C-Tek™ Fusion Study

This study has been terminated.

( MD decided he no langer wanted to participate and provide us information )

First Received: December 21, 2007 Last Updated: July 20, 2009 History of Changes

Sponsor:	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

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: 3 Months, 6 Months, 12 Months, 24 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 ]

Enrollment:	131
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:

Radiographic evidence of compressed cervical roots or cord by either ossified bony elements or herniated nucleus pulposus.
Symptomatic radiculopathy appropriate to compressed nerve root.
Cervical spondylosis as evidenced by reactive changes in the vertebral bodies about the interspace, and may be associated with chronic discopathy.
Primary anterior cervical spinal fusion performed using an anterior cervical plate and either a discectomy (Smith-Robinson technique) or a Corpectomy.
Adult male or female, 18 to 75 years of age.
The subject or his/her legal guardian is willing to consent to participate in this study.
The subject will be available for follow-up for a minimum of 24 months.

Exclusion Criteria:

Traumatic cervical injury.
Posterior augmentation or revision fusion.
Cervical fusion involving C1 and C2 vertebrae.
Cervical fusion involving more than three levels.
Previous spine surgery at the same levels as those that will be fixed with the C-Tek plate.
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
Subjects who are pregnant, nursing or plan to be pregnant within the next 24 months.
Mental or physical conditions that may preclude compliance with physician instruction or the study protocol.
Subjects who require non-steroidal medications chronically for other conditions.
Subject declines to cooperate with the follow-up schedule.
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

No publications provided

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 20, 2009
ClinicalTrials.gov Identifier:	NCT00585923 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Spinal Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Nervous System Diseases

Radiculopathy
Spondylolysis
Spondylolisthesis
Bone Diseases

ClinicalTrials.gov processed this record on February 08, 2010