ACDf: Stand Alone Cage Versus Cage Screw Fixation

NCT07713927 | Active Not Recruiting

• 1 other identifier: Soh-Med-26-6-19MS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Degenerative Disease

Outcome Measures

Primary Outcomes (3)

• 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).

  From enrollment to the end of treatment at 3 months

• 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.

  From enrollment to the end of treatment at 3 months

• 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°.

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Anterior Cervical Discectomy and fixation Using Stand-Alone Cage

ACTIVE COMPARATOR

Other: Anterior Cervical Discectomy and fixation using stand alone cage

Anterior Cervical Discectomy and fixation Using Cage-screw

ACTIVE COMPARATOR

Other: Anterior Cervical Discectomy and fixation

Interventions

Anterior Cervical Discectomy and fixation OTHER

Anterior Cervical Discectomy and fixation by using cage-screw fixation

Anterior Cervical Discectomy and fixation Using Cage-screw

Anterior Cervical Discectomy and fixation using stand alone cage OTHER

Anterior Cervical Discectomy and fixation using stand alone cage

Anterior Cervical Discectomy and fixation Using Stand-Alone Cage

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic cervical disc disease.
• Single- or multiple-level cervical degenerative disease.
• MRI-confirmed cervical disc prolapse or spondylosis.
• Failure of conservative treatment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82516, Egypt

Location

Related Publications (4)

• 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.

  PMID: 36787787 RESULT

• 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.

  PMID: 38606493 RESULT

• 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

  RESULT

• 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

  RESULT

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anterior Cervical Discectomy Using Stand-Alone Cage versus Cage-Screw Fixation: Functional Outcomes

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 20, 2026
• Study Start: June 14, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

EG (1)