Anterior Cervical Discectomy and Fusion (ACDF), Cervical Cage With Screw, Cervical Degenerative Disc Disease
Conditions
Brief summary
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
Detailed description
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
Interventions
Anterior Cervical Discectomy and Fusion (ACDF) procedure performed using a cervical cage that features integrated screw fixation. This device provides immediate biomechanical stability without the need for an additional anterior plate
Standard Anterior Cervical Discectomy and Fusion (ACDF) procedure using a traditional standalone interbody fusion cage (without integrated screws). This serves as the control intervention to compare stability and fusion rates
Sponsors
Study design
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological cervical interbody fusion. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of cervical alignment | Preoperatively, immediately postoperatively, and at 3, 6, and 12 months. | Measured by the Ishihara Cervical Lordosis Index on lateral cervical spine radiographs to evaluate the curvature of the neck. |
| Change in segmental alignment at the operated level | preoperatively and at 3, 6 and 12 months postoperatively | Evaluation of the local kyphotic angle and disc angle measured by Cobb's method on radiographs |
| Restoration and maintenance of intervertebral disc height | Preoperatively, immediately postoperatively, and at 3, 6, and 12 months postoperatively | Measured as the mean of anterior and posterior disc heights on lateral radiographs to assess space restoration. |
| Cage subsidence | 3, 6, and 12 months postoperatively | Defined as a reduction in disc height on serial radiographs, indicating the cage sinking into the vertebral endplates. |
| Implant related complications | Each postoperative follow up visit (3, 6, and 12 months) | Assessment of cage migration or dislodgement on follow-up radiographs. |
| Pain intensity and functional outcome | 3, 6, and 12 months postoperatively | Clinical assessment of neck and arm pain using the Visual Analog Scale (VAS) (0-10, lower is better) and functional disability using the Neck Disability Index (NDI) (0-100%, lower is better). |
Contacts
Assiut University, Faculty of Medicine, Orthopedic surgery and Traumatology.