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Sponsored by: |
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00585923 |
The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.
Condition | Intervention |
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HNP Radiculopathy Spondylolysis |
Device: C-Tek™ Plate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
Official Title: | A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-Tek™ Anterior Cervical Plates |
Estimated Enrollment: | 154 |
Study Start Date: | April 2002 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Fixed Hole Plate
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Device: C-Tek™ Plate
Fixed hole C-Tek™ Plate
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2: Active Comparator
Slotted Hole Plate
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Device: C-Tek™ Plate
Slotted hole C-Tek™ Plate
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Louisiana | |
Spine Institute of Louisiana | |
Shreveport, Louisiana, United States, 71101 |
Study Chair: | John Evangelsita, MD | EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing |
Responsible Party: | EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing ( Betsy Lowry, Supervisor Clinical Data, CRA ) |
Study ID Numbers: | CS-014 |
Study First Received: | December 21, 2007 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00585923 |
Health Authority: | United States: Institutional Review Board |
Spinal Diseases Neuromuscular Diseases Musculoskeletal Diseases Peripheral Nervous System Diseases |
Radiculopathy Spondylolysis Spondylolisthesis Bone Diseases |
Nervous System Diseases |