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

February 18, 2026 updated by: Momen Mohamed Roshdy Abdelaleem, Assiut University

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)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: cervical cage with integrated screws
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
Active Comparator: Traditional Cage Group
20 patients with cervical degenerative disc disease (CDDD) undergoing single or double-level ACDF using a traditional standalone cervical cage
Device: traditional standalone cervical cage
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3, 6, and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperatively, immediately postoperatively, and at 3, 6, and 12 months.
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
preoperatively and at 3, 6 and 12 months postoperatively
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.
Preoperatively, immediately postoperatively, and at 3, 6, and 12 months postoperatively
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.
3, 6, and 12 months postoperatively
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.
Each postoperative follow up visit (3, 6, and 12 months)
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).
3, 6, and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamed Abdel-Hay El-Meshtawy, Assiut University, Faculty of Medicine, Orthopedic surgery and Traumatology.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CDDD_Treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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