Myelopathy, Radiculopathy, Cervical
Conditions
Keywords
degenerative cervical disease, anterior cervical discectomy and fusion, plate and cage, cage alone
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.
Interventions
anterior cervical discectomy and fusion with anterior plating or not
DEVICECage and Plate
anterior cervical discectomy and fusion is performed using cervical cage and plate
DEVICECage alone
anterior cervical discectomy and fusion is performed using cage alone with plate.
Sponsors
Korean Society of Spine Surgery
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical fusion status | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| risk factors of dysphagia | 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. |
| risk factors of dysphonia | 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. |
| factors for quality of life | 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. |
| risk factors for adjacent segment degeneration | 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 |
| correlation between osteoporosis and fusion | 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. |
| relation between brace wearing and fusion | 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 (%). |
| predisposing factor of non-union | one year after surgery | Using logistic regression analysis, odds ratio of each variable is calculated for non-union after anterior cervical discectomy and fusion. |
| change of neck motion after surgery | 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. |
| neuropathy after anterior cervical discectomy and fusion surgery | 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. |
| relation between the method of bone graft and fusion | 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. |
| analysis of complication rates after anterior cervical discectomy and fusion surgery | 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 |
| The correlation between existence of co-morbidity and surgical outcome | 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. |
| The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability) | 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. |
| surgical outcomes for combined uncinectomy | 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. |
Countries
South Korea
Outcome results
None listed