A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion

NCT ID: NCT01911013

Last Updated: 2023-12-01

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-01

Study Completion Date

2025-09-01

Brief Summary

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The purpose of this study is firstly to determine the efficacy of cervical plate for anterior cervical discectomy and fusion using cervical cage, and secondly to investigate the determining factors for surgical outcomes.

Detailed Description

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Conditions

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Radiculopathy, Cervical Myelopathy

Keywords

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degenerative cervical disease anterior cervical discectomy and fusion plate and cage cage alone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cage and Plate

anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system

Group Type ACTIVE_COMPARATOR

anterior cervical discectomy and fusion

Intervention Type PROCEDURE

anterior cervical discectomy and fusion with anterior plating or not

Cage and Plate

Intervention Type DEVICE

anterior cervical discectomy and fusion is performed using cervical cage and plate

Cage alone

anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate

Group Type EXPERIMENTAL

anterior cervical discectomy and fusion

Intervention Type PROCEDURE

anterior cervical discectomy and fusion with anterior plating or not

Cage alone

Intervention Type DEVICE

anterior cervical discectomy and fusion is performed using cage alone with plate.

Interventions

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anterior cervical discectomy and fusion

anterior cervical discectomy and fusion with anterior plating or not

Intervention Type PROCEDURE

Cage and Plate

anterior cervical discectomy and fusion is performed using cervical cage and plate

Intervention Type DEVICE

Cage alone

anterior cervical discectomy and fusion is performed using cage alone with plate.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* degenerative cervical disease
* radiculopathy or myelopathy refractory to conservative treatment
* be scheduled to undergo one segment anterior cervical discectomy and fusion
* age is more than 19 years old
* all requirements of preoperative image studies are satisfied

Exclusion Criteria

* previous neck surgery or radiation treatments at neck area
* fusion at adjacent segments
* two segment fusion is expected
* C2-3 or C7-T1
* high risk for additional cervical surgery within one year
* ossification of posterior longitudinal ligaments, trauma, infection, tumor, congenital or developmental disease
* inadequate radiological images
* patient is not expected to be observed at long term follow-up (foreigner, international student)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korean Society of Spine Surgery

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin S. Yeom

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin S. Yeom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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National Health Insurance Service Ilsan Hospital

Ilsan, Gyounggi-do, South Korea

Site Status

Hallym University Dongtan Sacred Heart Hospital

Dongan, Gyounggido, South Korea

Site Status

Hallym University Hospital

Dongan, Gyounggido, South Korea

Site Status

Inje University Ilsan Paik Hospital

Ilsan, Gyounggido, South Korea

Site Status

Bundang Jesaeng Hospital

Seongnam, Gyounggido, South Korea

Site Status

Dongguk University Ilsan Hospital

Ilsan, Gyounggi, South Korea

Site Status

CHA Bundang Medical Center, CHA university

Seongnam, Gyoungido, South Korea

Site Status

Pusan National University Yangsan Hospital

Yangsan, Gyoungnam, South Korea

Site Status

Wonkwang University School of Medicine & Hospital

Iksan, Jeollabuk-do, South Korea

Site Status

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status

Pohang Semyung Christianity Hospital

Pohang, Kyoungpook, South Korea

Site Status

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Inje University Haeundae Paik Hospital

Busan, , South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Eulji University Hospital

Daejeon, , South Korea

Site Status

The Catholic University of Korea Daejeon ST. Mary's hospital

Daejeon, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Chosun University Hospital

Gwangju, , South Korea

Site Status

Kwangju Christian Hospital

Gwangju, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

The Catholic University of Korea, Incheon St. Mary's hospital

Incheon, , South Korea

Site Status

Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Gangnam severance hospital

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

National Police Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Soonchunhyang University Seoul Hospital

Seoul, , South Korea

Site Status

VHS Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KSSS-001

Identifier Type: -

Identifier Source: org_study_id