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BackgroundGiven 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).MethodsThe 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.ResultsThe primary time horizon used to estimate cost and health utility was 2-years following index surgery. On average, indexsurgery 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 asocietal 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.ConclusionsThe 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.

Background Multilevel anterior cervical discectomy and fusion (mACDF) is the gold standard for multilevel spinal disease; although safe and effective, mACDF can limit regular spinal motion and contribute to adjacent segment disease (ASD). Hybrid surgery, composed of ACDF and cervical disc arthroplasty, has the potential to reduce ASD by retaining spinal mobility. This study examined the safety of hybrid surgery by utilizing administrative claims data to compare real-world rates of subsequent surgery and post-procedural hospitalization within populations of patients undergoing hybrid surgery versus mACDF for multilevel spinal disease. Methods This observational, retrospective analysis used the MarketScan Commercial and Medicare Database from July 2013 through June 2020. Propensity score matched cohorts of patients who received hybrid surgery or mACDF were established based on the presence of spinal surgery procedure codes in the claims data and followed over a variable post-period. Rates of subsequent surgery and post-procedural hospitalization (30- and 90-day) were compared between hybrid surgery and mACDF cohorts. Results A total of 430 hybrid surgery patients and 2,136 mACDF patients qualified for the study; average follow-up was approximately 2 years. Similar rates of subsequent surgery (Hybrid: 1.9 surgeries/100 patient-years; mACDF: 1.8 surgeries/100 patient-years) were observed for the two cohorts. Hospitalization rates were also similar across cohorts at 30 days post-procedure (Hybrid: 0.67% hospitalized/patient-year; mACDF: 0.87% hospitalized/patient-year). At 90 days post-procedure, hybrid surgery patients had slightly lower rates of hospitalization compared to mACDF patients (0.23% versus 0.42% hospitalized/patient-year; p Conclusions Findings of this real-world, retrospective cohort study confirm prior reports indicating that hybrid surgery is a safe and effective intervention for multilevel spinal disease which demonstrates non-inferiority in relation to the current gold standard mACDF. The use of administrative claims data in this analysis provides a unique perspective allowing the inclusion of a larger, more generalizable population has historically been reported on in small cohort studies.

STUDY DESIGN Retrospective Cohort. OBJECTIVE Identify patient variables, injury characteristics, and costs associated with operative and non-operative treatment following inter-facility transfer of patients with isolated cervical spine fractures. SUMMARY OF BACKGROUND DATA Patients with isolated cervical spine fractures are subject to inter-facility transfer for surgical assessment, yet are often treated non-operatively. The American College of Surgeons' benchmark rate of "secondary over-triage" is < 50%. Identifying patient and injury characteristics as well as costs associated with treatment following transfer of patients with isolated cervical spine fractures may help reduce rates of secondary over-triage and healthcare expenditures. METHODS Patients transferred to a Level-1 trauma center with isolated cervical spine fractures between January 2015 and September 2020 were identified. Patient demographics, comorbidities, insurance data, injury characteristics, imaging workup, treatment, and financial data were collected for all patients. Multivariable logistic regression models were constructed to identify patient and injury characteristics associated with surgical treatment. RESULTS Nearly 75% of patients were treated non-operatively. Over 97% of transfers were accepted by the general surgery trauma service. Multivariable modeling found that higher BMI, presence of any neurologic deficit including spinal cord or isolated spinal nerve root injuries, current smoking status, or cervical spine MRI obtained post-transfer, were associated with surgical treatment for isolated cervical spine fractures. Among patients with type II dens fractures, increased fracture displacement was associated with surgical treatment. Median charges to patients treated operatively and non-operatively were $380,890 and $90,734, respectively. Median hospital expenditures for patients treated operatively and non-operatively were $55,115 and $12,131, respectively. CONCLUSION A large proportion of patients with isolated cervical spine fractures are subject to over-triage. Injury characteristics are important for determining need for surgical treatment, and therefore inter-facility transfer. Improving communication with spine surgeons when deciding to transfer patients may significantly reduce healthcare costs and resource use.Level of Evidence: 4.

The primary aim of this chapter will be to present an overview of the functionality and efficacy of the Aspen MIS spinous process fusion system, including a review of recent multicenter randomized data.

OBJECTIVE The aim of this study was to evaluate whether the investigational Neuro-Spinal Scaffold (NSS), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2–12 spinal cord injury (SCI) when implanted ≤ 96 hours postinjury. METHODS This was a prospective, open-label, multicenter, single-arm study in patients with a visible contusion on MRI. The NSS was implanted into the epicenter of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma. The primary efficacy endpoint was the proportion of patients who had an improvement of ≥ 1 AIS grade (i.e., conversion from complete paraplegia to incomplete paraplegia) at the 6-month follow-up visit. A preset objective performance criterion established for the study was defined as an AIS grade conversion rate of ≥ 25%. Secondary endpoints included change in neurological level of injury (NLI). This analysis reports on data through 6-month follow-up assessments. RESULTS Nineteen patients underwent NSS implantation. There were 3 early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure. Seven of 16 patients (43.8%) who completed the 6-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). Five patients showed improvement in NLI of 1 to 2 levels compared with preimplantation assessment, 3 patients showed no change, and 8 patients showed deterioration of 1 to 4 levels. There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators. CONCLUSIONS In this first-in-human study, implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilization for complete (AIS grade A) thoracic SCI. It was associated with a 6-month AIS grade conversion rate that exceeded historical controls. The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomized controlled trial. Clinical trial registration no.: NCT02138110 (clinicaltrials.gov)

BackgroundBased on 6-month data from the InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurological Recovery in Patients with Complete Thoracic Spinal Cord Injury (INSPIRE) study (NCT02138110), acute implantation of an investigational bioresorbable polymer device (Neuro-Spinal Scaffold [NSS]) appeared to be safe in patients with complete thoracic spinal cord injury (SCI) and was associated with an ASIA Impairment Scale (AIS) conversion rate that exceeded historical controls.ObjectiveTo evaluate outcomes through 24 months postimplantation.MethodsINSPIRE was a prospective, open-label, multicenter, single-arm study. Eligible patients had traumatic nonpenetrating SCI with a visible contusion on MRI, AIS A classification, neurological level of injury at T2-T12, and requirement for open spine surgery ≤96 hours postinjury.ResultsNineteen patients underwent NSS implantation. Three patients had early death determined by investigators to be unrelated to the NSS or its implantation procedure. Seven of 16 evaluable patients (44%) had improvement of ≥1 AIS grade at 6 months (primary end point) to AIS B (n = 5) or AIS C (n = 2). Three patients with AIS B at 6 months had further neurological improvement to AIS C by 12 (n = 2) and 24 (n = 1) months, respectively; none have deteriorated per latest available follow-up. No unanticipated or serious adverse device effects were reported.ConclusionIn this small group of patients with complete thoracic SCI, acute NSS implantation within the spinal cord appeared to be safe with no long-term neurological issues identified during the 24-month follow-up. Patients remain stable, with additional AIS conversions observed in some patients at 12 months and beyond. These data further support the safety and probable benefit of NSS implantation in this patient population.

Finite-element analysis. Intraoperative contouring of rods is a common procedure for spine surgeons to match the native curvature of the spine, but it may lead to premature weakening of the rod. This study investigated the effect of different bending methods on rod fatigue performance. Rod failure in the cervical spine is of clinical concern, particularly when spanning the cervicothoracic region and when considering corrective osteotomies for deformity correction and global spinal alignment. Finite-element models were developed to simulate rod bending (3.5 mm D, 40 mm L) to achieve a 23° angle with 3 different bending methods: French single, multiple bending, and in situ bending. Simulations were conducted in 4 steps: rod bending, rod spring back, residual stress relaxation, and F1717 mechanical test simulation. French single bending resulted in the highest residual stress concentrations for both titanium (TiAlV) and cobalt chrome (CoCr) at 783 MPa and 507 MPa, respectively. During F1717 test simulation, the French single bent rod had its highest tensile stress in the middle, with 917 MPa and 623 MPa, respectively, for TiAlV and CoCr, compared to in situ (580 MPa and 586 MPa for TiAlV and CoCr) and the French multiple bent rod (765 MPa and 619 MPa for TiAlV and CoCr). The computational model found that CoCr rods made the construct least prone to deformation. French single bend with TiAlV rods put the construct at highest risk of failure. CoCr rods led to minimal physical changes in microstructure while showing evidence of flattening.

Background: With the COVID-19 pandemic disrupting many facets of our society, physicians and patients have begun using telemedicine as a platform for the delivery of health care. One of the challenges in implementing telemedicine for the spine care provider is completing a comprehensive spinal examination. Currently, there is no standardized methodology to complete a full spinal examination through telemedicine. Methods: We propose a novel, remote spinal examination methodology that is easily implemented through telemedicine, where the patient is an active participant in the successful completion of his or her examination. This type of examination has been validated in a neurology setting. To facilitate the telemedicine visit, we propose that video instruction be shared with the patient prior to the telemedicine visit to increase the efficacy of the examination. Results: Since the issuance of stay-at-home order across the states, many spine practices around the country have rapidly adopted and increased their telemedicine program to continue provide care for patients during COVID-19 pandemic. At a tertiary academic center in a busy metropolitan area, nearly 700 telemedicine visits were successfully conducted during a 4-week period. There were no remote visits being done prior to the shutdown. Conclusions: Implementation of our proposed remote spinal examination has the potential to serve as a guideline for the spine care provider to efficiently assess patients with spine disease using telemedicine. Because these are only suggestions, providers should tailor examination to each individual patient9s needs. Level of Evidence: V. Clinical Relevance: It is likely that physicians will incorporate telemedicine into health care delivery services even after the COVID-19 pandemic subsides because of telemedicine9s efficiency in meeting patient needs. Using the standard maneuvers provided in our study, spine care providers can perform a nearly comprehensive spine examination through telemedicine. Further studies will be needed to validate the reproducibility and reliability of our methodology.

Acute traumatic spinal cord injury (SCI) can result in severe, lifelong neurological deficits. After SCI, Rho activation contributes to collapse of axonal growth cones, failure of axonal regeneration, and neuronal loss. This randomized, double-blind, placebo-controlled phase 2b/3 study evaluated the efficacy and safety of Rho inhibitor VX-210 (9 mg) in patients after acute traumatic cervical SCI. The study enrolled patients 14-75 years of age with acute traumatic cervical SCIs, C4-C7 (motor level) on each side, and American Spinal Injury Association Impairment Scale (AIS) Grade A or B who had spinal decompression/stabilization surgery commencing within 72 h after injury. Patients were randomized 1:1 with stratification by age (

Bart Thaci,1 Randy Yee,2 Kee Kim,1 Amir Vokshoor,2– 4 J Patrick Johnson,5 Jared Ament2– 5 1University of California, Davis, Sacramento, CA, USA; 2Neuronomics LLC, Los Angeles, CA, USA; 3Neurosurgery & Spine Group, Los Angeles, CA, USA; 4Institute of Neuro Innovation, Santa Monica, CA, USA; 5Cedars Sinai Medical Center, Los Angeles, CA, USACorrespondence: Jared AmentNeuronomics LLC, 7320 Woodlake Ave, Suite 215, West Hills, CA, 91307, USATel +1 800 899 0101Fax +1 310 870 8677Email jared.ament@cshs.orgStudy 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.Keywords: cost-effectiveness, i-factor, spine fusion, spine allograft, cervical spondylosis, anterior cervical discectomy and fusion, cost analysis, decision analysis

This study evaluated the safety and efficacy of a novel hyper-crosslinked carbohydrate polymer (HCCP) for the repair of critical-sized bone defects in comparison to two alternative treatments: autologous bone and poly(lactide-co-glycolide) with hyaluronic acid (PLGA/HA). Bilateral critical-sized defects were created in the lateral femoral condyles of skeletally mature New Zealand White rabbits, and they were subsequently implanted with HCCP, PLGA/HA, or autologous bone in a randomized manner. Clinical and behavioral observations were made daily, and radiological and histopathological evaluations were performed at 4, 10, and 16 weeks postimplantation. Defects implanted with HCCP showed progressive bone regeneration and bridging of the defect without adverse histological events. No signs of infection or inflammation associated with the implant material were observed in all animals that received HCCP implantation. A radiographic assessment performed at 16 weeks post-implantation showed significantly higher bone density and volume in defects implanted with HCCP compared to PLGA/HA. No statistically significant difference was observed in bone density and volume between HCCP and autologous bone. These findings demonstrate that HCCP is biocompatible, osteoconductive, and capable of promoting bone regeneration in vivo; therefore, it is suitable for both tissue engineering and the repair of critical-sized bone defects.

Objective Percutaneous vertebroplasty (VP) and medial branch block (MBB) are used to treat osteoporotic vertebral compression fractures (VCF). We compared the clinical outcomes, radiologic changes, and economic results of MBB with those of VP in treating osteoporotic VCFs. Methods A total of 164 patients with 1-level osteoporotic VCF were reviewed retrospectively. The clinical outcomes were measured with a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). To compare economic costs between groups, total hospital costs at the last follow-up day were calculated. Results The patients were divided into 2 groups: 72 patients in the conservative group treated by MBB (MBB group) and 92 patients in the group who underwent VP (VP group). The VAS and ODI scores improved significantly within postoperative week 1 in the VP group compared with the MBB group. However, the VAS and ODI scores did not differ between the groups after 1 postoperative year. After 2 years of follow-up, 14 new fractures occurred in the VP group and 3 in the MBB group. The improvement in compression ratio was statistically greater in the VP group than in the MBB group. However, after 2 years the radiologic changes between groups did not differ statistically. After the final follow-up visits, the hospital costs were significantly lower in the MBB group. Conclusions After 2 years of follow-up, VP and MBB both had similar efficacy in terms of pain relief and radiologic changes. MBB was more cost effective than VP. Thus, MBB alone can be a possible alternative to VP in patients with 1-level osteoporotic VCFs.

Purpose Despite being an extremely successful procedure, recurrent disc herniation is one of the most common post-discectomy complications in the lumbar spine and contributes significant health care and socioeconomic costs. Patients with large annular defects are at a high risk for reherniation, but an annular closure device (ACD) has been designed to reduce reherniation risk in this population and may, in turn, help control direct health care costs after discectomy. Patients and methods This analysis examined the 90-day post-discectomy cost estimates among ACD-treated (n=272) and control (discectomy alone; n=278) patients in a randomized controlled trial (RCT). Direct medical costs were estimated based on 2017 Humana and Medicare claims. Index discectomies were assumed to occur in an outpatient (OP) setting, whereas repeat discectomies were assumed to be 60% in OP and 40% in inpatient (IP). A sensitivity analysis was performed on this assumption. The device cost was not included in the analysis in order to focus on costs in the 90-day post-operative period. Results Within 90 days of follow-up, post-operative complications occurred in 3.3% of the ACD patients and 8.6% of the control patients (P=0.01). The average 90-day cost to treat an ACD patient was $10,257 compared to $11,299 per control patient for a 80:20 distribution of Commercial:Medicare coverage ($1,042 difference). This difference varied from $687 with 100% Medicare to $1,132 with 100% Commercial coverage. Varying the IP vs OP distribution resulted in a cost difference range of $968 to $1,156 with the ACD. Conclusion Augmenting discectomy with an ACD in high-risk patients with a large annular defect reduced reherniation and reoperation rates, which translated to a reduction of direct health care costs between $687 and $1,156 per patient during the 90-day post-operative period. Large annular defect patients are an easily identifiable high-risk population. Operative strategies that reduce complication risks in these patients, such as the ACD, could be advantageous from both patient care and economic perspectives.

STUDY DESIGN Cost-utility analysis of an annular closure device (ACD) based on data from a prospective, multicenter randomized controlled trial (RCT) OBJECTIVE.: The aim of this study was to determine the cost-effectiveness of a novel ACD in a patient population at high risk for recurrent herniation following discectomy. SUMMARY OF BACKGROUND DATA Lumbar disc herniation patients with annular defect widths ≥6 mm are at high risk for recurrent herniation following limited discectomy. Recurrent herniation is associated with worse clinical outcomes and greater healthcare costs. A novel ACD may reduce the incidence of recurrent herniation and the associated burdens. METHODS A decision analytical modeling approach with a Markov method was used to evaluate the cost-effectiveness of the ACD versus conventional discectomy. Health states were created by projecting visual analogue scale (VAS) onto Oswestry Disability Index (ODI). Direct costs were calculated based on Humana and Medicare 2014 claims to represent private and public payer data, respectively. Indirect costs were calculated for lost work days using 2016 US average annual wages. The incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life year (QALY) was compared to willingness-to-pay thresholds. Sensitivity analyses were also conducted. RESULTS Patients with the ACD had less symptomatic reherniations, reoperations, and complications and gained 0.0328 QALYs within the first 2 years. Total direct medical costs for the ACD group were similar to control. When productivity loss was considered, using the ACD became $2076 cheaper, per patient, than conventional discectomy. Based on direct costs alone, the ICER comparing ACD to control equaled $6030 per QALY. When indirect costs are included, the ICER became negative, which indicates that superior quality of life was attained at less cost. CONCLUSION For lumbar disc herniations patients with annular defects ≥6 mm, the ACD was, at 2 years, a highly cost-effective surgical modality compared to conventional lumbar discectomy. LEVEL OF EVIDENCE 1.

Cervicogenic headaches are a controversial clinical entity that affect many patients suffering from cervical spondylosis. Understanding the pathogenesis and identifying the nociceptive sources of cervicogenic headaches is critical to properly treat these headaches. A multimodal approach is necessary to treat these headaches using a variety of medical tools. Surgical interventions are reserved for patients that fail maximal medical therapy. The anterior cervical spine surgery has shown promise in the treatment of cervicogenic headaches and this success has hinted at a ventral source of nociceptive pathology. Continued research and development are required to improve outcomes in patients suffering from cervicogenic headaches.

Summary Background Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy. Methods This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18–80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8–14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov , NCT01257828 . Findings From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference −0·38 points (−0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications. Interpretation In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study. Funding AOSpine North America.

Objective Traditionally, laminectomy has been the preferred surgical approach for the resection of intradural spinal tumors. Recent trends towards minimally invasive techniques have generated interest in hemilaminectomy as an effective alternative surgical approach to resect spinal tumors. However, it remains unclear if the potential benefits of hemilaminectomies, used in other routine spinal procedures, apply to intradural spinal tumors. This report presents a six-year single institutional analysis of open resection of intradural tumors using laminectomies as compared to hemilaminectomies. Methods A single institution, multisurgeon, retrospective review of 52 patients undergoing resection of intradural spinal tumors over a six-year period was performed. Estimated blood loss, operative time, post-operative complications, length of stay, and post-operative clinical spinal instability were analyzed and compared between the two surgical techniques. Results The mean follow-up was 34 and 20 months for the laminectomy and hemilaminectomy groups, respectively. There was no statistically significant difference in operative times between the two groups (hemilaminectomy: 250.13±76.44 minutes, laminectomy: 244.49±92.85 minutes; p=0.43).Similarly, there was no difference in overall estimated blood loss (hemilaminectomy: 125±74 cc, laminectomy: 256.05±320.8 cc; p=0.27) or mean hospital length of stay (hemilaminectomy: 4.00±2.12 days, laminectomy: 5.26±3.0 days; p=0.60).No patient in either surgical group had post-operative evidence of clinical spinal instability. Conclusion Hemilaminectomy is a viable approach for the resection of intradural spinal tumors, with similar rates of post-operative complications to laminectomy when using an open surgical approach. The laminectomy allows for bilateral exposure of the entire spinal canal and neural foramina; and continues to be the preferred method for resection of large tumors with complex morphology.

Spinal durotomy, whether incidental or intentional, requires a watertight closure to prevent potentially significant complications. As a result of relatively recent technological advancements and research, spine surgeons now have many options for both intra-operative dural repair as well as managing post-operative cerebrospinal fluid (CSF) leak. This review presents a comprehensive overview of the current and historical treatment strategies in the management of spinal durotomy. Intra-operative treatment of intentional and incidental durotomies through a variety of available dural sutures, dural sealants and other patches and grafts as well as post-operative CSF leak management strategies including conservative measures, epidural blood patches, CSF diversion therapies and definitive surgical repair will be presented.

Mature thoracic intraspinal teratomas are rare tumors in adults. In this case study, we present a case of intradural, extramedullary teratoma, which was surgically resected. A 50 year old man presented with progressive bilateral leg pain, severe myelopathy and weakness. Magnetic Resonance Imaging (MRI) revealed a cystic mass lesion in the T11-12 region region. Microsurgical resection of the tumor using CO2 laser with neuromonitoring was performed. Postoperatively, the patient had a remarkable clinical improvement. Mature spinal teratomas are rare, slow growing spinal tumors. Surgical resection provides excellent recovery, and recurrence rates are low.

Study Design: A nonrandomized, two-armed prospective study. Objective: Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice. Methods: A total of 36 sites in the United States enrolled 429 patients treated with DESS as an adjunct to dural repair in the spinal sealant group and 406 patients treated with all other modalities in the control arm, from October 2011 to June 2016. The primary endpoint was the incidence of CSF leak within 90 days of operation. The secondary endpoints evaluated were deep surgical site infection and neurological serious adverse events. Results: The CSF leakage in the DESS group (6.6%) was not significantly different from the control group (6.5%) ( p = .83), and there was no significant difference in the time to first leak. The two groups had no significant differences in deep surgical site infection (1.6% versus control 2.1%, p = .61) or proportion of subjects with neurological serious adverse events (2.9% versus control 1.6%, p = .516). Conclusions: DuraSeal Exact Spinal Sealant is safe when compared to current alternatives for spinal dural repair.

Background Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. Objective To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. Methods This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. Results At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. Conclusion Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

OBJECTIVE:To evaluate whether anterior cervical spine surgery offers sustained (7 years) relief in patients with cervicogenic headaches (CGHs), and evaluate the difference between cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) for 1 and 2-level surgeries from a multicenter randomized clinical trial. METHODS:A post hoc analysis was performed of 575 patients who underwent one or 2-level CDA or ACDF for symptomatic cervical spondylosis as part of a prospective randomized clinical trial. Assessment of pain and functional outcome was done with the Neck Disability Index (NDI) in the trial. We used the NDI headache component to assess headache outcome. RESULTS:For both 1- and 2-level CDA and ACDF groups, there was significant headache improvement from preoperative baseline out to 7 years (p < 0.0001). For 1-level surgeries, headache improvement was similar for both groups at the 7-year point. For 2-level treatment, CDA patients had significantly improved headache scores versus ACDF patients at the 7-year point (p = 0.016). CONCLUSION:The headache improvement noted at early follow-up was sustained over the long-term period with ACDF and CDA populations. In the case of 2-level operations, CDA patients demonstrated significantly greater benefit compared to ACDF patients over the long-term. Sinuvertebral nerve irritation at the unco-vasculo-radicular junction and anterior dura may be the cause of CGH. Therefore, it is possible that improved cervical kinematics and preservation of range of motion at adjacent uncovertebral joints in CDA may contribute to the observed difference between the groups.

BACKGROUND CONTEXT PURPOSE Evaluate the safety and efficacy of a single intradiscal injection of STRO-3+ adult allogeneic mesenchymal precursor cells (MPCs) combined with hyaluronic acid (HA) in subjects with chronic low back pain (CLBP) associated with degenerative disc disease (DDD) through 36-month follow-up. STUDY DESIGN/SETTING A multicenter, randomized, controlled study conducted at 13 clinical sites (12 in the United States and 1 in Australia). SUBJECT SAMPLE A total of 100 subjects with chronic low back pain associated with moderate DDD (modified Pfirrmann score of 3–6) at one level from L1 to S1 for at least 6 months and failing 3 months of conservative treatment, including physical therapy were randomized in a 3:3:2:2 ratio to receive 6 million MPCs with HA, 18 million MPCs with HA, HA vehicle control, or saline control (placebo) treatment. OUTCOME MEASURES Subjects were clinically and radiographically evaluated at 1, 3, 6, 12, 24, and 36 months postinjection. Subject-reported outcomes including adverse events, LBP on a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), SF-36 and Work Productivity and Activity Index were collected. METHODS Clinical and radiographic measures were collected at each visit. All randomized subjects were included in the safety assessments and analyzed based on the treatment received. Safety assessments included assessments of AEs, physical and radiographic examinations and laboratory testing. Efficacy assessments evaluated changes in VAS, ODI, and modified Pfirrmann (MP) scores between all active and control groups, respectively. Assessments included least squares mean (Mean), LS mean change from baseline (Mean Change) and responder analyses in order to assess the clinical significance of observed changes from baseline. The population for efficacy assessments was adjusted for the confounding effects of post-treatment interventions (PTIs). This study was conducted under an FDA Investigational New Drug application sponsored and funded by Mesoblast. RESULTS There were significant differences between the control and MPC groups for improvement in VAS and ODI. The PTI-corrected VAS and ODI Means and Mean Change analyses; the proportion of subjects with VAS ≥30% and ≥50% improvement from baseline; absolute VAS score ≤20; and ODI reduction ≥10 and ≥15 points from baseline showed MPC therapy superior to controls at various time points through 36 months. Additionally, the proportion of subjects achieving the minimally important change and clinically significant change composite endpoints for the MPC groups was also superior compared with controls at various time points from baseline to 36 months. There were no significant differences in change in MP score from baseline across the groups. There were also no statistically significant differences in change in modified MP score at the level above or below the level treated between study arms. Both the procedure and treatment were well tolerated and there were no clinical symptoms of immune reaction to allogeneic MPCs. There was a low rate of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events, and the rates of these events in the MPC groups were not significantly different from the control groups. One TEAE of severe back pain was possibly related to study agent and one TEAE of implantation site infection was considered to be related to the study procedure. CONCLUSIONS Results provide evidence that intradiscal injection of MPCs could be a safe, effective, durable, and minimally invasive therapy for subjects who have CLBP associated with moderate DDD.

Background: Tarlov cyst disease is a collection of cerebrospinal fluid between the endoneurium and perineurium of spinal, usually sacral, nerve roots. These cysts can become symptomatic in 20% of patients, causing lower back pain, radiculopathy, bladder and bowel dysfunction necessitating medical or surgical intervention. Different surgical and non-surgical modalities have been described for the treatment of symptomatic Tarlov cysts. However, there has been no published study that examined types of surgical techniques side by side. Our study presents a preliminary experience in the surgical management of symptomatic Tarlov cysts using two surgical techniques: cyst fenestration and nerve root imbrication. Methods: Retrospective chart review and analysis was done for all patients who underwent surgical intervention for symptomatic Tarlov cyst(s) in the period 2007–2013. Operative reports, preoperative and postoperative clinic visit reports were reviewed. The surgical techniques of cyst fenestration and nerve root imbrication were each described in terms of intraoperative parameters, hospital course and outcome. Modified MacNab criteria were used for evaluation of the final clinical outcome. Results: Thirty-six surgical patients were identified. Three had repeat surgery (total of 39 operations). The median age was 51 years (range, 26–84 years). Eighty-six percent were females. The presenting symptoms were low back pain (94%), sensory radiculopathy (69%), bladder and bowel dysfunction (61%), sexual dysfunction (17%) and motor dysfunction (8%). Cyst fenestration was performed in 12 patients (31%) and nerve root imbrication was done in 27 (69%). All patients in the fenestration group but only 67% in the imbrication group had fibrin glue injection into the cyst or around the reconstructed nerve root. The overall surgery-related complication rate was 28%. The complication rate was 5/12 (42%) in the fenestration group and 6/27 (22%) in the imbrication group. At the time of the last clinic visit, improved clinical outcome was noted in 9/11 (82%) and 20/25 (80%) in the fenestration and the imbrication group, respectively. Conclusions: Cyst fenestration and nerve root imbrication are both surgical techniques to treat symptomatic Tarlov cyst(s), and both can result in clinical improvement.

Stem cells reside in their native microenvironment, which provides dynamic physical and chemical cues essential to their survival, proliferation and function. A typical cell-based therapeutic approach requires the mesenchymal stem cells (MSC) to depart their native microenvironment, transplant to in-vivo environment, differentiate toward multiple lineages and participate in bone formation. The long-term survival, function and fate of MSC are dependent on the microenvironment in which they are transplanted. Transplantation of morselized autologous bone, which contains both stem cells and their native microenvironment, results in a good clinical outcome. However, implantation of bone graft substitutes does not provide the complete and dynamic microenvironment for MSC. Current bone graft therapeutics may need to be improved further to provide an optimal engineered MSC microenvironment.

OBJECTIVE:To study risk factors of secondary lumbar discectomy (LD) for recurrent herniated lumbar disc (HLD) and identify methods to lower the rate of recurrence. METHODS:Data from 160 patients who underwent primary LD were collected retrospectively. Demographic features, radiologic findings including Pfirrmann disc degeneration, and surgical information were analyzed to compare risks between revision and non-revision patients. RESULTS:The revision rate was 15% (24 patients), and the mean follow-up was 28.3 months. HLD recurrence was not related to any demographic characteristics. Primary and secondary LD were most common at the L4-5 level, but the level of operation was not significantly associated with revision. Primary LD most commonly had a Pfirrmann disc degeneration grade of 3, followed by 4. For recurrent HLD, Pfirrmann grade 4 was most common and was statistically significant (p

Supplemental Digital Content is Available in the Text., BACKGROUND: The cervical total disc replacement (cTDR) was developed to treat cervical degenerative disc disease while preserving motion. OBJECTIVE: Cost-effectiveness of this intervention was established by looking at 2-year follow-up, and this update reevaluates our analysis over 5 years. METHODS: Data were derived from a randomized trial of 330 patients. Data from the 12-Item Short Form Health Survey were transformed into utilities by using the SF-6D algorithm. Costs were calculated by extracting diagnosis-related group codes and then applying 2014 Medicare reimbursement rates. A Markov model evaluated quality-adjusted life years (QALYs) for both treatment groups. Univariate and multivariate sensitivity analyses were conducted to test the stability of the model. The model adopted both societal and health system perspectives and applied a 3% annual discount rate. RESULTS: The cTDR costs $1687 more than anterior cervical discectomy and fusion (ACDF) over 5 years. In contrast, cTDR had $34 377 less productivity loss compared with ACDF. There was a significant difference in the return-to-work rate (81.6% compared with 65.4% for cTDR and ACDF, respectively; P = .029). From a societal perspective, the incremental cost-effective ratio (ICER) for cTDR was −$165 103 per QALY. From a health system perspective, the ICER for cTDR was $8518 per QALY. In the sensitivity analysis, the ICER for cTDR remained below the US willingness-to-pay threshold of $50 000 per QALY in all scenarios (−$225 816 per QALY to $22 071 per QALY). CONCLUSION: This study is the first to report the comparative cost-effectiveness of cTDR vs ACDF for 2-level degenerative disc disease at 5 years. The authors conclude that, because of the negative ICER, cTDR is the dominant modality. ABBREVIATIONS: ACDF, anterior cervical discectomy and fusion AWP, average wholesale price CE, cost-effectiveness CEA, cost-effectiveness analysis CPT, Current Procedural Terminology cTDR, cervical total disc replacement CUA, cost-utility analysis DDD, degenerative disc disease DRG, diagnosis-related group FDA, US Food and Drug Administration ICER, incremental cost-effectiveness ratio IDE, Investigational Device Exemption NDI, neck disability index QALY, quality-adjusted life years RCT, randomized controlled trial RTW, return-to-work SF-12, 12-Item Short Form Health Survey VAS, visual analog scale WTP, willingness-to-pay

BACKGROUND CONTEXT Degenerative spondylolisthesis (DS) with lumbar spinal stenosis (LSS) is commonly treated with decompression and fusion. The LimiFlex paraspinous tension band (PTB) is an investigational stabilization device for patients with DS and LSS. PURPOSE The purpose of this study is to assess the operative safety and short-term outcomes of decompression and PTB compared to transforaminal lumbar interbody fusion (TLIF) for patients with DS and LSS. STUDY DESIGN/SETTING Multicenter prospective concurrently controlled study. PATIENT SAMPLE Patients undergoing treatment (decompression and PTB or TLIF stabilization) of Grade I Meyerding lumbar degenerative spondylolisthesis. OUTCOME MEASURES Patient demographics, patient reported ODI, VAS leg, and VAS back, and procedural, discharge, and short-term clinical outcomes up to 12 months postoperatively. METHODS Patients with single-level Grade 1 DS with LSS were enrolled in the multicenter, FDA-IDE study comparing decompression with PTB and decompression with TLIF. Perioperative and patient-reported clinical outcomes were recorded at baseline and 6-week, 3-month, 6-month and 12-month follow-up. All patients who reached 12-month follow-up were included in this interim analysis. Summary statistics are reported, as well as paired t-tests to assess within-group changes. RESULTS A total of 93 patients (58 PTB, 35 TLIF) reached 12-month follow-up. Characteristics of PTB vs TLIF groups, respectively were: age 64.9±8.1, 64.1±7.4 yrs; BMI 28.7±4.9, 29.2±5.8; current smokers 2%, 3%. Perioperative outcomes for PTB vs TLIF were: operative time 110±29, 172±58 minutes; EBL 42±26, 241±155 mL; LOS 0.6±1.5, 3.3±1.7 nights. A significant reduction from baseline to 12 months for mean VAS-leg/hip (79.4±10.4 to 19.8±27.5), VAS-back (67.5±22.9 to 17.7±25.1) and ODI (53.1±13.1 to 12.6±16.0) was reported for PTB patients (all p CONCLUSIONS These preliminary results suggest that decompression with PTB stabilization for spondylolisthesis can be accomplished safely without a significant increase in complications during the perioperative and short-term follow-up periods. Similarly, statistically significant improvements in patient-reported outcomes were demonstrated in each group. As groups were not propensity matched, further investigation to include quantitative comparison between groups with long-term follow-up is needed to confirm these results. FDA DEVICE/DRUG STATUS LimiFlex Paraspinous Tension Band (Investigational/Not approved).

Primary spinal glioblastoma multiforme (GBM) of the conus medullaris is a rare and devastating pathologic entity. The presenting symptoms commonly include progressive neurologic deficits in the lower extremities, bowel and bladder dysfunction, and low back pain. Histologically, these tumors have high-grade features similar to their intracranial counterparts. However, recent advancements in the field of molecular oncology have been beginning to elucidate a unique molecular blueprint for these spinal gliomas. Given the lack of standardized treatment strategies, we have presented our institutional experience in treating a small series of patients with conus medullaris GBM and have reviewed the reported data on the relevant molecular markers, management strategies, and complication avoidance for this malignant pathologic entity.

Traumatic brain injury remains a leading cause of death and disability worldwide. Patients with severe traumatic brain injury are best treated with a multidisciplinary, evidence-based, protocol-directed approach, which has been shown to decrease mortality and improve functional outcomes. Therapy is directed at the prevention of secondary brain injury through optimizing cerebral blood flow and the delivery of metabolic fuel (ie, oxygen and glucose). This is accomplished through the measurement and treatment of elevated intracranial pressure (ICP), the strict avoidance of hypotension and hypoxemia, and in some instances, surgical management. The treatment of elevated ICP is approached in a protocolized, tiered manner, with escalation of care occurring in the setting of refractory intracranial hypertension, culminating in either decompressive surgery or barbiturate coma. With such an approach, the rates of mortality secondary to traumatic brain injury are declining despite an increasing incidence of traumatic brain injury. This review contains 3 figures, 5 tables and 69 reference Key Words: blast traumatic brain injury, brain oxygenation, cerebral perfusion pressure, decompressive craniectomy, hyperosmolar therapy, intracranial pressure, neurocritical care, penetrating traumatic brain injury, severe traumatic brain injury

Lumbar discectomy is largely successful surgical procedure; however, reherniation rates in patients with large annular defects are as high as 27%. The expense associated with a revision surgery places significant burden on the healthcare system.To compare the direct health care costs through 5 years follow-up of conventional discectomy (Control) with those of discectomy supplemented by an adjunctive annular closure device (ACD) in high-risk patients with large annular defects.This was a cost-effectiveness study.All-cause index level reoperations were reviewed from a multicenter, randomized controlled superiority trial that allocated 554 high-risk discectomy patients with large annular defects to either control or ACD. Medicare and private insurer (Humana) direct costs were derived from a commercially available payer database to estimate costs in the US healthcare system, including those associated with facility, surgeon, imaging, follow-up visits, physical therapy, and injections. A 50:50 split between Medicare and commercial insurers was assumed for the base case analysis. The analysis was also performed on a 80:20 commercial:Medicare payer basis. For the base case scenario, a 2-year time horizon and outpatient cost setting was established for the index procedure. Repeat discectomy was assumed to be performed on a 60:40 outpatient-to-inpatient basis. Complications requiring surgery, revisions, and/or fusion were assumed to be managed in the inpatient setting. Total costs of reoperation and per-patient costs of reoperation were compared between groups for both forms of insurers. One author received consulting fees of$50,000 for the completion of this study, and the other eight authors did not have any financial associations with the current work. Funding for this study was provided by Intrinsic Therapeutics, but all analyses, interpretation, and writing were performed independently by the authors.At two years follow-up, use of the ACD reduced the rate of symptomatic reherniations in a large defect population to 13% compared with 25% in the control group (p.001). This reduction in symptomatic reherniations in the ACD group translated to a savings of $2,802 per patient in direct health care costs compared with Control at 2 years and $5,315 per patient by 5 years based on 50% private and 50% public (Medicare) payer split. Under the scenario of 80:20 private:public insurance reimbursement, the estimated direct cost savings were $3,215 and $6,099 per patient at 2- and 5-years postoperatively, respectively, with the use of the ACD.Symptomatic reherniation and reoperation rates were nearly double among control patients compared with ACD-treated patients, which translated to markedly greater per-patient healthcare costs in the control group, where the ACD was not used.

Traumatic spinal cord injury currently affects approximately 285,000 persons in the United States and carries with it significant morbidity and cost. Early management focuses on adequate ventilation and hemodynamic resuscitation of the patient and limiting motion of the spine to prevent a second injury. Medical management targets maintenance of adequate blood flow to the spinal cord, whereas surgical management focuses on decompression, realignment, and stabilization of the vertebral column. In this chapter, we discuss the approach to the patient with traumatic spinal cord injury, injury types, and medical and surgical management. This review contains 9 figures, 4 tables and 30 references Key Words: American Spinal Injury Association score, burst fracture, Chance fracture, compression fracture, hangman, mean arterial pressure therapy, odontoid fracture, spinal cord injury, traction

Objective The purpose of this study was to determine reference values for the sagittal plane alignment of the thoracolumbar junction (TLJ) in a young adult Korean population. Methods Thoracolumbar computed tomography (CT) scans of 1000 individuals (age range, 20–39 years; 500 men and 500 women) from Hanyang University Health Care Center were reviewed. All subjects had no spinal pathology or a history of previous spinal surgery. The segmental (each level from T11 to L2) and global (T11-L1 and T11-L2) Cobb angles of the TLJ of the spine were measured in midsagittal CT scans. Moreover, comparisons between the 2 age groups (20s and 30s) and sexes were performed. Results The segmental Cobb angles of T11, T12, L1, and L2 were 6.5° ± 3.9°, 5.5° ± 4.1°, 2.2° ± 4.7°, and −3.3° ± 5.3°, respectively. The global Cobb angles of T11-L1 and T11-L2 were 6.5° ± 5.2° and 0.5° ± 6.1°, respectively. There were no differences in the sagittal alignment between the 2 age groups. Women presented less kyphotic and more lordotic alignment in the lumbar spine (L1 and L2) than men; however, the thoracic spine (T11 and T12) alignment was not different between the 2 groups. Conclusions This study provides reference values with a wide physiologic range for the sagittal alignment of the TLJ of the spine in a young adult Korean population.

BackgroundRigid interspinous process fixation (ISPF) has received consideration as an efficient, minimally disruptive technique in supporting lumbar interbody fusion. However, despite advantageous intraoperative utility, limited evidence exists characterizing midterm to long-term clinical outcomes with ISPF. The objective of this multicenter study was to prospectively assess patients receiving single-level anterior (ALIF) or lateral (LLIF) lumbar interbody fusion with adjunctive ISPF.MethodsThis was a prospective, randomized, multicenter (11 investigators), noninferiority trial. All patients received single-level ALIF or LLIF with supplemental ISPF (n = 66) or pedicle screw fixation (PSF; n = 37) for degenerative disc disease and/or spondylolisthesis (grade ≤2). The randomization patient ratio was 2:1, ISPF/PSF. Perioperative and follow-up outcomes were collected (6 weeks, 3 months, 6 months, and 12 months).ResultsFor ISPF patients, mean posterior intraoperative outcomes were: blood loss, 70.9 mL; operating time, 52.2 minutes; incision length, 5.5 cm; and fluoroscopic imaging time, 10.4 seconds. Statistically significant improvement in patient Oswestry Disability Index scores were achieved by just 6 weeks after operation (P

OBJECTIVEC1–2 is a highly mobile complex that presents unique surgical challenges to achieving biomechanical rigidity and fusion. Posterior wiring methods have been largely replaced with segmental constructs using the C1 lateral mass, C1 pedicle, C2 pars, and C2 pedicle. Modifications to reduce surgical morbidity led to the development of C2 laminar screws. The C1 posterior arch has been utilized mostly as a salvage technique, but recent data indicate that this method provides significant rigidity in flexion-extension and axial rotation. The authors performed biomechanical testing of a C1 posterior arch screw (PAS)/C2 pars screw construct, collected morphometric data from a population of 150 CT scans, and performed a feasibility study of a freehand C1 PAS technique in 45 cadaveric specimens.METHODSCervical spine CT scans from 150 patients were analyzed to determine the average C1 posterior tubercle thickness and size of C1 posterior arches. Eight cadavers were used to compare biomechanical stability of intact specimens, C1 lateral mass/C2 pars screw, and C1 PAS/C2 pars screw constructs. Paired comparisons were made using repeated-measures ANOVA and Holm-Sidak tests. Forty-five cadaveric specimens were used to demonstrate the feasibility and safety of the C1 PAS freehand technique.RESULTSMorphometric data showed the average craniocaudal thickness of the C1 posterior tubercle was 12.3 ± 1.94 mm. Eight percent (12/150) of cases showed thin posterior tubercles or midline defects. Average posterior arch thickness was 6.1 ± 1.1 mm and right and left average posterior arch length was 28.7 mm ± 2.53 mm and 28.9 ± 2.29 mm, respectively. Biomechanical testing demonstrated C1 lateral mass/C2 pars and C1 PAS/C2 pars constructs significantly reduced motion in flexion-extension and axial rotation compared with intact specimens (p < 0.05). The C1 lateral mass/C2 pars screw construct provided significant rigidity in lateral bending (p < 0.05). There was no statistically significant difference between the two constructs in flexion-extension, lateral bending, or axial rotation. Of the C1 posterior arches, 91.3% were successfully cannulated using a freehand technique with a low incidence of cortical breach (4.4%).CONCLUSIONSThis biomechanical analysis indicates equivalent stability of the C1 PAS/C2 pars screw construct compared with a traditional C1 lateral mass/C2 pars screw construct. Both provide significant rigidity in flexion-extension and axial rotation. Feasibility testing in 45 cadaveric specimens indicates a high degree of accuracy with low incidence of cortical breach. These findings are supported by a separate radiographic morphometric analysis.

Background The surgical treatment of cervical radiculopathy has centered around anterior cervical discectomy and fusion (ACDF). Alternatively, the posterior cervical laminoforaminotomy/microdiscectomy (PCF/PCM), which results in comparable outcomes and is more cost-effective, has been underutilized. Methods Here, we compared the direct/indirect costs, reoperation rates, and outcome for ACDF and PCF vs. PCM using PubMed, Medline, and Embase databases. Results There were no significant differences between the re-operative rates of PCF/PCM (2% to 9.8%) versus ACDF (2% to 8%). Direct costs of ACDF were also significantly higher; the 1-year cost-utility analysis demonstrated that ACDF had $131,951/QALY while PCM had $79,856/QALY. Conclusion PCF/PCM for radiculopathy are safe and more cost-effective vs. ACDF, and have similar clinical outcomes.

Traumatic spinal cord injury (SCI) is associated with a lifetime of disability stemming from loss of motor, sensory, and autonomic functions; these losses, along with increased comorbid sequelae, negatively impact health outcomes and quality of life. Early decompression surgery post-SCI can enhance patient outcomes, but does not directly facilitate neural repair and regeneration. Currently, there are no U.S. Food and Drug Administration–approved pharmacological therapies to augment motor function and functional recovery in individuals with traumatic SCI. After an SCI, the enzyme, Rho, is activated by growth-inhibitory factors and regulates events that culminate in collapse of the neuronal growth cone, failure of axonal regeneration, and, ultimately, failure of motor and functional recovery. Inhibition of Rho activation is a potential treatment for injuries such as traumatic SCI. VX-210, an investigational agent, inhibits Rho. When administered extradurally after decompression (corpectomy or laminectomy) and stabilization surgery in a phase 1/2a study, VX-210 was well tolerated. Here, we describe the design of the SPRING trial, a multicenter, phase 2b/3, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of VX-210 (NCT02669849). A subset of patients with acute traumatic cervical SCI is currently being enrolled in the United States and Canada. Medical, neurological, and functional changes are evaluated at 6 weeks and at 3, 6, and 12 months after VX-210 administration. Efficacy will be assessed by the primary outcome measure, change in upper extremity motor score at 6 months post-treatment, and by secondary outcomes that include question-based and task-based evaluations of functional recovery.