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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 assessments with clinical outcomes., Background: Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases., Patients and 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, 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-Visual Analog Scale, 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., Level of Evidence: II., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Study Design: This was a multicenter retrospective cohort study., Objective: We investigated the incidence of postoperative shoulder imbalance (PSI) and its risk factors in patients with Lenke types 1 and 2 scoliosis corrected using vertebral coplanar alignment (VCA)., Summary of Background Data: PSI in scoliosis affects patient quality of life. While other correction methods have reported a high correction rate for the main thoracic curve (MTC) in relation to PSI, this correlation has not been confirmed for the VCA technique., Methods: We studied 176 patients with Lenke types 1 and 2 scoliosis who underwent posterior corrective fusion surgery using the VCA technique at 11 institutions. At two years postoperatively, patients were divided into two groups based on radiographic shoulder height (RSH): PSI- (RSH<2 cm) and PSI+ (RSH≧2 cm) groups. We analyzed the risk factors for PSI., Results: The overall incidence of PSI two years postoperatively was 11.4% (20/176), with 9.2% (11/119) and 15.8% (9/57) in patients with Lenke types 1 and 2, respectively. Contrary to a previous study, a high MTC correction rate did not emerge as a risk factor for PSI. Instead, preoperative left shoulder elevation and low postoperative thoracic kyphosis and greater T1 tilt and high apical vertebral body-to-rib ratio were associated with PSI in patients with Lenke type 1. Preoperative left shoulder elevation and a low postoperative proximal thoracic curve (PTC) correction rate were identified as risk factors for PSI in patients with Lenke type 2., Conclusion: Our results suggest that proper correction of the PTC, rather than compromise MTC correction, may help prevent PSI in the VCA technique. This method is particularly advantageous for addressing Lenke type 1 scoliosis and yields favorable outcomes in shoulder balance. Patients with preoperative left shoulder elevation, especially Lenke type 2, are at high risk of developing PSI., Level of Evidence: 4., Competing Interests: No conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

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., Competing Interests: Declaration of competing interest The Authors declare that there is no conflict of interest., (Copyright © 2024 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.)

Background: This study aimed to evaluate the association between spinopelvic alignment parameters and hip osteoarthritis progression after spinal alignment correction surgery for adult spinal deformity, focusing on the preoperative to postoperative change in spinopelvic alignment., Methods: This retrospective study enrolled 100 adult spinal deformity patients (196 hip joints) who underwent spinal fusion surgery, after excluding four joints with previous total hip arthroplasty. Acetabular roof obliquity (ARO), center edge angle (CE) and Kellgren and Lawrence (KL) grade were measured in the hip joint. Spinopelvic alignment parameters were measured preoperatively and 1-month postoperatively and the changes (Δ) during this period were calculated. Patients were followed-up for ≥ 5 years and factors associated with KL grade progression at 5-years postoperatively were determined by logistic regression analysis., Results: In the analysis with all cases, KL grade progressed in 23 joints. Logistic regression analysis revealed age (OR: 1.098, 95% CI: 1.007-1.198, p = 0.019), ARO (OR: 1.176, 95% CI: 1.01-1.37, p = 0.026), and Δ PI (OR: 0.791, 95% CI: 0.688-0.997, p < 0.001) as parameters significantly associated with KL grade progression. On the other hand, in the analysis limited to 185 cases with 1-month postoperative KL grade of 0, KL grade progressed in 13 joints. Logistic regression analysis revealed PI-LL (OR: 1.058, 95% CI: 1.001-1.117, p = 0.04), ΔPI (OR: 0.785, 95% CI: 0.649-0.951, p < 0.001), and ΔCobb (OR: 1.127, 95% CI: 1.012-1.253, p = 0.009) as parameters significantly associated with progression., Conclusions: Both the overall and limited analyzes of this study identified preoperative to postoperative change in PI as parameters affecting the hip osteoarthritis progression after spinal fusion surgery. Decrease in PI might represent preexisting sacroiliac joint laxity. Patients with this risk factor should be carefully followed for possible hip osteoarthritis progression., (© 2024. The Author(s).)

Background: The natural history of the congenital spinal deformity and its clinical magnitude vary widely in human species. However, we previously reported that the spinal deformities of congenital scoliosis mice did not progress throughout our observational period according to soft X-ray and MRI data. In this study, congenital vertebral and intervertebral malformations in mice were assessed via magnetic resonance (MR) and histological images., Methods: Congenital spinal anomalies were chronologically assessed via soft X-ray and 7 T MR imaging. MR images were compared to the histological images to validate the findings around the malformations., Results: Soft X-ray images showed the gross alignment of the spine and the contour of the malformed vertebrae, with the growth plate and cortical bone visible as higher density lines, but could not be used to distinguish the existence of intervertebral structures. In contrast, MR images could be used to distinguish each structure, including the cortical bone, growth plate, cartilaginous end plate, and nucleus pulposus, by combining the signal changes on T1-weighted imaging (T1WI) and T2-weighted imaging (T2WI). The intervertebral structure adjacent to the malformed vertebrae also exhibited various abnormalities, such as growth plate and cartilaginous end plate irregularities, nucleus pulposus defects, and bone marrow formation. In the chronological observation, the thickness and shape of the malformed structures on T1WI did not change., Conclusions: Spinal malformations in mice were chronologically observed via 7 T MRI and histology. MR images could be used to distinguish the histological structures of normal and malformed mouse spines. Malformed vertebrae were accompanied by adjacent intervertebral structures that corresponded to the fully segmented structures observed in human congenital scoliosis, but the intervertebral conditions varied. This study suggested the importance of MRI and histological examinations of human congenital scoliosis patients with patterns other than nonsegmenting patterns, which may be used to predict the prognosis of patients with spinal deformities associated with malformed vertebrae., (© 2024. The Author(s).)

Background: The efficacy of anterior fusion with overcorrection in the instrumented vertebra for Lenke 1 AR type curves has been reported, but how to achieve overcorrection and how overcorrection affects spinal alignment are unclear. The purpose of this study was to identify the factors that cause overcorrection, and to investigate how overcorrection affects postoperative spinal alignment in the surgical treatment of Lenke 1 AR type curves., Methods: Patients who had anterior surgery for a Lenke type 1 or 2 and lumbar modifier AR (L4 vertebral tilt to the right) type scoliosis and minimum 2-year follow-up were included. The radiographic data were measured at preoperative, postoperative 1 month, and final follow-up. The UIV-LIV Cobb angle was determined as the Cobb angle between the upper instrumented vertebra (UIV) and the lower instrumented vertebra (LIV), and a negative number for this angle was considered overcorrection. The screw angle was determined to be the sum of the angle formed by the screw axis and the lower and upper endplates in the LIV and UIV, respectively. The change (Δ) in the parameters from postoperative to final follow-up was calculated. The relationships between the UIV-LIV Cobb angle and other radiographic parameters were evaluated by linear regression analyses., Results: Fourteen patients met the inclusion criteria. Their median age was 15.5 years, and the median follow-up period was 53.6 months. The median UIV-LIV Cobb angle was -1.4° at postoperative 1 month. The median screw angle was 4.7°, and overcorrection was achieved in 11 (79%) cases at postoperative 1 month. The screw angle (r 2  = 0.42, p = 0.012) and Δ FDUV-CSVL (the deviation of the first distal uninstrumented vertebra from the central sacral vertical line, r 2  = 0.53, p = 0.003) were significantly correlated with the UIV-LIV Cobb angle., Conclusions: Screw placement in the UIV and LIV not parallel to the endplate, but angled, was an effective method to facilitate overcorrection in the instrumented vertebrae. The results of the present study suggest that overcorrection could bring spontaneous improvement of coronal balance below the instrumented segment during the postoperative period., (© 2023. The Author(s).)

Purpose: This study aimed to investigate the recent 10-year trends in cervical laminoplasty and 30-day postoperative complications., Methods: This retrospective multi-institutional cohort study enrolled patients who underwent laminoplasty for cervical spondylotic myelopathy (CSM) or ossification of the posterior longitudinal ligament. The primary outcome was the occurrence of all-cause 30-day complications. Trends were investigated and compared in the early (2008-2012) and late (2013-2017) periods., Results: Among 1095 patients (mean age, 66 years; 762 [70%] male), 542 and 553 patients were treated in the early and late periods, respectively. In the late period, patients were older at surgery (65 years vs. 68 years), there were more males (66% vs. 73%), and open-door laminoplasty (50% vs. 69%) was the preferred procedure, while %CSM (77% vs. 78%) and the perioperative JOA scores were similar to the early period. During the study period, the rate of preservation of the posterior muscle-ligament complex attached to the C2/C7-spinous process (C2, 89% vs. 93%; C7, 62% vs. 85%) increased and the number of laminoplasty levels (3.7 vs. 3.1) decreased. While the 30-day complication rate remained stable (3.9% vs. 3.4%), C5 palsy tended to decrease (2.4% vs. 0.9%, P = 0.059); superficial SSI increased significantly (0% vs. 1.3%, P = 0.015), while the decreased incidence of deep SSI did not reach statistical significance (0.6% vs. 0.2%)., Conclusions: From 2008 to 2017, there were trends toward increasing age at surgery and surgeons' preference for refined open-door laminoplasty. The 30-day complication rate remained stable, but the C5 palsy rate halved., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Study Design: A prospective multicenter study., Objective: To investigate the effect of preoperative symptom duration on neurological recovery for the treatment of cervical ossification of the posterior longitudinal ligament (OPLL)., Summary of Background Data: The optimal timing to perform surgery in the setting of cervical OPLL remains unknown. It is important to know the influence of symptom duration on postoperative outcomes to facilitate discussions regarding the timing of surgery., Patients and Methods: The study included 395 patients (291 men and 104 women; mean age, 63.7 ± 11.4 yr): 204 were treated with laminoplasty, 90 with posterior decompression and fusion, 85 with anterior decompression and fusion, and 16 with other procedures. The Japanese Orthopedic Association (JOA) score and patient-reported outcomes of the JOA Cervical Myelopathy Evaluation Questionnaire were used to assess clinical outcomes preoperatively and 2 years after surgery. Logistic regression analysis was used to identify factors associated with the achievement of minimum clinically important difference (MCID) after surgery., Results: The recovery rate was significantly lower in the group with symptom duration of ≥5 years compared with the groups with durations of <0.5 years, 0.5 to 1 year, and 1 to 2 years. Improvement of JOA Cervical Myelopathy Evaluation Questionnaire in the upper extremity function score ( P < 0.001), lower extremity function ( P = 0.039), quality of life ( P = 0.053), and bladder function ( P = 0.034) were all decreased when the symptom duration exceeded 2 years. Duration of symptoms ( P = 0.001), age ( P < 0.001), and body mass index ( P < 0.001) were significantly associated with the achievement of MCID. The cutoff value we established for symptom duration was 23 months (area under the curve, 0.616; sensitivity, 67.4%; specificity, 53.5%)., Conclusions: Symptom duration had a significant impact on neurological recovery and patient-reported outcome measures in this series of patients undergoing surgery for cervical OPLL. Patients with symptom duration exceeding 23 months may be at greater risk of failing to achieve MCID after surgery., Level of Evidence: 3., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Study Design: A prospective multicenter study., Objective: The objective of this study was to investigate the incidence of loss of cervical lordosis after laminoplasty for cervical ossification of the posterior longitudinal ligament (OPLL). We also sought to determine associated risk factors and the relationship with patient-reported outcomes., Summary of Background Data: Loss of cervical lordosis is a sequelae often observed after laminoplasty, which may adversely impact surgical outcomes. Cervical kyphosis, especially in OPLL, is associated with reoperation, but risk factors and relationship to postoperative outcomes remain understudied at this time., Materials and Methods: This study was conducted by the Japanese Multicenter Research Organization for Ossification of the Spinal Ligament. We included 165 patients who underwent laminoplasty and completed Japanese Orthopaedic Association (JOA) score or Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaires (JOACMEQ), as well as Visual Analog Scales (VAS) for pain, with imaging. The participants were divided into two groups: those with loss of cervical lordosis of >10° or 20° after surgery and those without loss of cervical lordosis. A paired t test was applied to evaluate the association between changes in cervical spinal angles, range of motion, and cervical JOA and VAS scores before and at 2 years postoperatively. Mann-Whitney U test was used for JOACMEQ., Results: Postoperative loss of cervical lordosis >10° and >20° was observed in 32 (19.4%) and 7 (4.2%), respectively. JOA, JOACMEQ, and VAS scores were not significantly different between those with, and without, loss of cervical lordosis. Preoperative small extension range of motion (eROM) was significantly associated with postoperative loss of cervical lordosis, and the cutoff values of eROM were 7.4° [area under the curve (AUC): 0.76] and 8.2° (AUC: 0.92) for loss of cervical lordosis >10° and >20°, respectively. A large occupation ratio of OPLL was also associated with loss of cervical lordosis, with a cutoff value of 39.9% (AUC: 0.94). Laminoplasty resulted in functional improvement in most patient-reported outcomes; however, neck pain and bladder function tended to become worse postoperatively in cases with postoperative loss of cervical lordosis >20°., Conclusions: JOA, JOACMEQ, and VAS scores were not significantly different between those with, and without, loss of cervical lordosis. Preoperative small eROM and large OPLL may represent factors associated with loss of cervical lordosis after laminoplasty in patients with OPLL., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Study Design: A prospective multicenter study., Objective: The objective of this study is to compare the surgical outcomes of anterior and posterior fusion surgeries in patients with K-line (-) cervical ossification of the posterior longitudinal ligament (OPLL)., Summary of Background Data: Although laminoplasty is effective for patients with K-line (+) OPLL, fusion surgery is recommended for those with K-line (-) OPLL. However, whether the anterior or posterior approach is preferable for this pathology has not been effectively determined., Materials and Methods: A total of 478 patients with myelopathy due to cervical OPLL from 28 institutions were prospectively registered from 2014 to 2017 and followed up for two years. Of the 478 patients, 45 and 46 with K-line (-) underwent anterior and posterior fusion surgeries, respectively. After adjusting for confounders in baseline characteristics using a propensity score-matched analysis, 54 patients in both the anterior and posterior groups (27 patients each) were evaluated. Clinical outcomes were assessed using the cervical Japanese Orthopaedic Association and the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire., Results: Both approaches showed comparable neurological and functional recovery. The cervical range of motion was significantly restricted in the posterior group because of the large number of fused vertebrae compared with the anterior group. The incidence of surgical complications was comparable between the cohorts, but the posterior group demonstrated a higher frequency of segmental motor paralysis, whereas the anterior group more frequently reported postoperative dysphagia., Conclusions: Clinical improvement was comparable between anterior and posterior fusion surgeries for patients with K-line (-) OPLL. The ideal surgical approach should be informed based on the balance between the surgeon's technical preference and the risk of complications., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The uniqueness of spinal sagittal alignment in thoracic adolescent idiopathic scoliosis (AIS), for example, the drastically smaller thoracic kyphosis seen in some patients, has been recognized but not yet fully understood. The purpose of this study was to clarify the characteristics of sagittal alignment of thoracic AIS and to determine the contributing factors., Methods: Whole spine radiographs of 83 thoracic AIS patients (73 females) were analyzed. The measured radiographic parameters were the Cobb angle of thoracic scoliosis, thoracic kyphosis (TK), lumbar lordosis (LL), C7 sagittal vertical axis (C7 SVA), pelvic incidence (PI), pelvic tilt (PT), and sacral slope (SS). Additionally, max-LL, which was defined as the maximum lordosis angle from the S1 endplate, the inflection point between thoracic kyphosis and lumbar lordosis, and the SVA of the inflection point (IP SVA) were measured. The factors significantly related to a decrease in TK were assessed by stepwise logistic regression analysis. In addition, cluster analysis was performed to classify the global sagittal alignment., Results: The significant factors for a decrease in TK were an increase in SS (p = 0.0003, [OR]: 1.16) and a decrease in max-LL (p = 0.0005, [OR]: 0.89). According to the cluster analysis, the global sagittal alignment was categorized into the following three types: Type 1 (low SS, low max-LL, n = 28); Type 2 (high SS, low max-LL, n = 22); and Type 3 (high SS, high max-LL, n = 33)., Conclusions: In thoracic AIS, a decreased TK corresponded to an increased SS or a decreased max-LL. The sagittal alignment of thoracic AIS patients could be classified into three types based on SS and max-LL. One of these three types includes the unique sagittal profile of very small TK., (© 2022. The Author(s).)

Importance: The optimal management for acute traumatic cervical spinal cord injury (SCI) is unknown., Objective: To determine whether early surgical decompression results in better motor recovery than delayed surgical treatment in patients with acute traumatic incomplete cervical SCI associated with preexisting canal stenosis but without bone injury., Design, Setting, and Participants: This multicenter randomized clinical trial was conducted in 43 tertiary referral centers in Japan from December 2011 through November 2019. Patients aged 20 to 79 years with motor-incomplete cervical SCI with preexisting canal stenosis (American Spinal Injury Association [ASIA] Impairment Scale C; without fracture or dislocation) were included. Data were analyzed from September to November 2020., Interventions: Patients were randomized to undergo surgical treatment within 24 hours after admission or delayed surgical treatment after at least 2 weeks of conservative treatment., Main Outcomes and Measures: The primary end points were improvement in the mean ASIA motor score, total score of the spinal cord independence measure, and the proportion of patients able to walk independently at 1 year after injury., Results: Among 72 randomized patients, 70 patients (mean [SD] age, 65.1 [9.4] years; age range, 41-79 years; 5 [7%] women and 65 [93%] men) were included in the full analysis population (37 patients assigned to early surgical treatment and 33 patients assigned to delayed surgical treatment). Of these, 56 patients (80%) had data available for at least 1 primary outcome at 1 year. There was no significant difference among primary end points for the early surgical treatment group compared with the delayed surgical treatment group (mean [SD] change in ASIA motor score, 53.7 [14.7] vs 48.5 [19.1]; difference, 5.2; 95% CI, -4.2 to 14.5; P = .27; mean [SD] SCIM total score, 77.9 [22.7] vs 71.3 [27.3]; P = .34; able to walk independently, 21 of 30 patients [70.0%] vs 16 of 26 patients [61.5%]; P = .51). A mixed-design analysis of variance revealed a significant difference in the mean change in ASIA motor scores between the groups (F1,49 = 4.80; P = .03). The early surgical treatment group, compared with the delayed surgical treatment group, had greater motor scores than the delayed surgical treatment group at 2 weeks (mean [SD] score, 34.2 [18.8] vs 18.9 [20.9]), 3 months (mean [SD] score, 49.1 [15.1] vs 37.2 [20.9]), and 6 months (mean [SD] score, 51.5 [13.9] vs 41.3 [23.4]) after injury. Adverse events were common in both groups (eg, worsening of paralysis, 6 patients vs 6 patients; death, 3 patients vs 3 patients)., Conclusions and Relevance: These findings suggest that among patients with cervical SCI, early surgical treatment produced similar motor regain at 1 year after injury as delayed surgical treatment but showed accelerated recovery within the first 6 months. These exploratory results suggest that early surgical treatment leads to faster neurological recovery, which requires further validation., Trial Registration: ClinicalTrials.gov Identifier: NCT01485458; umin.ac.jp/ctr Identifier: UMIN000006780.

Objective: Previous studies have demonstrated that Lenke lumbar modifier A contains 2 distinct types (AR and AL), and the AR curve pattern is likely to develop adding-on (i.e., a progressive increase in the number of vertebrae included within the primary curve distally after posterior surgery). However, the results of anterior surgery are unknown. The purpose of this study was to present the surgical results in a cohort of patients undergoing scoliosis treatment for type 1AR curves and to compare anterior and posterior surgeries to consider the ideal indications and advantages of anterior surgery for type 1AR curves., Methods: Patients with a Lenke type 1 or 2 and lumbar modifier AR (L4 vertebral tilt to the right) and a minimum 2-year postoperative follow-up were included. The incidence of adding-on and radiographic data were compared between the anterior and posterior surgery groups. The numbers of levels between the end, stable, neutral, and last touching vertebra to the lower instrumented vertebra (LIV) were also evaluated., Results: Forty-four patients with a mean follow-up of 57 months were included. There were 14 patients in the anterior group and 30 patients in the posterior group. The main thoracic Cobb angle was not significantly different between the groups preoperatively and at final follow-up. At final follow-up, the anterior group had significantly less tilting of the LIV than the posterior group (-0.8° ± 4.5° vs 3° ± 4°). Distal adding-on was observed in no patient in the anterior group and in 6 patients in the posterior group at final follow-up (p = 0.025). In the anterior group, no LIV was set below the end vertebra, and all LIVs were set above last touching vertebra. The LIV was significantly more proximal in the anterior group than in the posterior surgery patients without adding-on for all reference vertebrae (p < 0.001)., Conclusions: This is the first study to investigate the surgical results of anterior surgery for Lenke type 1AR curve patterns, and it showed that anterior surgery for the curves could minimize the distal extent of the instrumented fusion without adding-on. This would leave more mobile disc space below the fusion.

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., (© The Author(s) (2021). Published by Oxford University Press on behalf of the Guarantors of Brain.)

Objective: Issues with spinopelvic fixation for adult spinal deformity (ASD) include loss of the physiological mobility of the entire lumbar spine, perioperative complications, and medical costs. Little is known about the factors associated with successful short fusion for ASD. The authors evaluated radiographic and clinical outcomes after shorter fusion for different subtypes of ASD at 2 years postoperatively and examined factors associated with successful short fusion., Methods: This was a single-center study of 37 patients who underwent short fusion and a minimum 2 years of follow-up for ASD in which lumbar kyphosis was the main deformity. The exclusion criteria were 1) age < 40 years, 2) previous lumbar vertebral fracture, 3) severe osteoporosis, 4) T10-L2 kyphosis > 20°, 5) scoliotic deformity with an upper end vertebra (UEV) above T12, and 6) concomitant Parkinson's disease or neurological disease. The surgical procedures, radiographic course, and Oswestry Disability Index (ODI) were assessed, and correlations between radiographic parameters and postoperative ODI at 2 years were analyzed., Results: A mean of 3.5 levels were fused. The mean radiographic parameters preoperatively, at 2 weeks, and at 2 years, respectively, were as follows: coronal Cobb angle: 22.9°, 11.5°, and 12.6°; lumbar lordosis (LL): 12.9°, 35.8°, and 32.2°; pelvic incidence (PI) minus LL: 35.5°, 14.7°, and 19.2°; pelvic tilt: 29.4°, 23.1°, and 25.0°; and sagittal vertical axis 85.3, 36.7, and 59.2 mm. Abnormal proximal junctional kyphosis occurred in 8 cases. Revision surgery was performed to extend the length of fusion from a lower thoracic vertebra to the pelvis in 2 cases. The mean ODI scores preoperatively and at 2 years were 50.7% and 24.1%, respectively. Patient age, number of fused intervertebral segments, and radiographic parameters were analyzed by the stepwise method to identify factors contributing to the ODI score at 2 years, preoperative PI, and sagittal vertical axis at 2 years. On receiver operating characteristic curve analysis of the minimal clinically important difference of ODI (15%) and preoperative PI, the cutoff value of the preoperative PI was 47° (area under the curve 0.75)., Conclusions: In terms of subtypes of ASD in which lumbar kyphosis is the main deformity, if the PI is < 47°, then the use of short fusion preserving mobile intervertebral segments can produce adequate LL for the PI, improving both postoperative global spinal alignment and quality of life.

Objectives: It is controversial whether to stop the fusion at L5 or S1 in adult spinal deformity (ASD) surgery. Our hypothesis is that we can stop long fusion at L5 for selected patients with less severe disability and less complex deformity. Aim was to compare minimum 5-year outcomes between ASD patients with fusion to L5 versus S1., Patients and Methods: Consecutive 40 patients (≥50 years of age) with ASD underwent spinal fusion from lower thoracic spine to L5 or S1 between 2008 and 2011. 33 patients (82.5 %) had a minimum 5-year follow-up. Lower instrumented vertebra (LIV) was L5 in 12 patients (L5 group) and S1 in 21 (S1 group). Clinical and radiographical parameters were compared between L5 and S1 group., Results: There were statistically significant differences between two groups (L5 vs S1) in %male (50 % vs 14 %), %type-N of SRS-Schwab classification (83 % vs 38 %), preop ODI (40.5 vs 56), correction loss of LL (11˚ vs 3˚), final TK (32˚ vs 50˚), correction loss of TK (-1˚ vs 17˚), final improvement of PT (3˚ vs 10˚), final improvement of PI-LL (26˚ vs 39˚), PJK (8% vs 48 %), and revision surgery rate (50 % vs 14 %). Causes of revision surgery in L5 group were distal junctional failure in 5 patients and foraminal stenosis at L5-S1 in 1. All of them underwent additional spinal fusion to the sacrum. Whereas, causes of revision surgery in S1 group were rod fracture in 2 patients and proximal junctional failure in 1., Conclusion: Although fusion to L5 was conducted for selected ASD patients with less severe disability (better ODI) and less complex deformity (type N), 50 % of the patients required additional fusion to the pelvis. Decision making to stop the long fusion at L5 for ASD patients ≥50 years of age should be made with careful considerations., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objective: The aim of this study was to show the surgical results of growing rod (GR) surgery with prior foundation surgery (PFS) and sublaminar taping at an apex vertebra., Methods: Twenty-two early-onset scoliosis (EOS) patients underwent dual GR surgery with PFS and sublaminar taping. PFS was performed prior to rod placement, including exposure of distal and proximal anchor areas and anchor instrumentation filled with a local bone graft. After a period of 3-5 months for the anchors to become solid, dual rods were placed for distraction. The apex vertebra was exposed and fastened to the concave side of the rods using sublaminar tape. Preoperative, post-GR placement, and final follow-up radiographic parameters were measured. Complications during the treatment period were evaluated using the patients' clinical records., Results: The median age at the initial surgery was 55.5 months (range 28-99 months), and the median follow-up duration was 69.5 months (range 25-98 months). The median scoliotic curves were 81.5° (range 39°-126°) preoperatively, 30.5° (range 11°-71°) after GR placement, and 33.5° (range 12°-87°) at the final follow-up. The median thoracic kyphotic curves were 45.5° (range 7°-136°) preoperatively, 32.5° (range 15°-99°) after GR placement, and 42° (range 11°-93°) at the final follow-up. The median T1-S1 lengths were 240.5 mm (range 188-305 mm) preoperatively, 286.5 mm (range 232-340 mm) after GR placement, and 337.5 mm (range 206-423 mm) at the final follow-up. Complications occurred in 6 patients (27%). Three patients had implant-related complications, 2 patients had alignment-related complications, and 1 patient had a wound-related complication., Conclusions: A dual GR technique with PFS and sublaminar taping showed effective correction of scoliotic curves and a lower complication rate than previous reports when a conventional dual GR technique was used.

Competing Interests: Conflicts of Interest: The authors declare that there are no relevant conflicts of interest.

Study Design: A retrospective study of consecutive patients undergoing surgery for adult spinal deformity (ASD)., Objective: The aim of this study was to classify postoperative ASD patients by sagittal compensation and characterize the features of each group., Summary of Background Data: Sagittal compensatory mechanisms to keep the erect position would function in not only nonoperative ASD patients but also in postoperative patients. However, details of sagittal compensatory mechanisms after surgery have been unclear, because the majority of previous studies examined the compensatory mechanisms in nonoperative patients., Methods: A total of 73 postoperative ASD patients were recruited. Spinopelvic parameters and Oswestry Disability Index (ODI) were measured before surgery, at 1-month and 2-year follow-up. The changes in parameters (Δ) between postoperative 1-month and 2-year were also evaluated. Cluster analysis based on pelvic tilt (PT) and sagittal vertical axis (SVA) at 2-year follow-up was performed, and then the parameters were compared among clusters., Results: Cluster analysis identified three clusters: the physiological group (n = 38, PT = 19.6°, SVA = 17.2 mm), the compensated group (n = 23, PT = 34.3°, SVA = 45.6 mm), and the decompensated group (n = 12, PT = 36.6°, SVA = 118.8 mm). Comparisons of the parameters among the groups showed that the physiological group had smaller pelvic incidence minus lumbar lordosis (PI-LL) and better ODI. The compensated group had significantly larger Δ thoracic kyphosis (TK), Δ proximal junctional angle (PJA), and ΔPT than the physiological group. The decompensated group had significantly higher PI and higher age., Conclusion: Three groups were defined in terms of postoperative compensatory mechanisms. Patients in the physiological group had little postoperative alignment change and good ODI value. The compensated group had pelvic retroversion to keep SVA in the physiological range, but the compensation in the thoracic spine was unlikely to work. High PI and advanced age were characteristics of the decompensated group., Level of Evidence: 4.

OBJECTIVE Instrumentation failure caused by the loosening of pedicle screws (PSs) in patients with osteoporosis is a serious problem after spinal surgery. The addition of a thin hydroxyapatite (HA) surface coating applied by using a sputtering process was reported recently to be a promising method for providing bone conduction around an implant without a significant risk of coating-layer breakage. In this study, the authors evaluated the biomechanical and histological features of the bone-implant interface (BII) of PSs with a thin HA coating in an in vivo porcine osteoporotic spine model. METHODS Three types of PSs (untreated/standard [STPS], sandblasted [BLPS], and HA-coated [HAPS] PSs) were implanted into the thoracic and lumbar spine (T9-L6) of 8 mature Clawn miniature pigs (6 ovariectomized [osteoporosis group] and 2 sham-operated [control group] pigs). The spines were harvested from the osteoporosis group at 0, 2, 4, 8, 12, or 24 weeks after PS placement and from the control group at 0 or 24 weeks. Their bone mineral density (BMD) was measured by peripheral quantitative CT. Histological evaluation of the BIIs was conducted by performing bone volume/tissue volume and bone surface/implant surface measurements. The strength of the BII was evaluated with extraction torque testing. RESULTS The BMD decreased significantly in the osteoporosis group (p < 0.01). HAPSs exhibited the greatest mean extraction peak torque at 8 weeks, and HAPSs and BLPSs exhibited significantly greater mean torque than the STPSs at 12 weeks (p < 0.05). The bone surface/implant surface ratio was significantly higher for HAPSs than for STPSs after 2 weeks (p < 0.05), and bonding between bone and the implant surface was maintained until 24 weeks with no detachment of the coating layer. In contrast, the bone volume/tissue volume ratio was significantly higher for HAPSs than for BLPSs or STPSs only at 4 weeks. CONCLUSIONS Using PSs with a thin HA coating applied using a sputtering process strengthens bonding at the BII, which might improve early implant fixation after spinal surgery for osteoporosis. However, the absence of increased bone mass around the screw remains a concern; prescribing osteoporosis treatment to improve bone quality might be necessary to prevent fractures around the screws.

Introduction: Granulocyte colony-stimulating factor (G-CSF) is generally used for neutropaenia. Previous experimental studies revealed that G-CSF promoted neurological recovery after spinal cord injury (SCI). Next, we moved to early phase of clinical trials. In a phase I/IIa trial, no adverse events were observed. Next, we conducted a non-randomised, non-blinded, comparative trial, which suggested the efficacy of G-CSF for promoting neurological recovery. Based on those results, we are now performing a phase III trial., Methods and Analysis: The objective of this study is to evaluate the efficacy of G-CSF for acute SCI. The study design is a prospective, multicentre, randomised, double-blinded, placebo-controlled comparative study. The current trial includes cervical SCI (severity of American Spinal Injury Association (ASIA) Impairment Scale B/C) within 48 hours after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group is administered 400 µg/m 2 /day×5 days of G-CSF in normal saline via intravenous infusion for 5 consecutive days. The placebo group is similarly administered a placebo. Our primary endpoint is changes in ASIA motor scores from baseline to 3 months. Each group includes 44 patients (88 total patients)., Ethics and Dissemination: The study will be conducted according to the principles of the World Medical Association Declaration of Helsinki and in accordance with the Japanese Medical Research Involving Human Subjects Act and other guidelines, regulations and Acts. Results of the clinical study will be submitted to the head of the respective clinical study site as a report after conclusion of the clinical study by the sponsor-investigator. Even if the results are not favourable despite conducting the clinical study properly, the data will be published as a paper., Trial Registration Number: UMIN000018752., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Study Design: Retrospective review of three spine surgery databases., Objectives: The purpose of the present study is to determine whether predictors of hospital readmission and surgical site infection (SSI) after lumbar fusion will be the same in United States, Denmark, and Japan., Summary of Background Data: Because clinical decision making becomes more data driven, risk stratification will be crucial to minimize complications. Spine surgeons worldwide face this issue, leading to parallel efforts to address risk stratification. This raises the question as to whether pooled data would be valuable and whether models generated in one country would be applicable to other populations., Methods: Predictors of SSI and 30-day readmission from three prospective databases (National Neurosurgery Quality and Outcomes Database [N2QOD] N = 2653, DaneSpine N = 1993, Japan Multicenter Spine Database [JAMSD] N = 3798) were determined and compared to identify common or divergent predictive risks., Results: Predictive variables differed in the three databases, for both readmission and SSI. Factors predictive for hospital readmission were American Society of Anesthesiologists (ASA) grade in N2QOD (P = 0.013, odds ratio [OR] 2.08), fusion levels in DaneSpine (P = 0.005, OR 1.67), and sex in JAMSD (P = 0.001, OR = 2.81). Associated differences in demographics and procedural factors included mean ASA grade (N2QOD = 2.45, JAMSD = 1.72) and fusion levels (N2QOD = 1.39, DaneSpine = 1.52, JAMSD = 1.34). For SSI, sex (P = 0.000, OR = 3.30), diabetes (P = 0.000, OR = 2.90), and length of stay (P = 0.000, OR = 1.02) were predictive in JAMSD. No predictors were identified in N2QOD or DaneSpine., Conclusion: Predictors of SSI and hospital readmission differ in the United States, Denmark, and Japan, suggesting that risk stratification models may need to be population specific or adjusted. Some differences in measured parameters exist in the three databases analyzed; however, patient and procedure selection also appear to differ and may limit the ability to directly pool data from different regions. Therefore, risk stratification models developed in one country may not be directly applicable to other countries., Level of Evidence: 2.

Background: Hybrid constructs have been widely used to surgically correct thoracic adolescent idiopathic scoliosis (AIS). To enhance the correction obtained with hybrid constructs, we perform concave rib head resection and convex costovertebral release as posterior release procedures. The objective of the study was to evaluate coronal and sagittal curve correction in patients with adolescent idiopathic scoliosis (AIS) treated with hybrid constructs combined with concave rib head resection and convex transverse process resection as posterior release procedures., Methods: The records of 24 patients with Lenke type 1 or 2 AIS treated with hybrid constructs combined with posterior release procedures were retrospectively reviewed. The mean age at surgery was 14.3 years. The mean follow-up period was 33.0 months (range, 24-60 months). Radiographs were evaluated before surgery, immediately postoperatively, and at latest follow-up., Results: The average preoperative Cobb angle of the main thoracic (MT) curve was 58.1 ± 12.6° (range, 45-88°). The MT curve was corrected to 12.8 ± 9.0° (range, 0-38°) immediately after surgery. At the latest follow-up, the average Cobb angle was 13.6 ± 9.9° (range, 0-44°; correction, 77.5 ± 14.0%). The average loss of coronal correction was 0.8°. The average preoperative flexibility of the MT curve was 54.6 ± 17.4%. The average Cincinnati correction index was 1.53 ± 0.48 at the latest follow-up. The average preoperative thoracic kyphosis (TK) was 13.7 ± 12.0° (range, -12-34°). Immediately after surgery, TK was corrected to 18.6 ± 5.9° (range, 10-29°). At the latest follow-up, TK measured 18.1 ± 6.5° (range, 6-32°)., Conclusions: Hybrid instrumentation combined with concave rib head resection and convex transverse process resection as posterior release procedures achieved satisfactory coronal and sagittal curve correction with little loss of correction at 2-year follow-up., (Copyright © 2017 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.)

Purpose: Adult spinal deformity (ASD) classification showing that ideal pelvic incidence minus lumbar lordosis (PI-LL) value is within 10° has been received widely. But no study has focused on the optimum level of PI-LL value that reflects wide variety in PI among patients. This study was conducted to determine the optimum PI-LL value specific to an individual's PI in postoperative ASD patients., Methods: 48 postoperative ASD patients were recruited. Spino-pelvic parameters and Oswestry Disability Index (ODI) were measured at the final follow-up. Factors associated with good clinical results were determined by stepwise multiple regression model using the ODI. The patients with ODI under the 75th percentile cutoff were designated into the "good" health related quality of life (HRQOL) group. In this group, the relationship between the PI-LL and PI was assessed by regression analysis., Results: Multiple regression analysis revealed PI-LL as significant parameters associated with ODI. Thirty-six patients with an ODI <22 points (75th percentile cutoff) were categorized into a good HRQOL group, and linear regression models demonstrated the following equation: PI-LL = 0.41PI-11.12 (r = 0.45, P = 0.0059)., Conclusions: On the basis of this equation, in the patients with a PI = 50°, the PI-LL is 9°. Whereas in those with a PI = 30°, the optimum PI-LL is calculated to be as low as 1°. In those with a PI = 80°, PI-LL is estimated at 22°. Consequently, an optimum PI-LL is inconsistent in that it depends on the individual PI.

Purpose: Sagittal vertical axis (SVA) is the most commonly used parameter for evaluating global sagittal alignment (GSA) in a static condition. However, its dynamic statuses remain unclear. The aim of this study was to evaluate dynamic GSA of degenerative lumbar kyphoscoliosis (DLKS) using three-dimensional motion analysis system (3D-MAS)., Methods: Twenty-six patients with DLKS underwent gait analysis using 3D-MAS. Static (S-) and dynamic (D-) trunk angle (TA) (the angle between the vertical axis and the line connecting C7 and S1 spinous processes) and S-sagittal trunk shift (STS) and D-STS (the distance between the two vertical lines running through C7 and S1 spinous process) were recorded during treadmill walking. Pelvic angle (PA) (the angle between the horizontal axis and the line connecting the posterior and anterior superior iliac spine) were also recorded. S-PA and D-PA represent retroversion or anteversion of the pelvis, which can be substituted for pelvic tilt. As to dynamic parameters, those at the initial five steps (Di) and the final five steps (Df) of treadmill walking were also recorded., Results: The median S-TA, S-STS, and S-PA were 16.0°, 11.9 cm, and -5.5° (retroversion). The median D parameters were Di-TA/Df-TA 21.8°/26.9°; Di-STS/Df-STS 14.1/21.1 cm; and Di-PA/Df-PA 15.7°/22.8° (anteversion). All D parameters were significantly greater than S parameters (P < 0.01) and all Df parameters were also significantly worse than Di parameters (P < 0.001). Thus, compensated GSA by pelvic retroversion in static condition was lost due to anteversion change of the pelvis immediately after start of walking and worsened over time., Conclusion: Dynamic GSA assessment using 3D-MAS can avoid underestimation of GSA loss that is detected by static standing full-length radiography.

Study Design: Retrospective comparative study of the postoperative subsidence of two interbody devices following posterior or transforaminal lumbar interbody fusion (PLIF/TLIF) for degenerative spondylolisthesis of the lumbar spine., Objective: To assess certain radiograph characteristics of PLIF/TLIF using two interbody fusion devices at L4-L5., Summary of Background Data: PLIF can achieve spinal stabilization with vertebral body support and direct neural decompression. Although various interbody devices have been used in PLIF procedures, no radiographic studies have compared the load-bearing capabilities of open box and fenestrated tube interbody cages., Methods: Seventy-five patients who underwent one-level PLIF in the L4-L5 [corrected] segment for degenerative spondylolisthesis were retrospectively reviewed with a minimum 2-year follow-up. Fenestrated tube (Group FT: n = 30 [corrected]) or open box (Group OB: n = 45 [corrected]) cages were used for the PLIF procedure. The following radiographic parameters were evaluated to compare the load-bearing capabilities: disc space height (DH); percent increase and decrease of disc height (% IDH and % DDH, respectively); and percent coverage of the cage on the endplate (% CC)., Results: There were no significant differences in the baseline data, including age, segmental instability and osteoporotic status, between the two groups. Anterior %IDH and % CC were significantly higher in Group OB than in Group FT (% IDH: 69.4% vs. 57.3%; % OC: 24.5% vs. 12.9%), and anterior and posterior % DDH were significantly higher in Group FT than in Group OB (anterior: -2.9% vs. -.1%; posterior: -6.6% vs. -.3%). Although the restored DH gradually reduced over time in both groups, significant reduction to the preoperative level only occurred in Group FT., Conclusions: The load-bearing capabilities of the open box cage are superior to those of the fenestrated tube cage. Since there were no significant differences between the baseline status of the two groups, the larger cross-sectional area and stable framework design of the open box cage appears to bring about a greater load-bearing capability. Therefore, the open box cage seems to be biomechanically more advantageous as an interbody device for PLIF than the fenestrated tube cage.

Object: There are no published reports of unilateral transforaminal lumbar interbody fusion (TLIF) in which two Brantigan I/F cages were placed per level through a single portal to achieve bilateral anterior-column support. The authors describe such a surgical technique and evaluate the clinical outcomes of this procedure., Methods: Data obtained in 86 (93.5%) of the first 92 consecutive patients who underwent the procedure were retrospectively reviewed; the minimum follow-up duration was 2 years. The clinical outcomes were evaluated using the Japanese Orthopaedic Association (JOA) scoring system. Disc height, disc angle, cage positioning in the axial plane, and fusion status were radiographically evaluated. The mean follow-up period was 33.8 months. The mean improvement in the JOA score was 77.2%. Fusion was successful in 93% of the cases. According to the Farfan method, the mean anterior and posterior disc heights increased from 20.2 and 16.9% preoperatively to 35.9 and 22.7% at follow up, respectively (p < 0.01). The mean disc angle increased from 4.8degrees preoperatively to 7.5degrees at last follow-up examination (p < 0.01). Two cages were correctly placed to achieve bilateral anterior-column support in greater than 85% of the cases. The following complications occurred: hardware migration in two patients and deep infection cured by intravenous antibiotic therapy in one patient., Conclusions: Unilateral TLIF involving the placement of two Brantigan cages per level led to good clinical results. Two Brantigan cages were adequately placed via a single portal, and reliable bilateral anterior-column support was achieved. Although the less invasive unilateral approach was used, the outcomes were as good as those in many reported series of posterior lumbar interbody fusion in which the Brantigan cages were placed via the bilateral approach.

This study aimed to investigate the long-term clinical results of the apatite wollastonite-containing glass ceramic (AWGC) iliac spacer and to discuss its efficacy in reconstruction of the bone graft donor site at the iliac crest. Thirty-one patients were studied for more than 10 years. All patients underwent anterior spinal fusion using autogenous tricortical iliac bone graft. After harvest of tricortical iliac bone graft, an AWGC iliac spacer ranging from 15 mm to 70 mm in length was press-fitted into the gap. Long-term clinical results were obtained from radiological and blood examinations. Thirty patients (97%) were satisfied with the spacer. There was new bone formation around the spacer on the radiograph. There was no abnormal silicon concentration in blood examinations. AWGC iliac spacer appears to be useful in the reconstruction of harvested iliac crest. New bone formation occurs, reducing the defect size.

Thirty-nine invasive mole patients treated during the last 6 years (1971-1976) in our clinic, were studied. The data were summarized in the following items. 1. Surgical treatment was done in 31 cases (79.5%), and methods of operation were removal of focus in 13 cases and hysterectomy in 18. Chemotherapy was performed in 31 cases (79.5%). 2. In 31 operated patients, all of invasive lesions were in uterine bodies. A degree of chorial invasion into myometrium was shallow in 12 cases, medium in 12 and deep in 7. Molar vesicles were observed in 17 cases and trophoblastic tissues were microscopically confirmed in 14. 3. Anti-cancer agents, such as ACTD and MTX, were required 1-4 courses in 8 patients received chemotherapy alone and 1-6 courses in 23 patients received operation combined with chemotherapy. 4. Up to the present time, 14 pregnancies in 11 cases out of these patients occurred, but 2 of them ended in spontaneous abortion and one was molar pregnancy. 5. Malignant sequela, that is, choriocarcinoma was occurred in 2 cases. But, these 2 cases are in remission. 6. Thirty-seven patients, including 2 choriocarcinoma cases, are healthy at present.