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NCT Number: NCT07713927

ACDf: Stand Alone Cage Versus Cage Screw Fixation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cervical Degenerative Disease

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University

Sohag, 82516, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Anterior Cervical Discectomy and fixation

Other

Anterior Cervical Discectomy and fixation by using cage-screw fixation

Anterior Cervical Discectomy and fixation using stand alone cage

Other

Anterior Cervical Discectomy and fixation using stand alone cage

Primary outcomes

  1. 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).

  2. 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.

  3. 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°.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 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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