Individualized cervical surgery for spinal stenosis
Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis
This study tests a personalized approach to cervical surgery for people with spinal stenosis to see if it can improve safety and effectiveness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 28 Years to 85 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shannxi Province) |
| Trial ID | NCT05786313 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a tailored approach to open-door posterior cervical surgery for patients with cervical spinal stenosis. It focuses on using a centerpiece titanium plate in a single-center exploratory clinical setting. The goal is to establish a more reliable treatment method for cervical spinal stenosis by standardizing and individualizing surgical techniques based on patient needs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 28-85 diagnosed with multilevel cervical spondylitis myelopathy or cervical spinal stenosis requiring posterior cervical surgery.
Not a fit: Patients with cervical radiculopathy, kyphosis, or other specific contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and recovery for patients with cervical spinal stenosis.
How similar studies have performed: While this approach is exploratory, similar individualized surgical techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shannxi Province
- Qi Wei — Xi'an, Shannxi Province, China (Recruiting)
Study contacts
- Study coordinator: Wei Qi
- Email: 14556263@qq.com
- Phone: +862984771012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.