Cervical Degenerative DiseaseNCT07713927
ACDf: Stand Alone Cage Versus Cage Screw Fixation
A study testing Anterior Cervical Discectomy and fixation and Anterior Cervical Discectomy and fixation using stand alone cage in people with Cervical Degenerative Disease, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cervical Degenerative Disease
- What is being tested?
- Anterior Cervical Discectomy and fixation and Anterior Cervical Discectomy and fixation using stand alone cage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Symptomatic cervical disc disease.
- Single- or multiple-level cervical degenerative disease.
- MRI-confirmed cervical disc prolapse or spondylosis.
- Failure of conservative treatment
Who cannot join
- • Previous cervical spine surgery.
- Cervical trauma.
- Cervical Infection.
- Cervical Tumors.
- Congenital cervical anomalies.
- Severe Cervical osteoporosis.
Show all 9Show fewer
- Rheumatoid arthritis.
- Ossification of posterior longitudinal ligament requiring another approach.
- Severe systemic illness preventing surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Cervical Discectomy Using Stand-Alone Cage Versus Cage-Screw Fixation: Functional Outcomes
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
- Being tested
- Anterior Cervical Discectomy and fixation, Anterior Cervical Discectomy and fixation using stand alone cage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Discectomy and fixationOther
Anterior Cervical Discectomy and fixation by using cage-screw fixation
Anterior Cervical Discectomy and fixation using stand alone cageOther
Anterior Cervical Discectomy and fixation using stand alone cage
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cervical Discectomy and fixation Using Stand-Alone Cage | Active comparator | Not described Receives: Other: Anterior Cervical Discectomy and fixation using stand alone cage |
| Anterior Cervical Discectomy and fixation Using Cage-screw | Active comparator | Not described Receives: Other: Anterior Cervical Discectomy and fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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°.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start14 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed AHmed Hassan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713927
- Sponsor's protocol ID
- Soh-Med-26-6-19MS
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 36787787Arnautovic 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 3860649310) 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cervical Discectomy Using Stand-Alone Cage Versus Cage-Screw Fixation: Functional Outcomes
- ClinicalTrials.gov ID
- NCT07713927
- Acronym / sponsor ID
- Soh-Med-26-6-19MS
- Conditions
- Cervical Degenerative Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Symptomatic cervical disc disease.
Key exclusion criteria (9 listed)
- • Previous cervical spine surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Cervical Discectomy and fixationAnterior Cervical Discectomy and fixation by using cage-screw fixation | Other | Anterior Cervical Discectomy and fixation Using Cage-screw |
| Anterior Cervical Discectomy and fixation using stand alone cageAnterior Cervical Discectomy and fixation using stand alone cage | Other | Anterior Cervical Discectomy and fixation Using Stand-Alone Cage |
Primary outcome
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).
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.
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°.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Results publication: PubMed 36787787Kim 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.
- Results publication: PubMed 38606493Arnautovic 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.
- Results publication10) 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
- Results publication2) 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Cervical Discectomy and fixation and Anterior Cervical Discectomy and fixation using stand alone cage in people with Cervical Degenerative Disease, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score - Clinical Outcome (time frame: From enrollment to the end of treatment at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07713927, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.