NCT07743801

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

2.2 years

First QC Date

July 25, 2026

Last Update Submit

August 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Neck and Arm Pain Intensity Measured by Visual Analog Scale (VAS)

    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)

    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.

Study Arms (1)

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

Interventions

Radiological and clinical outcomes of Anchored cage for CDD

Clinical and Radiological outcomes CDD by zero profile Anchored cage

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazhar University, Assiut

Asyut, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Orthopedic Surgery

Study Record Dates

First Submitted

July 25, 2026

First Posted

August 4, 2026

Study Start

February 1, 2024

Primary Completion

March 31, 2026

Study Completion

April 1, 2026

Last Updated

August 5, 2026

Record last verified: 2026-08

Locations