Clinical and Radiological Outcomes of Anterior Cervical Discectomy and Fusion by Zero Profile Anchored Cage for Cervical Degenerative Disc Disease

August 3, 2026 updated by: Mohammed Mousa Ali El Bashbeshy, Al-Azhar University
The incidence of degenerative cervical conditions is increasing with the aging population, and it is well-recognized as a primary cause of myelopathy, radiculopathy, and disc herniation. Degenerative cervical conditions are the most prevalent conditions of the spinal cord, mainly affecting male patients over 55 years old. Currently, the treatment of degenerative spinal diseases remains focused on managing symptoms using both conservative and surgical methods. Surgical decompression can enhance neurological function and prevent future deterioration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anterior cervical discectomy and fusion (ACDF) is one of the most performed spinal operations and is considered the gold standard for treating cervical spondylosis with myelopathy, radiculopathy, or disc herniation refractory to conservative management. The mechanical goal of ACDF is to eliminate motion between adjacent vertebrae by forming a solid bony union, which is obtained by minimizing intervertebral motion during the fusion phase. However, un-instrumented ACDF is associated with higher complication rates, pseudoarthrosis, and a propensity for kyphosis at the operative levels, leading to significant postoperative neck pain until fusion is achieved.

Study Type

Observational

Enrollment (Actual)

30

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
      • Asyut, Egypt
        • Alazhar University, Assiut

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

Sampling Method

Probability Sample

Study Population

Adult patients of both genders aged between 18 and 70 years admitted to the Orthopedic Surgery department at Al-Azhar University Hospitals, presenting with symptomatic single or multi-level cervical degenerative disc disease (from C3-C4 to C6-C7) causing radiculopathy or myelopathy that is refractory to conservative medical treatment, and undergoing anterior cervical discectomy and fusion (ACDF) using a zero-profile anchored cage system

Description

Inclusion Criteria:

  • Age 18-70 years old.
  • No prior cervical spine surgery.
  • Cervical degenerative disease:
  • Between C3-C4 to C6-C7.
  • Responsible for myelopathy or radiculopathy symptoms.
  • Resistant to conservative treatment.

Exclusion Criteria:

  • Systemic, spinal, or localized infection.
  • Active rheumatoid arthritis or any other medical conditions that interfere with normal healing or increase surgical risk.
  • Known allergy to the implant materials used.
  • Malignancy and spinal metastasis.
  • Refusal to participate.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clinical and Radiological outcomes CDD by zero profile Anchored cage
Patients with symptomatic single or multi-level cervical degenerative disc disease (C3-C4 to C6-C7) undergoing anterior cervical discectomy and fusion (ACDF) using a zero-profile anchored cage system with integrated screw fixation
Procedure: Anchored cage for CDD
Radiological and clinical outcomes of Anchored cage for CDD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neck and Arm Pain Intensity Measured by Visual Analog Scale (VAS)
Time Frame: Preoperatively, and postoperatively at 1 month, 3 months, 6 months, and 12 months
The Visual Analog Scale (VAS) is a self-reported score ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity. Pain will be assessed separately for neck, shoulder, and arm pain
Preoperatively, and postoperatively at 1 month, 3 months, 6 months, and 12 months
Change in Neck Functional Disability Measured by Neck Disability Index (NDI)
Time Frame: Preoperatively, and postoperatively at 1 month, 3 months, 6 months, and 12 months.
The Neck Disability Index (NDI) is a questionnaire measuring functional status and disability related to neck pain, scored as a percentage from 0% (no disability) to 100% (complete disability) . Lower scores indicate better functional capacity
Preoperatively, and postoperatively at 1 month, 3 months, 6 months, and 12 months.

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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)

February 1, 2024

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

July 25, 2026

First Submitted That Met QC Criteria

July 29, 2026

First Posted (Actual)

August 4, 2026

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ACDF with zero profile AC CDD

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.

Subscribe