A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-Tek™ Anterior Cervical Plates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Zimmer Biomet
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Fusion Success
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Usage of 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
Intervention: Fixed hole C-Tek™ Plate (Device)
Usage of Slotted hole C-Tek™ Plate
Slotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing.
Intervention: Slotted hole C-Tek™ Plate (Device)
Outcomes
Primary Outcomes
Fusion Success
Time Frame: 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 Outcomes
- 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))
- Pain at Rest(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.(Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up))
- Pain With Activity(Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up))