Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal … (NCT05786313) | Clinical Trial Compass
RecruitingNot Applicable
Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis
China500 participantsStarted 2023-03-01
Plain-language summary
To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.
Who can participate
Age range
28 Years – 85 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:
* The age of 28-85 years old; Through systematic clinical and imaging examination, patients diagnosed with C3-7 multilevel cervical spondylitis myelopathy or cervical spinal stenosis who need to undergo posterior cervical open-door surgery.
* No contraindications in preoperative routine tests and examinations.
* Informed consent of patients.
Exclusion Criteria:
* Cervical radiculopathy
* Cervical kyphosis or instability
* Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases
* Revision surgery or combined anterior-posterior surgery is required
* Serious neurological diseases affect the postoperative effect evaluation
* Mental illness cannot cooperate with follow-up
* Contraindications for MRI examination
* Patients themselves or their families do not agree to participate in the study
* Other situations that are not suitable for study participation.
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
JOA score change
Timeframe: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
2
NDI score change
Timeframe: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
3
VAS score
Timeframe: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery