Screw-Integrated vs Traditional Cervical Cages in ACDF for Degenerative Disc Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorAssiut University

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • cervical cage with integrated screws
  • traditional standalone cervical cage

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators