ACDf: Stand Alone Cage Versus Cage Screw Fixation

July 17, 2026 updated by: Mohamed AHmed Hassan, Sohag University

Anterior Cervical Discectomy Using Stand-Alone Cage Versus Cage-Screw Fixation: Functional Outcomes

Cervical degenerative disc disease is a common spinal disorder causing significant morbidity worldwide, Patients commonly present with neck pain, cervical radiculopathy, myelopathy, sensory disturbances, motor weakness, and gait abnormalities.

Degenerative changes may involve single or multiple cervical levels leading to neural compression and instability, Anterior cervical discectomy and fusion (ACDF) is considered the gold standard surgical procedure for treating symptomatic cervical disc disease refractory to conservative treatment, The procedure provides direct decompression of neural structures, restoration of disc height, correction of cervical alignment, and stabilization of the motion segment. Several modifications of ACDF have evolved over the years, Traditional plating systems improve stability and fusion rates but may increase the incidence of dysphagia, soft tissue irritation, and adjacent segment degeneration, Stand-alone cages were introduced to reduce plate-related complications and decrease operative time. Recently, integrated cage-screw fixation systems have gained popularity because they combine the advantages of stand-alone cages with improved immediate fixation and biomechanical stability.

Despite many studies comparing these techniques, controversy remains regarding which construct provides superior clinical and radiological outcomes, particularly in multilevel disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Egypt
      • Sohag, Egypt, 82516
        • Sohag University

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:

  • • Symptomatic cervical disc disease.

    • Single- or multiple-level cervical degenerative disease.
    • MRI-confirmed cervical disc prolapse or spondylosis.
    • Failure of conservative treatment

Exclusion Criteria:

  • • Previous cervical spine surgery.

    • Cervical trauma.
    • Cervical Infection.
    • Cervical Tumors.
    • Congenital cervical anomalies.
    • Severe Cervical osteoporosis.
    • Rheumatoid arthritis.
    • Ossification of posterior longitudinal ligament requiring another approach.
    • Severe systemic illness preventing surgery.

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
Active Comparator: Anterior Cervical Discectomy and fixation Using Stand-Alone Cage
Other: Anterior Cervical Discectomy and fixation using stand alone cage
Anterior Cervical Discectomy and fixation using stand alone cage
Active Comparator: Anterior Cervical Discectomy and fixation Using Cage-screw
Other: Anterior Cervical Discectomy and fixation
Anterior Cervical Discectomy and fixation by using cage-screw fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score - Clinical Outcome
Time Frame: From enrollment to the end of treatment at 3 months

The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

the patients rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimeters from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
From enrollment to the end of treatment at 3 months
dysphagia (Bazaz Score) - clinical outcome
Time Frame: From enrollment to the end of treatment at 3 months
dysphagia (Bazaz Score) is a clinical tool used to evaluate difficulty in swallowing (dysphagia). It is primarily used to track swallowing difficulties . severity into four distinct grades Grade 0 (None): No episodes of difficulty swallowing. Grade 1 (Mild): Rare episodes of difficulty swallowing. Grade 2 (Moderate): Occasional swallowing difficulty with solid foods. Grade 3 (Severe): Consistent swallowing difficulty with both solid foods and liquids.
From enrollment to the end of treatment at 3 months
radiological Outcome
Time Frame: From enrollment to the end of treatment at 3 months

cobb angle measurments The Cobb angle is the gold standard measurement used on standing X-rays to quantify the severity of spinal deformities like scoliosis, kyphosis, or lordosis. It measures the intersection of lines drawn along the endplates of the most tilted vertebrae at the top and bottom of a spinal curve.

A spinal curvature is only classified as scoliosis if the Cobb angle is greater than 10°.

The severity of the curve dictates the treatment path:

Mild: 10° to 24° Moderate: 25° to 50° Severe: Greater than 50°.
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

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

Sponsor

Sohag University

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

Helpful Links

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 (Actual)

June 14, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 17, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-26-6-19MS

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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