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

Study Overview
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Brief Summary
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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.

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

Conditions
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Radiculopathy, Cervical, Myelopathy

Intervention / Treatment
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* Procedure: anterior cervical discectomy and fusion
* Device: Cage and Plate
* Device: Cage alone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cage and Plate<br>anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system | Procedure: anterior cervical discectomy and fusion<br>* anterior cervical discectomy and fusion with anterior plating or not<br>Device: Cage and Plate<br>* anterior cervical discectomy and fusion is performed using cervical cage and plate<br>|
| Experimental: Cage alone<br>anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate | Procedure: anterior cervical discectomy and fusion<br>* anterior cervical discectomy and fusion with anterior plating or not<br>Device: Cage alone<br>* anterior cervical discectomy and fusion is performed using cage alone with plate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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degenerative cervical disease, anterior cervical discectomy and fusion, plate and cage, cage alone