Anterior Cervical Discectomy Using Stand-Alone Cage Versus Cage-Screw Fixation: Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- VAS score - Clinical Outcome
研究概览
简要总结
Cervical degenerative disc disease is a common spinal disorder causing significant morbidity worldwide, Patients commonly present with neck pain, cervical radiculopathy, myelopathy, sensory disturbances, motor weakness, and gait abnormalities.
Degenerative changes may involve single or multiple cervical levels leading to neural compression and instability, Anterior cervical discectomy and fusion (ACDF) is considered the gold standard surgical procedure for treating symptomatic cervical disc disease refractory to conservative treatment, The procedure provides direct decompression of neural structures, restoration of disc height, correction of cervical alignment, and stabilization of the motion segment. Several modifications of ACDF have evolved over the years, Traditional plating systems improve stability and fusion rates but may increase the incidence of dysphagia, soft tissue irritation, and adjacent segment degeneration, Stand-alone cages were introduced to reduce plate-related complications and decrease operative time. Recently, integrated cage-screw fixation systems have gained popularity because they combine the advantages of stand-alone cages with improved immediate fixation and biomechanical stability.
Despite many studies comparing these techniques, controversy remains regarding which construct provides superior clinical and radiological outcomes, particularly in multilevel disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Symptomatic cervical disc disease.
- •Single- or multiple-level cervical degenerative disease.
- •MRI-confirmed cervical disc prolapse or spondylosis.
- •Failure of conservative treatment
排除标准
- •• Previous cervical spine surgery.
- •Cervical trauma.
- •Cervical Infection.
- •Cervical Tumors.
- •Congenital cervical anomalies.
- •Severe Cervical osteoporosis.
- •Rheumatoid arthritis.
- •Ossification of posterior longitudinal ligament requiring another approach.
- •Severe systemic illness preventing surgery.
结局指标
主要结局
VAS score - Clinical Outcome
时间窗: From enrollment to the end of treatment at 3 months
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). the patients rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimeters from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
dysphagia (Bazaz Score) - clinical outcome
时间窗: From enrollment to the end of treatment at 3 months
dysphagia (Bazaz Score) is a clinical tool used to evaluate difficulty in swallowing (dysphagia). It is primarily used to track swallowing difficulties . severity into four distinct grades Grade 0 (None): No episodes of difficulty swallowing. Grade 1 (Mild): Rare episodes of difficulty swallowing. Grade 2 (Moderate): Occasional swallowing difficulty with solid foods. Grade 3 (Severe): Consistent swallowing difficulty with both solid foods and liquids.
radiological Outcome
时间窗: From enrollment to the end of treatment at 3 months
cobb angle measurments The Cobb angle is the gold standard measurement used on standing X-rays to quantify the severity of spinal deformities like scoliosis, kyphosis, or lordosis. It measures the intersection of lines drawn along the endplates of the most tilted vertebrae at the top and bottom of a spinal curve. A spinal curvature is only classified as scoliosis if the Cobb angle is greater than 10°. The severity of the curve dictates the treatment path: Mild: 10° to 24° Moderate: 25° to 50° Severe: Greater than 50°.
次要结局
未报告次要终点
研究者
Mohamed AHmed Hassan
Anterior Cervical Discectomy Using Stand-Alone Cage versus Cage-Screw Fixation: Functional Outcomes
Sohag University