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      • Stand-Alone Anterior Cervical Discectomy and Fusion Using an Additive Manufactured Individualized Bioactive Porous Titanium Implant without Bone Graft: Results of a Prospective Clinical Trial

        Fujibayashi Shunsuke,Takemoto Mitsuru,Nakamura Takashi,Matsushita Tomiharu,Kokubo Tadashi,Sasaki Kiyoyuki,Mori Shigeo,Matsuda Shuichi 대한척추외과학회 2021 Asian Spine Journal Vol.15 No.3

        The purpose of this study was to introduce our patient-specific bioactive porous titanium implant manufactured using selective laser melting (SLM) and to establish the efficacy and safety of the implant for stand-alone anterior cervical discectomy and fusion (ACDF) based on a prospective clinical trial. We designed a customized ACDF implant using patient-specific data and manufactured the implant using SLM. We produced a bioactive surface through a specific chemical and thermal treatment. Using this implant, we surgically treated four patients with cervical degenerative disc disease and evaluated the clinical and radiological results. We achieved successful bony union in all but one patient without autologous bone grafting within 1 year. We observed no implant subsidence during the follow-up period, and all clinical parameters improved significantly after surgery, with no reported implant-related adverse effects. Our customized bioactive porous titanium implant is a safe and promising implant for stand-alone ACDF.

      • KCI등재

        Multicenter Prospective Study of Lateral Lumbar Interbody Fusions Using Bioactive Porous Titanium Spacers without Bone Grafts

        Fujibayashi Shunsuke,Takemoto Mitsuru,Ishii Ken,Funao Haruki,Isogai Norihiro,Otsuki Bungo,Shimizu Takayoshi,Nakamura Takashi,Matsuda Shuichi 대한척추외과학회 2022 Asian Spine Journal Vol.16 No.6

        Study Design: Prospective multicenter clinical study.Purpose: To evaluate the efficacy of bioactive surface treatment for porous titanium spacers without bone graft for lateral lumbar interbody fusion (LLIF) through clinical and radiological examinations.Overview of Literature: LLIF is a minimally invasive spinal fusion procedure. To achieve bony union, a substantial volume of grafted bone is typically packed into the cage; however, this is related to donor site morbidities—one of the disadvantages of LLIF.Methods: For this prospective multicenter study, 40 patients were followed up through radiologic and clinical examinations for at least 1 year postoperatively. All surgical procedures were either single- or double-level LLIF using bioactive porous titanium spacers without bone grafts.Results: Four patients were excluded from the study owing to aggravation from other comorbidities. Another 36 patients, including 26 and 10 with single- and double-level LLIFs, respectively, participated in the follow-up. The mean age at the time of surgery was 63.7 years. The mean operating time was 50.5 minutes per level. The mean estimated intraoperative blood loss was 11.6 mL per level. Clinical scores improved in all cases and were maintained throughout the follow-up period. The intervertebral bony union rates were 67.4% and 84.8% at 6 and 12 months, respectively. Endplate cyst signs were observed in 13.0% and 8.7% of patients at 6 and 12 months, respectively. Fused segmental angles were maintained throughout the follow-up period, indicating no cage subsidence.Conclusions: Single- and double-level LLIFs using bioactive porous titanium spacers without bone grafts were found to be minimally invasive, resulting in clinical and imaging results comparable with conventional procedures. Therefore, this type of implant may be an option for minimally invasive spinal fusion surgery.

      • KCI등재

        Repair of Iliac Crest Defects with a Hydroxyapatite/Collagen Composite

        Murata Koichi,Fujibayashi Shunsuke,Otsuki Bungo,Shimizu Takayoshi,Matsuda Shuichi 대한척추외과학회 2020 Asian Spine Journal Vol.14 No.6

        Study Design: Retrospective study.Purpose: This study aimed to assess the effect of refilling with hydroxyapatite/collagen (HAp/Col) composite on an iliac crest defect after spinal fusion.Overview of Literature: The use of iliac crest bone graft has been the gold standard in spinal fusion for a long time because of its biological and non-immunologic properties. Few reports have addressed how bone defects recover after iliac crest bone harvest following spinal fusion.Methods: Cancellous bone was collected from the anterior iliac crest during lateral interbody fusion (LIF), and the bone void of the ilium was refilled with a porous HAp/Col composite. We assessed bone recovery using computed tomography (CT). From the 74 patients who underwent LIF between January 2015 and December 2016, we included 49 patients whose iliac crest could be evaluated using CT at 3 months and 1 year after the surgery.Results: Bone defects decreased in a time-dependent manner after the surgery. Cortical closure was observed in 28.5% of the cases 3 months after the surgery; at 1 year postoperatively, 95.9% of the patients had cortical closure. Complete repair of the cancellous bone was achieved in 57.1% of the patients at 3 months after the surgery and in 95.9% at 1 year after the surgery. There were no significant hematomas, infections, iliac crest fractures, or soft tissue herniation.Conclusions: Radiographic recovery of cortical and cancellous bone defects was achieved with high probability via refilling with HAp/Col composite over the 1-year period.

      • KCI등재

        Clinical Features and Surgical Outcomes of Lower Lumbar Osteoporotic Vertebral Collapse with Symptomatic Stenosis: A Surgical Strategy from a Multicenter Case Series

        Shimizu Takayoshi,Fujibayashi Shunsuke,Masuda Soichiro,Kimura Hiroaki,Ishibe Tatsuya,Ota Masato,Tamaki Yasuyuki,Onishi Eijiro,Ito Hideo,Otsuki Bungo,Murata Koichi,Matsuda Shuichi 대한척추외과학회 2022 Asian Spine Journal Vol.16 No.6

        Study Design: A retrospective multicenter case series was conducted.Purpose: This study was designed to investigate the clinical features and surgical outcomes of lower lumbar osteoporotic vertebral collapse (LL-OVC) with symptomatic stenosis based on various surgical procedures and classify them using the newly developed collapse severity criteria.Overview of Literature: The surgical outcomes of LL-OVC with symptomatic stenosis remain unclear.Methods: We investigated patients who underwent surgical intervention for LL-OVC (L3, L4, and/or L5) with symptomatic foraminal and/or central stenosis from eight spine centers. Only patients with a minimum follow-up duration of 1 year were included. We developed new criteria to grade vertebral collapse severity (grade 1, 0%–25%; grade 2, 25%–50%; grade 3, 50%–75%; and grade 4, 75%–100%). The clinical features and outcomes were compared based on the collapse grade and surgical procedures performed (i.e., decompression alone, posterior lateral fusion [PLF], lateral interbody fusion [LIF], posterior/transforaminal interbody fusion [PLIF/TLIF], or vertebral column resection [VCR]).Results: In this study, 59 patients (average age, 77.4 years) were included. The average follow-up period was 24.6 months. The clinical outcome score (Japanese Orthopaedic Association score) was more favorable in the LIF and PLIF/TLIF groups than in the decompression alone, PLF, and VCR groups. The use of VCR was associated with a high rate of revision surgery (57.1%). No significant difference in clinical outcomes was observed between the collapse grades; however, grade 4 collapse was associated with a high rate of revision surgery (40.0%).Conclusions: When treating LL-OVC, appropriate instrumented reconstruction with rigid intervertebral stability is necessary. According to our newly developed criteria, LIF may be a surgical option for any collapse grade. The use of VCR for grade 4 collapse is associated with a high rate of revision.

      • KCI등재

        Prognostic Factors after Surgical Treatment for Spinal Metastases

        Murotani Kazuhiro,Fujibayashi Shunsuke,Otsuki Bungo,Shimizu Takayoshi,Kyoto University Graduate School of Medicine, Kyoto, Japan,Onishi Eijiro,Kimura Hiroaki,Tamaki Yasuyuki,Tsubouchi Naoya,Ota Masato 대한척추외과학회 2024 Asian Spine Journal Vol.18 No.3

        Study Design: A retrospective multicenter case series was conducted.Purpose: This study aimed to investigate survival and prognostic factors after surgery for a metastatic spinal tumor.Overview of Literature: Prognostic factors after spinal metastasis surgery remain controversial.Methods: A retrospective multicenter study was conducted. The study participants included 345 patients who underwent surgery for spinal metastases from 2010 to 2020 at nine referral spine centers in Japan. Data for each patient were extracted from medical records. To identify the factors predicting survival prognosis after surgery, univariate analyses were performed using a Cox proportional hazards model.Results: The mean age was 65.9 years. Common primary tumors were lung (n=72), prostate (n=61), and breast (n=39), and 67.8% (n=234) presented with osteolytic lesions. The epidural spinal cord compression scale score 2 or 3 was recognized in 79.0% (n=271). Frankel grade A paralysis accounted for 1.4% (n=5), and 73.3% (n=253) were categorized as intermediate or high risk according to the new Katagiri score. The overall survival rates were -71.0% at 6 months, 57.4% at 12, and 43.3% at 24. In the univariate analysis, Frankel grade A (hazard ratio [HR], 3.59; 95% confidence interval [CI], 1.23–10.50; p<0.05), intermediate risk (HR, 3.34; 95% CI, 2.10–5.32; p<0.01), and high risk (HR, 7.77; 95% CI, 4.72–12.8; p<0.01) in the new Katagiri score were significantly associated with poor survival. On the contrary, postoperative chemotherapy (HR, 0.23; 95% CI, 0.15–0.36; p<0.01), radiation therapy (HR, 0.43; 95% CI, 0.26–0.70; p<0.01), and both adjuvant therapy (HR, 0.21; 95% CI, 0.14–0.32; p<0.01) were suggested to improve survival.Conclusions: Surgical indications for patients with Frankel grade A or intermediate or high risk in the new Katagiri score should be carefully considered because of poor survival. Chemotherapy or radiation therapy should be considered after surgery for better survival.

      • KCI등재

        Posterior Dural Shifts Following Spinous Process-Splitting Multi-Level Intervertebral Lumbar Laminectomies

        Takashi Sono,Shunsuke Fujibayashi,Yu Shimizu,Bungo Otsuki,Shimei Tanida,Shuichi Matsuda 대한척추외과학회 2019 Asian Spine Journal Vol.13 No.5

        Study Design: Retrospective cohort study. Purpose: The aim of our study is to evaluate the extent of posterior spinal dural shift following spinous process splitting multi-level intervertebral lumbar laminectomies, and determine the relationship between posterior spinal dural shift and preoperative parameters. Overview of Literature: There are no existing studies on the posterior spinal dural shift after spinous process-splitting multi-leveled lumbar laminectomies. Methods: We examined 37 patients who underwent spinous process-splitting laminectomies in at least two intervertebral levels, including at the L5/S level. We defined the distance between the vertebral bodies and the anterior edge of the dural sac in the magnetic resonance images at the L5 vertebral level as the anterior dural space (ADS) and detected the difference (d-ADS) between preoperative ADS (pre-ADS) and postoperative ADS (post-ADS). We assessed the relationship between ADS or d-ADS, and preoperative parameters, including age, sex, lumbar lordosis, focal lordosis (FL), and number of decompression levels. Results: Post-ADS was significantly greater than pre-ADS (p<0.001). Pre-ADS was significantly correlated with FL (p=0.44, p<0.01) and also with post-ADS (p=0.43, p<0.01). d-ADS was negatively correlated with pre-ADS (p=−0.37, p<0.05). A single regression analysis revealed that the relationship between d-ADS and pre-ADS was described as d-ADS=3.67−0.46×pre-ADS. In one of three patients whose d-ADS was above the range of two standard errors, reoperation was performed because of impingement of the nerve root caused by the excessive posterior dural shift. Conclusions: Posterior dural shifts occur after spinous process-splitting multi-level lumbar laminectomies, including at the L5/S level. FL and pre-ADS are good predictive factors for posterior dural shift. Excessive posterior dural shift may lead to stretching and impingement of nerve roots and thus require attention.

      • KCI등재

        Assessing lifestyle-related diseases with body and muscle mass using bioelectrical impedance analysis

        Taiju Miyagami,Hirohide Yokokawa,Kazutoshi Fujibayashi,Hiroshi Fukuda,Teruhiko Hisaoka,Toshio Naito 대한골다공증학회 2020 Osteoporosis and Sarcopenia Vol.6 No.1

        Objectives: To investigate the correlation between imbalance of muscle mass to body weight and lifestyle-related diseases using bioelectrical impedance analysis (BIA) among Japanese population. Methods: This was a retrospective, cross-sectional study conducted at Juntendo University Hospital in Tokyo, Japan, from May 2015 to November 2017. Their muscle-to-weight ratio were stratified into “muscle-to-weight ratio” quartiles as follows: men, Q1 (0.79), Q2 (0.75 to <0.79), Q3 (0.72 to <0.75), and Q4 (<0.72); women, Q1 (0.73), Q2 (0.68 to <0.73), Q3 (0.63 to <0.68), and Q4 (<0.63). The primary outcome was prevalence of 2 lifestyle-related diseases, including hypertension, dyslipidemia, type 2 diabetes mellitus, and hyperuricemia. Results: Data from 2009 individuals (men, 55%; mean age, 62 years) were analyzed. Compared to the lowest quartile, risk for the presence of2 lifestyle-related diseases, in a multivariable regression model for men was as follows: Q2 (odds ratio [OR],1.93; 95% confidence interval [CI],1.31e2.87), Q3 (OR, 2.85; 95% CI, 1.89e4.29), and Q4 (OR, 6.00; 95% CI, 4.07e8.84). For women, an increased risk was seen in Q2 (OR, 2.31; 95% CI, 1.20e4.46), Q3 (OR, 4.45; 95% CI, 2.40e8.26), and Q4 (OR, 12.6; 95% CI, 6.80e23.5). Cutoff values of muscle-to-weight ratio correlated with lifestyle-related diseases (2) were 0.76 for men and 0.68 for women. Conclusions: Our results showed that an imbalance of muscle mass to body weight confers an independent and stepwise increased risk for lifestyle-related diseases.

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