of opioid use before and after surgery is associated with worse European Quality of Life 5 level scores after surgery (P = 0.01 and P = 0.04) and worse Oswestry Disability Index scores after surgery (P = 0.006 and P = 0.002). CONCLUSIONS: This registry finds that younger age and lower functional status scores are associated with higher opioid use before surgery. Opioid use before surgery, younger age, and >4 levels of fusion are associated with higher opioid use after surgery. Overall, opioid use is associated with worse functional outcome and may serve as a marker of disease progression.

Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol.

BACKGROUND: Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation. The Barricaid annular closure device provides durable occlusion of the annular defect and has been shown to significantly lower the risk of symptomatic reherniation in a large European randomized trial. However, the performance of the Barricaid device in a United States (US) population has not been previously reported. DESIGN AND METHODS: This is a historically controlled post-market multicenter study to determine the safety and efficacy of the Barricaid device when used in addition to primary lumbar discectomy in a US population. A total of 75 patients with large annular defects will receive the Barricaid device following lumbar discectomy at up to 25 sites in the US and will return for clinical and imaging follow-up at 4 weeks, 3 months, and 1 year. Trial oversight will be provided by a data safety monitoring board and imaging studies will be read by an independent imaging core laboratory. Patients treated with the Barricaid device in a previous European randomized trial with comparable eligibility criteria, surgical procedures, and outcome measures will serve as historical controls. Main outcomes will include back pain severity, leg pain severity, Oswestry Disability Index, health utility on the EuroQol-5 Dimension questionnaire, complications, symptomatic reherniation, and reoperation. Propensity score adjustment using inverse probability of treatment weighting will be used to adjust for differences in baseline patient characteristics between the US trial participants and European historical controls. ETHICS AND DISSEMINATION: This study was approved by a central institutional review board. The study results of this trial will be widely disseminated at conference proceedings and published in peer-reviewed journals. The outcomes of this study will have important clinical and economic implications for all stakeholders involved in treating patients with lumbar discectomy in the US. STUDY REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov): NCT03986580. LEVEL OF EVIDENCE: 3.

De Novo Intraneural Arachnoid Cyst Presenting with Complete Third Nerve Palsy: Case Report and Literature Review.

BACKGROUND: Intraneural arachnoid cyst is an extremely rare etiology of isolated cranial nerve palsy. Although seldom encountered in clinical practice, this pathology is amenable to surgical intervention. Correct identification and treatment of the cyst are required to prevent permanent nerve damage and potentially reverse the deficits. We describe a rare case of isolated third nerve palsy caused by an intraneural arachnoid cyst. CASE DESCRIPTION: A 49-year-old woman with a recent history of headaches experienced acute onset of painless left-sided third nerve palsy. According to hospital records ptosis, mydriasis, absence of adduction, elevation, and intorsion were noted in the left eye. Computed tomography and magnetic resonance imaging studies showed an extra-axial, 1-cm lesion along the left paraclinoid region, causing mild indentation on the uncus. There was dense fluid layering dependently concerning for hemorrhage, but no evidence of aneurysms. A pterional craniotomy was performed, revealing a completely intraneural arachnoid cyst in the third nerve. The cyst was successfully fenestrated. At 7-month follow-up, the left eye had recovered intact intorsion and some adduction, but the left pupil remained dilated and nonreactive. There was still no elevation and no afferent pupillary defect. Double vision persisted with partial improvement in the ptosis, opening up to more than 75% early in the day. CONCLUSION: To our knowledge, this is the first report of an intraneural arachnoid cyst causing isolated third nerve palsy. This rare pathology proves to be both a diagnostic and therapeutic challenge.

Cost-Utility Analysis of Anterior Cervical Discectomy and Fusion With Plating (ACDFP) Versus Posterior Cervical Foraminotomy (PCF) for Patients With Single-level Cervical Radiculopathy at 1-Year Follow-up.

STUDY DESIGN: A retrospective 1-year cost-utility analysis. OBJECTIVE: To determine the cost-effectiveness of anterior cervical discectomy and fusion with plating (ACDFP) in comparison with posterior cervical foraminotomy (PCF) for patients with single-level cervical radiculopathy. SUMMARY OF BACKGROUND DATA: Cervical radiculopathy due to cervical spondylosis is commonly treated by either PCF or ACDFP for patients who are refractory to nonsurgical treatment. Although some have suggested superior outcomes with ACDFP as compared with PCF, the former is also associated with greater costs. The present study analyzes the cost-effectiveness of ACDFP versus PCF for patients with single-level cervical radiculopathy. METHODS: Forty-five patients who underwent ACDFP and 25 patients who underwent PCF for single-level cervical radiculopathy were analyzed. One-year postoperative health outcomes were assessed based on Visual Analogue Scale, Pain Disability Questionnaire, Patient Health Questionnaire, and EuroQOL-5 Dimensions questionnaires to analyze the comparative effectiveness of each procedure. Direct medical costs were estimated using Medicare national payment amounts and indirect costs were based on patient missed work days and patient income. Postoperative 1-year cost/utility ratios and the incremental cost-effectiveness ratio (ICER) were calculated to assess for cost-effectiveness using a threshold of $100,000/QALY gained. RESULTS: The 1-year cost-utility ratio for the PCF cohort was significantly lower ($79,856/QALY gained) than that for the ACDFP cohort ($131,951/QALY gained) (P<0.01). In calculating the 1-year ICER, as the ACDFP cohort showed lower QALY gained than the PCF cohort, the ICER was negative and is not reported, meaning that ACDFP was dominated by PCF. CONCLUSIONS: Statistically significant and clinically relevant improvements (through minimum clinically important differences) were seen in both cohorts. Although both cohorts showed improved health outcomes, ACDFP was not cost-effective relative to the threshold of $100,000/QALY gained at 1-year postoperatively, whereas PCF was. The durability of these results must be analyzed with long-term cost-utility analysis studies.

Cost-Utility Analysis of Instrumented Fusion Versus Decompression Alone for Grade I L4-L5 Spondylolisthesis at 1-Year Follow-up: A Pilot Study.

STUDY DESIGN: Retrospective 1-year cost-utility analysis. OBJECTIVE: To determine the cost-effectiveness of decompression with and without instrumented fusion for patients with grade I degenerative L4-L5 spondylolisthesis at 1-year follow-up. SUMMARY OF BACKGROUND DATA: Despite its benefits to health outcomes, lumbar fusion is associated with substantial costs. This study analyzed the cost-effectiveness of instrumented fusion for grade I L4-L5 spondylolisthesis at 1-year follow-up. MATERIALS AND METHODS: Four cohorts of 25 patients with grade I L4-L5 degenerative spondylolisthesis were analyzed: cohort 1 (decompression), cohort 2 (decompression with instrumented posterolateral fusion (PLF), cohort 3 (decompression with instrumented posterior lumbar interbody fusion/transforaminal lumbar interbody fusion), and cohort 4 (decompression with instrumented PLF and posterior lumbar interbody fusion/transforaminal lumbar interbody fusion). One-year postoperative health outcomes were assessed based on Visual Analogue Scale, Pain Disability Questionnaire, and EuroQol 5 Dimensions questionnaires. Direct medical costs were estimated using Medicare national payment amounts and indirect costs were based on patient missed work days. Postoperative 1-year cost/utility ratios and incremental cost-effectiveness ratios (ICERs) were calculated. Cost-effectiveness was assessed using a threshold of $100,000/QALY gained. RESULTS: Compared with preoperative health states, EuroQol 5 Dimensions QALY scores improved for all cohorts (P<0.01). The 1-year cost-utility ratio for cohort 1 was significantly lower ($56,610/QALY gained; P<0.01) than that for cohorts 2 ($116,991/QALY gained), 3 ($109,740/QALY gained), and 4 ($107,546/QALY gained). The 1-year ICERs relative to cohort 1 were: cohort 2 (dominated), cohort 3 ($1,060,549/QALY gained), and cohort 4 ($830,047/QALY gained). CONCLUSIONS: Decompression without fusion is cost-effective for patients with grade I L4-L5 spondylolisthesis. Decompression with fusion is not cost effective in a 1-year timeframe for these patients based on the threshold. Accordingly, although fusion is beneficial for improving health outcomes in patients with spondylolisthesis, it is not cost-effective when analyzing a 1-year timeframe based on the threshold. The durability of these results must be analyzed with longer term cost-utility analysis studies.

Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel.

OBJECTIVE: To determine whether patients who learned the views of an expert surgeons' panel's assessment of equipoise between 2 alternative operative treatments had increased likelihood of consenting to randomization. BACKGROUND: Difficulty obtaining patient consent to randomization is an important barrier to conducting surgical randomized clinical trials, the gold standard for generating clinical evidence. METHODS: Observational study of the rate of patient acceptance of randomization within a 5-center randomized clinical trial comparing lumbar spinal decompression versus lumbar spinal decompression plus instrumented fusion for patients with symptomatic grade I degenerative lumbar spondylolisthesis with spinal stenosis. Eligible patients were enrolled in the trial and then asked to accept randomization. A panel of 10 expert spine surgeons was formed to review clinical information and images for individual patients to provide an assessment of suitability for randomization. The expert panel vote was disclosed to the patient by the patient's surgeon before the patient decided whether to accept randomization or not. RESULTS: Randomization acceptance among eligible patients without expert panel review was 40% (19/48) compared with 81% (47/58) among patients undergoing expert panel review (P < 0.001). Among expert-reviewed patients, randomization acceptance was 95% when all experts or all except 1 voted for randomization, 75% when 2 experts voted against randomization, and 20% with 3 or 4 votes against (P < 0.001 for trend). CONCLUSIONS: Patients provided with an expert panel's assessment of their own suitability for randomization were twice as likely to agree to randomization compared with patients receiving only their own surgeon's recommendation.

Cost-Utility Analysis of 1- and 2-Level Dorsal Lumbar Fusions With and Without Recombinant Human Bone Morphogenic Protein-2 at 1-Year Follow-Up.

STUDY DESIGN: A retrospective 1-year cost-utility analysis. OBJECTIVE: To determine the cost-effectiveness of using recombinant human bone morphogenic protein (rhBMP-2) in addition to autograft for 1- and 2-level lumbar fusions. SUMMARY OF BACKGROUND DATA: rhBMP-2 has been studied extensively to identify its benefits, risks, patient outcomes, and costs relative to autograft [local bone or iliac crest bone graft (ICBG)]. This study seeks to analyze the cost-effectiveness of adding rhBMP-2 to autograft versus without rhBMP-2 in lumbar fusions. METHODS: Thirty-three patients receiving rhBMP-2 in addition to either local bone autograft or ICBG (rhBMP-2 cohort) and 42 patients receiving only local bone autograft or ICBG (control cohort) for 1- or 2-level dorsal lumbar fusion were analyzed. This included posterolateral fusion, posterior lumbar interbody fusion, and transforaminal lumbar interbody fusion. One-year postoperative health outcomes were assessed based on Visual Analogue Scale, Pain Disability Questionnaire, Patient Health Questionnaire, and EuroQol-5 Dimensions questionnaires. Direct medical costs were estimated using Medicare national payment amounts and indirect costs were based on patient missed work days and patient income. Postoperative 1-year cost-utility ratios and the incremental cost-effectiveness ratio (ICER) were calculated to assess for cost-effectiveness using a threshold of $100,000/QALY gained. RESULTS: The 1-year cost-utility ratio (total cost/ΔQALY) for the control cohort was significantly lower ($143,251/QALY gained) than that of the rhBMP-2 cohort ($272,414/QALY gained) (P<0.01). At 1-year follow-up, the control group dominated the ICER compared with the rhBMP-2 group. CONCLUSIONS: Statistically significant and clinically relevant improvements (through minimum clinically important differences) were seen for both cohorts. In the ICER analysis, the control cohort dominated the rhBMP-2 group. Assuming durable per year gains in QALY, by 2 years fusion with autograft but without rhBMP-2 would be considered cost-effective ($71,625/QALY gained), whereas fusion with both autograft and rhBMP-2 would not be cost-effective ($136,207/QALY gained).

Predictive value of 3-month lumbar discectomy outcomes in the NeuroPoint-SD Registry.

OBJECT: The authors have established a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures using prospectively collected outcomes. Collection of these data requires an extensive commitment of resources from each site. The aim of this study was to determine whether outcomes data from shorter-interval follow-up could be used to accurately estimate long-term outcome following lumbar discectomy. METHODS: An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level lumbar discectomy for treatment of disc herniation were included. SF-36 and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Quality-adjusted life year (QALY) data were calculated using SF-6D utility scores. Correlations among outcomes at each follow-up time point were tested using the Spearman rank correlation test. RESULTS: One hundred forty-eight patients were enrolled over 1 year. Their mean age was 46 years (49% female). Eleven patients (7.4%) required a reoperation by 1 year postoperatively. The overall 1-year follow-up rate was 80.4%. Lumbar discectomy was associated with significant improvements in ODI and SF-36 scores (p < 0.0001) and with a gain of 0.246 QALYs over the 1-year study period. The greatest gain occurred between baseline and 3-month follow-up and was significantly greater than improvements obtained between 3 and 6 months or 6 months and 1 year(p < 0.001). Correlations between 3-month, 6-month, and 1-year outcomes were similar, suggesting that 3-month data may be used to accurately estimate 1-year outcomes for patients who do not require a reoperation. Patients who underwent reoperation had worse outcomes scores and nonsignificant correlations at all time points. CONCLUSIONS: This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. Three-month outcome data may be used to accurately estimate outcome at future time points and may lower costs associated with registry data collection. This registry effort provides a practical foundation for the acquisition of outcome data following lumbar discectomy.

International classification of disease clinical modification 9 modeling of a patient comorbidity score predicts incidence of perioperative complications in a nationwide inpatient sample assessment of complications in spine surgery.

OF BACKGROUND DATA: A patient comorbidity score (RCS) was developed from a prospective study of complications occurring in spine surgery patients. OBJECTIVE: To validate the RCS, we present an International Classification of Disease Clinical Modification (ICD-CM)-9 model of the score and correlate the score with complication incidence in a group of patients from the Nationwide Inpatient Sample database. We compare the predictive value of the score with the Charlson index. STUDY DESIGN: We conducted a retrospective assessment of Nationwide Inpatient Sample patients undergoing cervical or thoracolumbar spine surgery for degenerative pathology from 2002 to 2009. METHODS: We generated an ICD-9-CM coding-based model of our prospectively derived RCS, categorizing diagnostic codes to represent relevant comorbidities. Multivariate models were constructed to eliminate the least significant variables. ICD-9-CM coding was also used to calculate a Charlson comorbidity score for each patient. The accuracy of the RCS was compared with the Charlson index through the use of a receiver-operating curve. RESULTS: A total of 352,535 patients undergoing 369,454 spine procedures for degenerative disease were gathered. Hypertension and hyperlipidemia were the most common comorbidities. Cervical procedures resulted in 8286 complications (4.50%), whereas thoracolumbar procedures produced 25,118 complications (13.55%). Increasing RCS correlated linearly with increasing complication incidence (odds ratio [OR] 1.11; 95% confidence interval [CI], 1.10-1.13; P<0.0001). Logistic regression revealed that neurological deficit, cardiac conditions, and drug or alcohol use had greatest association with complication occurrence. The Charlson index also correlated with complication occurrence in both cervical (OR 1.25; 95% CI, 1.23-1.27) and thoracolumbar (OR 1.11; 95% CI, 1.10-1.12) patient groups. Receiver-operating curve analysis allowed a comparison of accuracy of the indices by comparing predictive values. The RCS performed as well as the Charlson index in predicting complication occurrence in both cervical and thoracic spine patients. CONCLUSIONS: ICD-9-based modeling validated that RCS correlates with complication occurrence. The RCS performed as well as the Charlson index in predicting risk of complication in spine patients.

Quality-of-Life Outcomes following Thoracolumbar and Lumbar Fusion with and without the Use of Recombinant Human Bone Morphogenetic Protein-2: Does Recombinant Human Bone Morphogenetic Protein-2 Make a Difference?

Design Retrospective study. Objectives (1) To investigate the quality-of-life (QOL) outcomes in the population undergoing lumbar spine surgery with versus without recombinant human bone morphogenetic protein-2 (rhBMP-2); (2) to determine QOL outcomes for those patients who experience postoperative complications; and (3) to identify the effect of patient characteristics on postoperative QOL outcomes. Methods A retrospective review of QOL questionnaires, including the Patient Health Questionnaire-9, Patient Disability Questionnaire (PDQ), EuroQol-5D (EQ-5D), and quality of life-year (QALY), was performed for all patients who underwent thoracolumbar and lumbar fusion surgery with versus without rhBMP-2 between March 2008 and September 2010. Individual preoperative and postoperative QOL data were compared for each patient. Demographic factors and complications were reviewed. Results We identified 266 patients, including 60 with and 206 without rhBMP-2. Questionnaires were completed an average of 10.3 ± 5 months after surgery. For all measures, average scores improved postoperatively compared with preoperatively. No differences in postoperative QOL outcomes were identified between the rhBMP-2 and the control cohorts. Median annual household income was positively associated with EQ-5D and QALY. Compared with those without, patients with postoperative complications had fewer QOL improvements. Conclusions There was no difference in QOL outcomes in the rhBMP-2 compared with the control group. Socioeconomic status and postoperative complications affected QOL outcomes following surgery. The QOL questionnaires provide the clinician with information regarding the patients' self-perceived well-being and can be helpful in the selection of surgical candidates and for understanding the effectiveness of a given surgical procedure.

Cervical spondylotic myelopathy surgical trial: randomized, controlled trial design and rationale.

BACKGROUND: Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM. OBJECTIVE: To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures. METHODS: The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use. EXPECTED OUTCOMES: This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM. DISCUSSION: A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.