Comparing two surgical methods for cervical disc herniation
The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion for the Operation of Soft Cervical Disc Herniation.
NA · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT04175535
This study is testing two different surgical methods for treating a herniated disc in the neck to see which one works better and is safer for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 308 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04175535 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness, safety, and feasibility of Full-Endoscopic Cervical Posterior Discectomy with the standard Anterior Cervical Decompression and Fusion for patients with single-level soft cervical disc herniation. The study involves a randomized, double-blind design and aims to enroll 308 participants across three medical centers. Patients will be assigned to one of the two surgical interventions after a thorough preoperative evaluation, followed by a standard 5-year follow-up to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals with single cervical intervertebral disc herniation experiencing radicular pain or mild myelopathy who have not responded to conservative treatment.
Not a fit: Patients with multisegmental lesions, severe myelopathy, or those with prior surgical history at the target segment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a less invasive surgical option that may lead to quicker recovery and improved outcomes.
How similar studies have performed: Previous studies have shown promising results for endoscopic techniques in spinal surgery, suggesting potential benefits in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Single cervical intervertebral dis herniation wih symptoms of radicular pain or spinal cord compression ; 2) the herniated lesions had no obvious calcification; 3) conservative treatment fails ; 4) mild myelopathy (Nurick grade 3 or blow. (6) patients agree to participate in this study. Exclusion Criteria: 1. cervical segmental instability or deformity (cervical spondylolisthesis or Cobb Angle greater than 25°); 2) multisegmental lesions (≥2); 3) tumor, infection or other unknown space occupying in cervical vertebra; 4) surgical history of the target segment; 5) severe myelopathy (Nurick grade 4 or above); 6) the patients were not suitable for surgery, had poor medical management or did not agree to participate in this study.
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)
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.
Conditions: M-JOA Score, cervical disc herniation, endoscope, posterior, minimally invasive spine surgery