Slotted Hole Versus Fixed Hole C-Tek



Status:Terminated
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:3/7/2019
Start Date:April 2002
End Date:May 2008

Use our guide to learn which trials are right for you!

A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-Tek™ Anterior Cervical Plates

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.

This study's purpose is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior
Cervical Plate, Slotted Hole Design versus the Fixed Hole Design

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 (ACDF) 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.
We found this trial at
1
site
Shreveport, Louisiana 71101
?
mi
from
Shreveport, LA
Click here to add this to my saved trials