An interventional study of anterior cervical discectomy and fusion and Cage and Plate in Radiculopathy, Cervical and Myelopathy, sponsored by Seoul National University Hospital. Active, not recruiting at 31 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 376 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system
Procedure: anterior cervical discectomy and fusion · Device: Cage and Plate
anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate
Procedure: anterior cervical discectomy and fusion · Device: Cage alone
anterior cervical discectomy and fusion with anterior plating or not
anterior cervical discectomy and fusion is performed using cervical cage and plate
anterior cervical discectomy and fusion is performed using cage alone with plate.
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.
Time frame: five year after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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 (%).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: one year after surgery
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital