{"id":25281,"date":"2011-11-22T14:34:00","date_gmt":"2011-11-22T14:34:00","guid":{"rendered":"https:\/\/www.sciatica.com\/?p=25281"},"modified":"2023-06-28T15:44:14","modified_gmt":"2023-06-28T15:44:14","slug":"coflex-dynamic-interspinous-stabilization-device-clinical-trial","status":"publish","type":"post","link":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/","title":{"rendered":"Coflex\u00ae Dynamic Interspinous Stabilization Device Clinical Trial"},"content":{"rendered":"\n        <section id=\"wysiwyg-block_da67a6c10e0115f842e66ac995abd0f5\" class=\"wysiwyg white section-padding  bg-white js-animated-text-container\">\n\n            \n        \t<div class=\"container\">\n        \t\t<div class=\"row\">\n                                \t\t\t<div class=\"col-md-10 col-md-offset-1\">\n                            \t\t\t\t<div class=\"wysiwyg__content\">\n        \t\t\t\t\t<p><strong><em>UPDATE: FDA Approved!\u00a0<\/em><\/strong><\/p>\n<p><!-- wp:image {\"align\":\"right\",\"id\":25282,\"width\":130,\"height\":202,\"sizeSlug\":\"full\",\"linkDestination\":\"none\"} --><\/p>\n<figure class=\"wp-block-image alignright size-full is-resized\"><img decoding=\"async\" class=\"wp-image-25282\" src=\"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg\" alt=\"\" width=\"130\" height=\"202\" srcset=\"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg 200w, https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378-194x300.jpg 194w\" sizes=\"(max-width: 130px) 100vw, 130px\" \/><\/figure>\n<p>Dr. Anthony Yeung, Principal Investigator in the study, along with investigators Dr. Christopher Yeung and Dr. Justin Field, participated in this clinical trial that led to this FDA approval. DISC, the only site in Arizona involved in this trial, was in the top 5 sites whose data was used for papers presented to national and international meetings authored by Josh Auerbach.<\/p>\n<p><a class=\"btn btn-primary\" href=\"https:\/\/www.sciatica.com\/blog\/coflex-interlaminar-technology-receives-fda-approval\/\"><strong>More Information<\/strong><\/a><\/p>\n<p><a class=\"btn btn-primary\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/23680830\/\" target=\"_blank\" rel=\"noreferrer noopener\">Read on PubMed <\/a><\/p>\n<p><em><strong>Status: This trial is now full.<\/strong><\/em><\/p>\n<h2>Introduction<\/h2>\n<p><strong><br \/>\n<\/strong>The Coflex\u00ae Dynamic Interspinous Stabilization Device Clinical Trial is designed to compare the safety and effectiveness of a new way to treat <a href=\"https:\/\/www.sciatica.com\/blog\/9-treatment-options-for-spinal-stenosis\/\">spinal stenosis<\/a>. This trial is a multi-center, prospective, randomized controlled study that will evaluate the safety and effectiveness of lumbar laminotomy decompression augmented with the implantation of the Coflex\u00ae device as compared to the most common treatment of spinal stenosis; lumbar laminotomy decompression, augmented with pedicle screw fixation and fusion.<\/p>\n<h2>Study Overview<\/h2>\n<ul>\n<li>Up to twenty-five clinical sites will participate. Total enrollment of 460 or more patients is expected.<\/li>\n<li>Patients will be randomized to receive either decompression and Coflex\u00ae for stabilization, or decompression and pedicle screw fixation and fusion for stabilization.<\/li>\n<li>Patients will be followed at 6 weeks, 3 months, 6 months, 1 year, 2 years, and annually up to 5 years.<\/li>\n<\/ul>\n<h2>Who qualifies to enroll in this trial?<\/h2>\n<p>Before any trial procedures can begin, anyone who participates in this study must properly sign and date the Informed Consent Form (ICF). Your doctor will explain to you the trial procedures and the possible risks and benefits of your participation. As part of the informed consent process, your doctor will also explain to you what personal information of yours is to be collected, including medical records.<\/p>\n<p><strong>Although your doctor can explain the full details, here is a partial list of some of the criteria for participation in this study:<\/strong><\/p>\n<ul>\n<li>40-80 years old<\/li>\n<li>An appropriate candidate for surgery<\/li>\n<li>At least moderate lumbar stenosis<\/li>\n<li>No more than 2 levels should require surgery (those levels must be consecutive)<\/li>\n<li>No prior lumbar fusion<\/li>\n<li>No lumbar disc herniation requiring concurrent surgery<\/li>\n<li>No pregnancy or planned pregnancy<\/li>\n<li>Must have had at least 6 months prior care and failed non-operative treatment<\/li>\n<\/ul>\n<h2>Why is this trial being conducted?<\/h2>\n<p>Over 25,000 people outside the U.S. have been implanted with the coflex\u00ae investigational device. An article in the professional journal Medical News Today reports on some of the positive early clinical results for the Coflex\u00ae investigational device. These results include:<\/p>\n<ul>\n<li>Of a group of 200 patients implanted with the Coflex\u00ae device in Damp, Germany, 86% reported relief in low back pain that allowed them to significantly increase their walking distance.<\/li>\n<li>Based on a 12-month follow-up with 46 patients (with an average age of 63) treated with the Coflex\u00ae device in Straubing and Bogen, Germany, results showed reduced post-operative disability and pain scores as compared with pre-operative scores<\/li>\n<\/ul>\n<p>At this time, the sponsor company, Paradigm Spine, LLC, has received approval from the US FDA to conduct this clinical trial in the US. The company is seeking approval to market the Coflex\u00ae device in the US after all regulatory requirements have been fulfilled.<\/p>\n<p>To learn more about the Coflex\u00ae Study, please use:\u00a0<a href=\"https:\/\/coflexsolution.com\/\">https:\/\/coflexsolution.com\/<\/a>\u00a0or contact Jennifer Camoriano, Research Coordinator at: (602) 755-9058 ext. 124.<\/p>\n\n                                                        \n        \t\t\t\t<\/div>\n        \t\t\t<\/div>\n        \t\t<\/div>\n        \t<\/div>\n\n               \n        \t\n        <\/section>\n\n","protected":false},"excerpt":{"rendered":"<p>Dr. Anthony Yeung, Principal Investigator in the study, along with investigators Dr. Christopher Yeung and Dr. Justin Field, participated in this clinical trial that led to this FDA approval.<\/p>\n","protected":false},"author":4,"featured_media":25282,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[84],"tags":[],"class_list":["post-25281","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-trials"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Coflex\u00ae Dynamic Stabilization Device Clinical Trial | DISC<\/title>\n<meta name=\"description\" content=\"In this study, we evaluate the effectiveness of lumbar laminotomy decompression augmented with the implantation of the Coflex device. Learn more.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Coflex\u00ae Dynamic Stabilization Device Clinical Trial | DISC\" \/>\n<meta property=\"og:description\" content=\"In this study, we evaluate the effectiveness of lumbar laminotomy decompression augmented with the implantation of the Coflex device. Learn more.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/\" \/>\n<meta property=\"og:site_name\" content=\"Desert Institute for Spine Care\" \/>\n<meta property=\"article:published_time\" content=\"2011-11-22T14:34:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-06-28T15:44:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"200\" \/>\n\t<meta property=\"og:image:height\" content=\"310\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"WebFX\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"WebFX\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/\"},\"author\":{\"name\":\"WebFX\",\"@id\":\"https:\/\/www.sciatica.com\/#\/schema\/person\/3bf2bb626b50873c468dbb07d1a012ab\"},\"headline\":\"Coflex\u00ae Dynamic Interspinous Stabilization Device Clinical Trial\",\"datePublished\":\"2011-11-22T14:34:00+00:00\",\"dateModified\":\"2023-06-28T15:44:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/\"},\"wordCount\":7,\"commentCount\":0,\"image\":{\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg\",\"articleSection\":[\"Clinical Trials\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/\",\"url\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/\",\"name\":\"Coflex\u00ae Dynamic Stabilization Device Clinical Trial | DISC\",\"isPartOf\":{\"@id\":\"https:\/\/www.sciatica.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg\",\"datePublished\":\"2011-11-22T14:34:00+00:00\",\"dateModified\":\"2023-06-28T15:44:14+00:00\",\"author\":{\"@id\":\"https:\/\/www.sciatica.com\/#\/schema\/person\/3bf2bb626b50873c468dbb07d1a012ab\"},\"description\":\"In this study, we evaluate the effectiveness of lumbar laminotomy decompression augmented with the implantation of the Coflex device. Learn more.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#primaryimage\",\"url\":\"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg\",\"contentUrl\":\"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg\",\"width\":200,\"height\":310},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.sciatica.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Coflex\u00ae Dynamic Interspinous Stabilization Device Clinical Trial\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.sciatica.com\/#website\",\"url\":\"https:\/\/www.sciatica.com\/\",\"name\":\"Desert Institute for Spine Care\",\"description\":\"Desert Institute for Spine Care\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.sciatica.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.sciatica.com\/#\/schema\/person\/3bf2bb626b50873c468dbb07d1a012ab\",\"name\":\"WebFX\",\"sameAs\":[\"https:\/\/www.sciatica.com\"],\"url\":\"https:\/\/www.sciatica.com\/blog\/author\/webfx\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Coflex\u00ae Dynamic Stabilization Device Clinical Trial | DISC","description":"In this study, we evaluate the effectiveness of lumbar laminotomy decompression augmented with the implantation of the Coflex device. Learn more.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/","og_locale":"en_US","og_type":"article","og_title":"Coflex\u00ae Dynamic Stabilization Device Clinical Trial | DISC","og_description":"In this study, we evaluate the effectiveness of lumbar laminotomy decompression augmented with the implantation of the Coflex device. Learn more.","og_url":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/","og_site_name":"Desert Institute for Spine Care","article_published_time":"2011-11-22T14:34:00+00:00","article_modified_time":"2023-06-28T15:44:14+00:00","og_image":[{"width":200,"height":310,"url":"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg","type":"image\/jpeg"}],"author":"WebFX","twitter_card":"summary_large_image","twitter_misc":{"Written by":"WebFX"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#article","isPartOf":{"@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/"},"author":{"name":"WebFX","@id":"https:\/\/www.sciatica.com\/#\/schema\/person\/3bf2bb626b50873c468dbb07d1a012ab"},"headline":"Coflex\u00ae Dynamic Interspinous Stabilization Device Clinical Trial","datePublished":"2011-11-22T14:34:00+00:00","dateModified":"2023-06-28T15:44:14+00:00","mainEntityOfPage":{"@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/"},"wordCount":7,"commentCount":0,"image":{"@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#primaryimage"},"thumbnailUrl":"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg","articleSection":["Clinical Trials"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/","url":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/","name":"Coflex\u00ae Dynamic Stabilization Device Clinical Trial | DISC","isPartOf":{"@id":"https:\/\/www.sciatica.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#primaryimage"},"image":{"@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#primaryimage"},"thumbnailUrl":"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg","datePublished":"2011-11-22T14:34:00+00:00","dateModified":"2023-06-28T15:44:14+00:00","author":{"@id":"https:\/\/www.sciatica.com\/#\/schema\/person\/3bf2bb626b50873c468dbb07d1a012ab"},"description":"In this study, we evaluate the effectiveness of lumbar laminotomy decompression augmented with the implantation of the Coflex device. Learn more.","breadcrumb":{"@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#primaryimage","url":"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg","contentUrl":"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/coflex-1-ab72a378.jpg","width":200,"height":310},{"@type":"BreadcrumbList","@id":"https:\/\/www.sciatica.com\/blog\/coflex-dynamic-interspinous-stabilization-device-clinical-trial\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.sciatica.com\/"},{"@type":"ListItem","position":2,"name":"Coflex\u00ae Dynamic Interspinous Stabilization Device Clinical Trial"}]},{"@type":"WebSite","@id":"https:\/\/www.sciatica.com\/#website","url":"https:\/\/www.sciatica.com\/","name":"Desert Institute for Spine Care","description":"Desert Institute for Spine Care","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.sciatica.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.sciatica.com\/#\/schema\/person\/3bf2bb626b50873c468dbb07d1a012ab","name":"WebFX","sameAs":["https:\/\/www.sciatica.com"],"url":"https:\/\/www.sciatica.com\/blog\/author\/webfx\/"}]}},"_links":{"self":[{"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/posts\/25281","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/comments?post=25281"}],"version-history":[{"count":0,"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/posts\/25281\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/media\/25282"}],"wp:attachment":[{"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/media?parent=25281"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/categories?post=25281"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.sciatica.com\/wp-json\/wp\/v2\/tags?post=25281"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}