A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-Tek™ Anterior Cervical Plates
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Fusion Success
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Slotted hole C-Tek™ Plate (Device)
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
干预措施: Fixed hole C-Tek™ Plate (Device)
结局指标
主要结局
Fusion Success
时间窗: 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.
次要结局
- 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))