Slotted Hole Versus Fixed Hole C-Tek

Not Applicable

Terminated

Conditions: Herniated Disc
Radiculopathy
Spondylolysis

Interventions: Device: Slotted hole C-Tek™ Plate
Device: Fixed hole C-Tek™ Plate

Registration Number: NCT00585923

Lead Sponsor: Zimmer Biomet

Brief Summary: 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: 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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 115

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usage of Slotted hole C-Tek™ Plate	Slotted hole C-Tek™ Plate	Slotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing.
Usage of Fixed hole C-Tek™ Plate	Fixed hole C-Tek™ Plate	Fixed Hole Plate - The fixed hole plate means that the screws do not move, restricting motion and providing additional stability

Primary Outcome Measures

Name	Time	Method
Fusion Success	Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)	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

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