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ACDf: Stand Alone Cage Versus Cage Screw Fixation

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07713927
Enrollment
20
Registered
2026-07-20
Start date
2026-06-14
Completion date
2026-11-01
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Degenerative Disease

Brief 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.

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
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

* • 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.

Design outcomes

Primary

MeasureTime frameDescription
VAS score - Clinical OutcomeFrom enrollment to the end of treatment at 3 monthsThe 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).
dysphagia (Bazaz Score) - clinical outcomeFrom enrollment to the end of treatment at 3 monthsdysphagia (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.
radiological OutcomeFrom enrollment to the end of treatment at 3 monthscobb 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°.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026