Expired Study
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Shreveport, Louisiana 71101


Purpose:

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.


Criteria:

Inclusion Criteria: 1. Radiographic evidence of compressed cervical roots or cord by either ossified bony elements or herniated nucleus pulposus. 2. Symptomatic radiculopathy appropriate to compressed nerve root. 3. Cervical spondylosis as evidenced by reactive changes in the vertebral bodies about the interspace, and may be associated with chronic discopathy. 4. Primary anterior cervical spinal fusion performed using an anterior cervical plate and either a discectomy (Smith-Robinson technique) or a Corpectomy. 5. Adult male or female, 18 to 75 years of age. 6. The subject or his/her legal guardian is willing to consent to participate in this study. 7. The subject will be available for follow-up for a minimum of 24 months. Exclusion Criteria: 1. Traumatic cervical injury. 2. Posterior augmentation or revision fusion. 3. Cervical fusion involving C1 and C2 vertebrae. 4. Cervical fusion involving more than three levels. 5. Previous spine surgery at the same levels as those that will be fixed with the C-Tek plate. 6. Systemic conditions: Spondylitis, Paget's disease, Rheumatoid arthritis, Infection within two weeks before surgery, Cancer, Renal disease or insufficiency with creatinine level above 2, Chronic use of steroids or other conditions that may affect bone metabolism 7. Subjects who are pregnant, nursing or plan to be pregnant within the next 24 months. 8. Mental or physical conditions that may preclude compliance with physician instruction or the study protocol. 9. Subjects who require non-steroidal medications chronically for other conditions. 10. Subject declines to cooperate with the follow-up schedule. 11. Subject or legal guardian refuses or is unable to sign the informed consent.


NCT ID:

NCT00585923


Primary Contact:

Study Chair
John Evangelsita, MD
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing


Backup Contact:

N/A


Location Contact:

Shreveport, Louisiana 71101
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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