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Completed

NCT Number: NCT07743801

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alazhar University, Assiut

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Anchored cage for CDD

Procedure

Radiological and clinical outcomes of Anchored cage for CDD

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2026
Registry last updated
Aug 5, 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.

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