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.

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.

Unidirectional porous beta-tricalcium phosphate as a potential bone regeneration material for infectious bony cavity without debridement in pyogenic spondylitis.

An 81-year-old man was initially diagnosed with T11 osteoporotic vertebral fracture. The fractured vertebral body was filled with unidirectional porous beta-tricalcium phosphate (ß-TCP) granules, and posterior spinal fixation was conducted using percutaneous pedicle screws. However, the pain did not improve, the inflammatory response increased, and bone destructive changes extended to T10. The correct diagnosis was pyogenic spondylitis with concomitant T11 fragility vertebral fracture. Revision surgery was conducted 2 weeks after the initial surgery, the T10 and T11 pedicle screws were removed, and refixation was conducted. After the revision surgery, the pain improved and mobilization proceeded. The infection was suppressed by the administration of sensitive antibiotics. One month after surgery, a lateral bone bridge appeared at the T10/11 intervertebral level. This increased in size over time, and synostosis was achieved at 6 months. Resorption of the unidirectional porous ß-TCP granules was observed over time and partial replacement with autologous bone was evident from 6 months after the revision surgery. Two years and 6 months after the revision surgery, although there were some residual ß-TCP and bony defect in the center of the vertebral body, the bilateral walls have well regenerated. This suggested that given an environment of sensitive antibiotic administration and restricted local instability, unidirectional porous ß-TCP implanted into an infected vertebral body may function as a resorbable bone regeneration scaffold without impeding infection control even without debridement of the infected bony cavity.

Risk factors affecting vertebral collapse and kyphotic progression in postmenopausal osteoporotic vertebral fractures.

INTRODUCTION: We aimed to investigate the risk factors that affect vertebral deformity 6 months after osteoporotic vertebral fractures (OVFs) at the time of injury. MATERIALS AND METHODS: From May 2017 to May 2020, 70 postmenopausal women with OVFs were evaluated for age; body mass index; number of previous OVFs; total 25-hydroxy vitamin D [25(OH)D] levels; posterior wall injury on computed tomography; cross-sectional area (CSA) of the psoas major, erector spinae, and multifidus; fat infiltration; vertebral instability (VI) upon admission; collapse rate (CR); and kyphotic angle (KA) at 6 months after injury. A multiple regression analysis was conducted to identify the risk factors for the CR and KA. RESULTS: The CR was correlated with posterior wall injury (r = 0.295, p = 0.022), 25(OH)D levels (r = - 0.367, p = 0.002), and VI (r = 0.307, p = 0.010). In the multiple regression analysis, the 25(OH)D levels (p = 0.032) and VI (p = 0.035) were significant risk factors for the CR at the 6-month follow-up. The KA was correlated with the 25(OH)D levels (r = - 0.262, p = 0.031) and VI (r = 0.298, p = 0.012). In the multiple regression analysis, the CSA of the psoas major (p = 0.011) and VI (p < 0.001) were significant risk factors for the KA at the 6-month follow-up. CONCLUSION: In cases with large VI at the time of injury, the CR and KA were significantly higher at 6 months after injury. Moreover, the CR was affected by the 25(OH)D level, while the KA was affected by the CSA of the psoas major upon admission.

Randomized trial of granulocyte colony-stimulating factor for spinal cord injury.

Attenuation of the secondary injury of spinal cord injury (SCI) can suppress the spread of spinal cord tissue damage, possibly resulting in spinal cord sparing that can improve functional prognoses. Granulocyte colony-stimulating factor (G-CSF) is a haematological cytokine commonly used to treat neutropenia. Previous reports have shown that G-CSF promotes functional recovery in rodent models of SCI. Based on preclinical results, we conducted early phase clinical trials, showing safety/feasibility and suggestive efficacy. These lines of evidence demonstrate that G-CSF might have therapeutic benefits for acute SCI in humans. To confirm this efficacy and to obtain strong evidence for pharmaceutical approval of G-CSF therapy for SCI, we conducted a phase 3 clinical trial designed as a prospective, randomized, double-blinded and placebo-controlled comparative trial. The current trial included cervical SCI [severity of American Spinal Injury Association (ASIA) Impairment Scale (AIS) B or C] within 48 h after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group was administered 400 µg/m2/day × 5 days of G-CSF in normal saline via intravenous infusion for five consecutive days. The placebo group was similarly administered a placebo. Allocation was concealed between blinded evaluators of efficacy/safety and those for laboratory data, as G-CSF markedly increases white blood cell counts that can reveal patient treatment. Efficacy and safety were evaluated by blinded observer. Our primary end point was changes in ASIA motor scores from baseline to 3 months after drug administration. Each group includes 44 patients (88 total patients). Our protocol was approved by the Pharmaceuticals and Medical Device Agency in Japan and this trial is funded by the Center for Clinical Trials, Japan Medical Association. There was no significant difference in the primary end point between the G-CSF and the placebo control groups. In contrast, one of the secondary end points showed that the ASIA motor score 6 months (P = 0.062) and 1 year (P = 0.073) after drug administration tend to be higher in the G-CSF group compared with the placebo control group. Moreover, in patients aged over 65 years old, motor recovery 6 months after drug administration showed a strong trend towards a better recovery in the G-CSF treated group (P = 0.056) compared with the control group. The present trial failed to show a significant effect of G-CSF in primary end point although the subanalyses of the present trial suggested potential G-CSF benefits for specific population.

Development of a quantitative method to evaluate pedicle screw loosening after spinal instrumentation using digital tomosynthesis.

BACKGROUND: In general, the diagnosis of pedicle screw (PS) loosening is evaluated qualitatively based on the presence of a radiolucent area around the implant wider than 1 mm on plain radiographs and computed tomography (CT). Digital tomosynthesis is a novel imaging technology that can acquire reconstructed tomographic images of patients in different postures with relatively low radiation. In this study, PS loosening is evaluated quantitatively by measuring the PS displacement angle in the vertebrae using digital tomosynthesis. METHODS: We evaluated 41 patients who underwent posterior spinal fusion surgery using PS. The 72 pedicle screws at the cranial end of the fused segments were evaluated. The patients were divided in two groups, one with PS loosening (7 patients, 12 screws) and the other without PS loosening (34 patients, 60 screws), based on conventional CT findings. All patients underwent tomosynthesis in two different postures during a single CT session. RESULTS: The displacement angles of the PS in patients in a lying position and in a standing position were measured using selected slices of the same cross-sectional view from digital tomosynthesis. The displacement angle was significantly greater in the PS loosening group (5.7°) than in the group without PS loosening (0.6°) (p<0.01). Based on the ROC analysis, the optimal cut-off value of the PS displacement angle for identification of loosened screws was 1.7° with a sensitivity of 100% and specificity of 93% (AUC = 0.98). CONCLUSIONS: This new method using digital tomosynthesis has the potential to aid diagnosis of PS loosening quantitatively and more accurately than conventional evaluations.

Characteristic imaging findings predicting the risk of conservative treatment resistance in fresh osteoporotic vertebral fractures with poor prognostic features on magnetic resonance imaging.

BACKGROUND: Recent studies have reported that confined high-intensity and diffuse low-intensity on sagittal T2-weighted magnetic resonance imaging (MRI) are distinctive features that are highly predictive of delayed union or nonunion on osteoporotic vertebral fracture (OVF). The objective of this study was to identify the characteristics of imaging findings predicting the risk for requiring surgical treatment in fresh OVF with poor prognostic features on MRI. METHODS: We conducted a retrospective study of 74 patients (17 men and 57 women with a mean age of 81.1 years) of OVF with the poor prognostic MRI findings. We compared the imaging findings between the surgery group (16 patients) and the conservative group (58 patients): vertebral instability defined as the difference between the vertebral collapse ratio in dynamic X-rays, and the grade of posterior wall injury (Grade I, no spinal canal encroachment; Grade II, <2 mm; Grade III, ≥2 mm) as well as the presence or absence of pedicle fracture (Grade I, none; Grade II, unilateral; Grade III, bilateral) on computed tomography. RESULTS: The mean vertebral instability was 24.0% ± 10.1% in the surgery group and 13.0% ± 7.8% in the conservative group, which was significantly different. Posterior wall injury in the surgery and conservative groups was Grade I in 0 and 29 cases, Grade II in 5 and 21 cases, and Grade III in 11 and 8 cases, respectively, constituting a significant difference. Pedicle fracture in the surgery and conservative groups was Grade I in 5 and 55 cases, Grade II in 6 and 2 cases, and Grade III in 5 and 1 case, respectively, also constituting a significant difference. CONCLUSIONS: The most high-risk OVF patients with poor prognostic MRI findings who required surgical treatment were those who exhibited greater vertebral instability as well as either more severe posterior wall injury or pedicle fracture. STUDY DESIGN: Retrospective clinical study.

Correlation between osteoarthritis of the atlantoaxial facet joint and a high-riding vertebral artery.

BACKGROUND: A high-riding vertebral artery (HRVA) is an intraosseous anomaly that narrows the trajectory for C2 pedicle screws. The prevalence of a HRVA is high in patients who need surgery at the craniovertebral junction, but reports about HRVAs in subaxial cervical spine disorders are limited. We sought to determine the prevalence of HRVAs among patients with subaxial cervical spine disorders to elucidate the potential risk for VA injury in subaxial cervical spine surgery. METHODS: We included 215 patients, 94 were with a main lesion from C3 to C7 (subaxial group) and 121 were with a main lesion from T1 to L5 (thoracolumbar group). A HRVA was defined as a maximum C2 pedicle diameter of < 3.5 mm on axial CT. The sex, age of patients, body mass index (BMI), osteoarthritis of the atlantoaxial (C1-2) facet joints, and prevalence of a HRVA in the 2 groups were compared and logistic regression was used to identify the factors correlated with a HRVA. RESULTS: The patients in the subaxial group were younger than those in the thoracolumbar group, but their sex and BMI did not differ significantly between the 2 groups. The mean osteoarthritis grade of the C1-2 facet joints of patients in the subaxial group was significantly higher than that in those in the thoracolumbar group. A HRVA was found in 26 patients of 94 (27.7 %) in the subaxial group and in 19 of 121 (15.7 %) in the thoracolumbar group. The prevalence of a HRVA in the subaxial group was significantly higher and osteoarthritis of C1-2 facet joints correlated significantly with a HRVA. CONCLUSIONS: The prevalence of a HRVA in patients with subaxial cervical spine disorders is higher than in those without and osteoarthritis of the C1-2 facet joints is correlated with a HRVA.

Characteristics of relief and residual low back pain after discectomy in patients with lumbar disc herniation: analysis using a detailed visual analog scale.

BACKGROUND: Several authors have reported favorable results in low back pain (LBP) for patients with lumbar disc herniation (LDH) treated with discectomy. However, detailed changes over time in the characteristics and location of LBP before and after discectomy for LDH remain unclear. To clarify these points, we conducted an observational study to determine the detailed characteristics and location of LBP before and after discectomy for LDH, using a detailed visual analog scale (VAS) bilaterally. METHODS: We included 65 patients with LDH treated by discectomy in this study. A detailed VAS for LBP was administered with the patient under 3 different conditions: in motion, standing, and sitting. Bilateral VAS was also administered (affected versus opposite side) for LBP, lower extremity pain (LEP), and lower extremity numbness (LEN). The Oswestry Disability Index (ODI) was used to quantify clinical status. Changes over time in these VAS and ODI were investigated. Pfirrmann grading and Modic change as seen by magnetic resonance imaging (MRI) were reviewed before and 1 year after discectomy to determine disc and endplate condition. RESULTS: Before surgery, LBP on the affected side while the patients were in motion was significantly higher than LBP while they were sitting (p = 0.025). This increased LBP on the affected side in motion was improved significantly after discectomy (p < 0.001). By contrast, the residual LBP while sitting at 1 year after surgery was significantly higher than the LBP while they were in motion or standing (p = 0.015). At 1 year following discectomy, residual LBP while sitting was significantly greater in cases showing changes in Pfirrmann grade (p = 0.002) or Modic type (p = 0.025). CONCLUSIONS: Improvement of LBP on the affected side while the patient is in motion suggests that radicular LBP is improved following discectomy by nerve root decompression. Furthermore, residual LBP may reflect increased load and pressure on the disc and endplate in the sitting position.

Thoracic kyphosis and pelvic anteversion in patients with adult spinal deformity increase while walking: analyses of dynamic alignment change using a three-dimensional gait motion analysis system.

PURPOSE: To determine dynamic changes of spinopelvic alignment while walking using a three-dimensional (3D) gait motion analysis in adult spinal deformity (ASD) patients. METHODS: This study included 20 ASD patients. The 3D gait motion analysis (Vicon) was performed during continuous walking to their limit. Dynamic parameters were obtained using reflective markers on the spinous processes, which were segmented into thoracic (T-), lumbar (L-), and whole spine (S-), sagittal spinal distance (SVA) and coronal one (CVA), sagittal spinal angle to the vertical axis (SA) and coronal one (CA), sagittal pelvic angle to the horizontal axis (P-SA) and coronal (P-CA), and thoracic limited spinal angle to the pelvic angle (T-P SA) and lumbar one (L-P SA). The dynamic variables at the final lap were compared with those at the first lap of an oval walkway. RESULTS: Spinal kyphotic deformity deteriorated significantly. As for pelvic angle, the mean P-SA parameters (first lap/final lap) were 3.2°/5.2°. Anteversion of pelvic sagittal angle increased significantly after continuous walking to their limit. In particular, regarding limited spinal angle to the pelvic angle, the mean T-P SA parameters were 30.5°/36.2° and L-P SA parameters were 6.4°/6.8°. Thoracic kyphotic angle increased significantly, but lumbar kyphotic angle did not change. CONCLUSION: Decrease of thoracic kyphosis and pelvic retroversion has been recognized as a compensation for ASD on standing radiograph. Our 3D gait motion analysis to determine spinal balance found thoracic kyphosis and pelvic anteversion increased significantly in patients with ASD after continuous walking to the limit of their endurance until they were fatigued, indicating a failure of compensation for ASD. These slides can be retrieved under Electronic Supplementary Material.

Posterolateral lumbar spine fusion with unidirectional porous beta-tricalcium phosphate in a canine model.

We investigated the use of the autologous iliac bone and unidirectional porous beta-tricalcium phosphate (UDPTCP) in posterolateral lumbar spine fusion (PLF). Ten canine PLF models were prepared. Using only the autologous bone as the control group, 100%, 75%, 50%, and 25% groups were prepared according to the mixing ratios of UDPTCP. Radiological evaluation and histological analysis were performed 12 weeks after surgery. Bone fusion was evaluated according to anteroposterior plain X-rays and coronal reconstruction CT views using four grades: 0 = no osteogenesis, 1 = only slight discontinuous osteogenesis between transverse processes, 2 = discontinuous osteogenesis between transverse processes, and 3 = continuous osteogenesis between transverse processes. Bone fusion determined by X-ray was 2.8 ± 0.5 in the control group, 0 in the 100% UDPTCP group (p = 0.02), 1.8 ± 0.5 (p = 0.03) in the 75% UDPTCP group, 2.5 ± 0.6 (p = 0.54) in the 50% UDPTCP group, and 2.8 ± 0.5 (p = 1.0) in the 25% UDPTCP group. The bone fusion score was significantly lower in the 75% and 100% UDPTCP groups than in the control group. Bone fusion determined by CT was 2.8 ± 0.5 in the control group, 1.0 ± 0.8 (p = 0.01) in the 100% UDPTCP group, 2.0 ± 0.0 (p = 0.02) in the 75% UDPTCP group, 2.5 ± 0.6 (p = 0.54) in the 50% UDPTCP group, and 2.8 ± 0.5 (p = 1.0) in the 25% UDPTCP group. Similar to the bone fusion determination by X-ray, the bone fusion score was significantly lower in the 75% and 100% UDPTCP groups. These data suggest that, in a canine PLF model, the appropriate mixing ratio of UDPTCP is 50% or less.

Therapeutic Effects of Conservative Treatment with 2-Week Bed Rest for Osteoporotic Vertebral Fractures: A Prospective Cohort Study.

UPDATE: This article was updated on October 19, 2022, because of previous errors, which were discovered after the preliminary version of the article was posted online. On page 1787, in the legend for Figure 2, the sentence that had read "The vertebral collapse rate (in %) was defined as 1 - (A/P) × 100, and vertebral instability (in %) was defined as the difference in vertebral collapse rate between the loaded and non-loaded images." now reads "The vertebral collapse rate (in %) was defined as (1 - [A/P]) × 100, and vertebral instability (in %) was defined as the difference in vertebral collapse rate between the loaded and non-loaded images." On page 1788, in the section entitled "Data Collection," the sentence that had read "The vertebral collapse rate (in %) was defined as 1 - (anterior vertebral wall height/posterior vertebral wall height) × 100, and vertebral instability (in %) was defined as the difference in vertebral collapse rate between the loaded and non-loaded images 9 ." now reads "The vertebral collapse rate (in %) was defined as (1 - [anterior vertebral wall height/posterior vertebral wall height]) × 100, and vertebral instability (in %) was defined as the difference in vertebral collapse rate between the loaded and non-loaded images 9 ." Finally, on page 1791, in Table IV, the footnote for the "Primary outcome" row that had read "N = 113 in the rest group and 99 in the no-rest group." now reads "N = 116 in the rest group and 108 in the no-rest group."

Although imaging findings that predict resistance to conservative treatment in patients with osteoporotic vertebral fracture (OVF) have recently been reported, no conservative treatment method has been standardized. In this study, the effects of initial bed rest on the outcomes of patients with OVF and in patients with and without poor prognostic findings on magnetic resonance imaging (MRI) were compared. This prospective cohort study at 2 facilities involved consecutive patients aged ≥65 years with OVF who began treatment within 2 weeks after their injury and were observed for 6 months. Patients at one hospital rested for 2 weeks (116 patients; mean age, 80.4 years), whereas those at the other hospital were not instructed to rest (108 patients; mean age, 81.5 years). Patients were further divided according to the presence or absence of poor prognostic MRI findings. The primary end point was the rate of transition to surgery; secondary end points included bone union rate, vertebral collapse progression, local kyphosis progression, and changes in activities of daily living (ADL). Forty-five patients in the rest group (including 3 who required surgery) and 37 patients in the no-rest group (including 9 who required surgery) had poor prognostic MRI findings. Although the difference in the rate of transition to surgery between the rest and no-rest groups did not reach significance among all patients (p = 0.06), the transition rate in the rest group was significantly lower (p = 0.02) in the patients with poor prognostic MRI findings. Both the bone union rate and changes in ADL were not significantly different between the rest and no-rest groups. The mean vertebral collapse progression was 6.4% in the rest group and 20.9% in the no-rest group (p < 0.001), and the mean local kyphosis progression was 2.4° in the rest group and 8.8° in the no-rest group (p < 0.001). Although bed rest is not recommended for all patients, hospitalized bed rest for 2 weeks reduced the number of patients with OVF who require surgery among patients with poor prognostic MRI findings. Bed rest also reduced progression of vertebral collapse and kyphosis, regardless of the MRI findings. Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

Spinal Epidural Lipoma on the Ventral Dura Side and Intervertebral Foramen Causing Lumbar Radiculopathy.

A 56-year-old obese man with a body mass index of 30.9 kg/m2 presented with left sciatica and intermittent claudication. Computed tomography scans showed a posterior vertebral scalloping change in L3, L4, and L5. Meanwhile, magnetic resonance imaging revealed epidural mass posterior to the L3, L4, and L5 vertebral bodies. The solitary mass was isosignal to subcutaneous fat and asymmetrically compressed to the left side of the dural sac and L4 nerve root, as observed on axial T1- and T2-weighted images. To the best of our knowledge, there have been few reports of a solitary epidural lipoma causing lumbar radiculopathy. The patient underwent transforaminal lumbar interbody fusion at L4-L5, and his symptoms then resolved. Thus, we recommend decompression and fixation as appropriate management for lumbar radiculopathy caused by epidural lipoma located on the ventral side of the dura and intervertebral foramen.

Surgical treatment for kyphotic deformity after anterior cervical fusion with a severely tortuous vertebral artery: a case report.

We performed salvage surgery on a patient with kyphotic deformity after anterior cervical fusion with a tortuous vertebral artery (VA). A 69-year-old woman had undergone anterior cervical corpectomy and fusion 12 years ago. Her cervical alignment gradually became kyphotic because of bone graft collapse. Ten years after surgery, she experienced severe neck pain, recurrence of myelopathic symptoms and difficulty in keeping her head straight. The patient was diagnosed with rigid cervical kyphosis at C4-6 vertebral levels, with the right tortuous VA invaginating into the C4 vertebral body. We selected a three-stage, anterior-posterior-anterior approach to reduce cervical alignment. The key to a successful surgery in this case was to retract the tortuous VA within the C4 vertebral body, followed by total uncinectomy. Careful preoperative VA evaluation was a decisive factor in surgical planning.

Efficacy of platelet-rich plasma impregnation for unidirectional porous ß-tricalcium phosphate in lateral lumbar interbody fusion: study protocol for a prospective controlled trial.

BACKGROUND: The use of platelet-rich plasma has been increasing in spinal fusion surgery. However, the efficacy of platelet-rich plasma in lateral lumbar interbody fusion is unclear. In Japan, Affinos,® (Kuraray Co., Tokyo, Japan), a ß-tricalcium phosphate artificial bone, has been increasingly used for spinal fusion. The purpose of this trial is to demonstrate whether Affinos® impregnated with platelet-rich plasma can achieve a higher fusion rate and better clinical outcomes than Affinos® alone. METHODS: The current study is a prospective randomized controlled trial. This trial will include consecutive patients scheduled for lateral lumbar interbody fusion. An intervertebral cage for lateral lumbar interbody fusion has two spaces for bone grafts. As a consequence, two bone grafts are inserted at each intervertebral level. In this study, an artificial bone with platelet-rich plasma will be inserted into one space, and an artificial bone without platelet-rich plasma will be inserted into the other space. We will compare the fusion rates between the bone grafts with and without platelet-rich plasma. Our primary endpoint will be the interbody fusion rate at 1 year after surgery. DISCUSSION: This trial will verify the efficacy of platelet-rich plasma with Affinos® for bony fusion in lateral lumbar interbody fusion. It will also provide substantial evidence for the effectiveness and safety of platelet-rich plasma in spinal fusion surgery. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTb032200199 . First registered on 13 November 2020. jRCT is approved as a member of the Primary Registry Network of WHO ICTRP.

Can Proximal Junctional Kyphosis after Surgery for Adult Spinal Deformity Be Predicted by Preoperative Dynamic Sagittal Alignment Change with 3D Gait Analysis? A Case-Control Study.

BACKGROUND: Severe spinal deformity is a risk factor for proximal junctional kyphosis (PJK) in surgery for adult spinal deformity (ASD). However, standing X-ray imaging in patients with dynamic spinal imbalance can underestimate the risk of PJK because of compensation mechanisms. This study aimed to investigate whether preoperative dynamic spinal alignment can be a predictive factor for PJK. METHODS: We retrospectively included 27 ASD patients undergoing three-dimensional (3D) gait analysis before surgery. Dynamic spinal parameters were obtained using a Nexus motion capture system (Vicon, Oxford, UK). The patients were instructed to walk as long as possible around an oval walkway. The averaged dynamic parameters in the final lap were compared between patients with PJK (+) and with PJK (-). RESULTS: PJK occurred in seven patients (26%). The dynamic angle between the thoracic spine and pelvis was larger in patients with PJK (+) than in those with PJK (-) (32.3 ± 8.1 vs. 18.7 ± 13.5 °, p = 0.020). Multiple logistic regression analysis identified this angle as an independent risk factor for PJK. CONCLUSIONS: Preoperative thoracic anterior inclination exacerbated by gait can be one of preoperative independent risk factors for PJK in patients undergoing corrective surgery for ASD.

Surgical Apgar Score and Controlling Nutritional Status Score are significant predictors of major complications after cervical spine surgery.

Nutritional screening scores, including Controlling Nutritional Status (CONUT) Score and Surgical Apgar Score (SAS), which reflect intraoperative hemodynamics, have been reported to be useful for predicting major postoperative complications in various kinds of surgery. We assessed independent risk factors for major complications after cervical spine surgery using those scoring measurements. We retrospectively reviewed medical records of patients who underwent cervical spine surgery at our institution from 2014 to 2019. Baseline clinical information, including the CONUT Score, and surgical factors, including the SAS, were assessed as risk factors for major postoperative complications. We analyzed 261 patients. Major postoperative complications occurred in 40 cases (15.3%). In the multivariate analysis, SAS (odds ratio [OR], 0.42; P < 0.01), CONUT (OR, 1.39; P < 0.01), and operative time (OR, 1.42; P < 0.01) were significant independent risk factors of major complications. The area under the SAS curve was 0.852 in the receiver operating characteristic curve analysis. Postoperative hospitalization duration was significantly longer in major complications group. Evaluating preoperative nutritional condition and intraoperative hemodynamics with CONUT score and SAS was useful for predicting major postoperative complications of cervical spine surgery. In addition, both scoring measurements are easily calculated, objective evaluations. Perioperative management utilizing those scoring measurements may help prevent them.

Paravertebral foramen screw fixation for posterior cervical spine surgery: clinical case series.

OBJECTIVE: The goal of this study was to clarify the clinical utility of paravertebral foramen screws (PVFSs) and to determine intraoperative indicators for appropriate screw placement during posterior cervical fusion surgery to improve its safety. METHODS: The authors included data from 46 patients (29 men and 17 women, mean age 61.7 years) who underwent posterior cervical spine surgery with 94 PVFSs. Of the 94 PVFSs, 77 were used in C6, 9 in C3, 5 in C4, and 3 in C5. According to the cervical lateral radiographic view, the authors divided the 94 PVFSs into 3 groups as follows: a longer group, in which the tip of PVFS was located anteriorly from the line of the posterior wall of the vertebral body (> +0 mm); an intermediate group, in which the screw tip was located up to 2 mm posteriorly to the posterior wall of the vertebral body (-2 to 0 mm); and a shorter group, in which the screw tip was located more than 2 mm posteriorly (< -2 mm). The accuracy of screw placement was assessed using CT imaging in the axial plane, and the proportion of screws penetrating a vertebral foramen or a transverse foramen was compared between the 3 groups. Screw loosening was defined as a lucent zone around the screw evaluated on cervical radiography at 1 year after surgery. Complications related to PVFS insertion and revision surgery related to PVFS were evaluated. RESULTS: The authors classified 25 PVFSs into the longer group, 43 into the intermediate group, and 26 into the shorter group. The proportion of screws penetrating a vertebral foramen was largest in the shorter group, and the proportion penetrating a transverse foramen was largest in the longer group. Screw loosening was confirmed for 3 of 94 PVFSs. One PVFS inserted in C6 unilaterally within a long construct from C2 to C7 showed loosening, but it did not cause clinical symptoms. Revision surgery was required for 2 PVFSs inserted in C3 bilaterally as the lower instrumented vertebra in occiput-cervical fusion because they pulled out. There was no neurovascular complication related to PVFS insertion. CONCLUSIONS: PVFSs are useful for posterior cervical fusion surgery as alternative anchor screws, and the line of the posterior wall of the cervical body on lateral fluoroscopic images is a potential intraoperative reference to indicate an appropriate trajectory for PVFSs.

A Case of Postoperative Recurrent Lumbar Disc Herniation Conservatively Treated with Novel Intradiscal Condoliase Injection.

Although postoperative recurrent lumbar disc herniation (rec-LDH) is uncommon, it is a challenging situation that requires revision surgery when conservative treatment fails. Recently, an agent inducing chemical dissolution of the nucleus pulposus using condoliase has been approved as a novel intradiscal treatment for LDH. To date, no evidence has been reported regarding its effectiveness in the treatment of postoperative rec-LDH. A 25-year-old man with a history of LDH in L4/5, who underwent transforaminal full endoscopic lumbar discectomy when he was 17 years old, complained of severe pain radiating to his left leg since 1 month. The straight leg-raising test was limited to 25° on the left side. Lumbar T2-weighted magnetic resonance imaging (MRI) showed intracanal, left-sided transligamentous disc herniation at L4/5 with high-signal intensity. Because the conservative treatment with oral analgesics and selective left L5 nerve root block failed, the patient requested intradiscal condoliase injection instead of revision surgery. There were no adverse events reported after the condoliase treatment, and the pain radiating to the left leg improved within 2 weeks. A lumbar MRI performed 2 months after treatment revealed that the disc herniation had significantly decreased in size. The straight leg-raising test examined 3 months after treatment was negative. In this case, the disc herniation was of the transligamentous type and showed a high-signal intensity on T2-weighted MRI which could be suitably treated by condoliase injection therapy. This case report is the first to suggest that intradiscal condoliase injection could be a useful and novel conservative treatment option to treat postoperative rec-LDH.

Accidental anterior longitudinal ligament rupture during lateral lumbar interbody fusion disclosed after posterior corrective fusion surgery resulting in local hyper-lordosis.

Objective: To report a case of anterior longitudinal ligament (ALL) injury that was not noticeable during lateral lumbar interbody fusion and was disclosed after posterior corrective fusion surgery. Case presentation: After performing lateral lumbar interbody fusion followed by posterior corrective fusion surgery, we observed an anterior longitudinal ligament rupture that required additional surgery. Postoperative pain in the left lower limb and muscle weakness due to nerve traction appeared, but this was improved by stabilization between the vertebral bodies. Conclusion: Unidentified anterior longitudinal ligament rupture can result in unexpected local lordosis during posterior surgery, possibly related to lower extremity palsy. Therefore, checking for possible rupture during and after anterior surgery is important. If the ALL damage is disclosed before posterior surgery, the proper surgical strategy for the posterior surgery must be considered.