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Study Design: Retrospective cohort study Objectives: The criteria for determining completion of intervertebral stability after posterior lumbar interbody fusion (PLIF) remain controversial. Several new radiological indicators of bone growth and osteointegration have been established. We compared computed tomography (CT) findings related to osteointegration after PLIF with interbody cages of two different materials and designs. Methods: We retrospectively analyzed data from 103 patients who underwent PLIF with three-dimensional porous tantalum (Tn) cages or titanium-coated polyetheretherketone (TiP) cages. CT images obtained 3 months and 1 year after surgery were examined for trabecular bone remodeling (TBR), cancellous condensation (CC), and vertebral endplate cyst (VEC) formation. The incidences of each finding were compared by cage type, and rates of instrument failure and pseudarthrosis were determined. Results: Three months postoperatively, 87% of the levels with Tn cages exhibited TBR, whereas 96% of those with TiP cages did not (P <.001). Most levels with Tn cages levels exhibited TBR and no CC 3 months (81%) and 1 year (94%) after surgery. Although 78% of levels with TiP cages exhibited CC and no TBR 3 months after surgery, 59% exhibited both CC and TBR 1 year after surgery. Significantly fewer VECs formed around the Tn cages than around the TiP cages both 3 months (P =.002) and 1 year (P <.001) after surgery. Implant-related problems occurred at levels that exhibited neither TBR nor CC. Conclusions: The porous tantalum cage may enable intervertebral stability that is comparable to bony fusion soon after surgery. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective multicenter study Objectives: To investigate changes over a 10-years period in the profile of cervical spine and spinal cord injuries among the elderly in Japan. Methods: The current multicenter study was a retrospective analysis of inpatients aged ≥65 years, suffering cervical fracture (CF) and/or cervical spinal cord injury (CSCI). We analyzed 1413 patients' epidemiology (from 2010 to 2019). Moreover, 727 patients who underwent surgical treatment were analyzed in 2 groups: the early (2010-2014) and late period (2015-2019). Results: Both the number of patients and number of surgical patients showed a significant increasing trend (P <.001), while the mean age, the distribution of injury levels and paralysis severity, and the proportion of surgical indications remained the same. The number of surgical patients doubled from 228 to 499 from the early to late periods. Posterior surgery was the most common approach (90.4%), instrumentation surgery with screws increased significantly, and the range of fusion was significantly longer in the late period (2.1 vs 2.7 levels, P =.001). Significantly worsening neurological symptoms were recorded in the late period (1.3% vs 5.8%, P =.006), with C5 palsy being the major one. Otherwise, perioperative, major, and other complications, including mortality, did not differ significantly in incidence. Conclusions: Both the number of elderly CF and/or CSCI patients and number of patients undergoing surgery increased dramatically over the decade without any change in profile. Instrumentation surgeries with screws increased, without an increase in systemic complications. [ABSTRACT FROM AUTHOR]

This retrospective cohort study established malnutrition's impact on mortality and neurological recovery of older patients with cervical spinal cord injury (SCI). It included patients aged ≥ 65 years with traumatic cervical SCI treated conservatively or surgically. The Geriatric Nutritional Risk Index was calculated to assess nutritional-related risk. Overall, 789 patients (mean follow-up: 20.1 months) were examined and 47 had major nutritional-related risks on admission. One-year mortality rate, median survival time, neurological recovery, and activities of daily living (ADL) at 1 year post-injury were compared between patients with major nutrition-related risk and matched controls selected using 1:2 propensity score matching to adjust for age, pre-traumatic neurological impairment, and activity. In the Kaplan–Meier analysis, the median survival times were 44.9 and 76.5 months for patients with major nutrition-related risk and matched controls, respectively (p = 0.015). Matched controls had more individuals with a neurological improvement of American Spinal Injury Association Impairment Scale ≥ 1 grade (p = 0.039) and independence in ADL at 1 year post-injury than patients with major nutrition-related risk (p < 0.05). In conclusion, 6% of older patients with cervical SCI had major nutrition-related risks; they showed a significantly higher 1 year mortality rate, shorter survival time, poorer neurological improvement, and lower ADL at 1 year post-injury than matched controls. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective analysis of prospectively database Objective: Implant-related complications are an extremely important issue because they pose a burden to patients who underwent surgery. An understanding of these complications can help improve the postoperative management of patients undergoing spinal surgery. The current large-scale multicenter study aimed to identify postoperative implant-related complications that may require revision surgery. Methods: In total, 3447 patients who underwent spinal fusion surgery were included in the analysis. Data about age at surgery, sex, preoperative diagnosis, surgical level, type of implant-related complications, causes of reoperation, and time from the initial to revision surgery were reviewed. Moreover, the characteristics of reoperation in 3 periods (within 30, 31–90, and over 90 days) were assessed. Result: The overall incidence of implant-related complications was 4.6%. Adult spinal deformity was the most common diagnosis (9.9%), and thoracic-lumbar-sacral (42.9%) was the most common surgical level among patients with implant-related complications. Further, screw malposition was the most frequent implant-related complication (42.8%). In total, 89 (2.6%) patients underwent reoperation due to implant-related complications. The main causes of reoperation within 30, 31–90, and over 90 days were screw malposition (72.2%), screw loosening or pull out (81.8%), and rod or screw fracture (60.9%), respectively. Conclusion: To the best of our knowledge, this was the first large-scale multicenter study that assessed the characteristics of patients who underwent reoperation due to spinal implant-related complications. The study results could improve the preoperative informed consent procedure about spinal fusion. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort study. Objectives: We newly found that trabecular bone remodeling (TBR) often appeared in the fixed adjacent vertebrae during bony fusion. Thus, TBR might indicate osteointegration. Hence, we aimed to investigate whether TBR in the early postoperative period could predict future bony fusion after posterior lumbar interbody fusion (PLIF). Methods: We retrospectively analyzed 78 patients who underwent one-level PLIF. Demographic data were reviewed. Using computed tomography (CT) images taken at 3 months and 1 year postoperatively, we investigated the vertebral endplate cyst (VEC) formation, TBR in the vertebral body, cage subsidence, and clear zone around pedicle screw (CZPS). Results: TBR had high interobserver reliability regardless of cage materials. VECs, TBR, and both were found in 30, 53, and 16 patients at 3 months postoperatively and in 30, 65, and 22 patients at 1 year postoperatively, respectively. The incidence of VEC, which indicates poor fixation, was lower in early (3 months postoperatively) TBR-positive patients, with a significant difference at 1 year postoperatively (3 months, P =.074; 1 year, P =.003). Furthermore, 3 (5.7%) of the 53 early TBR-positive patients had CZPS without instability at 1 year postoperatively. In 25 TBR-negative patients, 1 (4.0%) had pedicle screw cutout requiring reoperation, 1 (4.0%) had pseudarthrosis, and 4 (16%) had CZPS. Conclusions: Patients with early TBR (3 months) did not experience pedicle screw cutout nor pseudarthrosis and had significantly fewer VECs than those without early TBR. Thus, TBR may be a new radiological marker of initial fixation after PLIF. [ABSTRACT FROM AUTHOR]

This document is a reply to a letter to the editor concerning an article titled "Trabecular Bone Remodeling as a New Indicator of Osteointegration After Posterior Lumbar Interbody Fusion." The authors of the article appreciate the comments made by the authors of the letter and provide further clarification on certain points. They discuss the evaluation of trabecular bone remodeling (TBR) on computed tomography imaging and the importance of its location. They also acknowledge the lack of analysis regarding the impact of osteoporosis on the study outcomes. The authors address the effect of cage material hardness and the need for further analysis on the associations with clinical outcomes. They also mention the need for prospective, randomized control trials to answer the questions raised. [Extracted from the article]

Background: We evaluated the clinical, functional, and quality of life (QoL) outcomes of surgical treatment of thoracic ossification of the posterior longitudinal ligament (T-OPLL)., Methods: We retrospectively evaluated 51 patients followed for ≥10 years after posterior decompression and corrective fusion surgery for T-OPLL. The data collected included demographics, comorbidities, and pre- and postoperative symptoms. The Japanese Orthopaedic Association (JOA) score, numerical rating scale (NRS) for back and leg pain, and EuroQol-5 Dimension-5 Level (EQ-5D-5L) were used to assess neurological function, pain, and QoL. Imaging evaluations were conducted to assess changes in kyphotic angles and ossification progression., Results: A significant improvement was observed in the JOA score from preoperatively (3.7) to 2 years postoperatively (7.9) (p < 0.05); the score remained stable thereafter. The mean EQ-5D-5L score improved from 0.53 preoperatively to 0.68 at 10 years postoperatively (p < 0.001). NRS scores for back and leg pain decreased from 5.4 to 3.5 and 4.0 to 3.0, respectively, from preoperatively to 10 years (p < 0.001 for both). Radiographic outcomes showed changes in kyphotic angles and ossification areas, with no significant progression after 2 years. Fourteen (27.5%) of the patients experienced postoperative complications. Of these, 8 (15.7%) required reoperation, 6 (11.8%) in the perioperative period and 2 (3.9%) later. Four (7.8%) of the patients underwent additional surgeries for conditions including lumbar spinal canal stenosis and cervical OPLL. Nonetheless, physical function in all cases with postoperative complications or additional surgery remained stable over the decade., Conclusions: Surgical treatment of T-OPLL is effective in improving neurological function, QoL, and pain management over an extended period. The long-term outcomes of T-OPLL surgery revealed that, although cervical and lumbar spinal lesions led to reoperations, they did not affect QoL, and relative improvement was maintained even after 10 years., Level of Evidence: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence., Competing Interests: Disclosure: No external funding was received for this work. The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article ( http://links.lww.com/JBJS/I119 )., (Copyright © 2024 by The Journal of Bone and Joint Surgery, Incorporated.)

C1-C2 fixation has been developed for the rigid fusion of atlantoaxial instability. C1 lateral mass screw (C1 LMS)-C2 pedicle screw fixation is used more frequently due to its rigid fixation and high bone fusion rate. However, C1 screw placement is relatively unsafe even with recently developed image-based navigation systems. Patient-specific screw guide templates (PSGT) were developed to improve the accuracy and safety of C1 screw placement. Herein, we investigated the outcomes of the C1-C2 posterior fixation technique using PSGT. This was a retrospective study of six patients who underwent posterior cervical spinal fusion using the PSGT between January 2022 and April 2023. Operative time, estimated blood loss, intraoperative radiation dose, surgical cost, and screw placement accuracy were evaluated and compared with those achieved with preoperative CT-based navigation (navigation group, n = 15). Screw accuracy was assessed using Neo's classification. PSGT showed good results, although the differences were not statistically significant (operation time: 104.3 ± 9.7 min vs 116.4 ± 20.8 min; estimated blood loss: 56.7 ± 72.4 mL vs 123.2 ± 162.3 mL; and radiation dose: 1.8 ± 1.2 mSv vs 2.6 ± 0.8 mSv, respectively). PSGT was particularly better in terms of the accuracy of C1 LMS (PSGT: 100%, navigation: 83.3%). The deviation at the entry point was minimal, and the difference between the sagittal and transversal angles from the preoperative plan was small. We investigated the clinical efficacy of using the PSGT for C1-C2 posterior fixation. PSGT improved the accuracy of C1 LMS insertion., Competing Interests: The authors declare that there are no relevant conflicts of interest.

Traumatic spinal cord injury is characterized by immediate and irreversible tissue loss at the lesion site and secondary tissue damage. Secondary injuries should, in principle, be preventable, although no effective treatment options currently exist for patients with acute spinal cord injury. Traumatized tissues release excessive amounts of adenosine triphosphate and activate the P2X purinoceptor 7/pannexin1 complex, which is associated with secondary injury. We investigated the neuroprotective effects of the blue dye Brilliant Blue FCF, a selective inhibitor of P2X purinoceptor 7/pannexin1 that is approved for use as a food coloring, by comparing it with Brilliant Blue G, a P2X7 purinoceptor antagonist, and carbenoxolone, which attenuates P2X purinoceptor 7/pannexin1 function, in a rat spinal cord injury model. Brilliant Blue FCF administered early after spinal cord injury reduced spinal cord anatomical damage and improved motor recovery without apparent toxicity. Brilliant Blue G had the highest effect on this neurological recovery, with Brilliant Blue FCF and carbenoxolone having comparable improvement. Furthermore, Brilliant Blue FCF administration reduced local astrocytic and microglial activation and neutrophil infiltration, and no differences in these histological effects were observed between compounds. Thus, Brilliant Blue FCF protects spinal cord neurons after spinal cord injury and suppresses local inflammatory responses as well as Brilliant Blue G and carbenoxolone., Competing Interests: The authors declare that there is no conflict of interest regarding this paper.

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., Competing Interests: Authors have no conflict of interest to declare., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)