C-Tek Fusion Study
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HNP; Radiculopathy; Spondylolysis
Intervention: C-TEK™ Plate (Device); C-TEK™ Plate (Device)
Phase: N/A
Status: Recruiting
Sponsored by: EBI, L.P. dba Biomet Spine and Biomet Trauma Official(s) and/or principal investigator(s):
John Evangelsita, MD, Study Chair, Affiliation: EBI, L.P. dba Biomet Spine and Biomet Trauma
Overall contact:
John Evangelista, MD, Phone: 973-299-9300, Ext: 3930, Email: john.evangelista@ebimed.com
Summary
To compare the fusion rates between the EBI, L. P. C-TEK™ Anterior Cervical Plate, Slotted
Hole Design versus the Fixed Hole Design.
Clinical Details
Official title: A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-TEK™ Anterior Cervical Plates
Study design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Primary outcome: Fusion Success
Secondary outcome: Decreased level of pain, maintained or improved neurological status, maintained or improved level of function
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
John Evangelista, MD, Phone: 973-299-9300, Ext: 3930, Email: john.evangelista@ebimed.com
Spine Institute of Louisiana, Shreveport, Louisiana 71101, United States; Recruiting
Ajay Jawahar, MD, Phone: 318-629-5555, Email: ajawahar@louisianaspine.org
Pierce D Nunley, MD, Principal Investigator
Additional Information
Starting date: April 2002
Ending date: December 2010
Last updated: December 21, 2007
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