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1.
Pain Physician ; 24(S1): S27-S208, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33492918

RESUMO

BACKGROUND: Chronic spinal pain is the most prevalent chronic disease with employment of multiple modes of interventional techniques including epidural interventions. Multiple randomized controlled trials (RCTs), observational studies, systematic reviews, and guidelines have been published. The recent review of the utilization patterns and expenditures show that there has been a decline in utilization of epidural injections with decrease in inflation adjusted costs from 2009 to 2018. The American Society of Interventional Pain Physicians (ASIPP) published guidelines for interventional techniques in 2013, and guidelines for facet joint interventions in 2020. Consequently, these guidelines have been prepared to update previously existing guidelines. OBJECTIVE: To provide evidence-based guidance in performing therapeutic epidural procedures, including caudal, interlaminar in lumbar, cervical, and thoracic spinal regions, transforaminal in lumbar spine, and percutaneous adhesiolysis in the lumbar spine. METHODS: The methodology utilized included the development of objective and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of epidural interventions was viewed with best evidence synthesis of available literature and  recommendations were provided. RESULTS: In preparation of the guidelines, extensive literature review was performed. In addition to review of multiple manuscripts in reference to utilization, expenditures, anatomical and pathophysiological considerations, pharmacological and harmful effects of drugs and procedures, for evidence synthesis we have included 47 systematic reviews and 43 RCTs covering all epidural interventions to meet the objectives.The evidence recommendations are as follows: Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness.The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality, placebo-controlled RCT is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections. For thoracic disc herniation, based on one relevant, high-quality RCT of thoracic epidural with fluoroscopic guidance, with or without steroids, the evidence is Level II with moderate to strong recommendation for long-term effectiveness.Spinal stenosis: The evidence based on one high-quality RCT in each category the evidence is Level III to II for fluoroscopically guided caudal epidural injections with moderate to strong recommendation and Level II for fluoroscopically guided lumbar and cervical interlaminar epidural injections with moderate to strong recommendation for long-term effectiveness.The evidence for lumbar transforaminal epidural injections is Level IV to III with moderate recommendation with fluoroscopically guided lumbar transforaminal epidural injections for long-term improvement. The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant, moderate to high quality RCTs, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. Axial discogenic pain: The evidence for axial discogenic pain without facet joint pain or sacroiliac joint pain in the lumbar and cervical spine with fluoroscopically guided caudal, lumbar and cervical interlaminar epidural injections, based on one relevant high quality RCT in each category is Level II with moderate to strong recommendation for long-term improvement, with or without steroids. Post-surgery syndrome: The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality RCT with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement. For percutaneous adhesiolysis, based on multiple moderate to high-quality RCTs and systematic reviews, the evidence is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. LIMITATIONS: The limitations of these guidelines include a continued paucity of high-quality studies for some techniques and various conditions including spinal stenosis, post-surgery syndrome, and discogenic pain. CONCLUSIONS: These epidural intervention guidelines including percutaneous adhesiolysis were prepared with a comprehensive review of the literature with methodologic quality assessment and determination of level of evidence with strength of recommendations.

2.
Tech Vasc Interv Radiol ; 23(4): 100701, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33308580

RESUMO

Vertebral compression fractures (VCFs) result from either trauma or a pathologic process that weakens the bone by conditions such as osteoporosis or tumor. The incidence of VCFs has been rising over the last few decades in accordance with the aging population. These fractures can result in severe pain, physical limitation and disability, as well as increased morbidity and mortality. Patients with VCFs are optimally treated by accurate and early diagnosis and treatment. An effective method to treat these fractures is percutaneous vertebral augmentation, which is a set of minimally invasive procedures that stabilizes osseous fractures, provides immediate pain relief, and improves quality of life. Vertebral augmentation procedures include vertebroplasty, kyphoplasty, and vertebral augmentation with implants. Each of these techniques is described in general terms in this article. The ideal candidate for vertebral augmentation is a patient with a symptomatic fracture seen on cross-sectional imaging in which nonsurgical management has failed and has positive signs on physical examination with no absolute contraindication. This procedure should be done with the appropriate equipment and personnel in a facility designed for this purpose. After the procedure, the patient should undergo the appropriate follow-up to ensure optimal recovery. Additionally, it is essential that the patient receives appropriate therapy for the underlying disorder that predisposed them to the vertebral fracture.


Assuntos
Fraturas por Compressão/cirurgia , Cifoplastia , Radiografia Intervencionista , Fraturas da Coluna Vertebral/cirurgia , Vertebroplastia , Tomada de Decisão Clínica , Protocolos Clínicos , Fraturas por Compressão/diagnóstico por imagem , Fraturas por Compressão/fisiopatologia , Humanos , Cifoplastia/efeitos adversos , Radiografia Intervencionista/efeitos adversos , Fatores de Risco , Fraturas da Coluna Vertebral/diagnóstico por imagem , Fraturas da Coluna Vertebral/fisiopatologia , Vertebroplastia/efeitos adversos
4.
Neuroradiology ; 62(12): 1607-1615, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32803337

RESUMO

This article is to review the different types of vertebral augmentation implants recently becoming available for the treatment of benign and malignant spinal compression fractures. After a detailed description of the augmentation implants, we review the available clinical data. We will conclude with a summary of the advantages and disadvantages of vertebral implants and how they can affect the future treatment options of compression fractures.

5.
Pain Physician ; 23(4): E343-E352, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32709180

RESUMO

BACKGROUND: The BenchMarket Medical (BMM) Vertebral Compression Fracture (VCF) Registry, now known as Talosix, is a collaborative effort between Talosix (the authorized registry vendor), Noridian Healthcare Solutions, and clinicians to gather outcomes evidence for cement augmentation treatments in patients with acute painful osteoporotic VCFs. The VCF Registry was designed to provide outcomes evidence to inform the Medicare payer's "coverage with evidence development" decision to authorize reimbursement for cement augmentation treatments. OBJECTIVES: The purpose of this article was to present a pathway for appropriate use of vertebral augmentation based on the findings of the VCF Registry. STUDY DESIGN: Prospective observational data, including patient characteristics, diagnosis, process of care, and patient-reported outcomes (PROs) for pain and function, were collected from patients undergoing cement augmentation treatment. The PROs were collected at baseline, 1, 3, and 6 months following the procedure. SETTING: The VCF Registry is a national ongoing registry with no specified end time or designated sample size. METHODS: Primary outcomes were pain improvement measured using the Numeric Rating Scale and function improvement, measured using the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included cement leakage, new neurologic deficits, adverse events, readmissions, and death. RESULTS: The VCF Registry delivered outcomes data to support Noridian's "coverage with evidence development" decision. A total of 732 patients were included in this study. Registry outcomes confirmed postmarket evidence of highly significant pain relief with mean pain score improvement of 6.5/10 points at 6 months. Function also improved significantly with mean RMDQ score change of 11.4/24 points 6 months after surgery. Results also showed the safety and reliability of cement augmentation. LIMITATIONS: The nature of the registry data is that it contains nonrandomized, nonplacebo controlled data and should not be perceived as such. The real-world setting and the large number of patients within the dataset should increase the external validity of the findings. CONCLUSIONS: Cement augmentation treatments of patients with acute painful VCFs reliably results in highly significant benefits of pain decrease and functional improvement for this Medicare population. KEY WORDS: Vertebral compression fractures, osteoporosis, kyphoplasty, back pain, registry.


Assuntos
Cimentos para Ossos , Fraturas por Compressão/cirurgia , Cifoplastia/normas , Sistema de Registros , Fraturas da Coluna Vertebral/cirurgia , Vertebroplastia/normas , Idoso , Idoso de 80 Anos ou mais , Cimentos para Ossos/uso terapêutico , Gerenciamento Clínico , Feminino , Fraturas por Compressão/diagnóstico , Fraturas por Compressão/epidemiologia , Humanos , Cifoplastia/métodos , Masculino , Pessoa de Meia-Idade , Osteoporose/diagnóstico , Osteoporose/epidemiologia , Osteoporose/cirurgia , Manejo da Dor/métodos , Manejo da Dor/normas , Medição da Dor/métodos , Medição da Dor/normas , Estudos Prospectivos , Reprodutibilidade dos Testes , Fraturas da Coluna Vertebral/diagnóstico , Fraturas da Coluna Vertebral/epidemiologia , Resultado do Tratamento , Estados Unidos/epidemiologia , Vertebroplastia/métodos
6.
Int J Spine Surg ; 14(2): 239-253, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32355632

RESUMO

Background: The function of the intervertebral disc is structural. Loss of tissue alters biomechanics, leads to subsequent disc degeneration, and is attributable to discogenic pain. A viable structural allograft was delivered into degenerate discs to determine whether intervention could safely stabilize anatomy, reduce pain, and improve function. Methods: Following institutional review board approval and patient consent, subjects were randomized to receive allograft or saline at either 1 or 2 levels or continue nonsurgical management (NSM). Data were collected at baseline, 3, 6, and 12 months. Back pain with a visual analog scale (VAS) and disability by the Oswestry Disability Index (ODI) were assessed, as were adverse events. This trial is registered on http://www.clinicaltrials.gov (NCT03709901). Results: At 6 and 12 months, the VAS improved from 54.81, 55.25, and 62.255 in the allograft, saline, and NSM subjects, respectively, to 16.0 and 41.0 in the allograft and saline groups at 6 months, and 12.27 and 19.67, respectively, at 12 months. All subjects in the NSM cohort crossed over to allograft treatment. At 6 and 12 months, ODI improved from 53.73, 49.25, and 55.75 in the allograft, saline, and NSM subjects, respectively, to 18.47 and 28.75 in the allograft and saline groups 1 and 2 at 6 months, and 15.67 and 9.33, respectively, at 12 months. At 3 months the ODI of the NSM group was 62.75 and subjects reached 19.0 and 11.0 at 6 and 12 months, respectively. Adverse events were transient and resolved in all cohorts. Conclusions: This study is supported by data demonstrating that improved pain and function at 12 months can be attained with a supplemental viable disc matrix. Subjects receiving the VIA Disc Matrix achieved improvements that were durable at 12 months. Level of Evidence: 1. Clinical Relevance: Initial assessments indicate that a 1-level or 2-level treatment offers a reliable intervention that is safe and beneficial.

7.
Int J Spine Surg ; 14(1): 18-25, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32128298

RESUMO

This International Society for the Advancement of Spine Surgery guideline is generated to respond to growing requests for background, supporting literature and evidence, and proper coding for intraosseous ablation of the basivertebral nerve for chronic low back pain.

8.
Int J Spine Surg ; 13(1): 1-10, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30805279

RESUMO

The ISASS Policy Statement on vertebral augmentation has the objectives to provide a background and an update with the latest clinical evidence for the international spine community. A SpineLine Panel Review (2010) appropriately recommended an exploration of "the seeming disconnect between the conclusions of … two [Level I] PRCT's and previous experience and data" regarding vertebral augmentation. ISASS responded by supporting a comprehensive meta-analysis to help frame a cogent historical analysis of vertebral augmentation. This ISASS Policy 2018 is based on a thorough literature search for relevant studies, including systematic reviews and meta-analyses, that are subjected to thorough quality appraisal for the purpose of informing public opinion and decision making. Given the abundance of high-quality information, ISASS can confidently advocate that there is strong support for vertebral augmentation in the treatment of symptomatic vertebral compression fractures.

9.
Neurosurgery ; 84(1): 169-178, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-29547939

RESUMO

BACKGROUND: Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful, threatening quality of life and increasing risk of morbidity and mortality. Balloon kyphoplasty is a percutaneous option for treating painful cancer- and osteoporosis-related VCFs, supported by 2 randomized trials demonstrating efficacy benefits of BKP over nonsurgical care. OBJECTIVE: To investigate 12-mo disability, quality of life, and safety outcomes specifically in a Medicare-eligible population, representing characteristic patients seen in routine clinical practice. METHODS: A total of 354 patients with painful VCFs were enrolled at 24 US sites with 350 undergoing kyphoplasty. Four coprimary endpoints-Numerical Rating Scale (NRS) back pain, Oswestry Disability Index (ODI), Short Form-36 Questionnaire Physical Component Summary (SF-36v2 PCS), EuroQol-5-Domain (EQ-5D)-were evaluated for statistically significant improvement 3 mo after kyphoplasty. Data were collected at baseline, 7 d, and 1, 3, 6, and 12 mo (www.clinicaltrials.gov registration NCT01871519). RESULTS: At the 3-mo primary endpoint, NRS improved from 8.7 to 2.7 and ODI improved from 63.4 to 27.1; SF-36 PCS was 24.2 at baseline improving to 36.6, and EQ-5D improved from 0.383 to 0.746 (P < .001 for each). These outcomes were statistically significant at every follow-up time point. Five device-/procedure-related adverse events, intraoperative asymptomatic balloon rupture, rib pain, and aspiration pneumonia, and a new VCF 25 d postprocedure, and myocardial infarction 105 d postprocedure were reported and each resolved with proper treatment. CONCLUSION: This large, prospective, clinical study demonstrates that kyphoplasty is a safe, effective, and durable procedure for treating patients with painful VCF due to osteoporosis or cancer.


Assuntos
Fraturas por Compressão/cirurgia , Cifoplastia/métodos , Fraturas por Osteoporose/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Feminino , Fraturas por Compressão/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Estudos Prospectivos , Qualidade de Vida , Fraturas da Coluna Vertebral/etiologia , Resultado do Tratamento , Estados Unidos
10.
J Neurointerv Surg ; 11(9): e7, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29444963

RESUMO

A 71-year-old man who had a L1/S1 posterior fusion revision surgery complained of increasing back pain 5 weeks after the open surgical procedure. The pain was initially estimated at 9/10 on the visual analog scale (VAS) and thought to be related to a right-sided L2 screw loosening. A right parapedicular vertebroplasty was performed and polymethylmethacrylate cement was instilled around the right pedicle screw, filling the anterior two-thirds of the vertebral body. On postvertebroplasty day 1, the patient had significant improvement in his low back pain. The pain further decreased at 1 and 3 months after the intervention (2/10 on the VAS). Vertebroplasty is a minimally invasive, accessible, effective, and long lasting treatment for compression fractures. We believe that this technique could also be indicated to treat pain related to low grade screw loosening in properly selected patients.


Assuntos
Cimentos para Ossos/uso terapêutico , Dor Lombar/cirurgia , Parafusos Pediculares , Polimetil Metacrilato/administração & dosagem , Vertebroplastia/métodos , Idoso , Seguimentos , Humanos , Dor Lombar/diagnóstico por imagem , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Masculino , Reoperação/instrumentação , Reoperação/métodos , Sacro/diagnóstico por imagem , Sacro/cirurgia , Vertebroplastia/instrumentação
11.
Spine J ; 18(11): 2152-2161, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30096377

RESUMO

BACKGROUND CONTEXT: Vertebral fragility fractures (VFFs), mostly due to osteoporosis, are very common and are associated with significant morbidity and mortality. There is a lack of consensus on the appropriate management of patients with or suspected of having a VFF. PURPOSE: This work aimed at developing a comprehensive clinical care pathway (CCP) for VFF. STUDY DESIGN/SETTING: The RAND/UCLA Appropriateness Method was used to develop patient-specific recommendations for the various components of the CCP. The study included two individual rating rounds and two plenary discussion sessions. METHODS: A multispecialty expert panel (orthopedic and neurosurgeons, interventional [neuro]radiologists and pain specialists) assessed the importance of 20 signs and symptoms for the suspicion of VFF, the relevance of 5 diagnostic procedures, the appropriateness of vertebral augmentation versus nonsurgical management for 576 clinical scenarios, and the adequacy of 6 aspects of follow-up care. RESULTS: The panel identified 10 signs and symptoms believed to be relatively specific for VFF. In patients suspected of VFF, advanced imaging was considered highly desirable, with MRI being the preferred diagnostic modality. Vertebral augmentation was considered appropriate in patients with positive findings on advanced imaging and in whom symptoms had worsened and in patients with 2 to 4 unfavorable conditions (eg, progression of height loss and severe impact on functioning), dependent on their relative weight. Time since fracture was considered less relevant for treatment choice. Follow-up should include evaluation of bone mineral density and treatment of osteoporosis. CONCLUSIONS: Using the RAND/UCLA Appropriateness Method, a multispecialty expert panel established a comprehensive CCP for the management of VFF. The CCP may be helpful to support decision-making in daily clinical practice and to improve quality of care.


Assuntos
Densidade Óssea/fisiologia , Fraturas por Osteoporose/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Consenso , Humanos , Imagem por Ressonância Magnética , Fraturas por Osteoporose/diagnóstico por imagem , Fraturas da Coluna Vertebral/diagnóstico por imagem
12.
Cardiovasc Intervent Radiol ; 41(10): 1463-1473, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29789873

RESUMO

Vertebral compression fractures (VCFs) may result in a kyphotic deformity which can cause potential systemic complications secondary to respiratory and gastrointestinal dysfunction. The use of implants in the spine for VCF treatment represents a paradigm shift away from cement injection on its own, aiming to combine the analgesic and stabilizing effect of injecting cement into the vertebral body with vertebral height restoration and kyphotic angle correction. Spine implants which can be used for VCF treatment include stents, jacks, PEEK cages and fracture reduction systems. Lumbar spinal stenosis (LSS) with neurogenic intermittent claudication is one of the most commonly occurring spinal conditions, usually affecting people older than 50, which can cause disability and a reducted quality of life. Percutaneous interspinous spacers for the relief of symptoms caused by spinal stenosis can be used in patients who are not surgical candidates. The purpose of this article is to describe the basic concepts of spinal implantation in patients with VCF or spinal stenosis. The role of biomechanics and the different types of implants will be described. Controversies concerning techniques and products will be addressed. Finally, the necessity for an individually tailored approach for the use of different implants in different cases and anatomic locations will be emphasized.


Assuntos
Fraturas por Compressão/cirurgia , Próteses e Implantes , Fraturas da Coluna Vertebral/cirurgia , Idoso , Terapia Combinada , Dilatação/instrumentação , Dilatação/métodos , Feminino , Humanos , Cifoplastia/instrumentação , Cifoplastia/métodos , Vértebras Lombares/lesões , Vértebras Lombares/cirurgia , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos/instrumentação , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Estenose Espinal/cirurgia , Stents , Telas Cirúrgicas , Vértebras Torácicas/lesões , Vértebras Torácicas/cirurgia , Titânio
13.
BMJ Case Rep ; 20182018 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-29367219

RESUMO

A 71-year-old man who had a L1/S1 posterior fusion revision surgery complained of increasing back pain 5 weeks after the open surgical procedure. The pain was initially estimated at 9/10 on the visual analog scale (VAS) and thought to be related to a right-sided L2 screw loosening. A right parapedicular vertebroplasty was performed and polymethylmethacrylate cement was instilled around the right pedicle screw, filling the anterior two-thirds of the vertebral body. On postvertebroplasty day 1, the patient had significant improvement in his low back pain. The pain further decreased at 1 and 3 months after the intervention (2/10 on the VAS). Vertebroplasty is a minimally invasive, accessible, effective, and long lasting treatment for compression fractures. We believe that this technique could also be indicated to treat pain related to low grade screw loosening in properly selected patients.


Assuntos
Cimentos para Ossos/uso terapêutico , Parafusos Pediculares/efeitos adversos , Polimetil Metacrilato/uso terapêutico , Falha de Prótese/efeitos adversos , Idoso , Dor nas Costas/etiologia , Cordoma/cirurgia , Humanos , Masculino , Reoperação , Fraturas da Coluna Vertebral , Fusão Vertebral/métodos , Neoplasias da Coluna Vertebral/cirurgia , Vertebroplastia/instrumentação , Vertebroplastia/métodos
14.
Pain Physician ; 20(7): E1063-E1072, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-29149151

RESUMO

BACKGROUND: The treatment of sacral fractures has evolved since its first description in 1982. Several techniques for sacral augmentation have been developed since 2001, and the rate of improvement is rapid with over 50% reduction in pain achieved prior to post-procedure discharge of the patient. Pain reduction occurs primarily within the first 3 months and is sustained at 12 months; however, the long-term outcomes have not previously been studied. OBJECTIVES: We aim to evaluate the long-term efficacy of sacroplasty versus non-surgical management (NSM) in treating sacral insufficiency fractures (SIFs), including the effect on pain relief, opioid and other analgesic use, patient satisfaction, and complication rates. Additionally, we aim to review the most current sacroplasty literature. STUDY DESIGN: A 10-year prospective, observational cohort study of patients with SIFs treated with sacral augmentation. SETTING: A single-center interventional pain management private practice. METHODS: Two-hundred and forty-four patients with SIFs were treated with sacroplasty (210 patients) or NSM (34 patients) beginning in January 2004 and then followed for 10 years. The patients' gender, age, pre-procedure pain duration, analgesic use, pain level, and satisfaction were recorded at baseline and at post-procedure follow-up intervals of 2, 4, 12, 24, 52 weeks, and 2 years. The experimental group was then contacted at 10 years. Post-procedure complications before discharge and at each follow-up were also evaluated. RESULTS: Both NSM and sacroplasty resulted in statistically significant drops in visual analog scale (VAS) scores from pre-treatment to 2-year follow-up (P < 0.001). When measured from follow-up to follow-up, the NSM group's only significant decrease in the mean VAS score was between pre-treatment and 2 weeks (P = 0.002). The experimental group had significant decreases over the periods pre-op through post-op (P < 0.001), post-op through 2 weeks (P < 0.001), 12 weeks through 24 weeks (P = 0.014), and 24 weeks through one year (P = 0.002). The experimental cohort experienced statistically significant drops in the mean VAS scores between follow-ups for a longer period of time. Opioid and non-opioid analgesic use was markedly decreased preoperatively to postoperatively and was sustained at the 10-year follow-up. LIMITATIONS: Patients were placed into the control group, NSM, if they did not meet inclusion criteria for sacroplasty. However, the baseline characteristics of the sacroplasty versus NSM group were not statistically different. Additionally, the control group was only followed through 2 years and was not contacted at the 10-year follow-up. CONCLUSIONS: Our results and those reported in previous studies establish that sacroplasty allows for decreased use of medications and results in pain relief, greater patient mobility, and improved patient satisfaction. In addition to the published body of literature, our results show strong evidence in support of sacroplasty as a safe and efficacious treatment of SIFs. KEY WORDS: Sacroplasty, sacral fracture, fracture, osteoporosis, insufficiency, radiology.


Assuntos
Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Sacro/lesões , Sacro/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Analgésicos Opioides/uso terapêutico , Cimentos para Ossos , Estudos de Coortes , Feminino , Seguimentos , Fraturas de Estresse , Humanos , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Medição da Dor , Satisfação do Paciente , Estudos Prospectivos , Sacro/diagnóstico por imagem , Fraturas da Coluna Vertebral/diagnóstico por imagem , Resultado do Tratamento
15.
Pain Physician ; 20(7): E1081-E1090, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-29149153

RESUMO

Osteoporotic vertebral compression fractures (OVCFs) are a significant cause of morbidity and mortality in the United States and worldwide, with estimates of 750,000 to 1.5 million occurring annually. As the elderly population continues to increase, the incidence of OVCFs will continue to rise, as will the morbidity and mortality associated with this condition. Vertebral augmentation (VA) was almost universally accepted as the appropriate treatment modality prior to 2 sham trials published in 2009 by the New England Journal of Medicine (NEJM). Subsequently, there is now significant controversy regarding the optimal treatment of OVCFs. Since 2009 there have been 6 prospective randomized controlled studies (PRCTs) and 2 meta-analyses on VA for the treatment of OVCFs. Five of the PRCTs and both of the meta-analyses have shown superior results with VA as compared with nonsurgical management (NSM). However, a recent health technology assessment and review article continue to over-emphasize the 2 NEJM sham trials, despite the most current literature. These are examples of inconsistent or biased data reporting with overemphasis on certain trial types and exclusion of other types of data, resulting in the reporting of conclusions that are partially representative or not representative of the complete data. As clinical investigators, we have a responsibility to limit bias and ensure that the appropriate treatment modalities are made available to vulnerable populations.The aim of this perspective analysis is to examine sources of bias in reporting and some of the publications that contain it, along with comparing the publications to the current body of published literature relevant to this topic. KEY WORDS: Vertebral augmentation, vertebroplasty, kyphoplasty, bias, osteoporosis, compression fracture.


Assuntos
Fraturas por Osteoporose/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Coluna Vertebral/cirurgia , Vertebroplastia/métodos , Humanos , Viés de Publicação
16.
Pain Physician ; 20(6): 521-528, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28934783

RESUMO

BACKGROUND: The KAST (Kiva Safety and Efficacy) investigation device exempt (IDE) study indicated that the majority of patients responded equally well to vertebral augmentation using either an implant-based approach or balloon kyphoplasty (BK). Additional investigation has suggested that a subset of patients may benefit further by avoiding repeated readmissions due to serious adverse events (SAEs) if they receive one vertebral augmentation approach over another. OBJECTIVES: The primary aim was to assess the effect of 2 different augmentation procedures on readmission rates for SAEs. STUDY DESIGN: The KAST trial is a pivotal, multicenter, randomized, controlled trial conducted to evaluate an implant-based vertebral augmentation approach (implant) against BK. Post-hoc analysis was performed to evaluate SAEs and readmission rates. SETTING: Twenty-one sites in North America and Europe. METHODS: The treatment effect of vertebral implant versus BK on SAEs requiring unplanned readmission was evaluated by estimating the risk of SAEs associated with readmissions in KAST while controlling for key baseline covariates using multivariate Poisson regression modeling. RESULTS: Forty (27.8%) patients with implants had 69 SAEs associated with readmission compared to 44 (31.2%) patients with BK having 103 events. The risk for all SAEs leading to readmission was 34.4% lower with the implant than for BK (95% confidence interval = 11.1%, 51.7%; P < 0.01). Multivariate analysis showed that the risk of SAEs associated with readmission was decreased in subjects treated with the implant compared to BK, and increased in patients with prior histories of vertebral compression fractures (VCFs) or significant osteoporosis. LIMITATIONS: The power of the KIVA study was based on clinical efficacy criteria to meet FDA requirements and recommendations for equivalency or noninferiority. The primary endpoint in this post-hoc analysis is SAEs associated with readmissions; as a result, the sample size is underpowered, although the results remain significant. CONCLUSION: The augmentation approaches compared here have similar pain relief and quality of life effects; the implant showed a lower risk of readmissions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01123512. Key words: Vertebral compression fracture, kiva implant, balloon kyphoplasty, vertebroplasty, health economics, osteoporosis.


Assuntos
Bioprótese/estatística & dados numéricos , Cetonas , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Readmissão do Paciente/estatística & dados numéricos , Polietilenoglicóis , Vertebroplastia/efeitos adversos , Vertebroplastia/estatística & dados numéricos , Idoso , Feminino , Humanos , Cifoplastia/efeitos adversos , Cifoplastia/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade
17.
Pain Physician ; 19(8): 593-601, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27906938

RESUMO

BACKGROUND: Percutaneous access to the vertebral bodies is commonly done via the transpedicular approach for both diagnoses and treatment of spinal pathology. While this approach is effective in most cases, it is difficult in certain situations such as a patient with obstructing hardware from prior surgery. OBJECTIVES: To investigate and illustrate an alternative to the typical percutaneous access to the vertebral body via an extrapedicular approach and to determine the complications associated with this approach. STUDY DESIGN: Description of a novel percutaneous vertebral body access technique developed during cadaver dissection and a report of complication rates in cases that were performed using this technique. SETTING: Radiology department at a private institution. METHODS: An effective extrapedicular access technique that could safely and consistently allow the needle tip to be placed in the center of the vertebral body was developed from cadaver dissection observations for the purpose of clinical use. A total of 96 vertebral compression fractures from T5 to L5 were treated via the extrapedicular technique at our institution between July 2008 and August 2012. There were 72 patients between ages 27 and 98 (mean age 73.2 years) who underwent treatment. RESULTS: Cadaver dissection revealed a relatively avascular and aneural portion of the inferior vertebral body just anterior to the pedicle. A total of 96 vertebral fractures were treated using the extrapedicular technique without any recognized clinical complications from the needle access or the instrumentation. LIMITATIONS: The trial included a relatively small sample size, representing 7.4 percent of total patients treated at our institution. This was likely the result of a smaller patient population with contraindications to typical transpedicular access. CONCLUSIONS: The thoracic and lumbar vertebral bodies may be accessed using a percutaneous extrapedicular access technique which represents a relatively avascular and aneural approach to the vertebral body. The technique presented allows access to the vertebral body around existing hardware and can accommodate the placement of large instruments. This technique was not associated with any known complications in our series of patients.Key words: Vertebral body, spine, extrapedicular, kyphoplasty, vertebroplasty, paraspinal, thoracic, lumbar.


Assuntos
Fraturas por Compressão/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Vértebras Torácicas , Vertebroplastia , Adulto , Idoso , Idoso de 80 Anos ou mais , Cadáver , Humanos , Vértebras Lombares
19.
Pain Physician ; 18(3): E299-306, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26000677

RESUMO

BACKGROUND: Vertebral compression fractures (VCFs) are the most common osteoporotic fractures and cause persistent pain, kyphotic deformity, weight loss, depression, reduced quality of life, and even death. Current surgical approaches for the treatment of VCF include vertebroplasty (VP) and balloon kyphoplasty (BK). The Kiva® VCF Treatment System (Kiva System) is a next-generation alternative surgical intervention in which a percutaneously introduced nitinol Osteo Coil guidewire is advanced through a deployment cannula and subsequently a PEEK Implant is implanted incrementally and fully coiled in the vertebral body. The Kiva System's effectiveness for the treatment of VCF has been evaluated in a large randomized controlled trial, the Kiva Safety and Effectiveness Trial (KAST). The Kiva System was non-inferior to BK with respect to pain reduction (70.8% vs. 71.8% in Visual Analogue Scale) and physical function restoration (38.1 % vs. 42.2% reduction in Oswestry Disability Index) while using less bone cement. The economic impact of the Kiva system has yet to be analyzed. OBJECTIVE: To analyze hospital resource use and costs of the Kiva System over 2 years for the treatment of VCF compared to BK. SETTING: A representative US hospital. STUDY DESIGN: Economic analysis of the KAST randomized trial, focusing on hospital resource use and costs. METHODS: The analysis was conducted from a hospital perspective and utilized clinical data from KAST as well as unit-cost data from the published literature. The cost of initial VCF surgery, reoperation cost, device market cost, and other medical costs were compared between the Kiva System and BK. The relative risk reduction rate in adjacent-level fracture with Kiva [31.6% (95% CI: -22.5%, 61.9%)] demonstrated in KAST was used in this analysis. RESULTS: With 304 vertebral augmentation procedures performed in a representative U.S. hospital over 2 years, the Kiva System will produce a direct medical cost savings of $1,118 per patient and $280,876 per hospital. This cost saving with the Kiva System was attributable to 19 reduced adjacent-level fractures with the Kiva System. LIMITATIONS: This study does not compare the Kiva System with VP or any other non-surgical procedures for the treatment of VCF. CONCLUSION: This first-ever economic analysis of the KAST data showed that the Kiva System for vertebral augmentation is hospital resource and cost saving over BK in a hospital setting over 2 years. These savings are attributable to reduced risk of developing adjacent-level fractures with the Kiva System compared to BK.


Assuntos
Redução de Custos , Cifoplastia/economia , Vertebroplastia/economia , Cimentos para Ossos/uso terapêutico , Custos e Análise de Custo/métodos , Fraturas por Compressão/economia , Fraturas por Compressão/cirurgia , Humanos , Cifoplastia/métodos , Próteses e Implantes/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fraturas da Coluna Vertebral/economia , Fraturas da Coluna Vertebral/cirurgia , Estatística como Assunto , Resultado do Tratamento , Estados Unidos , Vertebroplastia/instrumentação , Vertebroplastia/métodos
20.
Spine (Phila Pa 1976) ; 40(12): 865-75, 2015 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-25822543

RESUMO

STUDY DESIGN: The KAST (Kiva Safety and Effectiveness Trial) study was a pivotal, multicenter, randomized control trial for evaluation of safety and effectiveness in the treatment of patients with painful, osteoporotic vertebral compression fractures (VCFs). OBJECTIVE: The objective was to demonstrate noninferiority of the Kiva system to balloon kyphoplasty (BK) with respect to the composite primary endpoint. SUMMARY OF BACKGROUND DATA: Annual incidence of osteoporotic VCFs is prevalent. Optimal treatment of VCFs should address pain, function, and deformity. Kiva is a novel implant for vertebral augmentation in the treatment of VCFs. METHODS: A total of 300 subjects with 1 or 2 painful osteoporotic VCFs were randomized to blindly receive Kiva (n = 153) or BK (n = 147). Subjects were followed through 12 months. The primary endpoint was a composite at 12 months defined as a reduction in fracture pain by at least 15 mm on the visual analogue scale, maintenance or improvement in function on the Oswestry Disability Index, and absence of device-related serious adverse events. Secondary endpoints included cement usage, extravasation, and adjacent level fracture. RESULTS: A mean improvement of 70.8 and 71.8 points in the visual analogue scale score and 38.1 and 42.2 points in the Oswestry Disability Index was noted in Kiva and BK, respectively. No device-related serious adverse events occurred. Despite significant differences in risk factors favoring the control group at baseline, the primary endpoint demonstrated noninferiority of Kiva to BK. Analysis of secondary endpoints revealed superiority with respect to cement use and site-reported extravasation and a positive trend in adjacent level fracture warranting further study. CONCLUSION: The KAST study successfully established that the Kiva system is noninferior to BK based on a composite primary endpoint assessment incorporating pain-, function-, and device-related serious adverse events for the treatment of VCFs due to osteoporosis. Kiva was shown to be noninferior to BK and revealed a positive trend in several secondary endpoints. LEVEL OF EVIDENCE: 1.


Assuntos
Fixação Interna de Fraturas/instrumentação , Consolidação da Fratura , Fraturas por Compressão/cirurgia , Cifoplastia/métodos , Vértebras Lombares/cirurgia , Fraturas por Osteoporose/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Vértebras Torácicas/cirurgia , Idoso , Idoso de 80 Anos ou mais , Fenômenos Biomecânicos , Avaliação da Deficiência , Europa (Continente) , Feminino , Fixação Interna de Fraturas/efeitos adversos , Fraturas por Compressão/diagnóstico , Fraturas por Compressão/fisiopatologia , Humanos , Cifoplastia/efeitos adversos , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/fisiopatologia , Masculino , América do Norte , Fraturas por Osteoporose/diagnóstico , Fraturas por Osteoporose/fisiopatologia , Medição da Dor , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/prevenção & controle , Estudos Prospectivos , Desenho de Prótese , Radiografia , Recuperação de Função Fisiológica , Fraturas da Coluna Vertebral/diagnóstico , Fraturas da Coluna Vertebral/fisiopatologia , Vértebras Torácicas/diagnóstico por imagem , Vértebras Torácicas/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
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