Clinical and Radiological Outcomes of Anterior Cervical Discectomy and Fusion by Zero Profile Anc… (NCT07743801) | Clinical Trial Compass
CompletedNot Applicable
Clinical and Radiological Outcomes of Anterior Cervical Discectomy and Fusion by Zero Profile Anchored Cage for Cervical Degenerative Disc Disease
Egypt30 participantsStarted 2024-02-01
Plain-language summary
The incidence of degenerative cervical conditions is increasing with the aging population, and it is well-recognized as a primary cause of myelopathy, radiculopathy, and disc herniation. Degenerative cervical conditions are the most prevalent conditions of the spinal cord, mainly affecting male patients over 55 years old. Currently, the treatment of degenerative spinal diseases remains focused on managing symptoms using both conservative and surgical methods. Surgical decompression can enhance neurological function and prevent future deterioration.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-70 years old.
* No prior cervical spine surgery.
* Cervical degenerative disease:
* Between C3-C4 to C6-C7.
* Responsible for myelopathy or radiculopathy symptoms.
* Resistant to conservative treatment.
Exclusion Criteria:
* Systemic, spinal, or localized infection.
* Active rheumatoid arthritis or any other medical conditions that interfere with normal healing or increase surgical risk.
* Known allergy to the implant materials used.
* Malignancy and spinal metastasis.
* Refusal to participate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Neck and Arm Pain Intensity Measured by Visual Analog Scale (VAS)
Timeframe: Preoperatively, and postoperatively at 1 month, 3 months, 6 months, and 12 months
2
Change in Neck Functional Disability Measured by Neck Disability Index (NDI)
Timeframe: Preoperatively, and postoperatively at 1 month, 3 months, 6 months, and 12 months.