SAS journal最新文献

{"title":"Initial clinical experience with a next-generation artificial disc for the treatment of symptomatic degenerative cervical radiculopathy","authors":"Alejandro Reyes-Sanchez MD,&nbsp;Victor Miramontes MD,&nbsp;Luis M. Rosales Olivarez MD,&nbsp;Armando Alpizar Aquirre MD,&nbsp;Alfredo Ortega Quiroz MD,&nbsp;Baron Zarate-Kalfopulos MD","doi":"10.1016/j.esas.2010.01.002","DOIUrl":"10.1016/j.esas.2010.01.002","url":null,"abstract":"<div><h3>Background</h3><p>A feasibility trial was conducted to evaluate the initial safety and clinical use of a next-generation artificial cervical disc (M6-C artificial cervical disc; Spinal Kinetics, Sunnyvale, CA) for the treatment of patients with symptomatic degenerative cervical radiculopathy. A standardized battery of validated outcome measures was utilized to assess condition-specific functional impairment, pain severity, and quality of life.</p></div><div><h3>Methods</h3><p>Thirty-six consecutive patients were implanted with the M6-C disc and complete clinical and radiographic outcomes for 25 patients (mean age, 44.5 ± 10.1 years) with radiographically-confirmed cervical disc disease and symptomatic radiculopathy unresponsive to conservative medical management are included in this report. All patients had disc-osteophyte complex causing neural compression and were treated with discectomy and artificial cervical disc replacement at either single level (n = 12) or 2-levels (n = 13). Functional impairment was evaluated using the Neck Disability Index (NDI). Evaluation of arm and neck pain severity utilized a standard 11-point numeric scale, and health-related quality of life was evaluated with the SF-36 Health Survey. Quantitative radiographic assessments of intervertebral motion were performed using specialized motion analysis software, QMA (Quantitative Motion Analysis; Medical Metrics, Houston, TX). All outcome measures were evaluated pre-treatment and at 6 weeks, 3, 6, 12, and 24 months.</p></div><div><h3>Results</h3><p>The mean NDI score improved from 51.6 ± 11.3% pre-treatment to 27.9 ± 16.9% at 24 months, representing an approximate 46% improvement (<em>P</em> &lt; .0001). The mean arm pain score improved from 6.9 ± 2.5 pre-treatment to 3.9 ± 3.1 at 24 months (43%, <em>P</em> = .0006). The mean neck pain score improved from 7.8 ± 2.0 pre-treatment to 3.8 ± 3.0 at 24 months (51%, <em>P</em> &lt; .0001). The mean PCS score of the SF-36 improved from 34.8 ± 7.8 pre-treatment to 43.8 ± 9.3 by 24 months (26%, <em>P</em> = .0006). Subgroup analyses found that patients treated at single level and those with a shorter duration of symptoms showed better functional results. By 24 months, the mean range of motion (ROM) value at the treated level had returned to approximately pretreatment levels (12.2° vs 11.1°). There were no serious device-related adverse events, surgical re-interventions or radiographic evidence of heterotopic ossification, device migration, or expulsion in this study group.</p></div><div><h3>Conclusions</h3><p>These findings indicate substantial clinical improvement for all function, pain, and quality of life outcomes in addition to maintenance of ROM and increase in disc height at the treated level(s). The findings also exhibit an acceptable safety profile, as indicated by the absence of serious adverse events and reoperations following arthroplasty with a next-generation artificial cervical disc replacement device.</p></","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"4 1","pages":"Pages 9-15"},"PeriodicalIF":0.0,"publicationDate":"2010-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2010.01.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33036431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cement leakage and filling pattern study of low viscous vertebroplastic versus high viscous confidence cement","authors":"Mohamed Habib MSc ,&nbsp;Hassan Serhan PhD ,&nbsp;Connie Marchek MSc ,&nbsp;Gamal Baroud PhD","doi":"10.1016/j.esas.2010.01.001","DOIUrl":"10.1016/j.esas.2010.01.001","url":null,"abstract":"<div><h3>Background</h3><p>Vertebral augmentation has recently evolved as a medical procedure for the treatment of vertebral compression fractures, the most common type of skeletal fractures related to osteoporosis.</p></div><div><h3>Methods</h3><p>This study compared the cement leakage and filling behavior of 2 existing delivery systems (Confidence and Vertebroplastic; DePuy Spine, Raynham, MA). The Confidence system with the high viscosity cement has been recently introduced in an attempt to curtail cement leakage.</p></div><div><h3>Results</h3><p>The comparison was performed using an established benchmark model wherein the cement leakage, filling behavior can be assessed. A double-conduit introducer needle was used to deliver the cement and to measure the intravertebral pressure while delivering the cement. There were 5 experimental groups in this study: 3 low-viscosity groups, whose cement was injected at 3.5, 6.5, and 9.5 minutes after admixing the powder and monomer, and 2 high-viscosity groups injected at 3.5 and 6.5 minutes. The mass of leaked cement generally decreased with delaying the start of the injection. Specifically, for the low-viscosity, the average smallest leakage mass obtained was 2.6 ± 1.2g when the cement was delivered at 9.5 minutes. If delivered after 3.5 minutes, the mass of cement leak was 4.0 ± 1.2g. The high-viscosity system has showed improved results in curtailing cement leakage, as compared to low-viscosity. Specifically, if injected after 3.5 and 6.5 minutes, the cement leakage amounts were 1.5 ± 1.2g and 0.92 ± 0.6g, respectively. Similarly, the uniformity of cement filling increased when the delivery was delayed and when the high-viscosity system was applied. Furthermore, there were no significance changes in the intravertebral pressures between the low- and high-viscous groups. No correlation between the leakage mass and the IV pressures was noted.</p></div><div><h3>Conclusion</h3><p>The cement thickness and timing of delivery are key in controlling the intravertebral cement filling and physician may want to explore the use of low- or high-viscous cement for different fractures. The thickness of the cement has no significant impact on the intravertebral pressures.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"4 1","pages":"Pages 26-33"},"PeriodicalIF":0.0,"publicationDate":"2010-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2010.01.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33036433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anterolateral cervical disc removal and interbody fusion for cervical disc syndrome","authors":"Robert A. Robinson MD,&nbsp;George W. Smith MD","doi":"10.1016/j.esas.2010.01.003","DOIUrl":"https://doi.org/10.1016/j.esas.2010.01.003","url":null,"abstract":"","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"4 1","pages":"Pages 34-35"},"PeriodicalIF":0.0,"publicationDate":"2010-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2010.01.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136553650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A review of the biologic effects of spine implant debris: Fact from fiction","authors":"Nadim James Hallab","doi":"10.1016/j.esas.2009.11.005","DOIUrl":"10.1016/j.esas.2009.11.005","url":null,"abstract":"<div><h3>Background</h3><p>Biologic-reactivity to implant-debris is the primary determinant of long-term clinical performance. The following reviews: 1) the physical aspects of spinal-implant debris and 2) the local and systemic biologic responses to implant debris.</p></div><div><h3>Methods</h3><p>Methods included are: 1) gravimetric wear analysis; 2) SEM and LALLS; 3) metal-ion analysis; 4) ELISA, toxicity testing, patch testing; and 5) metal-lymphocyte transformation testing (metal-LTT).</p></div><div><h3>Results</h3><p>Wear and corrosion of spine-implants produce particles and ions. Particles (0.01–1000 μm) are generally submicron (&lt;1 μm). Wear rates of metal-on-polymer and metal-on-metal disc arthroplasties are approximately 2–20 and 1 mm³/yr, respectively. Metal-on-metal total disc replacement components have significant increases in circulating metal (less than 10-fold that of controls at 4 ppb-Co and 3 ppb-Cr or ng/mL). Debris reactivity is local and systemic. Local inflammation is caused primarily by ingestion of debris by local macrophages, which produce pro-inflammatory cytokines TNFα, IL-1β, IL-6, and PGE2. Systemic responses associated with implant-debris have been limited to hypersensitivity reactions. Elevated amounts of in the liver, spleen, etc of patients with failed TJA have not been associated with remote toxicological or carcinogenic pathology to date. Implant debris are differentially bioreactive. Greater numbers are pro-inflammatory; the smaller-sized debris are more bioreactive by virtue of their greater numbers (dose) for a given amount of implant mass loss (one 100-μm-diameter particle is equivalent in mass to 1 million 1-μm-diameter particles). Elongated particles are pro-inflammatory (ie, aspect ratio of greater than 3). Metal particles are more proinflammatory than polymers, <em>ceteris paribus</em>.</p></div><div><h3>Conclusion</h3><p>Spinal arthroplasty designs have been in use for more than 20 years internationally; therefore, concerns about neuropathology, toxicity, and carcinogenicity are mitigated. Debris-induced inflammation still depends on the individual and the type of debris. The consequence of debris-induced inflammation is continued; vigilance by physicians is recommended monitoring of spinal implants using physical exams and testing of metal content and bioreactivity, as is planning for the likelihood of revision in younger individuals.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 4","pages":"Pages 143-160"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2009.11.005","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33031260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The fundamentals of biotribology and its application to spine arthroplasty","authors":"Megan L. Harper MASc ,&nbsp;Andrew Dooris PhD ,&nbsp;Philippe E. Paré MASc","doi":"10.1016/j.esas.2009.11.004","DOIUrl":"10.1016/j.esas.2009.11.004","url":null,"abstract":"<div><p>The biological effect of wear of articulating surfaces is a continued concern with large joint replacements and, likewise, of interest for total disc replacements. There are a number of important biotribological testing parameters that can greatly affect the outcome of a wear study in addition to the implant design and material selection. The current ASTM and ISO wear testing standards/guides for spine arthroplasty leave many choices as testing parameters. These factors include but are not limited to the sequence of kinematics and load, phasing, type of lubricant, and specimen preparation (sterilization and artificial aging). The spinal community should critically assess wear studies and be cognizant of the influence of the selected parameters on the test results.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 4","pages":"Pages 125-132"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2009.11.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33031256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Metal wear particles: What we know, what we do not know, and why","authors":"Fabrizio Billi PhD ,&nbsp;Paul Benya PhD ,&nbsp;Edward Ebramzadeh PhD ,&nbsp;Pat Campbell PhD ,&nbsp;Frank Chan PhD ,&nbsp;Harry A. McKellop PhD","doi":"10.1016/j.esas.2009.11.006","DOIUrl":"10.1016/j.esas.2009.11.006","url":null,"abstract":"<div><p>The importance of wear particle characterization for orthopaedic implants has long been established in the hip and knee arthroplasty literature. With the increasing use of motion preservation implants in the spine, the characterization of wear debris, particularly metallic nature, is gaining importance. An accurate morphological analysis of wear particles provides for both a complete characterization of the biocompatibility of the implant material and its wear products, and an in-depth understanding of the wear mechanisms, ion release, and associated corrosive activity related to the wear particles. In this paper, we present an overview of the most commonly-used published protocols for the isolation and characterization of metal wear particles, and highlight the limitations and uncertainties inherent to metal particle analysis.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 4","pages":"Pages 133-142"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2009.11.006","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33031257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retrieval analysis of motion preserving spinal devices and periprosthetic tissues","authors":"Steven M. Kurtz PhD ,&nbsp;Marla Steinbeck PhD ,&nbsp;Allyson Ianuzzi PhD ,&nbsp;André van Ooij MD ,&nbsp;Ilona M. Punt ,&nbsp;Jorge Isaza MD ,&nbsp;E.R.S. Ross MD","doi":"10.1016/j.esas.2009.11.003","DOIUrl":"10.1016/j.esas.2009.11.003","url":null,"abstract":"<div><p>This article reviews certain practical aspects of retrieval analysis for motion preserving spinal implants and periprosthetic tissues as an essential component of the overall revision strategy for these implants. At our institution, we established an international repository for motion-preserving spine implants in 2004. Our repository is currently open to all spine surgeons, and is intended to be inclusive of all cervical and lumbar implant designs such as artificial discs and posterior dynamic stabilization devices. Although a wide range of alternative materials is being investigated for nonfusion spine implants, many of the examples in this review are drawn from our existing repository of metal-on-polyethylene, metal-on-metal lumbar total disc replacements (TDRs), and polyurethane-based dynamic motion preservation devices. These devices are already approved or nearing approval for use in the United States, and hence are the most clinically relevant at the present time. This article summarizes the current literature on the retrieval analysis of these implants and concludes with recommendations for the development of new test methods that are based on the current state of knowledge of in vivo wear and damage mechanisms. Furthermore, the relevance and need to evaluate the surrounding tissue to obtain a complete understanding of the biological reaction to implant component corrosion and wear is reviewed.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 4","pages":"Pages 161-177"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2009.11.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33031258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What standards can (and can't) tell us about a spinal device","authors":"Jove Graham PhD ,&nbsp;Bradley T. Estes PhD","doi":"10.1016/j.esas.2009.11.001","DOIUrl":"10.1016/j.esas.2009.11.001","url":null,"abstract":"<div><p>Standards are important tools in evaluating and predicting the performance of medical devices prior to implantation. There are three types of standards that are available: a material specification, a standard test method, and a standard test guide. Each of these types of standards is defined with examples of how each is used to facilitate evaluation of medical devices. The standards development process is also described: this is a complex process, requiring the involvement of a multidisciplinary team, usually consisting of engineers, scientists, and clinicians who represent healthcare, academia, government, and industry. Finally, standards have a clear and defined role in the development of medical devices, and the benefits, strengths, as well as the limitations in this role are discussed.</p></div>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 4","pages":"Pages 178-183"},"PeriodicalIF":0.0,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2009.11.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33031259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Symposium on osteoconductive carriers","authors":"Jeffrey C. Wang MD","doi":"10.1016/j.esas.2009.09.005","DOIUrl":"https://doi.org/10.1016/j.esas.2009.09.005","url":null,"abstract":"","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 3","pages":"Page 108"},"PeriodicalIF":0.0,"publicationDate":"2009-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2009.09.005","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90001390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anterior cervical arthrodesis using an osteoconductive scaffold: The use of beta-tricalcium phosphate with local bone marrow aspirate in over 100 patients","authors":"Wilson Z. Ray MD,&nbsp;Neill M. Wright MD","doi":"10.1016/j.esas.2009.09.008","DOIUrl":"10.1016/j.esas.2009.09.008","url":null,"abstract":"","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 3","pages":"Pages 114-117"},"PeriodicalIF":0.0,"publicationDate":"2009-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.esas.2009.09.008","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33031254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}