NCT01911013

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

31 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

July 21, 2013

Last Update Submit

November 30, 2023

Conditions

Radiculopathy, CervicalMyelopathy

Keywords

degenerative cervical diseaseanterior cervical discectomy and fusionplate and cagecage alone

Outcome Measures

Primary Outcomes (1)

  • Cervical fusion status

    Cervical fusion rates (%) is compared using CT and flexion/extension X-ray between two groups. For statistical analysis, Chi-Square test is used.

    five year after surgery

Secondary Outcomes (14)

  • predisposing factor of non-union

    one year after surgery

  • risk factors of dysphagia

    one year after surgery

  • risk factors of dysphonia

    one year after surgery

  • factors for quality of life

    one years after operation

  • risk factors for adjacent segment degeneration

    five year after surgery

  • +9 more secondary outcomes

Study Arms (2)

Cage and Plate

ACTIVE COMPARATOR

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

Procedure: anterior cervical discectomy and fusionDevice: Cage and Plate

Cage alone

EXPERIMENTAL

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

Procedure: anterior cervical discectomy and fusionDevice: Cage alone

Interventions

anterior cervical discectomy and fusionPROCEDURE

anterior cervical discectomy and fusion with anterior plating or not

Cage aloneCage and Plate
Cage and PlateDEVICE

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

Cage and Plate
Cage aloneDEVICE

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

Cage alone

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

National Health Insurance Service Ilsan Hospital

Ilsan, Gyounggi-do, 602-702, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Dongan, Gyounggido, 602-702, South Korea

Location

Hallym University Hospital

Dongan, Gyounggido, 602-702, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, Gyounggido, 602-702, South Korea

Location

Bundang Jesaeng Hospital

Seongnam, Gyounggido, 602-702, South Korea

Location

Dongguk University Ilsan Hospital

Ilsan, Gyounggi, 602-702, South Korea

Location

CHA Bundang Medical Center, CHA university

Seongnam, Gyoungido, 602-702, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyoungnam, 602-702, South Korea

Location

Wonkwang University School of Medicine & Hospital

Iksan, Jeollabuk-do, 602-702, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 110-744, South Korea

Location

Pohang Semyung Christianity Hospital

Pohang, Kyoungpook, 602-702, South Korea

Location

Inje University Busan Paik Hospital

Busan, 602-702, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 602-702, South Korea

Location

Pusan National University Hospital

Busan, 602-702, South Korea

Location

Kyungpook National University Hospital

Daegu, 602-702, South Korea

Location

Eulji University Hospital

Daejeon, 602-702, South Korea

Location

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

Daejeon, 602-702, South Korea

Location

Chonnam National University Hospital

Gwangju, 602-702, South Korea

Location

Chosun University Hospital

Gwangju, 602-702, South Korea

Location

Kwangju Christian Hospital

Gwangju, 602-702, South Korea

Location

Inha University Hospital

Incheon, 602-702, South Korea

Location

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

Incheon, 602-702, South Korea

Location

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 602-702, South Korea

Location

Chung-Ang University Hospital

Seoul, 602-702, South Korea

Location

Gangnam severance hospital

Seoul, 602-702, South Korea

Location

Korea University Anam Hospital

Seoul, 602-702, South Korea

Location

National Police Hospital

Seoul, 602-702, South Korea

Location

Seoul National University Hospital

Seoul, 602-702, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 602-702, South Korea

Location

Soonchunhyang University Seoul Hospital

Seoul, 602-702, South Korea

Location

VHS Medical Center

Seoul, 602-702, South Korea

Location

MeSH Terms

Conditions

RadiculopathySpinal Cord Diseases

Interventions

Gene FusionBone Plates

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic PhenomenaInternal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Officials

  • Jin S. Yeom, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2013

First Posted

July 30, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2017

Study Completion

September 1, 2025

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

KR(31)