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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Seoul National University Hospital
Sponsor:
Collaborator:
Korean Society of Spine Surgery
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01911013
First received: July 21, 2013
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Radiculopathy, Cervical
Myelopathy
Procedure: anterior cervical discectomy and fusion
Device: Cage and Plate
Device: Cage alone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Cervical fusion status [ Time Frame: five year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    Using logistic regression analysis, odds ratio of each variable is calculated for non-union after anterior cervical discectomy and fusion.

  • risk factors of dysphagia [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one years after operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: five year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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) [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911013

Contacts
Contact: Jin S. Yeom, MD, PhD +82 31 787 7195 highcervical@gmail.com
Contact: Ho-Joong Kim, MD, PhD +82 31 787 7202 oshjkim@gmail.com

Locations
Korea, Republic of
National Health Insurance Service Ilsan Hospital Recruiting
Ilsan, Gyounggi-do, Korea, Republic of, 602-702
Contact: Yung Park, M.D.       yungspine@gmail.com   
Sub-Investigator: Yung Park, M.D.         
Hallym University Hospital Not yet recruiting
Dongan, Gyounggido, Korea, Republic of, 602-702
Contact: Moon Soo Park, M.D.       amhangpark@gmail.com   
Sub-Investigator: Moon Soo Park, M.D.         
Hallym University Dongtan Sacred Heart Hospital Not yet recruiting
Dongan, Gyounggido, Korea, Republic of, 602-702
Contact: Young Woo Kim, M.D.       ywkimmd@naver.com   
Sub-Investigator: Young Woo Kim, M.D.         
Inje University Ilsan Paik Hospital Not yet recruiting
Ilsan, Gyounggido, Korea, Republic of, 602-702
Contact: Jin Hwan Kim, M.D.       oskim@paik.ac.kr   
Sub-Investigator: Jin Hwan Kim, M.D.         
Bundang Jesaeng Hospital Not yet recruiting
Seongnam, Gyounggido, Korea, Republic of, 602-702
Contact: Hwa Yeop Na, M.D.       hynaspin@naver.com   
Sub-Investigator: Hwa Yeop Na, M.D.         
Dongguk University Ilsan Hospital Recruiting
Ilsan, Gyounggi, Korea, Republic of, 602-702
Contact: Jae Jun Yang, M.D.       jaejunyang@gmail.com   
Sub-Investigator: Jae Jun Yang, M.D.         
CHA Bundang Medical Center, CHA university Recruiting
Seongnam, Gyoungido, Korea, Republic of, 602-702
Contact: Dong Eun Shin, M.D.       shinde@cha.ac.kr   
Sub-Investigator: Dong Eun Shin, M.D.         
Pusan National University Yangsan Hospital Recruiting
Yangsan, Gyoungnam, Korea, Republic of, 602-702
Contact: Sung-Shik Kang, M.D.       osdockang@gmail.com   
Sub-Investigator: Sung-Shik Kang, M.D.         
Wonkwang University School of Medicine & Hospital Not yet recruiting
Iksan, Jeonbuk, Korea, Republic of, 602-702
Contact: Tae Kyun Kim, M.D.       osktg@wonkwang.ac.kr   
Sub-Investigator: Tae Kyun Kim, M.D.         
Seoul National University Hospital Not yet recruiting
Seoul, Jongno-gu, Korea, Republic of, 110-744
Sub-Investigator: Bong-Soong Chang, MD, PhD         
Pohang Semyung Christianity Hospital Recruiting
Pohang, Kyoungpook, Korea, Republic of, 602-702
Contact: Bo-Gun Suh, M.D.       ortho99@naver.com   
Sub-Investigator: Bo-Gun Suh, M.D.         
Inje University Busan Paik Hospital Recruiting
Busan, Korea, Republic of, 602-702
Contact: Ki Chan An, M.D.       osahnkc@inje.ac.kr   
Sub-Investigator: Ki Chan An, M.D.         
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of, 602-702
Contact: Byung Wan Choi, M.D.       alla1013@naver.com   
Sub-Investigator: Byung Wan Choi, M.D.         
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 602-702
Contact: Jung Sub Lee, M.D.       jungsublee@pusan.ac.kr   
Sub-Investigator: Jung Sub Lee, M.D.         
Kyungpook National University Hospital Not yet recruiting
Daegu, Korea, Republic of, 602-702
Contact: Woo-Kie Min, M.D.       wkmin@knu.ac.kr   
Sub-Investigator: Woo-Kie Min, M.D.         
Eulji University Hospital Not yet recruiting
Daejeon, Korea, Republic of, 602-702
Contact: Whoan Jeang Kim, M.D.       hjkim@eulji.ac.kr   
Sub-Investigator: Whoan Jeang Kim, M.D.         
Eulji University Hospital Not yet recruiting
Daejeon, Korea, Republic of, 602-702
Contact: Jong Won Kang, M.D.       jwkang@eulji.ac.kr   
Sub-Investigator: Jong Won Kang, M.D.         
The Catholic University of Korea Daejeon ST. Mary's hospital Not yet recruiting
Daejeon, Korea, Republic of, 602-702
Contact: Young Yul Kim, M.D.       kimtwins72@paran.com   
Sub-Investigator: Young Yul Kim, M.D.         
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of, 602-702
Contact: Hyoung Yeon Seo Seo, M.D.       hyseo2001@hanmail.net   
Sub-Investigator: Hyoung Yeon Seo Seo, M.D.         
Chosun University Hospital Recruiting
Gwangju, Korea, Republic of, 602-702
Contact: Hong-Moon Sohn, M.D.       hmsohn@chosun.ac.kr   
Sub-Investigator: Hong-Moon Sohn, M.D.         
Kwangju Christian Hospital Recruiting
Gwangju, Korea, Republic of, 602-702
Contact: Yong Soo Choi, M.D.       stemcellchoi@hanmail.net   
Sub-Investigator: Yong Soo Choi, M.D.         
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 602-702
Contact: Kyu Jung Cho, M.D.       qjungcho@gmail.com   
Sub-Investigator: Kyu Jung Cho, M.D.         
The Catholic University of Korea, Incheon St. Mary's hospital Not yet recruiting
Incheon, Korea, Republic of, 602-702
Contact: In Soo Oh, M.D.       insoooh@naver.com   
Sub-Investigator: In Soo Oh, M.D.         
VHS Medical Center Not yet recruiting
Seoul, Korea, Republic of, 602-702
Contact: Youngbae Kim, M.D.       benspine@gmail.com   
Sub-Investigator: Youngbae Kim, M.D.         
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 602-702
Contact: Dong-Ho Lee, M.D.       dlee@amc.seoul.kr   
Sub-Investigator: Dong-Ho Lee, M.D.         
Asan Medical Center, University of Ulsan College of Medicine Not yet recruiting
Seoul, Korea, Republic of, 602-702
Contact: Jae Hwan Cho, M.D.       doctork78@hanmail.net   
Sub-Investigator: Jae Hwan Cho, M.D.         
Gangnam severance hospital Not yet recruiting
Seoul, Korea, Republic of, 602-702
Contact: Kyung-Soo Suk, M.D.       sks111@khmc.or.kr   
Sub-Investigator: Kyung-Soo Suk, M.D.         
Korea University Anam Hospital Not yet recruiting
Seoul, Korea, Republic of, 602-702
Contact: Si Young Park, M.D.       drspine90@gmail.com   
Sub-Investigator: Si Young Park, M.D.         
National Police Hospital Not yet recruiting
Seoul, Korea, Republic of, 602-702
Contact: Seong Wan Kim, M.D.       xamxara@naver.com   
Sub-Investigator: Seong Wan Kim, M.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 602-702
Contact: Hyoungmin Kim, M.D.       hmkim21@gmail.com   
Sub-Investigator: Hyoungmin Kim, M.D.         
SMG-SNU Boramae Medical Center Not yet recruiting
Seoul, Korea, Republic of, 602-702
Contact: Jae Hyup Lee, M.D.       haesu25@hanmail.net   
Sub-Investigator: Jae Hyup Lee, M.D.         
Soonchunhyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of, 602-702
Contact: Jae Chul Lee, M.D.       jlee@hosp.sch.ac.kr   
Sub-Investigator: Jae Chul Lee, M.D.         
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 602-702
Contact: Kwang-Sup Song, M.D.       ksong70@cau.ac.kr   
Sub-Investigator: Kwang-Sup Song, M.D.         
Sponsors and Collaborators
Seoul National University Hospital
Korean Society of Spine Surgery
Investigators
Principal Investigator: Jin S. Yeom, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Jin S. Yeom, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01911013     History of Changes
Other Study ID Numbers: KSSS-001
Study First Received: July 21, 2013
Last Updated: June 13, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
degenerative cervical disease
anterior cervical discectomy and fusion
plate and cage
cage alone

Additional relevant MeSH terms:
Radiculopathy
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014