The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion

Study Overview
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Brief Summary
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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
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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

Official Title
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The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion for the Operation of Soft Cervical Disc Herniation.

Conditions
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M-JOA Score

Intervention / Treatment
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* Procedure: Percutaneous Posterior Endoscopic Cervical Discectomy
* Procedure: Anterior cervical decompression and fusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The experimental group<br>PPECD was performed in the experimental group | Procedure: Percutaneous Posterior Endoscopic Cervical Discectomy<br>* The most common alternative in the case of soft cervical disc herniations.<br>|
| Other: control group<br>ACDF was performed in the control group | Procedure: Anterior cervical decompression and fusion<br>* The standard procedure for operation of cervical disc herniations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate | M-JOA Scoring | Follow up for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basic information of participants | Age in year, gender in male or female, occupation | Follow up for 5 years | 
| Basic information of participants | weight and height will be combined to report BMI in kg/m^2 | Follow up for 5 years | 
| Imaging examination | Cervical cobb angle change i | Follow up for 5 years | 
| Pain Assessment | VAS Score | Follow up for 5 years | 
| Operation duration | Operation duration in minute | intraoperative | 
| Amount of bleeding during operation | Amount of bleeding during operation in milliliter | Follow up for 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical disc herniation, endoscope, posterior, minimally invasive spine surgery