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C-Tek™ Fusion Study
This study has been completed.
Sponsored by: EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Information provided by: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00585923
  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.


Condition Intervention
HNP
Radiculopathy
Spondylolysis
Device: C-Tek™ Plate

U.S. FDA Resources
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

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Fusion Success [ Time Frame: 23 Momths, 6 Months, 12 Months, 4 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decreased level of pain [ Time Frame: 3 Month, 6 Month, 12 Month, 24 Month ] [ Designated as safety issue: No ]
  • Maintained or improved neurological status [ Time Frame: 3 Month, 6 Month, 12 Month, 24 Month ] [ Designated as safety issue: No ]
  • Maintained or improved level of function [ Time Frame: 3 Month, 6 Month, 12 Month, 24 Month ] [ Designated as safety issue: No ]

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
1: Active Comparator
Fixed Hole Plate
Device: C-Tek™ Plate
Fixed hole C-Tek™ Plate
2: Active Comparator
Slotted Hole Plate
Device: C-Tek™ Plate
Slotted hole C-Tek™ Plate

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585923

Locations
United States, Louisiana
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
Sponsors and Collaborators
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Investigators
Study Chair: John Evangelsita, MD EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
  More Information

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

Study placed in the following topic categories:
Spinal Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Radiculopathy
Spondylolysis
Spondylolisthesis
Bone Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009