Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07430163

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cervical cage with integrated screws

Device

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

traditional standalone cervical cage

Device

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

Primary outcomes

  1. Radiological cervical interbody fusion.

    Time frame: 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 outcomes

  1. Maintenance of cervical alignment

    Time frame: 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.

  2. Change in segmental alignment at the operated level

    Time frame: 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

  3. Restoration and maintenance of intervertebral disc height

    Time frame: 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.

  4. Cage subsidence

    Time frame: 3, 6, and 12 months postoperatively

    Defined as a reduction in disc height on serial radiographs, indicating the cage sinking into the vertebral endplates.

  5. Implant related complications

    Time frame: Each postoperative follow up visit (3, 6, and 12 months)

    Assessment of cage migration or dislodgement on follow-up radiographs.

  6. Pain intensity and functional outcome

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Essam mohamed El-Morshidy, MD

CONTACT

[email protected]

00201119343404

momen mohamed Roshdy, MBBCH

CONTACT

[email protected]

00201129692785

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.