Clinical and Radiological Outcomes of Anterior Cervical Discectomy and Fusion by Zero Profile Anchored Cage for Cervical Degenerative Disc Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Neck and Arm Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
The incidence of degenerative cervical conditions is increasing with the aging population, and it is well-recognized as a primary cause of myelopathy, radiculopathy, and disc herniation. Degenerative cervical conditions are the most prevalent conditions of the spinal cord, mainly affecting male patients over 55 years old. Currently, the treatment of degenerative spinal diseases remains focused on managing symptoms using both conservative and surgical methods. Surgical decompression can enhance neurological function and prevent future deterioration.
详细描述
Anterior cervical discectomy and fusion (ACDF) is one of the most performed spinal operations and is considered the gold standard for treating cervical spondylosis with myelopathy, radiculopathy, or disc herniation refractory to conservative management. The mechanical goal of ACDF is to eliminate motion between adjacent vertebrae by forming a solid bony union, which is obtained by minimizing intervertebral motion during the fusion phase. However, un-instrumented ACDF is associated with higher complication rates, pseudoarthrosis, and a propensity for kyphosis at the operative levels, leading to significant postoperative neck pain until fusion is achieved.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old.
- •No prior cervical spine surgery.
- •Cervical degenerative disease:
- •Between C3-C4 to C6-C
- •Responsible for myelopathy or radiculopathy symptoms.
- •Resistant to conservative treatment.
排除标准
- •Systemic, spinal, or localized infection.
- •Active rheumatoid arthritis or any other medical conditions that interfere with normal healing or increase surgical risk.
- •Known allergy to the implant materials used.
- •Malignancy and spinal metastasis.
- •Refusal to participate.
研究组 & 干预措施
Clinical and Radiological outcomes CDD by zero profile Anchored cage
Patients with symptomatic single or multi-level cervical degenerative disc disease (C3-C4 to C6-C7) undergoing anterior cervical discectomy and fusion (ACDF) using a zero-profile anchored cage system with integrated screw fixation
干预措施: Anchored cage for CDD (Procedure)
结局指标
主要结局
Change in Neck and Arm Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: Preoperatively, and postoperatively at 1 month, 3 months, 6 months, and 12 months
The Visual Analog Scale (VAS) is a self-reported score ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity. Pain will be assessed separately for neck, shoulder, and arm pain
Change in Neck Functional Disability Measured by Neck Disability Index (NDI)
时间窗: Preoperatively, and postoperatively at 1 month, 3 months, 6 months, and 12 months.
The Neck Disability Index (NDI) is a questionnaire measuring functional status and disability related to neck pain, scored as a percentage from 0% (no disability) to 100% (complete disability) . Lower scores indicate better functional capacity
次要结局
未报告次要终点
研究者
Mohammed Mousa Ali El Bashbeshy
Assistant Lecturer of Orthopedic Surgery
Al-Azhar University