The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion for the Operation of Soft Cervical Disc Herniation.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- M-JOA Score
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 308
- Locations
- 1
- Primary Endpoint
- Improvement rate
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
Anterior cervical decompression and fusion is the standard procedure for operation of cervical disc herniations. Mobility-preserving Full-Endoscopic Cervical Posterior discectomy is the most common alternative in the case of soft localization of the pathology. Endoscopic techniques are considered standard in many areas, since they may offer advantages in surgical technique and rehabilitation. These days, all disc herniations can be operated in full-endoscopic technique. With the full-endoscopic posterior cervical discectomy a procedures is available for cervical disc operations.
Detailed Description
Investigators conducted a differential, randomized, 1:1, double-blind clinical control trial to compare the clinical effect, safety and feasibility of Full-Endoscopic Cervical Posterior discectomy and Anterior cervical decompression and fusion. The study was conducted in three centers at the same time, including the Second Affiliated Hospital of Zhejiang University Medical College, Zhejiang Provincial People's Hospital and Ningbo University Medical College Affiliated Hospital. This study is expected to include 308 patients with single level soft cervical disc herniation.Participants were randomly assigned to different groups for corresponding surgical intervention after complete preoperative evaluation.Participants received a standard 5-year follow-up procedure
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
Improvement rate
Time Frame: Follow up for 5 years
M-JOA Scoring
Secondary Outcomes
- Operation duration(intraoperative)
- Basic information of participants(Follow up for 5 years)
- Imaging examination(Follow up for 5 years)
- Pain Assessment(Follow up for 5 years)
- Amount of bleeding during operation(Follow up for 5 years)