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

NCT ID: NCT04175535

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-12-01

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

Conditions

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M-JOA Score

Keywords

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cervical disc herniation endoscope posterior minimally invasive spine surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Participants were unaware of the grouping process. The surgeons were unaware of the grouping process. The follow-up recorders were unaware of the grouping process.

Study Groups

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The experimental group

PPECD was performed in the experimental group

Group Type OTHER

Percutaneous Posterior Endoscopic Cervical Discectomy

Intervention Type PROCEDURE

The most common alternative in the case of soft cervical disc herniations.

control group

ACDF was performed in the control group

Group Type OTHER

Anterior cervical decompression and fusion

Intervention Type PROCEDURE

The standard procedure for operation of cervical disc herniations.

Interventions

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Percutaneous Posterior Endoscopic Cervical Discectomy

The most common alternative in the case of soft cervical disc herniations.

Intervention Type PROCEDURE

Anterior cervical decompression and fusion

The standard procedure for operation of cervical disc herniations.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yongjian Zhu, PhD

Role: primary

Other Identifiers

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zeyy1985811

Identifier Type: -

Identifier Source: org_study_id