Osteoporosis as a Risk Factor for Intraoperative Complications and Long-term Instrumentation Failure in Patients With Scoliotic Spinal Deformity.

STUDY DESIGN: A retrospective review study. OBJECTIVE: This study aims to determine the effect of osteoporosis on spine instrumentation. SUMMARY OF BACKGROUND DATA: Osteoporosis is a common skeletal pathology that affects systemic cortical bone maintenance and remodeling. This disease accelerates the degeneration of the spine, often necessitating spinal surgery for progressive vertebral deformity, pathologic fracture, bony canal stenosis, and/or neural element decompression. There is a paucity of literature describing the role of osteoporosis as it relates to both perioperative complications and outcomes after spine fusion surgery. MATERIALS AND METHODS: A retrospective review was conducted of a prospectively maintained database for patients undergoing spine surgery between January 1, 2006 and October 3, 2017. Inclusion criteria included age 18 years and above and surgery performed for the correction of thoracolumbar scoliosis. Data collected included various demographic, clinical, and operative variables. RESULTS: A total of 532 patients met inclusion criteria, including 144 (27%) patients with a diagnosis of osteoporosis. Osteoporosis was significantly associated with increased blood volume loss (P=0.003). Postoperatively, osteoporosis was associated with increased rates of instrumentation failure (19% vs. 10%; P=0.008) and the need for revision surgery (33% vs. 16%; P<0.001). Multivariate analysis confirmed osteoporosis to be an independent risk factor for increased mean number of spinal segments fused (P<0.05), mean blood volume loss (P<0.05), rate of postoperative deep venous thrombosis/pulmonary embolism (P<0.05), rate of instrumentation failure (P<0.05), and need for revision surgery (P<0.05). CONCLUSION: Osteoporosis is a significant risk factor for instrumentation failure and need for revision surgery following arthrodesis for scoliosis correction. Furthermore, patients with osteoporosis have a significantly higher risk of intraoperative blood volume loss and postoperative thromboembolic events.

Developing and Implementing Noninvasive Ventilator Training in Haiti during the COVID-19 Pandemic.

Background: Noninvasive ventilation (NIV) is an important component of respiratory therapy for a range of cardiopulmonary conditions. The World Health Organization recommends NIV use to decrease the use of intensive care unit resources and improve outcomes among patients with respiratory failure during periods of high patient capacity from coronavirus disease (COVID-19). However, healthcare providers in many low- and middle-income countries, including Haiti, do not have experience with NIV. We conducted NIV training and evaluation in Port-au-Prince, Haiti. Objectives: To design and implement a multimodal NIV training program in Haiti that would improve confidence and knowledge of NIV use for respiratory failure. Methods: In January 2021, we conducted a 3-day multimodal NIV training consisting of didactic sessions, team-based learning, and multistation simulation for 36 Haitian healthcare workers. The course included 5 didactic session and 10 problem-based and simulation sessions. All course material was independently created by the study team on the basis of Accreditation Council for Continuing Medical Education-approved content and review of available evidence. All participants completed pre- and post-training knowledge-based examinations and confidence surveys, which used a 5-point Likert scale. Results: A total of 36 participants were included in the training and analysis, mean age was 39.94 years (standard deviation [SD] = 9.45), and participants had an average of 14.32 years (SD = 1.21) of clinical experience. Most trainees (75%, n = 27) were physicians. Other specialties included nursing (19%, n = 7), nurse anesthesia (3%, n = 1), and respiratory therapy (3%, n = 1). Fifty percent (n = 18) of participants stated they had previous experience with NIV. The majority of trainees (77%) had an increase in confidence survey score; the mean confidence survey score increased significantly after training from 2.75 (SD = 0.77) to 3.70 (SD = 0.85) (P < 0.05). The mean knowledge examination score increased by 39.63% (SD = 15.99%) after training, which was also significant (P < 0.001). Conclusion: This multimodal NIV training, which included didactic, simulation, and team-based learning, was feasible and resulted in significant increases in trainee confidence and knowledge with NIV. This curriculum has the potential to provide NIV training to numerous low- and middle-income countries as they manage the ongoing COVID-19 pandemic and rising burden of noncommunicable disease. Further research is necessary to ensure the sustainability of these improvements and adaptability to other low- and middle-income settings.

The Interdisciplinary Stem Cell Institute's Use of Food and Drug Administration-Expanded Access Guidelines to Provide Experimental Cell Therapy to Patients With Rare Serious Diseases.

The U.S. Food and Drug Administration (FDA) provides guidance for expanded access to experimental therapies, which in turn plays an important role in the Twenty-first Century Cures Act mandate to advance cell-based therapy. In cases of incurable diseases where there is a lack of alternative treatment options, many patients seek access to cell-based therapies for the possibility of treatment responses demonstrated in clinical trials. Here, we describe the use of the FDA's expanded access to investigational new drug (IND) to address rare and emergency conditions that include stiff-person syndrome, spinal cord injury, traumatic brain stem injury, complex congenital heart disease, ischemic stroke, and peripheral nerve injury. We have administered both allogeneic bone marrow-derived mesenchymal stem cell (MSC) and autologous Schwann cell (SC) therapy to patients upon emergency request using Single Patient Expanded Access (SPEA) INDs approved by the FDA. In this report, we present our experience with 10 completed SPEA protocols.

Sports-Related Cervical Spine Injuries - Background, Triage, and Prevention.

ABSTRACT: Cervical spinal injuries are a rare, but potentially devastating occurrence in sports. Although many of these injuries occur in unsupervised sports, they are also seen in organized sports - most commonly in football, wrestling, and ice hockey. Additionally, although each sport is associated with its own unique injury patterns, axial loading remains a common theme seen in cervical injuries associated with significant neurologic impairment. Regardless of the mechanism, a cautious and conservative approach should be taken with regards to evaluation, management, and return to play.

Effects of menopausal state on lumbar decompression and fusion surgery.

Menopause leads to fluctuations in androgenic hormones which directly affect bone metabolism. Bone resorption, mineralization, and remodeling at fusion sites are essential in order to obtain a solid and biomechanically stable fusion mass. Bone metabolic imbalance seen in the postmenopausal state may predispose to fusion related complications. The aim of this study was to investigate fusion outcomes in lumbar spinal fusion surgery in women based on menopausal status. A retrospective analysis of all female patients who underwent posterior lumbar decompression and fusion at a single institution from 2013 to 2017 was performed. A total of 112 patients were identified and stratified into premenopausal (n = 25) and postmenopausal (n = 87) groups. Clinical and radiographic data was assessed at 1 year follow up. Postmenopausal patients had a higher rates of pseudarthrosis (11.63% vs 0%, p = 0.08), PJK (15.1% vs 4%, p = 0.14), and revision surgery (3.5% vs 0%, p = 0.35). The number of levels fused was associated with increased risk of pseudarthrosis (OR 1.4, p = 0.02); however, there was no association between age, hormonal use, prior tobacco use, or T-score. Age was associated with increased risk of developing PJK (OR = 1.11, p = 0.01); however, PJK was not associated with menopause, hormonal use, prior tobacco use, or T-score. Revision surgery was not associated with age, hormonal use, prior tobacco use, or T-score. This study suggests that postmenopausal women may be prone to have higher rates of pseudarthrosis, PJK and revision surgery, although our results were not statistically significant. Larger studies with longer follow up will help elucidate the true effects of menopause in spine surgery.

Surgical Site Infection as a Risk Factor for Long-Term Instrumentation Failure in Patients with Spinal Deformity: A Retrospective Cohort Study.

BACKGROUND: Surgical site infection (SSI) remains a complication of spine deformity surgery. Although fusion/instrumentation failure in the setting of SSI has been reported, few studies have investigated the relationship between these entities. We examine the relationship between early SSI and fusion/instrumentation failure after instrumented fusion in patients with thoracolumbar scoliosis. METHODS: A retrospective review of a prospectively maintained case series for patients undergoing spine surgery between January 1, 2006, and October 3, 2017. Inclusion criteria included age ≥18 years and surgery performed for correction of thoracolumbar scoliosis. Data collected included various demographic, clinical, and operative variables. RESULTS: 532 patients met inclusion criteria, with 20 (4%) experiencing SSI. Diabetes mellitus was the only demographic risk factor for increased SSI (P = 0.026). Number of fused levels, blood volume loss, and operative time were similar between groups. Fusion/instrumentation failure occurred in 68 (13%) patients, 10 of whom (15%) had SSI, whereas of the 464 patients with no fusion/instrumentation failure, only 10 (2%) had SSI (P < 0.001). Of the 20 patients with SSI, 10 (50%) had fusion/instrumentation failure, whereas in the 512 patients with no infection, only 58 (11%) had fusion/instrumentation failure (P < 0.001). Patients with infection also experienced significantly shorter time to fusion/instrumentation failure (P = 0.025), higher need for revision surgery (P < 0.001), and shorter time to revision surgery (P = 0.012). CONCLUSIONS: Early SSI significantly increases the risk of fusion/instrumentation failure in patients with thoracolumbar scoliotic deformity, and it significantly shortens the time to failure. Patients with early SSI have a significantly higher likelihood of requiring revision surgery and after a significantly shorter time interval.

Short-term safety of tranexamic acid use in posterior cervical decompression and fusion surgery.

Posterior cervical decompression and fusion (PCDF) can result in substantial blood loss, leading to blood transfusions and associated complications, such as infections, hypotension and organ damage. The antifibrinolytic tranexamic acid (TXA), an inhibitor of the activation of plasminogen, has been shown to be beneficial in multiple surgical procedures without any apparent increase in postoperative complications. However, there are only few studies reporting TXA utilization in cervical spine surgery and there is currently no literature detailing the short-term safety of its use in this setting. The purpose of our study is to determine the safety profile of TXA in posterior cervical decompression and fusion. From January 2015 to April 2018, 47 patients were identified to have undergone PCDF, 19 with the utilization of a TXA protocol at our institution. The incidence of adverse events was evaluated in the perioperative period and at 1 month follow-up. Of 39 patients, Nineteen (49%) received TXA as per our instructional protocol and 20 (51%) did not. Post-operative blood was significantly reduced (453 ml vs 701 ml; p = 0.03) in the group that received TXA. There was also a significant reduction in duration of surgery associated with TXA use (269 min vs 328 min; p = 0.05). There were no complications on the first 30 days after surgical intervention on the TXA group. TXA use during PCDF is a safe, effective method to reduce postoperative blood loss. Considering the limited number of patients in this study, these results should be validated on a larger group of patients.

Imaging characteristics of chronic spinal cord injury identified during screening for a cell transplantation clinical trial.

OBJECTIVEIn cell transplantation trials for spinal cord injury (SCI), quantifiable imaging criteria that serve as inclusion criteria are important in trial design. The authors' institutional experience has demonstrated an overall high rate of screen failures. The authors examined the causes for trial exclusion in a phase I, open-lab clinical trial examining the role of autologous Schwann cell intramedullary transplantation. Specifically, they reviewed the imaging characteristics in people with chronic SCI that excluded applicants from the trial, as this was a common cause of screening failures in their study.METHODSThe authors reviewed MRI records from 152 people with chronic (> 1 year) SCI who volunteered for intralesional Schwann cell transplantation but were deemed ineligible by prospectively defined criteria. Rostral-caudal injury lesion length was measured along the long axis of the spinal cord in the sagittal plane on T2-weighted MRI. Other lesion characteristics, specifically those pertaining to lesion cavity structure resulting in trial exclusion, were recorded.RESULTSImaging records from 152 potential participants with chronic SCI were reviewed, 42 with thoracic-level SCI and 110 with cervical-level SCI. Twenty-three individuals (55%) with thoracic SCI and 70 (64%) with cervical SCI were not enrolled in the trial based on imaging characteristics. For potential participants with thoracic injuries who did not meet the screening criteria for enrollment, the average rostral-caudal sagittal lesion length was 50 mm (SD 41 mm). In applicants with cervical injuries who did not meet the screening criteria for enrollment, the average sagittal lesion length was 34 mm (SD 21 mm).CONCLUSIONSWhile screening people with SCI for participation in a cell transplantation clinical trial, lesion length or volume can exclude potential subjects who appear appropriate candidates based on neurological eligibility criteria. In planning future cell-based therapy trials, the limitations incurred by lesion size should be considered early due to the screening burden and impact on candidate selection.

Clinical and Neurophysiological Changes after Targeted Intrathecal Injections of Bone Marrow Stem Cells in a C3 Tetraplegic Subject.

High-level quadriplegia is a devastating condition with limited treatment options. Bone marrow derived stem cells (BMSCs) are reported to have immunomodulatory and neurotrophic effects in spinal cord injury (SCI). We report a subject with complete C2 SCI who received three anatomically targeted intrathecal infusions of BMSCs under a single-patient expanded access investigational new drug (IND). She underwent intensive physical therapy and was followed for >2 years. At end-point, her American Spinal Injury Association Impairment Scale (AIS) grade improved from A to B, and she recovered focal pressure touch sensation over several body areas. We conducted serial neurophysiological testing to monitor changes in residual connectivity. Motor, sensory, and autonomic system testing included motor evoked potentials (MEPs), somatosensory evoked potentials (SSEPs), electromyography (EMG) recordings, F waves, galvanic skin responses, and tilt-table responses. The quality and magnitude of voluntary EMG activations increased over time, but remained below the threshold of clinically obvious movement. Unexpectedly, at 14 months post-injury, deep inspiratory maneuvers triggered respiratory-like EMG bursting in the biceps and several other muscles. This finding means that connections between respiratory neurons and motor neurons were newly established, or unmasked. We also report serial analysis of MRI, International Standards for Neurological Classification of SCI (ISNCSCI), pulmonary function, pain scores, cerebrospinal fluid (CSF) cytokines, and bladder assessment. As a single case, the linkage of the clinical and neurophysiological changes to either natural history or to the BMSC infusions cannot be resolved. Nevertheless, such detailed neurophysiological assessment of high cervical SCI patients is rarely performed. Our findings indicate that electrophysiology studies are sensitive to define both residual connectivity and new plasticity.

A novel technique for stabilization of high-grade spondylolisthesis with transvertebral fusion without reduction.

Surgical treatment of high-grade spondylolisthesis and spondyloptosis is recommended in symptomatic patients, yet there exists much debate regarding the optimal surgical approach and the need for reduction. Similar to the Bohlman technique in that fixation is achieved across two vertebral endplates, we discuss a novel technique with the advantage of using bilateral threaded pedicle screws of large diameter and length instead of a single fibula allograft. Patients underwent posterior instrumented fusion without spondylolisthesis reduction using a novel technique placing pedicle screws with a transvertebral trajectory through the two end plates involved in the spondylolisthesis. Following screw placement, patients underwent decompression ±â€¯discectomy. Screws were connected to adjacent pedicle screws either in the upper adjacent vertebrae (i.e. L5) or the more rostral adjacent vertebrae (i.e. L4) if spinal alignment or instability necessitate including additional levels of fixation. Three patients were reviewed with ages of 67, 62, 58 years, operative times of 377-790 min, estimated blood loss 400-1050 cc, and follow-up times of 478-1082 days. There were no CSF leaks, intragenic neurologic deficits post-operatively, implant failures, revisions, or other systemic events. Two patients achieve radiographic fusion assessed by CT. At the time of final follow up, all patients were satisfied and essentially pain free. This one-stage technique offers the ability to manage local malalignment with a technique that inherently minimizes risk. The minimal complications and favorable outcomes make this technique an effective, efficient and safe procedure. Additional studies will focus on long term outcomes and should include larger patient samples.

Preoperative skin antisepsis with chlorhexidine gluconate versus povidone-iodine: a prospective analysis of 6959 consecutive spinal surgery patients.

OBJECTIVE The aim of this study was to determine the efficacy of 2 common preoperative surgical skin antiseptic agents, ChloraPrep and Betadine, in the reduction of postoperative surgical site infection (SSI) in spinal surgery procedures. METHODS Two preoperative surgical skin antiseptic agents-ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol) and Betadine (7.5% povidone-iodine solution)-were prospectively compared across 2 consecutive time periods for all consecutive adult neurosurgical spine patients. The primary end point was the incidence of SSI. RESULTS A total of 6959 consecutive spinal surgery patients were identified from July 1, 2011, through August 31, 2015, with 4495 (64.6%) and 2464 (35.4%) patients treated at facilities 1 and 2, respectively. Sixty-nine (0.992%) SSIs were observed. There was no significant difference in the incidence of infection between patients prepared with Betadine (33 [1.036%] of 3185) and those prepared with ChloraPrep (36 [0.954%] of 3774; p = 0.728). Neither was there a significant difference in the incidence of infection in the patients treated at facility 1 (52 [1.157%] of 4495) versus facility 2 (17 [0.690%] of 2464; p = 0.06). Among the patients with SSI, the most common indication was degenerative disease (48 [69.6%] of 69). Fifty-one (74%) patients with SSI had undergone instrumented fusions in the index operation, and 38 (55%) patients with SSI had undergone revision surgeries. The incidence of SSI for minimally invasive and open surgery was 0.226% (2 of 885 cases) and 1.103% (67 of 6074 cases), respectively. CONCLUSIONS The choice of either ChloraPrep or Betadine for preoperative skin antisepsis in spinal surgery had no significant impact on the incidence of postoperative SSI.

Changes in Cervical Alignment after Multilevel Schwab Grade II Thoracolumbar Osteotomies for Adult Spinal Deformity.

STUDY DESIGN: A retrospective cohort. OBJECTIVE: The aim of this study was to describe changes in cervical alignment (CA) and cervical deformity (CD) after multilevel Schwab Grade II Osteotomies for adult spinal deformity (ASD). SUMMARY OF BACKGROUND DATA: Reciprocal cervical and global changes after ASD surgery have not been previously described in the setting of multilevel osteotomy. METHODS: Patients with long-segment (> five levels) fusion and osteotomy for ASD were radiographically evaluated. Pre- and postoperative cervical parameters evaluated included cervical lordosis (CL), C2-C7 sagittal vertical axis (C2-C7 SVA), and the T1 slope (T1S) minus the CL (T1S-CL). CD was defined as C2-C7 SVA >4 cm, CL < 0°, or T1S-CL ≥15°. RESULTS: Eighty-five patients (mean age 64 ±â€Š11.1) were identified. Preoperative lumbar lordosis (LL) was 28.7°â€Š±â€Š13.8°, thoracic kyphosis (TK) was 28.2°â€Š±â€Š17.0°, C7 plumbline (C7 SVA) was 7.54 ±â€Š6.7 cm, pelvic tilt (PT) was 30.0°â€Š±â€Š8.96°, lumbopelvic mismatch was 32°â€Š±â€Š17.1°, and the T1 pelvic angle (TPA) was 26.8°â€Š±â€Š12.9°. The C7 SVA and TPA corrected to 3.90 cm (P < 0.0001) and 17.5°, respectively (P < 0.0001). CD increased from 41 (48%) to 47 (55%) patients. The mean CL changed from 16.5° to 11.9° (P < 0.013), C2 SVA from 10.1 to 6.37 cm (P < 0.0001), T1S-CL from 10.2° to 14.3° (P = 0.021), and TK from 28° to 39° (P < 0.0001). A correlation was observed between T1S and CL (ρ = 0.435, P < 0.0001) and C2-C7 SVA (ρ = 0.624, P < 0.0001). T1S was the only independent predictor of both the postoperative C2-C7 SVA and CL.In this study, the presence of any single preoperative CD criterion was noted to be a risk for persistent global deformity on postoperative radiograph [odds ratio (OR) = 2.5] and the development of PJK (OR = 2.1). The T1-CL < 15° may indicate an even greater risk for persistent global deformity (OR = 3.5). CONCLUSION: Thoracolumbar fusion with multilevel Schwab Grade II Osteotomies was associated with a decreased CL and reciprocal increases in TK and T1S-CL. LEVEL OF EVIDENCE: 3.

Multilevel Schwab grade II osteotomies for sagittal plane correction in the management of adult spinal deformity.

BACKGROUND CONTEXT: Prior reports have compared posterior column osteotomies with pedicle subtraction osteotomies in terms of utility for correcting fixed sagittal imbalance in adolescent patients with deformity. No prior reports have described the use of multilevel Smith-Petersen Osteotomies (SPOs) alone for surgical correction in the adult spinal deformity (ASD) population. PURPOSE: The study aimed to determine the utility of multilevel SPOs in the management of global sagittal imbalance in ASD patients. STUDY DESIGN/SETTING: This is a retrospective observational study at a single academic center. PATIENT SAMPLE: The sample included 85 ASD patients. OUTCOME MEASURES: This is a radiographic outcomes cohort study. METHODS: The radiographs of 85 ASD patients were retrospectively evaluated before and after long-segment (>5 spinal levels) fusion and multilevel SPO (≥3 levels) for sagittal imbalance correction. The number of osteotomies, correction in regional lumbar lordosis (LL), and correction per osteotomy was evaluated. Independent predictors of correction per SPO were evaluated with a hierarchical linear regression analysis. RESULTS: Eighty-five patients (mean age: 67.5±11 years) were identified with ASD (372 SPOs). The mean preoperative sagittal vertical axis (SVA) and T1 pelvic angle (TPA) were 8.16±6.75 cm and 25°±13.23°, respectively. The mean postoperative central sacral vertical line (CSVL) and SVA were 0.67±0.70 cm and 1.29±5.41 cm, respectively. The mean improvement in SVA was 6.29 cm achieved with a correction of approximately 5.05° per SPO. The mean LL restoration was 20.3°±13.9°, and 33(39%) patients achieved a final pelvic incidence minus lumbar lordosis (PI-LL) ≤10°. Fifty-four (64%) achieved a postoperative PI-LL ≤15°, 75 (88%) with a PI-LL ≤20°, and 85 (100%) achieved a PI-LL ≤25°. Correction per SPO was similar regardless of prior fusion (4.87° vs. 5.72° for revisions, p=.192). In a subgroup analysis of SVA greater than 10 cm, there was no significant difference in the final LL, thoracic kyphosis, PI-LL, SVA, CSVL, and TPA, as compared with SVA <10 cm. The LL was the only independent predictor of osteotomy correction per level (LL: ß coefficient=-0.108, confidence interval: -0.141 to 0.071, p<.0001). CONCLUSIONS: Multilevel SPOs are feasible for restoration of LL as well as sagittal and coronal alignment in the ASD population with or without prior instrumented fusion.

Prophylactic vertebral cement augmentation at the uppermost instrumented vertebra and rostral adjacent vertebra for the prevention of proximal junctional kyphosis and failure following long-segment fusion for adult spinal deformity.

BACKGROUND CONTEXT: Proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) are common problems after long-segment (>5 levels) thoracolumbar instrumented fusions in the treatment of adult spinal deformity (ASD). No specific surgical strategy has definitively been shown to lower the risk of PJK as the result of a multifactorial etiology. PURPOSE: The study aimed to assess the incidence of PJK and PJF in patients treated with prophylactic polymethylmethacrylate (PMMA) cement augmentation at the uppermost instrumented vertebrae (UIV) and rostral adjacent vertebrae (UIV+1). STUDY DESIGN/SETTING: This is a retrospective cohort-matched surgical case series at an academic institutional setting. PATIENT SAMPLE: Eighty-five adult patients over a 16-year enrollment period were identified with long-segment (>5 levels) posterior thoracolumbar instrumented fusions for ASD. OUTCOME MEASURES: Primary outcomes measures were PJK magnitude and PJF formation. Secondary outcomes measures were spinopelvic parameters, as well as global and regional sagittal alignment. METHODS: The impact of adjunctive PMMA use in long-segment (≥5 levels) fusion for ASD was assessed in adult patients aged 18 and older. Patients were included with at least one of the following: lumbar scoliosis >20°, pelvic tilt >25°, sagittal vertical axis >5 cm, central sacral vertical line >2 cm, and thoracic kyphosis >60°. The frequency of PJF and the magnitude of PJK were measured radiographically preoperatively, postoperatively, and at maximum follow-up in controls (Group A) and PMMA at the UIV and UIV+1 (Group B). RESULTS: Eighty-five patients (64±11.1 years) with ASD were identified: 47 control patients (58±10.6) and 38 patients (71±6.8) treated with PMMA at the UIV and UIV+1. The mean follow-up was 27.9 and 24.2 months in Groups A and B, respectively (p=.10). Preoperative radiographic parameters were not significantly different, except the pelvic tilt which was greater in Group A (26.6° vs. 31.4°, p=.03). Postoperatively, the lumbopelvic mismatch was greater in Group B (14.6° vs. 7.9°, p=.037), whereas the magnitude of PJK was greater in controls (9.36° vs. 5.65°, p=.023). The incidence of PJK was 36% (n=17) and 23.7% (n=9) in Groups A and B, respectively (p=.020). The odds ratio of PJK with vertebroplasty was 0.548 (95% confidence interval=0.211 to 1.424). Proximal junctional kyphosis was observed in 6 (12.8%) controls only (p=.031). The UIV+1 angle, a measure of PJK, was significantly greater in controls (10.0° vs. 6.8°, p=.02). No difference in blood loss was observed. No complications were attributed to PMMA use. CONCLUSIONS: The use of prophylactic vertebral cement augmentation at the UIV and rostral adjacent vertebral segment at the time of deformity correction appears to be preventative in the development of proximal junctional kyphosis and failure.

Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury.

The rationale for implantation of autologous human Schwann cells (SCs) in persons with subacute spinal cord injury (SCI) is based on evidence that transplanted SCs are neuroprotective, support local axonal plasticity, and are capable of myelinating axons. A Phase I clinical trial was conducted to evaluate the safety of autologous human SC transplantation into the injury epicenter of six subjects with subacute SCI. The trial was an open-label, unblinded, non-randomized, non-placebo controlled study with a dose escalation design and standard medical rehabilitation. Participants were paraplegics with neurologically complete, trauma-induced spinal lesions. Autologous SCs were cultured in vitro from a sural nerve harvested from each participant and injected into the epicenter of the spinal lesion. Outcome measures for safety were protocol compliance, feasibility, adverse events, stability of neurological level, absence of detectable mass lesion, and the emergence of clinically significant neuropathic pain or muscle spasticity no greater than expected for a natural course cohort. One year post-transplantation, there were no surgical, medical, or neurological complications to indicate that the timing or procedure for the cell transplantation was unsafe. There were no adverse events or serious adverse events related to the cell therapy. There was no evidence of additional spinal cord damage, mass lesion, or syrinx formation. We conclude that it is feasible to identify eligible candidates, appropriately obtain informed consent, perform a peripheral nerve harvest to obtain SCs within 5-30 days of injury, and perform an intra-spinal transplantation of highly purified autologous SCs within 4-7 weeks of injury.

Excision of a centrally based ventral intradural extramedullary tumor of the cervical spine through a direct posterior approach.

INTRODUCTION: Intradural extramedullary (IDEM) tumors of the cervical spine are removed through an assortment of surgical approaches including: dorsolateral, ventrolateral, and anterior or transoral. Historically, midline ventral IDEM tumors are ostensibly thought to be unfavorable candidates for removal through a direct posterior approach. A case report of a patient with a ventrally based centrally located meningioma in the upper cervical spine (C2/C3) that was removed with direct posterior approach is described. CASE PRESENTATION: A 51-year-old male presented with cervicalgia and radiating scapular pain following a remote motor vehicle collision. A ventrally located meningioma in relation to the C2 body was noted on MRI. Management of this patient included obtaining adequate exposure through a posterior approach, complete tumor excision, and maintenance of cervical spine stability. Cervical stability was maintained following total unilateral facetectomy and application of instrumentation from C1-C3. DISCUSSION: Subsequent to tumor removal, the patient had complete resolution of his cervicalgia, headaches, and scapular pain by his two month follow-up appointment. Although adhesions can make total resection difficult, a posterior approach can grant adequate access to midline ventral meningiomas. Cervical spine stability, tumor location, infection risk, and surgeon familiarity with the approach should all be weighed in decision-making.

Magnetic resonance imaging-based measures predictive of short-term surgical outcome in patients with Chiari malformation Type I: a pilot study.

OBJECTIVE This study identifies quantitative imaging-based measures in patients with Chiari malformation Type I (CM-I) that are associated with positive outcomes after suboccipital decompression with duraplasty. METHODS Fifteen patients in whom CM-I was newly diagnosed underwent MRI preoperatively and 3 months postoperatively. More than 20 previously described morphological and physiological parameters were derived to assess quantitatively the impact of surgery. Postsurgical clinical outcomes were assessed in 2 ways, based on resolution of the patient's chief complaint and using a modified Chicago Chiari Outcome Scale (CCOS). Statistical analyses were performed to identify measures that were different between the unfavorable- and favorable-outcome cohorts. Multivariate analysis was used to identify the strongest predictors of outcome. RESULTS The strongest physiological parameter predictive of outcome was the preoperative maximal cord displacement in the upper cervical region during the cardiac cycle, which was significantly larger in the favorable-outcome subcohorts for both outcome types (p < 0.05). Several hydrodynamic measures revealed significantly larger preoperative-to-postoperative changes in the favorable-outcome subcohort. Predictor sets for the chief-complaint classification included the cord displacement, percent venous drainage through the jugular veins, and normalized cerebral blood flow with 93.3% accuracy. Maximal cord displacement combined with intracranial volume change predicted outcome based on the modified CCOS classification with similar accuracy. CONCLUSIONS Tested physiological measures were stronger predictors of outcome than the morphological measures in patients with CM-I. Maximal cord displacement and intracranial volume change during the cardiac cycle together with a measure that reflects the cerebral venous drainage pathway emerged as likely predictors of decompression outcome in patients with CM-I.