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

Primary Purpose

Radiculopathy, Cervical, Myelopathy

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
anterior cervical discectomy and fusion
Cage and Plate
Cage alone
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy, Cervical focused on measuring degenerative cervical disease, anterior cervical discectomy and fusion, plate and cage, cage alone

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • National Health Insurance Service Ilsan Hospital
  • Hallym University Dongtan Sacred Heart Hospital
  • Hallym University Hospital
  • Inje University Ilsan Paik Hospital
  • Bundang Jesaeng Hospital
  • Dongguk University Ilsan Hospital
  • CHA Bundang Medical Center, CHA university
  • Pusan National University Yangsan Hospital
  • Wonkwang University School of Medicine & Hospital
  • Seoul National University Hospital
  • Pohang Semyung Christianity Hospital
  • Inje University Busan Paik Hospital
  • Inje University Haeundae Paik Hospital
  • Pusan National University Hospital
  • Kyungpook National University Hospital
  • Eulji University Hospital
  • The Catholic University of Korea Daejeon ST. Mary's hospital
  • Chonnam National University Hospital
  • Chosun University Hospital
  • Kwangju Christian Hospital
  • Inha University Hospital
  • The Catholic University of Korea, Incheon St. Mary's hospital
  • Asan Medical Center, University of Ulsan College of Medicine
  • Chung-Ang University Hospital
  • Gangnam severance hospital
  • Korea University Anam Hospital
  • National Police Hospital
  • Seoul National University Hospital
  • SMG-SNU Boramae Medical Center
  • Soonchunhyang University Seoul Hospital
  • VHS Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cage and Plate

Cage alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

predisposing factor of non-union
Using logistic regression analysis, odds ratio of each variable is calculated for non-union after anterior cervical discectomy and fusion.
risk factors of dysphagia
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.
risk factors of dysphonia
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.
factors for quality of life
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.
risk factors for adjacent segment degeneration
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
correlation between osteoporosis and fusion
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.
relation between brace wearing and fusion
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 (%).
surgical outcomes for combined uncinectomy
In relation with uncinectomy, the clinical outcomes (VAS, NDI) and radiological outcome (fusion rates(%)) is compared using t-test and Chi-square test.
change of neck motion 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.
neuropathy after anterior cervical discectomy and fusion 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.
relation between the method of bone graft and fusion
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.
analysis of complication rates after anterior cervical discectomy and fusion 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
The correlation between existence of co-morbidity and surgical outcome
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.
The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability)
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.

Full Information

First Posted
July 21, 2013
Last Updated
May 3, 2022
Sponsor
Seoul National University Hospital
Collaborators
Korean Society of Spine Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT01911013
Brief Title
A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion
Official Title
A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korean Society of Spine Surgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Cervical, Myelopathy
Keywords
degenerative cervical disease, anterior cervical discectomy and fusion, plate and cage, cage alone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cage and Plate
Arm Type
Active Comparator
Arm Description
anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system
Arm Title
Cage alone
Arm Type
Experimental
Arm Description
anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate
Intervention Type
Procedure
Intervention Name(s)
anterior cervical discectomy and fusion
Intervention Description
anterior cervical discectomy and fusion with anterior plating or not
Intervention Type
Device
Intervention Name(s)
Cage and Plate
Intervention Description
anterior cervical discectomy and fusion is performed using cervical cage and plate
Intervention Type
Device
Intervention Name(s)
Cage alone
Intervention Description
anterior cervical discectomy and fusion is performed using cage alone with plate.
Primary Outcome Measure Information:
Title
Cervical fusion status
Description
Cervical fusion rates (%) is compared using CT and flexion/extension X-ray between two groups. For statistical analysis, Chi-Square test is used.
Time Frame
five year after surgery
Secondary Outcome Measure Information:
Title
predisposing factor of non-union
Description
Using logistic regression analysis, odds ratio of each variable is calculated for non-union after anterior cervical discectomy and fusion.
Time Frame
one year after surgery
Title
risk factors of dysphagia
Description
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.
Time Frame
one year after surgery
Title
risk factors of dysphonia
Description
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.
Time Frame
one year after surgery
Title
factors for quality of life
Description
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.
Time Frame
one years after operation
Title
risk factors for adjacent segment degeneration
Description
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
Time Frame
five year after surgery
Title
correlation between osteoporosis and fusion
Description
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.
Time Frame
one year after surgery
Title
relation between brace wearing and fusion
Description
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 (%).
Time Frame
one year after surgery
Title
surgical outcomes for combined uncinectomy
Description
In relation with uncinectomy, the clinical outcomes (VAS, NDI) and radiological outcome (fusion rates(%)) is compared using t-test and Chi-square test.
Time Frame
one year after surgery
Title
change of neck motion after surgery
Description
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.
Time Frame
one year after surgery
Title
neuropathy after anterior cervical discectomy and fusion surgery
Description
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.
Time Frame
one year after surgery
Title
relation between the method of bone graft and fusion
Description
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.
Time Frame
one year after surgery
Title
analysis of complication rates after anterior cervical discectomy and fusion surgery
Description
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
Time Frame
one year after surgery
Title
The correlation between existence of co-morbidity and surgical outcome
Description
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.
Time Frame
one year after surgery
Title
The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability)
Description
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.
Time Frame
one year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin S. Yeom, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Health Insurance Service Ilsan Hospital
City
Ilsan
State/Province
Gyounggi-do
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Hallym University Dongtan Sacred Heart Hospital
City
Dongan
State/Province
Gyounggido
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Hallym University Hospital
City
Dongan
State/Province
Gyounggido
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
State/Province
Gyounggido
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Bundang Jesaeng Hospital
City
Seongnam
State/Province
Gyounggido
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Dongguk University Ilsan Hospital
City
Ilsan
State/Province
Gyounggi
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA university
City
Seongnam
State/Province
Gyoungido
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyoungnam
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Wonkwang University School of Medicine & Hospital
City
Iksan
State/Province
Jeonbuk
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pohang Semyung Christianity Hospital
City
Pohang
State/Province
Kyoungpook
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Daejeon
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Daejeon ST. Mary's hospital
City
Daejeon
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Chosun University Hospital
City
Gwangju
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Kwangju Christian Hospital
City
Gwangju
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Incheon St. Mary's hospital
City
Incheon
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Gangnam severance hospital
City
Seoul
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
National Police Hospital
City
Seoul
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
Soonchunhyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
602-702
Country
Korea, Republic of
Facility Name
VHS Medical Center
City
Seoul
ZIP/Postal Code
602-702
Country
Korea, Republic of

12. IPD Sharing Statement

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

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