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

Not Applicable

Recruiting

• Conditions: M-JOA Score
• Interventions: Procedure: Percutaneous Posterior Endoscopic Cervical Discectomy; Procedure: Anterior cervical decompression and fusion

• Registration Number: NCT04175535
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Study Timeline

• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-25
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-27
• Last Update Posted: 2020-12-29
• Study Start: 2021-03-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 308

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The experimental group	Percutaneous Posterior Endoscopic Cervical Discectomy	PPECD was performed in the experimental group
control group	Anterior cervical decompression and fusion	ACDF was performed in the control group

Primary Outcome Measures

Name	Time	Method
Improvement rate	Follow up for 5 years	M-JOA Scoring

Secondary Outcome Measures

Name	Time	Method
Basic information of participants	Follow up for 5 years	weight and height will be combined to report BMI in kg/m\^2
Imaging examination	Follow up for 5 years	Cervical cobb angle change i
Pain Assessment	Follow up for 5 years	VAS Score
Operation duration	intraoperative	Operation duration in minute
Amount of bleeding during operation	Follow up for 5 years	Amount of bleeding during operation in milliliter

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China