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

November 30, 2023 updated by: Jin S. Yeom, Seoul National University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-702
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 602-702
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of, 602-702
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 602-702
        • Kyungpook National University Hospital
      • Daejeon, Korea, Republic of, 602-702
        • Eulji University Hospital
      • Daejeon, Korea, Republic of, 602-702
        • The Catholic University of Korea Daejeon St. Mary's Hospital
      • Gwangju, Korea, Republic of, 602-702
        • Chonnam National University Hospital
      • Gwangju, Korea, Republic of, 602-702
        • Chosun University Hospital
      • Gwangju, Korea, Republic of, 602-702
        • Kwangju Christian Hospital
      • Incheon, Korea, Republic of, 602-702
        • Inha University Hospital
      • Incheon, Korea, Republic of, 602-702
        • The Catholic University of Korea, Incheon St. Mary's Hospital
      • Seoul, Korea, Republic of, 602-702
        • Asan Medical Center, University of Ulsan College of Medicine
      • Seoul, Korea, Republic of, 602-702
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of, 602-702
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 602-702
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 602-702
        • National Police Hospital
      • Seoul, Korea, Republic of, 602-702
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 602-702
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 602-702
        • Soonchunhyang University Seoul Hospital
      • Seoul, Korea, Republic of, 602-702
        • VHS medical center
    • Gyounggi
      • Ilsan, Gyounggi, Korea, Republic of, 602-702
        • Dongguk University Ilsan Hospital
    • Gyounggi-do
      • Ilsan, Gyounggi-do, Korea, Republic of, 602-702
        • National Health Insurance Service Ilsan Hospital
    • Gyounggido
      • Dongan, Gyounggido, Korea, Republic of, 602-702
        • Hallym University Dongtan Sacred Heart Hospital
      • Dongan, Gyounggido, Korea, Republic of, 602-702
        • HALLYM UNIVERSITY HOSPITAL
      • Ilsan, Gyounggido, Korea, Republic of, 602-702
        • Inje University Ilsan Paik Hospital
      • Seongnam, Gyounggido, Korea, Republic of, 602-702
        • Bundang Jesaeng Hospital
    • Gyoungido
      • Seongnam, Gyoungido, Korea, Republic of, 602-702
        • CHA Bundang Medical Center, CHA University
    • Gyoungnam
      • Yangsan, Gyoungnam, Korea, Republic of, 602-702
        • Pusan National University Yangsan Hospital
    • Jeonbuk
      • Iksan, Jeonbuk, Korea, Republic of, 602-702
        • Wonkwang University School of Medicine & Hospital
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 110-744
        • Seoul National University Hospital
    • Kyoungpook
      • Pohang, Kyoungpook, Korea, Republic of, 602-702
        • Pohang Semyung Christianity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cage and Plate
anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system
Procedure: anterior cervical discectomy and fusion
anterior cervical discectomy and fusion with anterior plating or not
Device: Cage and Plate
anterior cervical discectomy and fusion is performed using cervical cage and plate
Experimental: Cage alone
anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate
Procedure: anterior cervical discectomy and fusion
anterior cervical discectomy and fusion with anterior plating or not
Device: Cage alone
anterior cervical discectomy and fusion is performed using cage alone with plate.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cervical fusion status
Time Frame: five year after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
predisposing factor of non-union
Time Frame: one year after surgery
Using logistic regression analysis, odds ratio of each variable is calculated for non-union after anterior cervical discectomy and fusion.
one year after surgery
risk factors of dysphagia
Time Frame: one year after surgery
a specific questionnaire is used for assessment for dysphagia after anterior cervical discectomy and fusion. For comparison of dysphagia rates(%) between two group, Chi-square analysis is used. Furthermore, odds ratio of each variable for dysphagia is calculated for logistic regression analysis.
one year after surgery
risk factors of dysphonia
Time Frame: one year after surgery
a specific questionnaire is used for assessment for dysphonia after anterior cervical discectomy and fusion. For comparison of dysphonia rates(%) between two group, Chi-square analysis is used. Furthermore, odds ratio of each variable for dysphonia is calculated for logistic regression analysis.
one year after surgery
factors for quality of life
Time Frame: one years after operation
Firstly, total cost is calculated for each case. European Quality of Life-5 Dimensions is also used for assessment of quality of life after operation. Between two groups, quality of life per cost is evaluated.
one years after operation
risk factors for adjacent segment degeneration
Time Frame: five year after surgery
The rates (%) of radiological and clinical adjacent segment degeneration is evaluated using X-ray and clinical evaluation in both groups. For statistical analysis, Chi-Square test is used for comparison of rates (%) for adjacent segment degeneration. Furthermore, logistic regression test is also used for calculating odds ratio for adjacent segment degeneration
five year after surgery
correlation between osteoporosis and fusion
Time Frame: one year after surgery
The rates (%) of fusion is evaluated in relation to osteoporosis. For statistical analysis, Chi-Square test is used for comparison between osteoporosis group and non-osteoporosis group.
one year after surgery
relation between brace wearing and fusion
Time Frame: one year after surgery
The rates (%) of fusion is evaluated using X-ray and CT scan according to kinds of brace in both groups. For statistical analysis, Chi-Square test is used for comparison of fusion rates (%).
one year after surgery
surgical outcomes for combined uncinectomy
Time Frame: one year after surgery
In relation with uncinectomy, the clinical outcomes (VAS, NDI) and radiological outcome (fusion rates(%)) is compared using t-test and Chi-square test.
one year after surgery
change of neck motion after surgery
Time Frame: one year after surgery
Serial changes of whole cervical neck motion (degree) is evaluated and compared between pre- and post-operative states. statistical significance is evaluated using one-way ANOVA or paired t test.
one year after surgery
neuropathy after anterior cervical discectomy and fusion surgery
Time Frame: one year after surgery
The occurrence rates(%) of neuropathic pain is evaluated using a specific questionnaires. Several factors to be associated with neuropathic pain is evaluated using logistic regression analysis.
one year after surgery
relation between the method of bone graft and fusion
Time Frame: one year after surgery
The rates (%) of fusion is evaluated using X-ray and CT scan according to methods of bone graft in both groups. For statistical analysis, Chi-Square test is used for comparison of fusion rates(%) in relation to the bone graft method.
one year after surgery
analysis of complication rates after anterior cervical discectomy and fusion surgery
Time Frame: one year after surgery
After anterior cervical discectomy and fusion, complication rates (%) was evaluated, and this is compared between two groups. Further, factors to be associated with complication rates is assessed using Chi-square test
one year after surgery
The correlation between existence of co-morbidity and surgical outcome
Time Frame: one year after surgery
The clinical and radiological outcomes is evaluated using VAS, NDI, and X-ray in relation with existence of coexistence. T-test and Chi-square test are used for statistical analysis for comparison between co-morbidity group and non-co-morbidity group.
one year after surgery
The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability)
Time Frame: one year after surgery
The surgical outcomes such as fusion rates(%), VAS, and NDI score were evaluated in relation with smoking history. For analysis, Chi-square and t-test are used for comparison between smoking group and non-smoking group.
one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Korean Society of Spine Surgery

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jin S. Yeom, MD, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSSS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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