Comparative Study Between Cervical Cage With Screws and Traditional Cage in Anterior Cervical Discectomy and Fusion (ACDF) for Treatment of Cervical Degenerative Disc Disease (CDDD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Radiological cervical interbody fusion.
研究概览
简要总结
This study is a prospective, comparative clinical trial conducted at Assiut University Hospitals to evaluate the effectiveness of two different interbody fusion devices in patients with Cervical Degenerative Disc Disease (CDDD). The primary objective is to compare cervical cages with integrated screws against traditional stand-alone cervical cages during single or double-level Anterior Cervical Discectomy and Fusion (ACDF). While ACDF is the gold standard for CDDD, traditional cages can sometimes lead to complications like subsidence or incomplete fusion; integrated screw designs aim to provide immediate stability and reduce these risks.
Investigators will assess 40 patients over a 12-month follow-up period, focusing on primary outcomes of radiological interbody fusion using the Daniel Riew grading system.
Secondary outcomes include the maintenance of cervical alignment (Ishihara Index), change in segmental angles (Cobb's method), disc height restoration, and clinical improvements in pain and function measured by the Visual Analog Scale (VAS) and Neck Disability Index (NDI). The study's rationale is to provide clearer evidence on whether screw-integrated cages offer superior radiological and clinical outcomes to help guide future surgical preferences
详细描述
Cervical degenerative disc disease (CDDD) is a common degenerative spinal disorder and a well-recognized cause of neck pain, cervical radiculopathy, and myelopathy. In patients who fail to respond to conservative treatment, anterior cervical discectomy and fusion (ACDF) is considered the gold standard surgical procedure for single-level disease, as originally described and validated in several classical and long-term studies. The main objectives of ACDF include adequate neural decompression, restoration of disc height, maintenance of cervical alignment, and achievement of solid interbody fusion.
Various interbody fusion devices have been developed to improve fusion outcomes. The traditional standalone cervical cage has demonstrated acceptable clinical results; however, several authors have reported potential complications such as cage subsidence, segmental kyphosis, and delayed or incomplete fusion. To overcome these limitations, cervical cages with integrated screw fixation and zero-profile devices have been introduced to provide immediate segmental stability and reduce micromotion at the fusion site, as supported by biomechanical and clinical evidence.
Available data from the literature show inconsistent results regarding the superiority of screw-integrated cages compared to traditional cages in single-level ACDF. While some studies reported improved radiological stability, better maintenance of cervical lordosis, and higher fusion rates with screw-fixed cages, other studies demonstrated comparable clinical and radiological outcomes between both techniques. Currently, the choice of fusion device is largely based on surgeon preference rather than definitive evidence. Therefore, the rationale of this research is to conduct a comparative evaluation of cervical cages with screws versus traditional cervical cages in ACDF, aiming to clarify their impact on fusion, alignment, and clinical outcomes
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged above 18 years old.
- •Clinical diagnosis of cervical degenerative disc disease (CDDD).
- •Single or double level cervical degenerative disc disease (CDDD) confirmed by MRI
- •Failure of conservative treatment for at least 6 weeks.
- •Patients indicated for Anterior Cervical Discectomy and Fusion (ACDF).
- •Availability of complete preoperative and postoperative clinical and radiological data.
- •Willing and able to provide informed consent.
排除标准
- •Previous cervical spine surgery.
- •Mutli-level (more than double level) cervical degenerative disc disease (CDDD).
- •Significant cervical instability requiring additional posterior fixation
- •Cervical trauma, fracture, or spinal infection.
- •Cervical tumors or inflammatory spinal disease.
- •Severe cervical deformity (fixed kyphosis)
- •Osteoporosis or metabolic bone disease.
- •Pregnancy
- •Psychiatric illness or substance abuse that would compromise follow-up
研究组 & 干预措施
Screw-Integrated Cage Group
20 patients with cervical degenerative disc disease (CDDD) undergoing single or double-level ACDF using a cervical cage with integrated screw fixation.
干预措施: cervical cage with integrated screws (Device)
Traditional Cage Group
20 patients with cervical degenerative disc disease (CDDD) undergoing single or double-level ACDF using a traditional standalone cervical cage
干预措施: traditional standalone cervical cage (Device)
结局指标
主要结局
Radiological cervical interbody fusion.
时间窗: 3, 6, and 12 months postoperatively
Assessment of solid bone fusion at the operated level(s) using dynamic lateral cervical radiographs and graded according to the Daniel-Riew grading system (± CT when indicated)
次要结局
- Restoration and maintenance of intervertebral disc height(Preoperatively, immediately postoperatively, and at 3, 6, and 12 months postoperatively)
- Cage subsidence(3, 6, and 12 months postoperatively)
- Implant related complications(Each postoperative follow up visit (3, 6, and 12 months))
- Pain intensity and functional outcome(3, 6, and 12 months postoperatively)
- Maintenance of cervical alignment(Preoperatively, immediately postoperatively, and at 3, 6, and 12 months.)
- Change in segmental alignment at the operated level(preoperatively and at 3, 6 and 12 months postoperatively)
研究者
Momen Mohamed Roshdy Abdelaleem
Resident of Orthopedic Surgery and Traumatology
Assiut University