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INTRODUCTION: Spinal cord injury (SCI) is a devastating injury and remains one of the largest medical and social burdens because of its intractable nature. According to the recent advances in stem cell biology, the possibility of spinal cord regeneration and functional restoration has been suggested by introducing appropriate stem cells. Multilineage-differentiating stress enduring (Muse) cells are a type of nontumorigenic endogenous reparative stem cell. The positive results of Muse cell transplantation for SCI was shown previously. As a first step for clinical application in human SCI, we conducted a clinical trial aiming to confirm the safety and feasibility of intravenously injected donor-Muse cells. METHODS: The study design of the current trial was a prospective, multicenter, nonrandomized, nonblinded, single-arm study. The clinical trial registration number was JRCT1080224764. Patients with a cervical SCI with a neurological level of injury C4 to C7 with the severity of modified Frankel classification B1 and B2 were included. A primary endpoint was set for safety and feasibility. Our protocol was approved by the PMDA, and the trial was funded by the Life Science Institute, Tokyo, Japan. The present clinical trial recruited 10 participants (8 males and 2 females) with an average age of 49.3 ± 21.2 years old. All 10 participants received a single dose of allogenic CL2020 (a total of 15 × 106 cells, 2.1-2.7 × 105 cells/kg of body weight), which is a Muse cell-based product produced from human mesenchymal stem cells, by an intravenous drip. RESULTS: There were two reported severe adverse events, both of which were determined to have no causal relationship with Muse cell treatment. The change in the ISNCSCI motor score, the activity of daily living and quality of life scores showed statistically significant improvements compared to those data at the time of CL2020 administration. CONCLUSION: In the present trial, no safety concerns were identified, and Muse cell product transplantation demonstrated good tolerability. Future clinical trials with appropriate study designs incorporating a control arm will clarify the definitive efficacy of single-dose allogenic Muse cell treatment with intravenous administration to treat SCI. TRIAL REGISTRATION: jRCT, JRCT1080224764. Registered 03 July 2019, https://jrct.niph.go.jp/latest-detail/jRCT1080224764 .
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Administration, Intravenous , Spinal Cord Injuries , Humans , Spinal Cord Injuries/therapy , Female , Male , Adult , Middle Aged , Feasibility Studies , Prospective Studies , Aged , Cervical VertebraeABSTRACT
OBJECTIVE: This study aimed to elucidate postoperative outcomes in patients with spinal metastases of prostate cancer, with a focus on patient-oriented assessments. METHODS: This was a prospective multicenter registry study involving 35 centers. A total of 413 patients enrolled in the Japanese Association for Spine Surgery and Oncology Multicenter Prospective Study of Surgery for Metastatic Spinal Tumors were evaluated for inclusion. The eligible patients were followed for at least 1 year after surgery. The Frankel Classification, Eastern Cooperative Oncology Group Performance Status, visual analog scale for pain, face scale, Barthel Index, vitality index, indications for oral pain medication, and the EQ-5D-5L questionnaire were used for evaluating functional status, activities of daily living, and patient motivation. RESULTS: Of the 413 eligible patients, 41 with primary prostate cancer were included in the study. The patient-oriented assessments indicated that the patients experienced postoperative improvements in quality of life and motivation in most items, with the improvements extending for up to 6 months. More than half of the patients with Frankel classifications B or C showed improved neurological function at 1 month after surgery, and most patients presented maintained or improved their classification at 6 months. CONCLUSION: Surgical intervention for spinal metastases of prostate cancer significantly improved neurological function, quality of life, and motivation of the patients. Consequently, our results support the validity of surgical intervention for improving the neurological function and overall well-being of patients with spinal metastases of prostate cancer.
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STUDY DESIGN: Multicenter, prospective registry study. OBJECTIVE: To clarify minimal clinically important differences (MCIDs) for surgical interventions for spinal metastases, thereby enhancing patient care by integrating quality of life (QoL) assessments with clinical outcomes. SUMMARY OF BACKGROUND DATA: Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases. METHODS: This study included 171 (out of 413) patients from the multicenter "Prospective Registration Study on Surgery for Metastatic Spinal Tumors" by the Japan Association of Spine Surgeons. These were evaluated preoperatively and at 6 months postoperatively using the Face scale, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), including the visual analog scale (VAS), and performance status. The MCIDs were calculated using an anchor-based method, classifying participants into the improved, unchanged, and deteriorated groups based on the Face scale scores. Focusing on the improved and unchanged groups, the change in the EQ-5D-5L values from before to after treatment was analyzed, and the cutoff value with the highest sensitivity and specificity was determined as the MCID through receiver operating characteristic curve analysis. The validity of the MCIDs was evaluated using a distribution-based calculation method for patient-reported outcomes. RESULTS: The improved, unchanged, and deteriorated groups comprised 121, 28, and 22 participants, respectively. The anchor-based MCIDs for the EQ-5D-5L index, EQ-VAS, and domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were 0.21, 15.50, 1.50, 0.50, 0.50, 0.50, and 0.50, respectively; the corresponding distribution-based MCIDs were 0.17, 15,99, 0.77, 0.80, 0.78, 0.60, and 0.70, respectively. CONCLUSION: We identified MCIDs for surgical treatment of spinal metastases, providing benchmarks for future clinical research. By retrospectively examining whether the MCIDs are achieved, factors favoring their achievement and risks affecting them can be explored. This could aid in decisions on surgical candidacy and patient counseling.
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There are not many reports on cervical spine alignment, and only a few analyze ideal surgical approaches and optimal amounts of correction needed for the various types of deformity. We comprehensively reviewed the present literature on cervical spinal deformities (with or without myelopathy) and their surgical management to provide a framework for surgical planning. A general assessment of the parameters actually in use and correlations between cervical and thoracolumbar spine alignment are provided. We also analyzed posterior, anterior, and combined cervical surgical approaches and indications for the associated techniques of laminoplasty, laminectomy and fusion, and anterior cervical discectomy and fusion. Finally, on the basis of the NDI, SF-36, VAS, and mJOA questionnaires, we fully evaluated the outcomes and measures of postoperative health-related quality of life. We found the need for additional prospective studies to further enhance our understanding of the importance of cervical alignment when assessing and treating cervical deformities with or without myelopathy. Future studies need to focus on correlations between cervical alignment parameters, disability scores, and myelopathy outcomes. Through this comprehensive literature review, we offer guidance on practical and important points of surgical technique, cervical alignment, and goals surgeons can meet to improve symptoms in all patients.
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The age-related degenerative pathologies of the cervical spinal column that comprise degenerative cervical myelopathy (DCM) cause myelopathy due spinal cord compression. Functional neurological assessment of DCM can potentially reveal the severity and pathological mechanism of DCM. However, functional assessment by conventional MRI remains difficult. This study used resting-state functional MRI (rs-fMRI) to investigate the relationship between functional connectivity (FC) strength and neurophysiological indices and examined the feasibility of functional assessment by FC for DCM. Preoperatively, 34 patients with DCM underwent rs-fMRI scans. Preoperative central motor conduction time (CMCT) reflecting motor functional disability and intraoperative somatosensory evoked potentials (SEP) reflecting sensory functional disability were recorded as electrophysiological indices of severity of the cervical spinal cord impairment. We performed seed-to-voxel FC analysis and correlation analyses between FC strength and the two electrophysiological indices. We found that FC strength between the primary motor cortex and the precuneus correlated significantly positively with CMCT, and that between the lateral part of the sensorimotor cortex and the lateral occipital cortex also showed a significantly positive correlation with SEP amplitudes. These results suggest that we can evaluate neurological and electrophysiological severity in patients with DCM by analyzing FC strengths between certain brain regions.
Subject(s)
CME-Carbodiimide/analogs & derivatives , Sensorimotor Cortex , Spinal Cord Compression , Spinal Cord Diseases , Humans , Spinal Cord Compression/surgery , Spinal Cord Diseases/diagnostic imaging , Cervical Vertebrae/surgery , Magnetic Resonance Imaging , Sensorimotor Cortex/diagnostic imagingABSTRACT
PURPOSE: The disc level in the thoracolumbar junction at which measurement of the central motor conduction time in the lower limbs (CMCT-LL) is useful for a diagnosis remains unclear. Therefore, this study investigated the spinal vertebral level at which compressive myelopathy due to ossification of the ligamentum flavum in the thoracolumbar junction is detectable using CMCT-LL. METHODS: We preoperatively measured CMCT-LL in 57 patients (42 men, 15 women; aged 35-85 years) with a single ossification of the ligamentum flavum from the T10-11 to T12-L1 disc levels and in 53 healthy controls. Motor evoked potentials after transcranial magnetic stimulation, compound muscle action potentials, and F waves were recorded from the abductor hallucis. Central motor conduction time in the lower limbs was calculated as follows: Motor evoked potential latency - (compound muscle action potential latency + F latency - 1)/2 (ms). Central motor conduction time in the lower limbs was compared between patients and controls. RESULTS: Compressive lesions were located at the T10 to 11 level in 27 patients, the T11 to 12 level in 28, and the T12-L1 level in 2. Central motor conduction time values in the lower limbs at the T10 to 11 level (19.9 ± 4.7 ms) and T11 to 12 level (18.1 ± 3.4 ms) were significantly longer than control values (11.8 ± 1.1 ms; P < 0.01). Central motor conduction time in the lower limbs was not calculated at the T12-L1 level because motor evoked potentials were not recorded in any patient. CONCLUSIONS: We confirmed that CMCT-LL was significantly longer in patients with ossification of the ligamentum flavum at the T10 to 11 and T11 to 12 levels because the S2 segment of the spinal cord is caudal at the T12 vertebral body level. Therefore, CMCT-LL is useful for diagnosing thoracolumbar junction disorders proximal to the T12 vertebral body level.
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BACKGROUND: Osteosarcoma, the most common primary malignant bone tumor in childhood, very rarely occurs in the spine. Criteria of complete tumor resection/stable reconstruction of osteosarcoma and the latest protocol of neoadjuvant chemotherapy of the spine have not been reported because of its rarity, technical difficulties, and its continued severe surgical risk. CASE REPORT: A 11-year-old female complained of back pain for several months and walking disability. The workup discovered a large destructive bone lesion in the thoracic 12th (Th12) with vertebral body collapse and subluxation, large amount of associated anteroposterior soft tissue components, and narrowing of the spinal canal. Histology at the 1st decompression and emergent instrumentation surgery revealed giant cell-rich osteosarcoma. Following the 1st surgery, we performed three cycles of neoadjuvant chemotherapy based on the osteosarcoma 95J (NECO95J) protocol and evaluated efficacy of chemotherapy on the Th12 tumor. The tumor was isolated only to Th12 spine following chemotherapy. Therefore, following vascular embolization of the Th12 tumor, we performed surgical resection by single posterior approach that included total en bloc spondylectomy (TES). She recovered well postoperatively, without motor or sensory deficit and no back pain. Six cycles of postoperative neoadjuvant chemotherapy were administered after the 2nd surgery and TES. The patient was disease-free at the 8-months clinical and radiological follow-up and showed no neurological involvement at 8-months. CONCLUSION: We reported a case of pediatric spinal osteosarcoma, the surgical technique of complete tumor resection, and stable reconstruction of spinal osteosarcoma. We also discussed the recent neoadjuvant chemotherapy protocol for osteosarcoma.
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Osteosarcoma , Spinal Neoplasms , Female , Humans , Child , Follow-Up Studies , Spinal Neoplasms/diagnostic imaging , Spinal Neoplasms/surgery , Spine/pathology , Osteosarcoma/surgery , Giant Cells/pathologyABSTRACT
STUDY DESIGN: Prospective multicenter study. OBJECTIVE: To investigate the validity of transcranial motor-evoked potentials (Tc-MEP) in thoracic spine surgery and evaluate the impact of specific factors associated with positive predictive value (PPV). METHODS: One thousand hundred and fifty-six cases of thoracic spine surgeries were examined by comparing patient backgrounds, disease type, preoperative motor status, and Tc-MEP alert timing. Tc-MEP alerts were defined as an amplitude decrease of more than 70% from the baseline waveform. Factors were compared according to preoperative motor status and the result of Tc-MEP alerts. Factors that showed significant differences were identified by univariate and multivariate analysis. RESULTS: Overall sensitivity was 91.9% and specificity was 88.4%. The PPV was significantly higher in the preoperative motor deficits group than in the preoperative no-motor deficits group for both high-risk (60.3% vs 38.3%) and non-high-risk surgery groups (35.1% vs 12.8%). In multivariate logistic analysis, the significant factors associated with true positive were surgical maneuvers related to ossification of the posterior longitudinal ligament (odds ratio = 11.88; 95% CI: 3.17-44.55), resection of intradural intramedullary spinal cord tumor (odds ratio = 8.83; 95% CI: 2.89-27), preoperative motor deficit (odds ratio = 3.46; 95% CI: 1.64-7.3) and resection of intradural extramedullary spinal cord tumor (odds ratio = 3.0; 95% CI: 1.16-7.8). The significant factor associated with false positive was non-attributable alerts (odds ratio = .28; 95% CI: .09-.85). CONCLUSION: Surgeons are strongly encouraged to use Tc-MEP in patients with preoperative motor deficits, regardless of whether they are undergoing high-risk spine surgery or not. Knowledge of PPV characteristics will greatly assist in effective Tc-MEP enforcement and minimize neurological complications with appropriate interventions.
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Quantitative sensory testing (QST) is useful when analysing musculoskeletal pain disorders. A handheld algometer is most commonly used for pressure pain threshold (PPT) tests. However, reference intervals for PPTs are not elucidated. We assessed reference intervals of PPTs for QST in 158 healthy adult Japanese with no history of musculoskeletal or neurological problems. A handheld algometer was used to record PPT at five different assessment sites on the body: lumbar paravertebral muscle, musculus gluteus maximus, quadriceps, tibialis anterior muscle, and anterior talofibular ligament. Multiple regression analysis was performed to explore sources of variation of PPT according to sex, age, body mass index, UCLA Activity Level Rating, and Tegner Activity Score. Reference intervals were determined parametrically by Gaussian transformation of PPT values using the two-parameter Box-Cox formula. Results of multiple regression analysis revealed that age was significantly associated with PPT of lumbar paravertebral muscle and musculus gluteus maximus. In females, body mass index showed significant positive correlation with PPT of anterior talofibular ligament, and UCLA Activity Level Rating also showed significant positive association with tibialis anterior muscle and anterior talofibular ligament. Site-specific reference intervals of PPTs for Japanese are of practical relevance in fields of pain research using a handheld algometer.
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East Asian People , Musculoskeletal Pain , Pain Measurement , Pain Threshold , Adult , Female , Humans , Muscle, Skeletal , Pain Measurement/instrumentation , Pain Measurement/methods , Pain Threshold/physiology , Musculoskeletal Pain/diagnosis , Musculoskeletal Pain/physiopathology , Pressure , Reference Values , Healthy VolunteersABSTRACT
OBJECTIVE: Thoracolumbar vertebral fractures are one of the most common fractures; however, there is a lack of mechanical analyses for what the posterior fixation is for different spine alignments. METHODS: This study used a three-dimensional finite element model of a T1-sacrum. Three alignment models were created: intact, degenerative lumbar scoliosis (DLS), and adolescent idiopathic scoliosis (AIS). The burst fracture was assumed to be at the L1 vertebral level. Posterior fixation models with pedicle screws (PS) were constructed for each model: 1 vertebra above to 1 below PS (4PS) and 1 vertebra above to 1 below PS with additional short PS at the L1 (6PS); intact-burst-4PS, intact-burst-6PS, DLS-burst-4PS, DLS-burst-6PS, AIS-burst-4PS, and AIS-burst-6PS models. T1 was loaded with a moment of 4 Nm assuming flexion and extension. RESULTS: The vertebrae stress varied with spinal alignment. The stress of L1 in intact burst (IB), DLS burst, and AIS burst increased by more than 190% compared with each nonfractured model. L1 stress in IB, DLS, and AIS-4PS increased to more than 47% compared with each nonfractured model. L1 stress in IB, DLS, and AIS-6PS increased to more than 25% compared with each nonfractured model. In flexion and extension, stress on the screws and rods of intact-burst-6PS, DLS-6PS, and AIS-6PS was lower than in the intact-burst-4PS, DLS-4PS, and AIS-4PS models. CONCLUSIONS: It may be more beneficial to use 6PS compared with 4PS to reduce stresses on the fractured vertebrae and instrumentation, regardless of the spinal alignment.
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BACKGROUND: The weakness of the tibialis anterior remains to be a controversial topic. There has been no study that used electrophysiological assessment of the function of the lumbar and sacral peripheral motor nerves. The aim is to evaluate surgical outcomes in patients with weakness of the tibialis anterior using neurological and electrophysiological assessments. METHODS: We enrolled 53 patients. Tibialis anterior weakness was quantified by muscle strength, as assessed using a manual muscle test on a scale of 1 through 5, with scores <5 indicating weakness. Postoperative improvement in muscle strength was classified as excellent (5 grades recovered), good (more than one grade recovered), or fair (less than one grade recovered). RESULTS: Surgical outcomes for tibialis anterior function were categorized as "excellent" in 31, "good" in 8, "fair" in 14 patients. Significant difference in outcomes were observed depending on diabetes mellitus status, type of surgery, and the compound muscle action potentials amplitudes of the abductor hallucis and extensor digitorum brevis (p < 0.05). Surgical outcomes were classified into two groups, patients with excellent and good outcomes (Group 1) and patients with fair outcome (Group 2). Using the forward selection stepwise method, sex and the compound muscle action potentials amplitudes of the extensor digitorum brevis were identified as significant factors for their positive association with Group 1 status. The diagnostic power of the predicted probability was as high as 0.87 in terms of area under curve of the receiver operating characteristic curve. CONCLUSIONS: There was a significant correlation between the prognosis of tibialis anterior weakness and sex and the compound muscle action potentials amplitude of extensor digitorum brevis, suggesting that recording the compound muscle action potentials amplitude of extensor digitorum brevis will aid the outcome assessment of future surgical interventions for tibialis anterior weakness.
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BACKGROUND: Elderly patients with degenerative cervical myelopathy frequently have severe symptoms due to spondylolisthesis. The effectiveness of laminoplasty for degenerative cervical spondylolisthesis (DCS) is an important question. OBJECTIVE: The aim of this study is to elucidate factors associated with the outcome of laminoplasty for DCS. METHOD: Eighty-nine patients with cervical spondylotic myelopathy (CSM) who underwent laminoplasty without instrumented posterior fusion were enrolled. Positive spondylolisthesis was defined as more than 2 mm during neck flexion or extension, from this, 46 DCS cases and 43 non-DCS cases were classified. Radiological parameters, including cervical alignment, balance, range of motion, and slippage along with the Japanese Orthopedic Association (JOA) score, were obtained before and 1 year after surgery. Factors associated with good surgical outcomes for DCS were analyzed using multivariate logistic analysis. RESULTS: There were no significant differences in background and preoperative JOA score, but the DCS group recovery rate was significantly less (42% vs 53%). Multivariate logistic analysis revealed only the postoperative C2-7 angle during neck flexion was associated with a favorable outcome for DCS (P = 0.0039, Odds ratio: 1.49, 95% CI: 1.14-1.94). Multivariate regression analysis positively correlated the preoperative C2-7 angle in neutral and during flexion with the postoperative C2-7 angle during flexion. CONCLUSION: The major factor related to poor outcome was the magnitude of postoperative kyphotic C2-7 angle during neck flexion. Slippage was not directly related to outcome and postoperative cervical alignment. Caution is recommended for surgeons performing laminoplasty on patients with risk factors for postoperative excessive kyphotic C2-7 angle during flexion.
Subject(s)
Kyphosis , Laminoplasty , Spinal Cord Diseases , Spondylolisthesis , Spondylosis , Humans , Aged , Spondylolisthesis/diagnostic imaging , Spondylolisthesis/surgery , Spondylolisthesis/complications , Laminoplasty/adverse effects , Spinal Cord Diseases/diagnostic imaging , Spinal Cord Diseases/etiology , Spinal Cord Diseases/surgery , Kyphosis/diagnostic imaging , Kyphosis/etiology , Kyphosis/surgery , Cervical Vertebrae/diagnostic imaging , Cervical Vertebrae/surgery , Treatment Outcome , Retrospective Studies , Spondylosis/diagnostic imaging , Spondylosis/surgery , Spondylosis/complicationsABSTRACT
STUDY DESIGN: A prospective multicenter observational cohort study. OBJECTIVE: This study aimed to investigate the role of transcranial motor evoked potential (TcMEP) monitoring during traumatic spinal injury surgery, the timing of TcMEP alerts, and intervention strategies to avoid intraoperative neurological complications. SUMMARY OF BACKGROUND DATA: Intraoperative neuromonitoring, including TcMEP monitoring, is commonly used in high-risk spinal surgery to predict intraoperative spinal cord injury; however, little information is available on its use in traumatic spinal injury surgery. METHODS: The TcMEP monitoring data of 350 consecutive patients who underwent traumatic spinal injury surgery (mean age, 69.3 y) between 2017 and 2021 were prospectively reviewed. In this study, a TcMEP amplitude reduction ≥70% was established as a TcMEP alert. A rescue case was defined as a case with the recovery of TcMEP amplitudes after certain procedures and without postoperative neurological complications. RESULTS: Among the 350 patients who underwent traumatic spinal injury surgery (TcMEP derivation rate 94%), TcMEP monitoring revealed seven true-positive (TP) (2.0%), three rescues (0.9%; rescue rate 30%), 31 false-positive, one false-negative, and 287 true-negative cases, resulting in 88% sensitivity, 90% specificity, 18% positive predictive value, and 99% negative predictive value. The TP rate in patients with preoperative motor deficits was 2.9%, which was higher than that in patients without preoperative motor deficits (1.1%). The most common timing of TcMEP alerts was during decompression (40%). During decompression, suspension of surgery with intravenous steroid injection was ineffective (rescue rate, 0%), and additional decompression was effective. CONCLUSION: Given the low prevalence of neurological complications (2.3%) and the low positive predictive value (18.4%), single usage of TcMEP monitoring during traumatic spinal injury surgery is not recommended. Further efforts should be made to reduce FP alert rates through better interpretation of multimodal Intraoperative neuromonitorings and the incorporation of anesthesiology to improve the positive predictive value. LEVEL OF EVIDENCE: 3.
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Evoked Potentials, Motor , Intraoperative Neurophysiological Monitoring , Spinal Injuries , Aged , Humans , East Asian People , Evoked Potentials, Motor/physiology , Intraoperative Neurophysiological Monitoring/methods , Monitoring, Intraoperative/methods , Prospective Studies , Spinal Injuries/diagnosis , Spinal Injuries/surgeryABSTRACT
Introduction: Although intraoperative spinal neuromonitoring (IONM) is recommended for spine surgeries, there are no guidelines regarding its use in Japan, and its usage is mainly based on the surgeon's preferences. Therefore, this study aimed to provide an overview of the current trends in IONM usage in Japan. Methods: In this web-based survey, expert spine surgeons belonging to the Japanese Society for Spine Surgery and Related Research were asked to respond to a questionnaire regarding IONM management. The questionnaire covered various aspects of IONM usage, including the preferred modality, operation of IONM, details regarding muscle-evoked potential after electrical stimulation of the brain (Br(E)-MsEP), and need for consistent use of IONM in major spine surgeries. Results: Responses were received from 134 of 186 expert spine surgeons (response rate, 72%). Of these, 124 respondents used IONM routinely. Medical staff rarely performed IONM without a medical doctor. Br(E)-MsEP was predominantly used for IONM. One-third of the respondents reported complications, such as bite injuries caused by Br(E)-MsEP. Interestingly, two-thirds of the respondents did not plan responses to alarm points. Intramedullary spinal cord tumor, scoliosis (idiopathic, congenital, or neuromuscular in pediatric), and thoracic ossification of the posterior longitudinal ligament were representative diseases that require IONM. Conclusions: IONM has become an essential tool in Japan, and Br(E)-MsEP is a predominant modality for IONM at present. Although we investigated spine surgeries for which consistent use of IONM is supported, a cost-benefit analysis may be required.
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Spinal cord injury (SCI) is a catastrophic condition associated with significant neurological deficit and social and financial burdens. It is currently being managed symptomatically, with no real therapeutic strategies available. In recent years, a number of innovative regenerative strategies have emerged and have been continuously investigated in preclinical research and clinical trials. In the near future, several more are expected to come down the translational pipeline. Among ongoing and completed trials are those reporting the use of biomaterial scaffolds. The advancements in biomaterial technology, combined with stem cell therapy or other regenerative therapy, can now accelerate the progress of promising novel therapeutic strategies from bench to bedside. Various types of approaches to regeneration therapy for SCI have been combined with the use of supportive biomaterial scaffolds as a drug and cell delivery system to facilitate favorable cell-material interactions and the supportive effect of neuroprotection. In this review, we summarize some of the most recent insights of preclinical and clinical studies using biomaterial scaffolds in regenerative therapy for SCI and summarized the biomaterial strategies for treatment with simplified results data. One hundred and sixty-eight articles were selected in the present review, in which we focused on biomaterial scaffolds. We conducted our search of articles using PubMed and Medline, a medical database. We used a combination of "Spinal cord injury" and ["Biomaterial", or "Scaffold"] as search terms and searched articles published up until 30 April 2022. Successful future therapies will require these biomaterial scaffolds and other synergistic approaches to address the persistent barriers to regeneration, including glial scarring, the loss of a structural framework, and biocompatibility. This database could serve as a benchmark to progress in future clinical trials for SCI using biomaterial scaffolds.
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Biocompatible Materials , Spinal Cord Injuries , Humans , Biocompatible Materials/therapeutic use , Biocompatible Materials/chemistry , Tissue Scaffolds/chemistry , Spinal Cord Injuries/therapy , Stem Cell Transplantation , Spinal CordABSTRACT
This study is nationwide retrospective multi-center study to investigate the incidence and characteristics of blunt cerebrovascular injury (BCVI) in elderly Japanese patients with traumatic cervical spine injuries (CSI) including spinal cord injury (SCI) without major bone injury. The study enrolled 1512 patients (average age: 75.8 ± 6.9 years; 1007 males, 505 females) from 33 nationwide institutions, and 391 (26%) of the participants had digital subtraction angiography and/or computed tomography angiography. Fifty-three patients were diagnosed as having BCVI by angiography. We assessed neurological evaluation, comorbidities and classification of CSI in the elderly patients with/without BCVI and collected 6-month follow-up data on treatment, complications, and patient outcome. We also statistically analyzed the relative risk (RR) and relationship between BCVI and other factors. Significant differences were identified between BCVI (+) (n = 53) and (-) (n = 1459) patients with American Spinal Injury Association Impairment Scale (ASIA) A, C, D, cervical fracture, C3-7 injury level (AO type F and/or C), cervical dislocation, spinal surgery for CSI, tetraplegia type of SCI, and/or head injury. Fifty-three (3.5%) elderly patients had CSI complicated by BCVI including 10 (19%) cases of Denver grade I, four (7%) of grade II, 1 (2%) of grade III, 29 (55%) of grade IV, and nine (17%) of grade V. Sixteen cases were treated by interventional radiology. Rates of mortality and brain infarction from BCVI were 0.13% and 0.40%, respectively. RR of BCVI was significantly higher in the elderly cervical injury patients with head injury, severe neurological deficit, ASIA A (RR: 4.33), cervical fracture at the C3-7 level (RR: 7.39), and cervical dislocation at the C1-6 level (RR: 3.06-7.18). In conclusion, 53 (3.5%) elderly patients were complicated with BCVI. BCVI more frequently complicated head injury, severe neurological deficit (ASIA A or tetraplegia), AO type F, and/or C fractures and cervical dislocation in these patients. Six patients (11%) suffered brain infarction and two patients died from BCVI.
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Cerebrovascular Trauma , Head Injuries, Closed , Spinal Fractures , Wounds, Nonpenetrating , Male , Female , Humans , Aged , Aged, 80 and over , Japan/epidemiology , Cerebrovascular Trauma/diagnostic imaging , Cerebrovascular Trauma/epidemiology , Wounds, Nonpenetrating/therapy , Head Injuries, Closed/complications , Retrospective Studies , Spinal Fractures/complications , Cervical Vertebrae/diagnostic imaging , Cervical Vertebrae/injuriesABSTRACT
STUDY DESIGN: A retrospective single-center study. OBJECTIVE: The present study investigated whether postoperative cervical alignment changes, in addition to preoperative patient backgrounds, imaging parameters, and disease severity, affect outcomes 1 year after laminoplasty. METHODS: One hundred and three cervical spondylotic myelopathy (CSM) patients who underwent laminoplasty were enrolled. Preoperative and postoperative (1-year) Japanese Orthopedic Association (JOA) scores, cervical alignment, and balance on X-rays were assessed. Patients were classified into 2 groups for a univariate analysis according to the status of the recovery rate (RR) of the JOA score ≥50%. A multiple logistic regression analysis was performed to identify factors associated with good surgical outcomes a. RESULTS: The mean RR of the JOA score was 47.5% and the loss of cervical lordosis in the neutral position was 5.5°. The univariate analysis revealed slight differences in age, sex, and the duration of disease. Preoperative C2-7 angles were not significantly different. The C2-7 angle during flexion after surgery was significantly smaller in Group F. In the multiple logistic regression analysis, significant factors associated with the status of RR≥50% were a younger age (OR: .75, 95%CI: .59-.96), shorter duration of disease (OR: .94, 95%CI: .89-.99), and a lordotic C2-7 angle during neck flexion after surgery (OR: 1.47, 95%CI: 1.1-1.95). CONCLUSION: We retrospectively assessed the surgical outcomes of laminoplasty in 103 CSM cases. In addition to an older age and longer duration of disease, postoperative deteriorations in cervical kyphosis during neck flexion had a negative impact on outcomes.
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STUDY DESIGN: Retrospective multicenter cohort study. OBJECTIVES: We aimed to clarify the efficacy of multimodal intraoperative neuromonitoring (IONM), especially in transcranial electrical stimulation of motor-evoked potentials (TES-MEPs) with spinal cord-evoked potentials after transcranial stimulation of the brain (D-wave) in the detection of reversible spinal cord injury in high-risk spinal surgery. METHODS: We reviewed 1310 patients who underwent TES-MEPs during spinal surgery at 14 spine centers. We compared the monitoring results of TES-MEPs with D-wave vs TES-MEPs without D-wave in high-risk spinal surgery. RESULTS: There were 40 cases that used TES-MEPs with D-wave and 1270 cases that used TES-MEPs without D-wave. Before patients were matched, there were significant differences between groups in terms of sex and spinal disease category. Although there was no significant difference in the rescue rate between TES-MEPs with D-wave (2.0%) and TES-MEPs (2.5%), the false-positivity rate was significantly lower (0%) in the TES-MEPs-with-D-wave group. Using a one-to-one propensity score-matched analysis, 40 pairs of patients from the two groups were selected. Baseline characteristics did not significantly differ between the matched groups. In the score-matched analysis, one case (2.5%) in both groups was a case of rescue (P = 1), five (12.5%) cases in the TES-MEPs group were false positives, and there were no false positives in the TES-MEPs-with-D-wave group (P = .02). CONCLUSIONS: TES-MEPs with D-wave in high-risk spine surgeries did not affect rescue case rates. However, it helped reduce the false-positivity rate.