Safety and feasibility of intravenous administration of a single dose of allogenic-Muse cells to treat human cervical traumatic spinal cord injury: a clinical trial.

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 .

Exploring factors affecting activities of daily living in patients with osteoporotic vertebral fractures managed conservatively: a post-hoc analysis of a prospective cohort study.

Study Design: A post-hoc analysis of a prospective cohort study. Purpose: This study aimed to identify factors at the time of injury associated with declining activities of daily living (ADLs) in the chronic phase of osteoporotic vertebral fractures (OVFs) managed conservatively. Overview of Literature: Although a conservative approach is the treatment of choice for OVFs, ADLs do not improve or eventually decrease in some cases. However, the risk factors for ADL decline after the occurrence of OVFs, particularly the difference between those with or without initial bed rest, are unknown. Methods: A total of 224 consecutive patients with OVFs aged ≥65 years who received treatment within 2 weeks after the occurrence of injury were enrolled. The patients were followed up for 6 months thereafter. The criteria for evaluating the degree of independence were applied to evaluate ADLs. Multivariable analysis with a logistic regression model was performed to evaluate the risk factors for ADL decline. Results: In total, 49/224 patients (21.9%) showed a decline in ADLs. Of these, 23/116 patients (19.8%) in the rest group and 26/108 patients (24.1%) in the no-rest group experienced a decline in ADLs. In the logistic regression analyses, a diffuse low signal on T2- weighted magnetic resonance imaging (MRI) (odds ratio, 5.78; 95% confidence interval, 2.09-16.0; p=0.0007) and vertebral instability (odds ratio, 3.89; 95% confidence interval, 1.32-11.4; p=0.0135) were identified as independent factors in the rest and no-rest groups, respectively. Conclusions: In patients with acute OVFs, a diffuse low signal on T2-weighted MRI and severe vertebral instability were independently associated with ADL decline in patients treated with and without initial bed rest, respectively.

Multimodal Deep Learning-based Radiomics Approach for Predicting Surgical Outcomes in Patients with Cervical Ossification of the Posterior Longitudinal Ligament.

STUDY DESIGN: A retrospective analysis. OBJECTIVE: This research sought to develop a predictive model for surgical outcomes in patients with cervical ossification of the posterior longitudinal ligament (OPLL) using deep learning and machine learning (ML) techniques. SUMMARY OF BACKGROUND DATA: Determining surgical outcomes assists surgeons in communicating prognosis to patients and setting their expectations. Deep learning and ML are computational models that identify patterns from large datasets and make predictions. METHODS: Of the 482 patients, 288 patients were included in the analysis. A minimal clinically important difference (MCID) was defined as gain in Japanese Orthopaedic Association (JOA) score of 2.5 points or more. The predictive model for MCID achievement at 1 year post-surgery was constructed using patient background, clinical symptoms, and preoperative imaging features (x-ray, CT, MRI) analyzed via LightGBM and deep learning with RadImagenet. RESULTS: The median preoperative JOA score was 11.0 (IQR: 9.0-12.0), which significantly improved to 14.0 (IQR: 12.0-15.0) at 1 year after surgery (P < 0.001, Wilcoxon signed-rank test). The average improvement rate of the JOA score was 44.7%, and 60.1% of patients achieved the MCID. Our model exhibited an area under the receiver operating characteristic curve of 0.81 and the accuracy of 71.9% in predicting MCID at 1 year. Preoperative JOA score and certain preoperative imaging features were identified as the most significant factors in the predictive models. CONCLUSION: A predictive ML and deep learning model for surgical outcomes in OPLL patients is feasible, suggesting promising applications in spinal surgery. LEVEL OF EVIDENCE: 4.

Early Recurrence of Thoracic Ossification of the Ligamentum Flavum After Posterior Decompression Surgery: A Case Report.

Thoracic ossification of the ligamentum flavum (OLF) is known to result in spinal canal stenosis and myelopathy. It is typically treated through decompressive laminectomy and resection of the ossified ligament, which is known to improve neurological deficits. However, the recurrence of OLF post-surgery remains a relatively undocumented and complex issue. The present report describes the case of a 58-year-old male patient who had obesity (BMI 34), diabetes mellitus, and Basedow's disease. The patient presented with bilateral lower limb paresthesia and associated gait impairment, resulting in an urgent hospital admission. Imaging diagnostics identified extensive thoracic ossification of the posterior longitudinal ligament and OLF, both of which resulted in significant spinal cord compression. He underwent posterior decompression with instrumented fusion from T1 to T9 and additional laminectomy and OLF resection at T10/11. Despite an initial improvement in the postoperative period, the patient developed an epidural hematoma one week following surgery, causing significant paralysis of the lower limbs. This complication was promptly addressed with hematoma removal surgery. Six months after the initial procedure, his walking function improved significantly, but eight months after surgery, he experienced a sudden regression in motor functions due to the recurrence of OLF at T10/11, necessitating an additional posterior instrumented fusion surgery. Subsequent to the additional surgical procedure, the patient experienced an amelioration in paralysis, enabling him to ambulate with the aid of a cane. The recurrence of thoracic OLF after decompression surgery is a significant concern, especially in cases where decompression without instrumented fusion is performed. When determining the surgical procedure for thoracic OLF in cases with extensive ossification of the spinal ligaments, it is crucial to consider the degree of spontaneous fusion and mobility of the spinal segments, as demonstrated in the present case. The concentration of mechanical stress due to fusion at adjacent segments and intervertebral mobility at the thoracolumbar junction may increase the risk of OLF recurrence and should be carefully assessed preoperatively, even though posterior decompression surgery is typically considered a sufficient option for thoracic OLF.

Pedicle screw insertion into infected vertebrae reduces operative time and range of fixation in minimally invasive posterior fixation for thoracolumbar pyogenic spondylitis: a multicenter retrospective cohort study.

BACKGROUND: Minimally invasive posterior fixation surgery for pyogenic spondylitis is known to reduce invasiveness and complication rates; however, the outcomes of concomitant insertion of pedicle screws (PS) into the infected vertebrae via the posterior approach are undetermined. This study aimed to assess the safety and efficacy of PS insertion into infected vertebrae in minimally invasive posterior fixation for thoracolumbar pyogenic spondylitis. METHODS: This multicenter retrospective cohort study included 70 patients undergoing minimally invasive posterior fixation for thoracolumbar pyogenic spondylitis across nine institutions. Patients were categorized into insertion and skip groups based on PS insertion into infected vertebrae, and surgical data and postoperative outcomes, particularly unplanned reoperations due to complications, were compared. RESULTS: The mean age of the 70 patients was 72.8 years. The insertion group (n = 36) had shorter operative times (146 versus 195 min, p = 0.032) and a reduced range of fixation (5.4 versus 6.9 vertebrae, p = 0.0009) compared to the skip group (n = 34). Unplanned reoperations occurred in 24% (n = 17) due to surgical site infections (SSI) or implant failure; the incidence was comparable between the groups. Poor infection control necessitating additional anterior surgery was reported in four patients in the skip group. CONCLUSIONS: PS insertion into infected vertebrae during minimally invasive posterior fixation reduces the operative time and range of fixation without increasing the occurrence of unplanned reoperations due to SSI or implant failure. Judicious PS insertion in patients with minimal bone destruction in thoracolumbar pyogenic spondylitis can minimize surgical invasiveness.

Safety and feasibility of in-hospital autonomous transportation using a driverless mobility for patients with musculoskeletal disorders: preliminary clinical study to achieve mobility as a service in medical care.

BACKGROUND: Recent advancements in and the proliferation of autonomous mobility technology, such as intelligent wheelchairs, have made it possible to provide mobility services for patients with reduced mobility due to musculoskeletal disorders. In the present study, we conducted a preliminary clinical study to assess the safety and feasibility of in-hospital autonomous transportation using a driverless mobility (wheelchair) for patients with musculoskeletal disorders. METHODS: From January to February 2022, 51 patients with musculoskeletal disorders exhibiting gait disturbance who presented to our institution were included in the present study. Driverless mobility rides were conducted over a straight-line distance of 100 m from the orthopaedic outpatient reception to the payment counter after the outpatient consultation. We assessed the quality of life using an EQ-5D-5 L index and pain using a VAS score before riding the mobility to investigate the patient's condition. After the ride, a questionnaire survey was conducted to assess patient satisfaction on a 5-point scale. In addition, adverse events during the mobility ride were investigated. RESULTS: Overall satisfaction levels showed that 44 out of 51 (86%) patients rated the level as 3 or higher. There were no significant differences in the level of satisfaction based on the cause of disorders or EQ-5D-5 L Index. Among 19 patients who rated the level of satisfaction as 2-3, the ratio of postoperative patients and those with pain tended to be higher (p < 0.05). While 26 of 51 (51%) patients reported moments of feeling unsafe during the mobility ride, no actual adverse events, such as collisions, were observed. CONCLUSIONS: An in-hospital autonomous transportation service using a driverless mobility for patients with musculoskeletal disorders demonstrated high satisfaction levels and was safe with no severe adverse events observed. The expansion of autonomous mobility deployment is expected to achieve mobility as a service in medical care.

The association between variations in the number of thoracic and lumbar vertebrae and rib morphology in adolescent idiopathic scoliosis.

PURPOSE: Preoperative counting of thoracic and lumbar vertebrae is crucial in adolescent idiopathic scoliosis (AIS) due to reported anatomical variations and potential surgical site misidentification. This study investigated characteristics associated with the vertebral number variations AIS, particularly focusing on rib morphology. METHODS: Based on three-dimensional computed tomography, patients were categorized into the non-variant number group, comprising individuals with 12 thoracic and 5 lumbar vertebrae, and the variant number group, comprising individuals with different numbers of vertebrae. Additionally, the most caudal rib morphology was classified as normal, unilateral, or hypoplastic. RESULTS: A total of 359 patients were included in our study (41 males, 318 females, age: 16.3 ± 3.1 years), with 44 patients (12.3%) assigned to the variant number group. Logistic regression analysis identified unilateral ribs (odds ratio [OR]: 10.50) and lumbosacral transitional vertebrae (LSTV) (OR 6.49) as significant risk factors associated with variations. Further analysis revealed hypoplastic ribs as a significant risk factor associated with LSTV (OR: 4.58). 8 CONCLUSION: Our study suggests that abnormal rib morphology may be associated with vertebral number variations. Close attention to rib morphology is, therefore, warranted in cases with atypical vertebral numbers. Accordingly, to ensure surgical safety and accuracy, spine surgeons must communicate these variations to the surgical team, standardize nomenclature for describing them, and intraoperatively verify fusion levels with them.

The Optimal Patient Position on the Surgical Table for Lateral Lumbar Interbody Fusion in Adult Spinal Deformity Using Three-Dimensional Computed Tomography: A Retrospective Study.

Introduction: Lateral lumbar interbody fusion (LLIF) techniques have been extensively used in adult spinal deformity surgery. Preoperative knowledge of the optimal position of the patient on the surgical table is essential for a safe procedure. Therefore, this study aims to determine the optimal angle for positioning the patient on the surgical table during LLIF using three-dimensional computed tomography (3DCT). Methods: Data from 59 patients (2 males, 57 females, mean age 66.3±8.6 years) with adult spinal deformities treated by performing corrective spinal surgery were included in this observational retrospective study. Simulated fluoroscopic images were obtained using 3DCT images rotated from the reference position with the spinous process of S1 as the midline to the position with the spinous process in the center of the bilateral pedicle of T12-L5. The rotation angle of each vertebra was measured and defined as the optimal rotation angle (ORA). The angle that bisected the angle between the maximum and minimum ORA was defined as the optimal mean angle of the maximum and minimum ORA (OMA) and considered the optimal angle for the patient's position on the surgical table, as this position could minimize the rotation angle of the surgical table during surgery. A multiple regression analysis was performed to predict OMA. Results: Multiple regression analysis revealed the following equation: OMA=1.959+(0.238×lumbar coronal Cobb angle)+(-0.208×sagittal vertical axis). Conclusions: When the patient is placed on the surgical table by rotating them at the OMA, the rotation of the surgical table can be reduced, ensuring a safe and efficient surgical procedure.

Factors Influencing Optimal Bracing Compliance in Adolescent Idiopathic Scoliosis: A Single Center Prospective Cohort Study.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To identify factors contributing to optimal bracing compliance in adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Poor brace compliance is a key factor affecting brace treatment success in AIS. Predictive factors influencing optimal brace compliance to achieve brace treatment success remain unknown. MATERIALS AND METHODS: This study included AIS patients, aged 10-15, with a Cobb angle of 20-40 degrees. Demographics data, radiographic assessments, and patient-reported outcomes (including the SRS-22r patient questionnaire) were collected. Brace compliance was monitored using in-brace thermometers, defining optimal bracing time as more than 18 hours/day. Multivariable logistic regression analysis was employed to identify predictors of optimal bracing time from the demographic and patient- reported outcomes score before bracing. RESULTS: Among 122 patients, 59.0% achieved optimal bracing time by six months. The achieved group indicated higher scores in satisfaction domain before bracing (3.3±0.7 vs. 3.1±0.6; P=0.034). Multivariable logistic regression analysis demonstrated that Satisfaction domain before bracing was an independent factor associated with achievement of the optimal bracing time (OR 1.97 [95%CI 1.00 - 3.89], P=0.049). The model with bracing at 1-month follow-up also demonstrated the bracing at 1-month was a significant factor (OR 1.52 [95%CI 1.30 - 1.79], P<0.001). CONCLUSION: Optimal bracing compliance in AIS is significantly influenced by pre-bracing satisfaction and brace compliance at earlier time point. These findings highlight the need to address psychological factors and early compliance in AIS bracing treatment. SRS-22r can be useful to identify the need for psychological support.

Bone union-promoting effect of romosozumab in an ovariectomized rat posterolateral lumbar fusion model.

Spinal fixation surgery has been increasingly performed in patients with osteoporosis. Romosozumab, a drug that was introduced in Japan recently, is known to possibly promote bone healing. However, few studies have reported the therapeutic effects of romosozumab in clinical practice in Japan. Therefore, here, we investigated the effects of romosozumab dosage on bone fusion promotion using an ovariectomized rat spinal fusion model. Eight-week-old female Sprague-Dawley rats were matched by body weight and divided into three groups: 1.0 romosozumab (R) group (Evenity®, 25 mg/kg), 1/10R group (Evenity®, 2.5 mg/kg), and control (C) group (saline). Subcutaneous injections were administered twice a week for 8 weeks postoperatively. Computed tomography scans were performed every 2 weeks from the time of surgery till 8 weeks postoperatively. The mean fusion rates in terms of volume were significantly higher in the R groups [1/10R, 1.0R] than in the C group from 4 weeks postoperatively. The rate of increase was significantly higher in the 1.0R group from 4 weeks postoperatively and in the 1/10R group from 6 weeks postoperatively, than in the C group. The proportion of trabecular bone area was approximately 1.5 times higher in the R groups than in the C group. No significant differences were observed between the R groups. Our results suggest that romosozumab stimulates bone growth at the graft site, and similar effects were achieved at 1/10 of the standard dosage.

Verification of the Effects of a YouTube-Based Home-Based (Self-Managed Intervention) Training System Developed for Frailty Prevention: A Pilot Study.

Resistance training is considered the most effective intervention for increasing older people's muscle mass and strength. Thus, we created the Sukubara®, a self-administered training system (squat + balance training) that incorporates a new low-load exercise. In this study, we hypothesize that introducing Sukubara will positively affect skeletal muscle mass and physical function. A preliminary verification was carried out on healthy, non-elderly participants who were recruited from the hospital staff. Participants were randomly assigned to two groups for a 12-week intervention: the resistance training group (R group) that performed the Sukubara exercise program and the control group (C group) that did not. This study's primary end¬point was a change in skeletal muscle mass, while the secondary endpoints were knee extension strength and one-leg standing time with eyes closed. An analysis of the 18 participants (R group = 8; C group = 10) was performed. Results showed that skeletal muscle mass, knee extension strength, and one-leg standing time were significantly improved or tended to be significantly higher in the R group than in the C group. Our study concluded that, by incorporating low-load exercise, Sukubara resulted in muscle hypertrophy and improved physical function.

Short-Term Clinical and Radiographic Evaluation of Patients Treated With Expandable and Static Interbody Spacers Following Lumbar Lateral Interbody Fusion.

OBJECTIVE: The goal of this study was to evaluate, using computed tomography (CT) and magnetic resonance imaging (MRI), patients who underwent oblique lateral interbody fusion (OLIF) using either expandable or static interbody spacers. METHODS: Thirty-five patients with degenerative disc disease were surgically treated with one-level OLIF and were followed up for more than 6 months. The Static group consisted of 22 patients, and 13 patients were in the Expandable group. Intraoperative findings included operative time (min), blood loss (ml), and cage size. Low back pain, leg pain, and leg numbness were measured using the Japanese Orthopedic Association score, visual analogue score, and the Roland-Morris Disability Questionnaire. Radiologic evaluation using computed tomography (CT) and magnetic resonance imaging (MRI) allowed measurement of cage subsidence, cross-sectional area (CSA) of the dural sac, disc height, segmental lordosis, foraminal height, and foraminal CSA preoperatively and 6 months postoperatively. RESULTS: The Expandable group had significantly larger cage height and lordosis than the Static group (P < 0.05). The Expandable group also had greater dural sac area expansion and enlargement of the intervertebral foramen, as well as better correction of vertebral body slip (P < 0.05). Cage subsidence was significantly lower in the Expandable group (P < 0.05). JOA and VAS scores for leg numbness were significantly better in the Expandable group (P < 0.05). CONCLUSIONS: Compared with static spacers, expandable spacers significantly enlarged the dural sac area, corrected vertebral body slippage, expanded the intervertebral foramen, and achieved good indirect decompression while reducing cage subsidence, resulting in improvement in clinical symptoms.

Effectiveness of a Remote Monitoring-Based Home Training System for Preventing Frailty in Older Adults in Japan: A Preliminary Randomized Controlled Trial.

This study examined whether SUKUBARA®, a remotely managed training system that we developed, could improve skeletal muscle mass and muscle strength in community-dwelling older adults. SUKUBARA® is a composite exercise program that combines lower-load resistance training and balance exercises. Participants were instructed to exercise while watching individually assigned videos on YouTube, such that the research administrators could verify the viewing records of each participant. Fifteen participants (69 ± 4 years) were randomly assigned to the intervention (eight participants; the RT group) or the control group (seven participants; the CO group). The primary endpoint was a change in fat-free mass (FFM; kg), whereas the secondary endpoints included a change in knee extension strength (KES; Nm/kg). Correlation analyses were conducted to examine the relationship between FFM and KES. During the 12-week intervention period, significant differences were observed between the RT and CO groups in the changes in FFM (0.5 ± 0.5 vs. -0.1 ± 0.5) and KES (0.20 ± 0.22 vs. 0.02 ± 0.13), and significant positive correlations were found between the changes. Thus, SUKUBARA®-based interventions have the potential to improve muscle hypertrophy and enhance muscle strength among community-dwelling older adults. Thus, SUKUBARA® -based interventions show promise in improving muscle hypertrophy and enhance muscle strength among community-dwelling older adults. However, appropriately powered future research is needed to replicate these findings.

Association between Osteoporosis and Skeletal Muscle Mass in Men.

STUDY DESIGN: Cross-sectional study. PURPOSE: This cross-sectional study aimed to investigate the risk factors for osteoporosis in men by assessing bone mineral density (BMD), skeletal muscle mass, body fat mass, grip strength, and advanced glycation end products (AGEs). OVERVIEW OF LITERATURE: Fewer studies have reported the correlation between BMD and skeletal muscle mass in women. Moreover, a few studies have examined the relationship between osteoporosis and skeletal muscle mass. METHODS: This study included 99 men (mean age, 74.9 years; range, 28-93 years) who visited Qiball Clinic for BMD and body composition examinations. The osteoporosis group consisted of 24 patients (mean age, 72.5 years; range, 44-92 years), and the control group consisted of 75 individuals (mean age, 74.9 years; range, 28-93 years). Whole-body skeletal muscle mass was measured using a bioelectrical impedance analyzer. BMD was measured by dual X-ray absorptiometry. Skin autofluorescence (SAF), a marker of dermal AGE accumulation, was measured using a spectroscope. Osteoporosis was defined as a bone density T score of -2.5 or less. Physical findings, skeletal muscle mass, BMD, grip strength, and SAF were compared between the osteoporosis and control groups. RESULTS: The osteoporosis group had significantly lower trunk muscle mass (23.1 kg vs. 24.9 kg), lower leg muscle mass (14.4 kg vs. 13.0 kg), and skeletal mass index (7.1 kg/m2 vs. 6.7 kg/m2) than the control group (all p<0.05). Lower limb muscle mass was identified as a risk factor for osteoporosis in men (odds ratio, 0.64; p=0.03). CONCLUSIONS: Conservative treatment of osteoporosis in men will require an effective approach that facilitates the maintenance or strengthening of skeletal muscle mass, including exercise therapy with a focus on lower extremities and nutritional supplementation.

Effect of urgent surgery within 8 hours compared to surgery between 8 and 24 hours on perioperative complications and neurological prognosis in patients older than 70 years with cervical spinal cord injury: a propensity score-matched analysis.

OBJECTIVE: This study aimed to investigate the effect of surgery within 8 hours on perioperative complications and neurological prognosis in older patients with cervical spinal cord injury by using a propensity score-matched analysis. METHODS: The authors included 87 consecutive patients older than 70 years who had cervical spinal cord injury and who had undergone posterior decompression and fusion surgery within 24 hours of injury. The patients were divided into two groups based on the time from injury to surgery: surgery within 8 hours (group 8 hours) and between 8 and 24 hours (group 8-24 hours). Following the preliminary study, the authors established a 1:1 matched model using propensity scores to adjust for baseline characteristics and neurological status on admission. Perioperative complication rates and neurological outcomes at discharge were compared between the two groups. RESULTS: Preliminary analysis of 87 prematched patients (39 in group 8 hours and 48 in group 8-24 hours) revealed that the motor index score (MIS) on admission was lower for lower extremities (12.3 ± 15.5 vs 20.0 ± 18.6, respectively; p = 0.048), and total extremities (26.7 ± 27.1 vs 40.2 ± 30.6, respectively; p = 0.035) in group 8 hours. In terms of perioperative complications, group 8 hours had significantly higher rates of cardiopulmonary dysfunction (46.2% vs 25.0%, respectively; p = 0.039). MIS improvement (the difference in scores between admission and discharge) was greater in group 8 hours for lower extremities (15.8 ± 12.6 vs 9.0 ± 10.5, respectively; p = 0.009) and total extremities (29.4 ± 21.7 vs 18.7 ± 17.7, respectively; p = 0.016). Using a 1:1 propensity score-matched analysis, 29 patient pairs from group 8 hours and group 8-24 hours were selected. There were no significant differences in baseline characteristics, neurological status on admission, and perioperative complications between the two groups, including cardiopulmonary dysfunction. Even after matching, MIS improvement was significantly greater in group 8 hours for upper extremities (13.0 ± 10.9 vs 7.8 ± 8.3, respectively; p = 0.045), lower extremities (14.8 ± 12.7 vs 8.3 ± 11.0, respectively; p = 0.044) and total extremities (27.8 ± 21.0 vs 16.0 ± 17.5, respectively; p = 0.026). CONCLUSIONS: Results of the comparison after matching demonstrated that urgent surgery within 8 hours did not increase the perioperative complication rate and significantly improved the MIS, suggesting that surgery within 8 hours may be efficient, even in older patients.

A nationwide multicenter study of the cost effectiveness of five leading drugs for pharmacological management of cervicobrachial symptoms.

BACKGROUND: Cervicobrachial pain frequently affects the quality of life (QOL) of the general public and has a significant economic impact on the health care systems of various countries. There are a number of treatment options for this disease, including widely-used drug therapy, but the effectiveness of each option is indeterminate, and there have been no published cost-effectiveness analysis studies so far. This prospective observational study aimed to examine the cost-effectiveness of drug treatment for cervicobrachial symptoms. METHODS: A 6-month medication regimen for each of five frequently-prescribed drugs for cervicobrachial symptoms was administered to 322 patients at 24 centers in Japan. Outcome measures, including of the EuroQol Group 5D, Short Form-8, and Visual Analog Scale (VAS), were investigated at baseline and every month thereafter. Incremental cost-effectiveness ratios (ICERs) of the drug cost to quality-adjusted life years (QALYs) were calculated. A stratified analysis of patient characteristics was also performed to identify baseline factors potentially affecting cost-effectiveness. RESULTS: The ICER of entire drug treatment for cervicobrachial symptoms was 7,491,640 yen. Compared with the reference willingness-to-pay, the ICER was assumed to not be cost-effective. A certain number of QALYs were gained during the first 3 months after the treatment intervention, but almost no QALYs were gained during the following 3 months. Stratified analysis showed that cost-effectiveness was extremely low for patients with high baseline VAS and high QOL. CONCLUSIONS: The available medications for cervicobrachial symptoms did not have excellent cost-effectiveness. Although a certain number of QALYs were gained during the first 3 months after medication, no QALYs were gained in the latter half of the study period, suggesting that it is not advisable to continue the medication needlessly. LEVEL OF EVIDENCE: II, prospective cohort study.