C-Tek™ Fusion Study - Full Text View

Sponsor:	EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Information provided by (Responsible Party):	Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] [ Designated as safety issue: No ]
The fusion criteria will include radiographic evidence of no motion at the affected levels on flexion/extension and evidence of bony bridging and no lucent lines on AP/lateral views.

Fusion Grading

"fused" "probably fused" "pseudarthrosis"

This determination was made by Dr. Nunley and there was never any more specific details given on how the determination was made between fused and probably fused.

Secondary Outcome Measures:

Pain at Rest [ Time Frame: Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] [ Designated as safety issue: No ]
Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain at Rest Improved, Maintained or Worsened from Baseline to "last follow-up visit". This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Best Case is 0 and worst case is 100.
Pain With Activity [ Time Frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] [ Designated as safety issue: No ]
Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain with Activity Improved, Maintained or Worsened from Baseline to "last follow-up visit". This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Scores range from 0 to 100 with 0 being the best score.
Neurological Status Change in Neurological Status Since Surgery. [ Time Frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] [ Designated as safety issue: No ]
Patients were categorized as maintained, improved or decreased Neurological Status. This was assessed pre-operatively and at each follow-up visit but reported on last follow-up. Motor Function was measured at each cervical level Reflex Function (0: Not elicitable; 1: Elicited with reinforcement; 2: Normal; 3:Brisk; 4:Clonus, unsustained; 5: Clonus, sustained) was measured for Bicep, Brachioradialis, and Triceps Sensory Function (0: Sensation is absent; 1: Sensating is diminished; 2: Sensation is normal; 3: Sensation is present, but pathological, was measured at each cervical dermatome
Level of Function (Neck Disability Index) [ Time Frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] [ Designated as safety issue: No ]
Number of patients who have an improved, maintained or decreased level of function based on the results of their NDI (Neck Disabillity Index) from surgery to last follow-up visit. The NDI scale ranges from 0-100. If a subject has a score of 0, it means that they have no limitations and no pain. This is calculated by subtracting the NDI at the last follow-up from the NDI at the baseline visit.

Enrollment:	115
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
Active Comparator: 1 Fixed Hole Plate - The fixed hole plate means that the screws do not move, restricting motion and providing additional stability	Device: C-Tek™ Plate Fixed hole C-Tek™ Plate
Active Comparator: 2 Slotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing.	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:	Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier:	NCT00585923 History of Changes
Other Study ID Numbers:	CS-014
Study First Received:	December 21, 2007
Results First Received:	November 11, 2009
Last Updated:	August 29, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Spondylolysis
Radiculopathy
Spondylosis
Spinal Diseases
Bone Diseases

Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012