Slotted Hole Versus Fixed Hole C-Tek

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Herniated Disc, Radiculopathy, Spondylolysis

Intervention / Treatment
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* Device: Fixed hole C-Tek™ Plate
* Device: Slotted hole C-Tek™ Plate


Participation Criteria
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Eligibility Criteria
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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 (ACDF) 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usage of Fixed hole C-Tek™ Plate<br>Fixed Hole Plate - The fixed hole plate means that the screws do not move, restricting motion and providing additional stability | Device: Fixed hole C-Tek™ Plate<br>* Fixed hole C-Tek™ Plate<br>|
| Active Comparator: Usage of Slotted hole C-Tek™ Plate<br>Slotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing. | Device: Slotted hole C-Tek™ Plate<br>* Slotted hole C-Tek™ Plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Success | 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. | Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at Rest | 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. | Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) | 
| Pain With Activity | 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. | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) | 
| Neurological Status Change in Neurological Status Since Surgery. | 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 | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) | 
| Level of Function (Neck Disability Index) | 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. | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |