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

Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01911013
• Other study ID #: KSSS-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2013
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Myelopathy
• Radiculopathy
• Radiculopathy, Cervical
• Spinal Cord Diseases

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korean Society of Spine Surgery

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	one year after surgery
Secondary	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.	one year after surgery
Secondary	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.	one year after surgery
Secondary	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.	one years after operation
Secondary	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	five year after surgery
Secondary	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.	one year after surgery
Secondary	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 (%).	one year after surgery
Secondary	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.	one year after surgery
Secondary	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.	one year after surgery
Secondary	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.	one year after surgery
Secondary	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.	one year after surgery
Secondary	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	one year after surgery
Secondary	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.	one year after surgery
Secondary	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.	one year after surgery