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Active, not recruitingNCT07713927Updated Jul 20, 2026

ACDf: Stand Alone Cage Versus Cage Screw Fixation

An interventional study of Anterior Cervical Discectomy and fixation and Anterior Cervical Discectomy and fixation using stand alone cage in Cervical Degenerative Disease, sponsored by Sohag University. Active, not recruiting at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Cervical Degenerative Disease
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In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Anterior Cervical Discectomy and fixation Using Stand-Alone Cage

    Other: 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

Interventions

  • OtherAnterior Cervical Discectomy and fixation

    Anterior Cervical Discectomy and fixation by using cage-screw fixation

  • OtherAnterior Cervical Discectomy and fixation using stand alone cage

    Anterior Cervical Discectomy and fixation using stand alone cage

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What researchers measure

Primary outcomes

  1. VAS score - Clinical Outcome

    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).

    Time frame: From enrollment to the end of treatment at 3 months

  2. dysphagia (Bazaz Score) - clinical outcome

    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.

    Time frame: From enrollment to the end of treatment at 3 months

  3. radiological Outcome

    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°.

    Time frame: From enrollment to the end of treatment at 3 months

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Study locations

1 site
  • Sohag University
    Sohag, 82516, Egypt
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References and documents

Publications

  • Kim MW, Kang CN, Choi SH. Update of the Natural History, Pathophysiology, and Treatment Strategies of Degenerative Cervical Myelopathy: A Narrative Review. Asian Spine J. 2023 Feb;17(1):213-221. doi: 10.31616/asj.2022.0440. Epub 2023 Feb 15. PubMed 36787787 ↗
  • Arnautovic A, Mijares J, Begagic E, Ahmetspahic A, Pojskic M. Four-level ACDF surgical series 2000-2022: a systematic review of clinical and radiological outcomes and complications. Br J Neurosurg. 2025 Dec;39(6):750-761. doi: 10.1080/02688697.2024.2337020. Epub 2024 Apr 12. PubMed 38606493 ↗
  • 10) Hwang S, Mun M-H. Relationship of neck disability index, shoulder pain and disability index, and visual analogue scale in individuals with chronic neck pain. Phys Ther Rehabil Sci. 2013; 2:111-4
  • 2) Zamzam Aberuka, MD, Amr Madkour, MD, Ihab Zidan, MD. Comparative Study Between the Cervical Cage with Screws and the Classical Cage in Anterior Cervical Discectomy and Fusion. ADVANCED SPINE JOURNAL 2025; 44:31-39

Related links

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07713927
Lead sponsor
Sohag University
Responsible party
Mohamed AHmed Hassan (Anterior Cervical Discectomy Using Stand-Alone Cage versus Cage-Screw Fixation: Functional Outcomes, Sohag University) — Principal investigator
First posted
Jul 20, 2026
Start date
Jun 14, 2026
Primary completion
Oct 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jul 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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