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      The First Algorithm Calculating Cement Injection Volumes in Patients with Spine Metastases Treated with Percutaneous Vertebroplasty

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          This study aims to develop an algorithm to predict cement injection volumes in patients with spine metastases treated with percutaneous vertebroplasty (PVP). Risk factors were also analyzed for intra-spinal canal cement leakages.

          Patients and Methods

          A retrospective analysis of 584 vertebrae in 251 patients. Patients and vertebrae were divided into three groups based on grades of tumor invasion to the spinal cord. Patients with the complete posterior wall of vertebrae were classified into group A, patients without the complete posterior wall of vertebrae but with normal Dural sac were classified into group B, and patients with deformation of the Dural sac but without neurological symptom were classified into group C. We systematically reviewed demographic data, clinical parameters, radiology features, and cement leakages among the three groups. The multiple linear regressions were used to screen potential risk factors and develop the algorithm to predict injected cement volumes in vertebrae. Significant factors were included in the algorithm. Potential risk factors for intra-spinal canal cement leakage were analyzed using the multiple logistic regressions.


          In the study, 17.1% (100/584) of vertebrae occurred cement leakages. Vertebrae in group C (28.6%, 8/28) had the highest cement leakage rate than patients in group A (14.4%, 61/424) and B (23.5%, 31/132) (P=0.014). Vertebrae in group C (14.3%, 4/28) were also more prone to intra-spinal canal leakages (P=0.003). The multiple logistic analysis showed that the Bilsky scale was significantly associated with intra-spinal canal cement leakages (P<0.001). The multiple linear regression analysis showed that intercept (P<0.001), treated vertebrae level (P<0.001), cortical osteolytic destruction in posterior wall (P<0.001), and Bilsky scale (P=0.014) were significant and those variables were included in the algorithm. The algorithm was Y=3.1627-0.8677×treated vertebrae level-0.6182×cortical osteolytic destruction in the posterior wall-0.2819×Bilsky scale.


          An algorithm is proposed and can be used to calculate cement injection volumes in spine metastases treated with PVP. This algorithm can facilitate surgical planning and guide cement injections. Bilsky scale is an independent risk factor for intra-spinal canal cement leakages. We do not recommend PVP treated in patients with a Bilsky scale of 2 and 3 mainly due to a high rate of intra-spinal canal cement leakages.

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          Most cited references 33

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          Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies.

          Systematic literature review. To evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures. Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures. Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This article aimed to compile all available data and evaluate the clinical outcome of the 2 procedures. This is a systematic review of all the available data presented in peer-reviewed published clinical trials. The methodological quality of included studies was evaluated, and data were collected targeting specific standard measurements. Where possible, a quantitative aggregation of the data was performed. A large proportion of subjects had some pain relief, including 87% with vertebroplasty and 92% with kyphoplasty. Vertebral height restoration was possible using kyphoplasty (average 6.6 degrees ) and for a subset of patients using vertebroplasty (average 6.6 degrees ). Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty, respectively. New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture. The problem with stating definitely that vertebroplasty and kyphoplasty are safe and effective procedures is the lack of comparative, blinded, randomized clinical trials. Standardized evaluative methods should be adopted.
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            Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial.

            Non-randomised trials have reported benefits of kyphoplasty in patients with cancer and vertebral compression fractures (VCFs). We aimed to assess the efficacy and safety of balloon kyphoplasty compared with non-surgical management for patients with cancer who have painful VCFs. The Cancer Patient Fracture Evaluation (CAFE) study was a randomised controlled trial at 22 sites in Europe, the USA, Canada, and Australia. We enrolled patients aged at least 21 years who had cancer and one to three painful VCFs. Patients were randomly assigned by a computer-generated minimisation randomisation algorithm to kyphoplasty or non-surgical management (control group). Investigators and patients were not masked to treatment allocation. The primary endpoint was back-specific functional status measured by the Roland-Morris disability questionnaire (RDQ) score at 1 month. Outcomes at 1 month were analysed by modified intention to treat, including all patients with data available at baseline and at 1 month follow-up. Patients in the control group were allowed to crossover to receive kyphoplasty after 1 month. This study is registered with ClinicalTrials.gov, NCT00211237. Between May 16, 2005, and March 11, 2008, 134 patients were enrolled and randomly assigned to kyphoplasty (n=70) or non-surgical management (n=64). 65 patients in the kyphoplasty group and 52 in the control group had data available at 1 month. The mean RDQ score in the kyphoplasty group changed from 17·6 at baseline to 9·1 at 1 month (mean change -8·3 points, 95% CI -6·4 to -10·2; p<0·0001). The mean score in the control group changed from 18·2 to 18·0 (mean change 0·1 points; 95% CI -0·8 to 1·0; p=0·83). At 1 month, the kyphoplasty treatment effect for RDQ was -8·4 points (95% CI -7·6 to -9·2; p<0·0001). The most common adverse events within the first month were back pain (four of 70 in the kyphoplasty group and five of 64 in the control group) and symptomatic vertebral fracture (two and three, respectively). One patient in the kyphoplasty group had an intraoperative non-Q-wave myocardial infarction, which resolved and was attributed to anaesthesia. Another patient in this group had a new VCF, which was thought to be device related. For painful VCFs in patients with cancer, kyphoplasty is an effective and safe treatment that rapidly reduces pain and improves function. Medtronic Spine LLC. Copyright © 2011 Elsevier Ltd. All rights reserved.
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              Reliability analysis of the epidural spinal cord compression scale.

              The evolution of imaging techniques, along with highly effective radiation options has changed the way metastatic epidural tumors are treated. While high-grade epidural spinal cord compression (ESCC) frequently serves as an indication for surgical decompression, no consensus exists in the literature about the precise definition of this term. The advancement of the treatment paradigms in patients with metastatic tumors for the spine requires a clear grading scheme of ESCC. The degree of ESCC often serves as a major determinant in the decision to operate or irradiate. The purpose of this study was to determine the reliability and validity of a 6-point, MR imaging-based grading system for ESCC. To determine the reliability of the grading scale, a survey was distributed to 7 spine surgeons who participate in the Spine Oncology Study Group. The MR images of 25 cervical or thoracic spinal tumors were distributed consisting of 1 sagittal image and 3 axial images at the identical level including T1-weighted, T2-weighted, and Gd-enhanced T1-weighted images. The survey was administered 3 times at 2-week intervals. The inter- and intrarater reliability was assessed. The inter- and intrarater reliability ranged from good to excellent when surgeons were asked to rate the degree of spinal cord compression using T2-weighted axial images. The T2-weighted images were superior indicators of ESCC compared with T1-weighted images with and without Gd. The ESCC scale provides a valid and reliable instrument that may be used to describe the degree of ESCC based on T2-weighted MR images. This scale accounts for recent advances in the treatment of spinal metastases and may be used to provide an ESCC classification scheme for multicenter clinical trial and outcome studies.

                Author and article information

                Ther Clin Risk Manag
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                14 May 2020
                : 16
                : 417-428
                [1 ]Department of Orthopedic Surgery, Peking University First Hospital , Beijing, People’s Republic of China
                [2 ]Department of Orthopedic Surgery, Hainan Hospital of Chinese PLA General Hospital , Sanya, People’s Republic of China
                Author notes
                Correspondence: Xuedong Shi Department of Orthopedic Surgery, The Peking University First Hospital No. 8 Xishiku Street, Xicheng DistrictBeijing100032People’s Republic of ChinaTel +86-010-83572211 Email 172998774@qq.com

                These authors contributed equally to this work

                © 2020 Cui et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 5, Tables: 5, References: 35, Pages: 12
                This study was supported by the Medical and health science and technology innovation project of Sanya (NO. 2018YW04).
                Original Research


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