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
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.
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.
Parallel
cervical cage with integrated screws
DeviceAnterior 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
traditional standalone cervical cage
DeviceStandard 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
Radiological cervical interbody fusion.
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)
Maintenance of cervical alignment
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
Evaluation of the local kyphotic angle and disc angle measured by Cobb's method on radiographs
Restoration and maintenance of intervertebral disc height
Measured as the mean of anterior and posterior disc heights on lateral radiographs to assess space restoration.
Cage subsidence
Defined as a reduction in disc height on serial radiographs, indicating the cage sinking into the vertebral endplates.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
