{"id":25275,"date":"2011-11-22T12:29:00","date_gmt":"2011-11-22T12:29:00","guid":{"rendered":"https:\/\/www.sciatica.com\/?p=25275"},"modified":"2023-06-28T15:47:28","modified_gmt":"2023-06-28T15:47:28","slug":"cervicore-intervertebral-disc-clinical-study","status":"publish","type":"post","link":"https:\/\/www.sciatica.com\/blog\/cervicore-intervertebral-disc-clinical-study\/","title":{"rendered":"CerviCore\u2122 Intervertebral Disc Clinical Study"},"content":{"rendered":"\n        <section id=\"wysiwyg-block_95114ad66112ca848d7c7f547c21b70e\" 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><em><strong>Status: This trial has been completed.<\/strong><\/em><!-- wp:paragraph --><\/p>\n<p><img decoding=\"async\" width=\"200\" height=\"169\" class=\"wp-image-25276 alignleft\" style=\"font-size: 16px;\" src=\"https:\/\/www.sciatica.com\/wp-content\/uploads\/2023\/05\/inter_disc-cae1630e.jpg\" alt=\"\" \/><\/p>\n<h2><strong>Introduction<!-- wp:image {\"align\":\"right\",\"id\":25276,\"sizeSlug\":\"full\",\"linkDestination\":\"none\"} --><\/strong><\/h2>\n<p>The study is a multi-center, prospective, randomized controlled clinical trial that will compare the safety and effectiveness of the CerviCore\u2122 Intervertebral Disc to anterior cervical discectomy and fusion (ACDF) with a rigid plate for radicular symptoms associated with loss of disc height, disc\/osteophyte complex, or herniated disc at a single cervical spine level. The trade name of the investigational device is CerviCore\u2122 Intervertebral Disc.<\/p>\n<h2>Study objectives<\/h2>\n<p>The objective of this clinical investigation is to compare the safety and effectiveness of the CerviCore\u2122 to ACDF surgery in the treatment of cervical radicular symptoms (upper extremity pain and\/or neurological deficit) associated with loss of disc height, disc\/osteophyte complex, or herniated disc at a single level between C3 and C7.<\/p>\n<h2>Study overview<\/h2>\n<ul>\n<li>Up to twenty-five (25) study centers will participate<\/li>\n<li>Approximately four hundred (400) patients will enroll in the study<\/li>\n<li>Patients will be randomized to receive either the CerviCore\u2122 Intervertebral Disc or the control treatment (ACDF)<\/li>\n<li>Study patients will be followed at 6 weeks, 3 months, 6 months, 12 months 24 months and annually thereafter, as feasible, through post-operative year 5<\/li>\n<\/ul>\n<p><strong>Study sponsor<\/strong><\/p>\n<ul>\n<li>Stryker Spine, Allendale, NJ<\/li>\n<\/ul>\n<p><strong>Inclusion criteria (key criteria):<\/strong><\/p>\n<ul>\n<li>Skeletally mature and between 18 and 65 years of age, inclusively<\/li>\n<li>Clinically confirmed radicular symptoms in the distribution of a single degenerated disc from C3\/4 to C6\/7 in either or both of the upper extremities defined by the following complaint(s):<\/li>\n<li>a. Pain unresponsive to non-operative treatment, AND\/OR<\/li>\n<li>b. Neurological deficit<\/li>\n<li>Radicular symptoms are consistent with radiographic evidence of single-level nerve root compression (from C3\/4 to C6\/7) associated with at least one of the following:\n<ul>\n<li>a. significant loss of disc height as judged by the Investigator on MRI and\/or CT as compared to the normal and clinically asymptomatic adjacent levels,<\/li>\n<li>b. posterior osteophytes or disc\/osteophyte complex or posterior soft disc herniation<\/li>\n<\/ul>\n<p><strong>Exclusion criteria (key criteria):<\/strong><\/p>\n<ul>\n<li>Axial neck pain or referred shoulder pain alone (without radicular symptoms)<\/li>\n<li>Radicular symptoms in the distribution of more than one cervical nerve root\/disc<\/li>\n<li>Previous cervical surgery including any discectomy, any anterior cervical fusion, or any posterior cervical fusion or instrumentation. (This is not intended to exclude a patient with a prior laminectomy\/laminotomy at a level that is not the target or adjacent level)<\/li>\n<li>History of metabolic bone disease<\/li>\n<li>Post-menopausal woman with a DEXA scan hip t-score of &lt; -2.5<\/li>\n<li>Taking any of the following medications:\n<ul>\n<li>a. Chronic oral or IV corticosteroid therapy (this is not intended to exclude inhalation medications for asthma),<\/li>\n<li>b. Medications known to potentially interfere with bone\/soft tissue healing (e.g. methotrexate),<\/li>\n<li>c. Medications that increase bone mineral density (e.g. Fosamax\u00ae, Didronel\u00ae)<\/li>\n<\/ul>\n<\/li>\n<li>Diabetes mellitus requiring daily insulin management<\/li>\n<li>Has any of the following:<\/li>\n<li>a. progressive neuromuscular disease;<\/li>\n<li>b. rheumatoid arthritis;<\/li>\n<li>c. active malignancy within the last 15 years (unless the malignancy was treated with curative intent and there have been no clinical signs or symptoms for at least 5 years);<\/li>\n<li>d. active hepatitis;<\/li>\n<li>e. AIDS, ARC, or is HIV positive;<\/li>\n<li>f. cervical myelopathy at any cervical level (This is not intended to exclude cervical myelopathy at the level to be treated due to a soft disc herniation within the past 12 months that can be decompressed by an anterior discectomy);<\/li>\n<li>&gt;<\/li>\n<li>g. syringomyelia at any spinal level;<\/li>\n<li>h. any condition that would interfere with patient self-assessment of pain, function or quality of life<\/li>\n<li>Pregnant or is considering pregnancy within the next 3 years (excluded due to x-ray requirements)<\/li>\n<\/ul>\n<p><em><strong>Caution:<\/strong>\u00a0Investigational device limited by United State law to investigational use. If you think you might be a candidate for this clinical trial,\u00a0<a href=\"https:\/\/www.sciatica.com\/contact\/\">contact us for more information<\/a>\u00a0or\u00a0<\/em><\/p>\n<p><em><a href=\"https:\/\/www.sciatica.com\/for-patients\/patient-forms\/\">fill out and submit our online forms<\/a><\/em><\/p>\n<\/li>\n<\/ul>\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>The study is a multi-center, prospective, randomized controlled clinical trial that will compare the safety and effectiveness of the CerviCore\u2122 Intervertebral Disc to anterior cervical discectomy and fusion (ACDF) with a rigid plate for radicular symptoms associated with loss of disc height, disc\/osteophyte complex, or herniated disc at a single cervical spine level. <\/p>\n","protected":false},"author":4,"featured_media":25276,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[84],"tags":[],"class_list":["post-25275","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>CerviCore\u2122 Intervertebral Disc Clinical Study | DISC<\/title>\n<meta name=\"description\" content=\"How does the safety and effectiveness of the CerviCore\u2122 Intervertebral Disc compare to ACDF surgery in cervical radicular treatment? Read on to find out.\" \/>\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\/cervicore-intervertebral-disc-clinical-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CerviCore\u2122 Intervertebral Disc Clinical Study | DISC\" \/>\n<meta property=\"og:description\" content=\"How does the safety and effectiveness of the CerviCore\u2122 Intervertebral Disc compare to ACDF surgery in cervical radicular treatment? 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