Adjunctive Use of Bone Growth Stimulation Increases Cervical Spine Fusion Rates in Patients at Risk for Pseudarthrosis.

STUDY DESIGN: A prospective multicenter clinical trial (NCT03177473) was conducted with a retrospective cohort used as a control arm. OBJECTIVE: The purpose of this study was to evaluate cervical spine fusion rates in subjects with risk factors for pseudarthrosis who received pulsed electromagnetic field (PEMF) treatment. SUMMARY OF BACKGROUND DATA: Certain risk factors predispose patients to pseudarthrosis, which is associated with prolonged pain, reduced function, and decreased quality of life. METHODS: Subjects in the PEMF group were treated with PEMF for 6 months postoperatively. The primary outcome measure was fusion status at the 12-month follow-up period. Fusion status was determined using anterior/posterior, lateral, and flexion/extension radiographs and computed tomography (without contrast). RESULTS: A total of 213 patients were evaluated (PEMF, n=160; Control, n=53). At baseline, the PEMF group had a higher percentage of subjects who used nicotine ( P =0.01), had osteoporosis ( P <0.05), multi-level disease ( P <0.0001), and were >65 years of age ( P =0.01). The PEMF group showed over two-fold higher percentage of subjects that had ≥3 risk factors (n=92/160, 57.5%) compared with the control group (n=14/53, 26.4%). At the 12-month follow-up, the PEMF group demonstrated significantly higher fusion rates compared with the control (90.0% vs. 60.4%, P <0.05). A statistically significant improvement in fusion rate was observed in PEMF subjects with multi-level surgery ( P <0.0001) and high BMI (>30 kg/m 2 ; P =0.0021) when compared with the control group. No significant safety concerns were observed. CONCLUSIONS: Adjunctive use of PEMF stimulation provides significant improvements in cervical spine fusion rates in subjects having risk factors for pseudarthrosis. When compared with control subjects that did not use PEMF stimulation, treated subjects showed improved fusion outcomes despite being older, having more risk factors for pseudarthrosis, and undergoing more complex surgeries.

A prospective study of lumbar facet arthroplasty in the treatment of degenerative spondylolisthesis and stenosis: cost-effective assessment from the Total Posterior Spine system (TOPSTM) IDE Study: 2-year model revision and sensitivity analyses based on 305 subjects.

BACKGROUND CONTEXT: A previous cost-effectiveness analysis published in 2022 found that the Total Posterior Spine (TOPSTM) system was dominant over transforaminal lumbar interbody fusion (TLIF). This analysis required updating to reflect a more complete dataset and pricing considerations. PURPOSE: To evaluate the cost-effectiveness of TOPSTM system as compared with TLIF based on an updated and complete FDA investigational device exemption (IDE) data set. STUDY DESIGN/SETTING: Cost-utility analysis of the TOPSTM system compared to TLIF. PATIENT SAMPLE: A multicenter, FDA IDE, randomized control trial (RCT) investigated the efficacy of TOPSTM compared to TLIF with a current population of n=305 enrolled and n=168 with complete 2-year follow-up. OUTCOME MEASURES: Cost and quality adjusted life years (QALYs) were calculated to determine our primary outcome measure, the incremental cost-effectiveness ratio. Secondary outcome measures included: net monetary benefit as well at willingness-to-pay (WTP) thresholds. METHODS: The primary outcome of cost-effectiveness is determined by incremental cost-effectiveness ratio. A Markov model was used to simulate the health outcomes and costs of patients undergoing TOPSTM or TLIF over a 2-year period. alternative scenario sensitivity analysis, one-way sensitivity analysis, and probabilistic sensitivity analysis were conducted to assess the robustness of the model results. RESULTS: The updated base case result demonstrated that TOPSTM was immediately and longitudinally dominant compared with the control with an incremental cost-effectiveness ratio of -9,637.37 $/QALY. The net monetary benefit was correspondingly $2,237, both from the health system's perspective and at a WTP threshold of 50,000 $/QALY at the 2-year time point. This remained true in all scenarios tested. The Alternative Scenario Sensitivity Analysis suggested cost-effectiveness irrespective of payer type and surgical setting. To remain cost-effective, the cost difference between TOPSTM and TLIF should be no greater than $1,875 and $3,750 at WTP thresholds of $50,000 and 100,000 $/QALY, respectively. CONCLUSIONS: This updated analysis confirms that the TOPSTM device is a cost-effective and economically dominant surgical treatment option for patients with lumbar stenosis and degenerative spondylolisthesis compared to TLIF in all scenarios examined.

Pulsed Electromagnetic Field Stimulation in Lumbar Spine Fusion for Patients With Risk Factors for Pseudarthrosis.

BACKGROUND: Lumbar spinal fusion surgeries are increasing steadily due to an aging and ever-growing population. Patients undergoing lumbar spinal fusion surgery may present with risk factors that contribute to complications, pseudarthrosis, prolonged pain, and reduced quality of life. Pulsed electromagnetic field (PEMF) stimulation represents an adjunct noninvasive treatment intervention that has been shown to improve successful fusion and patient outcomes following spinal surgery. METHODS: A prospective, multicenter study investigated PEMF as an adjunct therapy to lumbar spinal fusion procedures in patients at risk for pseudarthrosis. Patients with at least 1 of the following risk factors were enrolled: prior failed fusion, multilevel fusion, nicotine use, osteoporosis, or diabetes. Fusion status was determined by radiographic imaging, and patient-reported outcomes were also evaluated. RESULTS: A total of 142 patients were included in the analysis. Fusion status was assessed at 12 months follow-up where 88.0% (n = 125/142) of patients demonstrated successful fusion. Fusion success for patients with 1, 2+, or 3+ risk factors was 88.5%, 87.5%, and 82.3%, respectively. Significant improvements in patient-reported outcomes using the Short Form 36, EuroQol 5 Dimension (EQ-5D) survey, Oswestry Disability Index, and visual analog scale for back and leg pain were also observed compared with baseline scores (P < 0.001). A favorable safety profile was observed. PEMF treatment showed a positive benefit-risk profile throughout the 6-month required use period. CONCLUSIONS: The addition of PEMF as an adjunct treatment in patients undergoing lumbar spinal surgery provided a high rate of successful fusion with significant improvements in pain, function, and quality of life, despite having risk factors for pseudarthrosis. CLINICAL RELEVANCE: PEMF represents a useful tool for adjunct treatment in patients who have undergone lumbar spinal surgery. Treatment with PEMF may result in improved fusion and patient-reported outcomes, regardless of risk factors. TRIAL REGISTRATION: NCT03176303.

Posterior cervical congenital dermal sinus tract: case report and review of literature.

BACKGROUND AND IMPORTANCE: Congenital dermal sinus tract (DST) is a rare spinal dysraphism characterized by a persistent tract lined by epithelial cells, beginning at the epidermis and terminating in deeper tissue layers. With 1% of all congenital DST cases found in the cervical region, only 4% of all cases are diagnosed after the age of 20. CLINICAL PRESENTATION: In this case, a 65-year-old woman with a congenital DST at the cervical level presented with symptoms of neck and some arm pain, suboccipital headaches, and unique external characteristics. Neck Disability Index and visual analog scale were used to assess the patient's preoperative and postoperative pain, and quality of life. Patient underwent an operative intervention, where the DST was surgically removed followed by interlaminar decompression at C1-C2, excision of the epidural component, and biopsy followed by plastic surgical repair. Pathology analysis indicated a squamous epithelial-lined sinus tract interacting with the dura. Most notably, a meningothelial proliferation with associated psammomatous calcifications was identified, similar to a meningioma. CONCLUSION: A review of literature was conducted to further discuss clinical and radiological presentation as well as to document the novel appearance of this congenital DST. As one of the oldest cases of DST, it demonstrated unusual pathological characteristics with a meningothelial proliferation, compatible with meningioma, reported at the epidural level.

Intraoperative neuromonitoring in spine surgery: large database analysis of cost-effectiveness.

Background: Given the increased attention to functional improvement in spine surgery as it relates to activities of daily living and cost, it is critical to fully understand the health care economic impact of enabling technologies. The use of intraoperative neuromonitoring (IOM) during spine surgery has long been controversial. Questions pertaining to utility, medico-legal considerations, and cost-effectiveness continue to be unresolved. The purpose of this study is to determine the cost-effectiveness by assessing quality-of-life due to adverse events averted, decreased postoperative pain, decreased revision rates, and improved patient reported outcomes (PROs). Methods: The study patient population was extracted from a large multicenter database collected by a single, national IOM provider. Over 50,000 patient charts were abstracted and included in this analysis. The analysis was conducted in accordance with the second panel on cost-effectiveness health and medicine. Health-related utility was derived from questionnaire answers and expressed in quality-adjusted life years (QALYs). Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. Cost-effectiveness was calculated as the incremental cost-effectiveness ratio (ICER) for IOM. A value under the commonly accepted United States-based willingness-to-pay (WTP) threshold of $100,000 per QALY was considered cost-effective. Scenario (including litigation), probabilistic (PSA), and threshold sensitivity analyses were conducted to determine model discrimination and calibration. Results: The primary time horizon used to estimate cost and health utility was 2-years following index surgery. On average, index surgery for patients with IOM costs are approximately $1,547 greater than non-IOM cases. The base case assumed an inpatient Medicare population however multiple outpatient and payer scenarios were assessed in the sensitivity analysis. From a health system perspective IOM is cost-effective, yielding better utilities but at a higher cost than the non-IOM strategy (ICER $60,734 per QALY). From a societal perspective the IOM strategy was dominant, suggesting that better outcomes were achieved at less cost. Except for an entirely privately insured population, alternative scenarios such as, outpatient and a 50:50 Medicare/privately insured population sample also demonstrated cost-effectiveness. Notably, IOM benefits were unable to overcome the sheer costs associated many litigation scenarios, but the data was severely limited. In the 5,000 iteration PSA, at a WTP of $100,000, 74% of simulations using IOM were cost-effective. Conclusions: The use of IOM in spine surgery is cost-effective in most scenarios examined. In the emerging and rapidly expanding field of value-based medicine, there will be an increased demand for these analyses, ensuring surgeons are empowered to make the best, most sustainable solutions for their patients and the health care system.

A Systematic Review and Meta-Analysis of Silicon Nitride and Biomaterial Modulus as it Relates to Subsidence Risk in Spinal Fusion Surgery.

Introduction: For decades, researchers and surgeons have sought to determine the optimal biomaterial for spinal fusion implants. Successful fusion is associated with improved quality of life while failures are often associated with costly and complex revisions. One common failure is subsidence. Biomaterials with higher modulus are thought to be related to subsidence risk but this has not been thoroughly investigated. The aim of this systematic review and meta-analysis is to assess silicon nitride and biomaterial modulus as they relate to subsidence risk in spinal fusions. Methods: A systematic review was conducted using the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Databases searched included PubMed-Medline, Google Scholar, Embase, EBSCO, and Cochrane Library. Study quality was assessed according to the Newcastle-Ottawa Scale. A network meta-analysis was chosen, allowing for direct and indirect comparisons for multiple treatments using a Bayesian hierarchical framework with Markov chain Monte Carlo methods. Outcomes were reported as odds ratios with 95% confidence intervals. Heterogeneity between studies was evaluated using the I2 test. A pairwise meta-analysis was also produced to compare the results of network analysis for consistency. Publication bias was assessed using a funnel plot, Egger test, and Begg test. All analyses were conducted using R (Project for Statistical Computing, ver. 4.0.4). Results: The initial search yielded a total of 821 articles. After removal of duplicates and screening based on inclusion and exclusion criteria, 64 articles were available for review and 13 were selected for meta-analysis. Biomaterial implant types in the final studies included: silicon nitride (Si3N4), polyetheretherketone (PEEK), titanium (Ti), and two composites, nano-hydroxyapatite/polyamide 66 (n-HA/PA66) and a carbon fiber reinforced polymer (CFRP). A total of 1,192 patients were included in this analysis - 419 with titanium implants, 460 with PEEK, 96 with Si3N4, 332 with n-HA/PA66, and 35 with CFRP. Titanium had the highest rate of subsidence compared to other biomaterials. Pairwise analysis was consistent with these results. Both the Egger test (p = 0.28) and Begg test (p = 0.37) were found to be non-significant for publication bias. Conclusions: Spinal fusion implants derived from Si3N4, compared to PEEK and titanium, do not appear to be correlated with increased subsidence risk.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study.

Background: Given the increased attention to functional improvement in spine surgery as it relates to motion preservation, activities of daily living, and cost, it is critical to fully understand the healthcare economic impact of new devices being tested in large FDA randomized controlled trials (RCT). The purpose of this analysis was to comprehensively evaluate the cost-effectiveness of the novel Total Posterior Spine (TOPS™) System investigational device compared with the trial control group, standard transforaminal lumbar interbody fusion (TLIF). Objective: To evaluate the cost-effectiveness of TOPS™ compared with TLIF. Methods: The study patient population was extracted from a multicenter RCT with current enrollment at n=121 with complete 1-year follow-up. The primary outcome was cost-effectiveness, expressed as the incremental cost-effectiveness ratio. Secondary outcomes were health-related utility, presented as quality-adjusted life-years (QALYs), and cost, calculated in US dollars. Analysis was conducted following Second Panel on Cost-Effectiveness Health and Medicine recommendations. The base case analysis utilized SF-36 survey data from the RCT. Both cost and QALY outcomes were discounted at a yearly rate of 3% to reflect their present value. A cohort Markov model was constructed to analyze perioperative and postoperative costs and QALYs for both TOPS™ and control groups. Scenario, probabilistic, and threshold sensitivity analyses were conducted to determine model discrimination and calibration. Results: The primary time horizon used to estimate cost and health utility was 2 years after index surgery. From a health system perspective, assuming a 50/50 split between Medicare and private payers, the TOPS™ cohort is cost-effective 2 years postoperatively ($6158/QALY) compared with control. At 6 years and beyond, TOPS™ becomes dominant, irrespective of payer mix and surgical setting. At willingness-to-pay thresholds of $100 000/QALY, 63% of all 5000 input parameter simulations favor TOPS, even with a $4000 upcharge vs TLIF. Discussion: The novel TOPS™ device is cost-effective compared with TLIF and becomes the dominant economic strategy over time. Conclusions: In the emerging, rapidly expanding field of value-based medicine, there will be an increased demand for these analyses, ensuring surgeons are empowered to make the best, most sustainable solutions for their patients and society.

Cost-Effectiveness of Peptide Enhanced Bone Graft i-Factor versus Use of Local Autologous Bone in Anterior Cervical Discectomy and Fusion Surgery.

STUDY DESIGN: We conducted decision analytical modeling using a Markov model to determine the ICER of i-factor compared to autograft in ACDF surgery. OBJECTIVE: The efficacy and safety of traditional anterior cervical discectomy and fusion (ACDF) surgery has improved with the introduction of new implants and compounds. Cost-effectiveness of these innovations remains an often-overlooked aspect of this effort. To evaluate the cost-effectiveness of i-FACTOR compared to autograft for patients undergoing ACDF surgery. METHODS: The patient cohort was extracted from a prospective, multicenter randomized control trial (RCT) from twenty-two North American centers. Patients randomly received either autograft (N = 154) or i-Factor (N = 165). We analyzed various real-world scenarios, including inpatient and outpatient surgical settings as well as private versus public insurances. Two primary outcome measures were assessed: cost and utility. In the base-case analysis, both health and societal system costs were evaluated. Health-related utility outcome was expressed in quality-adjusted life years (QALYs). Cost-effectiveness was expressed as an incremental cost-effectiveness ratio (ICER). RESULTS: In all scenarios, i-FACTOR reduced costs within the first year by 1.4% to 2.1%. The savings proved to be incremental over time, increasing to 3.7% over an extrapolated 10 years. The ICER at 90 days was $13,333 per QALY and became negative ("dominated") relative to the control group within one year and onwards. In a threshold sensitivity analysis, the cost of i-FACTOR could theoretically be increased 70-fold and still remain cost-effective. CONCLUSION: The novel i-FACTOR is not only cost-effective compared to autograft in ACDF surgery but is the dominant economic strategy.

Clinical and radiographic outcomes after spinous process fixation and posterior fusion in an elderly cohort.

Spinous process fixation (SPF) has gained attention as a less invasive option for lumbar fusion surgery. Minimally invasive techniques are of interest in an elderly population due to decreased surgical time and post-operative complications. Clinical outcomes and fusion rates have not been determined in a large cohort. Our objective was to describe significant predictors of visual analog scale (VAS), length of stay, blood loss, fusion rates, and complication rates for patients treated for degenerative lumbar spondolysis with ISP fixation with and without supplemental instrumentation. Charts were assessed for post-operative VAS vs. pre-operative VAS at: 1-3, >3-6, and >6-12 months. To control confounding variables, VAS scores were modeled as a repeated-measures linear-mixed-model. In a sub-cohort CT images were assessed for interspinous and interbody (IB) fusion. The images were reviewed by an independent radiologist to evaluate fusion status. Eighty-six SPF patients (91 levels, mean age 67 years) were identified. After determining the model, age and sex remained predictors of VAS. Adjusting for age and sex, patients saw a decrease of 3.6 VAS points from baseline to three months (95% CI: 2.9-4.4, p<0.0001) that was maintained over the six to 12 month follow-up period. A sub-cohort of 50 patients with CT scans were identified and assessed for ISP and IB fusion at a mean of 181 days postoperatively. Ninety-four percent of levels demonstrated ISP fusion. Sixty-one percent of solid ISP fusion patients also had an interbody cage, but this did not impact fusion rates. Eighty-six percent of these levels showed solid IB fusion (BSF-3). Of the four pseudoarthrosed levels, two had pedicle screw fixation, and two were IB and ISP fixation. Only two patients went on to re-exploration and explantation due to pain secondary to spinous process and/or lamina fracture. This elderly cohort treated with SPF demonstrated significant improvement in VAS with reliable fusion rates.