{"id":25319,"date":"2014-09-19T17:38:00","date_gmt":"2014-09-19T17:38:00","guid":{"rendered":"https:\/\/www.sciatica.com\/?p=25319"},"modified":"2023-06-28T15:39:36","modified_gmt":"2023-06-28T15:39:36","slug":"title-m6-c-artificial-disc-fda-ide-pivotal-study","status":"publish","type":"post","link":"https:\/\/www.sciatica.com\/blog\/title-m6-c-artificial-disc-fda-ide-pivotal-study\/","title":{"rendered":"M6-C Artificial Disc: FDA IDE Pivotal Study"},"content":{"rendered":"\n        <section id=\"wysiwyg-block_b59a41e8c38e107cc72037fa0fd77647\" 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>Status: This trial has been completed.<\/em><\/strong><\/p>\n<p><!-- wp:image {\"align\":\"right\",\"id\":25320,\"width\":215,\"height\":138,\"sizeSlug\":\"full\",\"linkDestination\":\"none\"} --><\/p>\n<figure class=\"wp-block-image alignright size-full is-resized\"><img decoding=\"async\" class=\"wp-image-25320\" src=\"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/m6-c-disc-1-62c12df0.jpg\" alt=\"\" width=\"215\" height=\"138\" \/><\/figure>\n<h2>Introduction<\/h2>\n<p>\nDISC is one of 12 sites in US, only in AZ where patients have access to the M6-C Artificial Disc: FDA IDE Pivotal Study. \u00a0If you are a patient who is interested in participating in this study, please contact DISC directly.<\/p>\n<h2>Study Objective<\/h2>\n<p>\nThe primary objective is to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc in patients with symptomatic cervical radiculopathy with or without cord compression.<\/p>\n<p>The Study is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy. A total of 243 subjects will be treated; 162 M6-C subjects from up to 15 clinical sites, and 81 ACDF subjects at up to 5 clinical sites. The minimum required post-operative clinical evaluations of subjects will be conducted at 6 weeks, 3 months, 6 months, 1 year and 2 years. Evaluations beyond 2 years may be requested.<\/p>\n<h2>Who Will Qualify?<\/h2>\n<p>\nPatients eligible for the study will have a diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgery at one level from C3 to C7, demonstrated by signs and\/or symptoms of disc herniation and\/or osteophyte formation (e.g. neck and\/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies. Patients will have not adequately responded to conservative medical care over a period of at least six weeks. Patients must also be available for regular, scheduled follow-up visits by their treating physician for a minimum of two years post-surgery.<\/p>\n<p>The M6-C Artificial Disc Study is now closed to enrollment due to completion.<\/p>\n<p><a class=\"btn btn-primary\" href=\"https:\/\/curvafix.com\/\">Additional Information<\/a><\/p>\n<p><a class=\"btn btn-primary\" href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01609374?term=NCT01609374&amp;rank=1\">More Detail on the Study Protocol<\/a><\/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>DISC is one of 12 sites in US, only in AZ where patients have access to the M6-C Artificial Disc: FDA IDE Pivotal Study. \u00a0If you are a patient who is interested in participating in this study, please contact DISC directly.<\/p>\n","protected":false},"author":4,"featured_media":25320,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[84],"tags":[],"class_list":["post-25319","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>M6-C Artificial Disc: FDA IDE Pivotal Study | DISC<\/title>\n<meta name=\"description\" content=\"We evaluated the effectiveness of the Spinal Kinetics M6-C artificial cervical disc in patients with symptomatic cervical radiculopathy. See 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\/title-m6-c-artificial-disc-fda-ide-pivotal-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"M6-C Artificial Disc: FDA IDE Pivotal Study | DISC\" \/>\n<meta property=\"og:description\" content=\"We evaluated the effectiveness of the Spinal Kinetics M6-C artificial cervical disc in patients with symptomatic cervical radiculopathy. 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